The New York Times: Pfizer Asks The F.D.A. To Authorize Its Covid Antiviral Pill
Pfizer has applied to the Food and Drug Administration to authorize its antiviral pill to treat unvaccinated people with Covid-19 who are at high risk of becoming severely ill, the company said on Tuesday. The drug, which will be sold under the brand name Paxlovid, could become available within weeks if authorization is granted. It is meant to be dispensed by pharmacies and taken at home. Paxlovid is the second antiviral pill to show effectiveness against Covid, in a new class of treatments for the disease that are expected to reach far more patients than other drugs that are typically given by infusion. (Robbins, 11/16)

The Wall Street Journal: Pfizer Submits Covid-19 Pill For FDA Authorization
“There is an urgent need for lifesaving treatment options,” Pfizer Chief Executive Albert Bourla said Thursday. “We are moving as quickly as possible in our effort to get this potential treatment into the hands of patients.” Health authorities and doctors have struggled with only a handful of options for treating Covid-19 patients, especially shortly after infection. A Gilead Sciences Inc. GILD -0.46% antiviral, remdesivir, is mostly used to treat hospitalized patients, while monoclonal antibody treatments have proven effective but are costly and typically given in doctor’s offices or hospitals. (Hopkins, 11/16)

The Biden administration has plans to buy many doses —

The Washington Post: Biden Administration To Buy Pfizer Antiviral Pills For 10 Million People, Hoping To Transform Pandemic
The Biden administration is planning to purchase 10 million courses of Pfizer’s covid pill, a $5 billion investment in a treatment that officials think will help change the trajectory of the coronavirus pandemic by reducing severe illness and deaths, according to two people with knowledge of the transaction. As the administration and Pfizer on Tuesday hammered out the final details, the company asked federal regulators to authorize the five-day antiviral pill regimen called Paxlovid. The medication is the second easy-to-take treatment aimed at keeping newly infected people out of the hospital to go before the Food and Drug Administration. The other is by Merck and Ridgeback Biotherapeutics. (Pager, McGinley, Johnson, Taylor and Parker, 11/16)

The New York Times: U.S. To Buy Enough Of Pfizer’s Covid Antiviral Pills For 10 Million People
The Biden administration plans to pay more than $5 billion for a stockpile of Pfizer’s new Covid-19 pill, enough for about 10 million courses of treatment to be delivered in the next 10 months, according to people familiar with the agreement. Senior federal health officials are counting on the drug to be a powerful weapon against Covid. When given promptly to trial groups of high-risk unvaccinated people who developed symptoms of the disease, the drug sharply reduced the risk of hospitalization and death. (LaFraniere and Robbins, 11/16)

Also —

Axios: Pfizer Agrees To Share Recipe For COVID-19 Pill 
Pfizer has agreed to a licensing deal with the UN's Medicines Patent Pool for its COVID-19 pill — roughly a month after Merck said it licensed its COVID pill with the MPP. These antiviral pills have showed promising results in reducing the severity of infection and preventing death among the unvaccinated, and Pfizer's licensing agreement, combined with Merck's, will allow generic drug companies to cheaply produce the pills for more than 100 low- and middle-income countries. (Herman, 11/16)

Stat: Like Merck, Pfizer Strikes A Licensing Deal With The Medicines Patents Pool
Amid considerable anticipation over its Covid-19 pill, Pfizer (PFE) reached a licensing agreement with the Medicines Patent Pool, which in turn can now strike deals with other manufacturers to provide generic versions of the drug to 95 low and middle-income countries. The agreement follows a similar arrangement with Merck (MRK) concerning its own antiviral pill for combating the coronavirus. Notably, this also marks only the second time that a pharmaceutical company has struck a licensing deal with the Medicines Patent Pool — a public health organization backed by the United Nations — to widen access to a Covid-19 medical product. (Silverman, 11/16)

The New York Times: F.D.A. Plans To Authorize Pfizer Boosters For All Adults This Week
The Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, a move that would expand the number of Americans eligible for additional shots by tens of millions, according to people familiar with the agency’s plans. The Centers for Disease Control and Prevention’s independent committee of vaccine experts has scheduled a meeting for Friday to discuss data on the booster dose’s efficacy and safety. If both the F.D.A. and the C.D.C. sign off this week, they will have acted strikingly quickly — a little more than a week after Pfizer asked for authorization of boosters for everyone 18 and older. (Weiland and LaFraniere, 11/16)

Roll Call: FDA To Sidestep Advisers On Boosters-For-All Approval
The move signals that the Biden administration is willing to forge ahead without the signoff of the FDA’s scientific advisers, who twice voted to reject boosters for the young and healthy who don’t face high exposure risks, as pockets of the country show foreboding signs of a coming winter wave. After CQ Roll Call reported Tuesday that an advisory meeting was unlikely, the agency confirmed that a decision on eligibility for boosters is expected to be made without the input of the committee. (Kopp, 11/17)

The New York Times: The U.S. Aims To Lift Covid Vaccine Manufacturing To Create A Billion Doses A Year
The White House, under pressure from activists to increase the supply of coronavirus vaccines to poor nations, is prepared to invest billions of dollars to expand U.S. manufacturing capacity, with the goal of producing at least one billion doses a year beginning in the second half of 2022, two top advisers to President Biden said in an interview on Tuesday. The investment is the first step in a new plan, to be announced on Wednesday, for the government to partner with industry to address immediate vaccine needs overseas and domestically and to prepare for future pandemics, said Dr. David Kessler, who oversees vaccine distribution for the administration, and Jeff Zients, Mr. Biden’s coronavirus response coordinator. (Gay Stolberg, 11/17)

In other news on boosters —

Reuters: Fauci Says Boosters For All Key To U.S. Reaching COVID-19 Endemic Level
"To me, if you want to get to endemic, you have got to get the level of infection so low that it does not have an impact on society, on your life, on your economy," Fauci said. "People will still get infected. People might still get hospitalized, but the level would be so low that we don't think about it all the time and it doesn't influence what we do." To get there, he said, would take a lot more people rolling up their sleeves for initial COVID-19 shots and boosters. If the United States makes boosters available for everyone, it is possible the country can get control of the virus by spring of 2022, Fauci added. (Steenhuysen, 11/17)

Axios: Fauci: Boosters Could See COVID Reach Endemic Level In U.S. Next Year 
NIAID director Anthony Fauci believes the COVID-19 pandemic could become endemic in the U.S. next year, but increased vaccination rates and booster shots would be key to achieving this. The nation's top infectious disease expert made the comments in an interview with Reuters Tuesday on the sidelines of the STAT Summit. But he noted to CNBC that coronavirus cases need to fall "well below 10,000" a day for the U.S. "to get back to a degree of normality." (11/17)

The New York Times: New York’s Governor Urges A Broader Group Of Adults To Get Boosters Based On Risk
Gov. Kathy Hochul urged New Yorkers on Tuesday to get a coronavirus vaccine booster if they believed they were at high risk or lived in a “high transmission area,” jumping ahead of a possible decision by federal regulators to authorize an additional shot for all adults. Ms. Hochul went further than earlier comments, but still created some confusion by offering a vague definition of high risk. That may not be an issue for too long, as the Food and Drug Administration is aiming to authorize booster doses of Pfizer-BioNTech’s coronavirus vaccine for all adults as early as Thursday, according to people familiar with the agency’s plans. (Ferré-Sadurní, 11/16)

NPR: U.S. COVID Cases Start To Rise Again As The Holidays Approach
It's a worrying sign for the U.S. ahead of the holiday travel season: coronavirus infections are rising in more than half of all states. Experts warn this could be the start of an extended winter surge. The rise is a turnaround after cases had steadily declined from mid September to late October. The country is now averaging more than 83,000 cases a day — about a 14% increase compared to a week ago, and 12% more than two weeks ago. (Stone, 11/16)

The Hill: US Daily COVID-19 Cases Up Nearly 27 Percent In Last Three Weeks
COVID-19 cases in the U.S. are up nearly 27 percent in the last three weeks after steadily increasing since mid-October, according to data from the Centers for Disease Control and Prevention (CDC). The CDC reported that as of Nov. 14, the 7-day average was at 80,823 daily cases, up from 63,852 on Oct. 24, representing a 26.6 percent increase in three weeks time. The COVID-19 increase could be a troubling indicator for what is ahead in the U.S. if it follows Europe's lead into another coronavirus wave. (Breslin, 11/16)

AP: Cases Surge In New COVID Hot Spots Of Michigan, Minnesota
Hospitals in Michigan and Minnesota on Tuesday reported a wave of COVID-19 patients not seen in months as beds were filled with unvaccinated people and health care leaders warned that staff were being worn down by yet another surge. Michigan had slightly more than 3,000 COVID-19 patients in hospitals this week, the first time it had crossed that threshold since spring, while nearly all hospital beds were occupied in Minnesota. Both held the unflattering rank of national virus hotspots. (White, 11/17)

CNBC: Fauci: Covid Cases Must Fall Below 10,000 A Day For U.S. To Get To 'Degree Of Normality'
Covid-19 cases in the U.S. need to fall “well below 10,000” per day for the country to achieve some semblance of pre-pandemic life, White House chief medical advisor Dr. Anthony Fauci estimated Tuesday. The U.S. reported an average of nearly 83,500 new Covid cases every day over the last week, a 14% increase from the week before, according to a CNBC analysis of data from Johns Hopkins University. Fauci said in an interview at the 2021 STAT Summit that Covid cases may need to fall as low as 3,300 per day for the nation to gain control over the virus. Daily infections in the U.S. haven’t been below 10,000 since March 2020. (Towey, 11/16)

Fox News: Fauci On Holidays: Fully Vaccinated Families Can 'Feel Good' About Gatherings
National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci said Monday that families who are fully vaccinated against COVID-19 should "feel good" about gathering for the holidays this year. Speaking about the future of the pandemic at the Bipartisan Policy Center, the chief medical adviser to the president joined former Senate majority leader Bill Frist, former Baltimore health commissioner Dr. Leana Wen and former U.S. Surgeon General Dr. Jerome Adams. (Musto, 11/16)

The Washington Post: Ad Campaign Features Testimonials From Young ‘Long Haulers’ To Motivate Vaccine-Holdouts
Resolve to Save Lives, a New York City-based nonprofit headed by Tom Frieden, a former director of the Centers for Disease Control and Prevention, launched a campaign Tuesday that features testimonials from three people in their 20s who have been battling long-term health complications of covid-19 for the past year. They talk in television, radio and social media ads about devastating and lasting symptoms that prevent them from working, socializing and doing the simplest tasks. The nonprofit is hoping the voices of those “long haulers” can encourage vaccine uptake, especially among young adults. (Sun, 11/16)

NYC's New Year's Eve will be almost back to normal —

The New York Times: New Year’s Eve Will Return To Times Square For Vaccinated Guests
After a scaled-down celebration last year, the famously frigid event will return at “full strength,” Mayor Bill de Blasio said on Tuesday. It will be Mr. de Blasio’s final act running New York City, after eight years in office, and serve as a prelude to his possible bid for governor next year. “We want to welcome all those hundreds of thousands of folks, but everyone needs to be vaccinated,” Mr. de Blasio said. “Join the crowd, join the joy, join a historic moment as New York City provides further evidence to the world that we are 100 percent back.” (Wong and Rubinstein, 11/16)

But many younger people won't have shots by Thanksgiving —

CNBC: Young Kids Won't Be Fully Vaccinated By Thanksgiving: How To Stay Safe
Most American children won’t be fully vaccinated by Christmas — but the kid-sized Covid vaccines can still make your holiday gatherings a lot safer, according to one Harvard epidemiologist. “Vaccinate,” Dr. Michael Mina, an assistant professor of epidemiology at the Harvard T.H. Chan School of Public Health, tweeted on Sunday. “Even a single dose for your kid 10 days prior is an incredible safeguard.” (Stieg, 11/16)

AP: 2nd Group Of States Challenges Health Worker Vaccine Mandate
A second set of states has filed a federal lawsuit challenging the Biden administration’s COVID-19 vaccine mandate for health care workers. The latest suit, dated Monday, was filed in Louisiana on behalf of 12 states and comes less than a week after another lawsuit challenging the rule was filed in Missouri by a coalition of 10 states. “The federal government will not impose medical tyranny on Louisiana’s people without my best fight,” Louisiana Attorney General Jeff Landry said in a news release announcing the lawsuit. (McGill, 11/17)

Meanwhile, earlier challenges have been moved to an Ohio court —

AP: GOP-Majority Court Chosen To Consider Biden Vaccine Mandate
Challenges to President Joe Biden’s COVID-19 vaccine mandate for private employers will be consolidated in the U.S. 6th Circuit Court of Appeals, a panel dominated by judges appointed by Republicans. The Cincinnati-based court was selected Tuesday in a random drawing using ping-pong balls, a process employed when challenges to certain federal agency actions are filed in multiple courts. (Mulvihill, 11/16)

The New York Times: Biden Vaccine Mandate Challenges Moved To Appeals Court In Ohio
A federal judicial panel on Tuesday assigned the appeals court in Cincinnati to handle at least 34 lawsuits that have been filed around the country challenging the Biden administration’s attempt to mandate that large employers require their workers to get vaccinated against the coronavirus or submit to weekly testing. A court clerk for the U.S. Judicial Panel on Multidistrict Litigation randomly selected the Court of Appeals for the Sixth Circuit by drawing from a drum containing entries for the twelve regional courts of appeal, each of which has at least one related case pending. The procedure can be used to consolidate cases that are all raising the same issue. (Savage, 11/16)

Stat: GOP Opposition To Vaccine Mandates Extends Far Beyond Covid-19
Right-wing politicians’ resistance to vaccine mandates is extending far beyond Covid-19 immunizations, a startling new development that carries vast implications for the future of public health. In Idaho, a lawmaker introduced a bill that would define vaccine mandates — of any kind — as a form of assault. In Florida, a prominent state senator has called for a review of all vaccine requirements, including those for immunizations that have enjoyed wide public acceptance for decades, like polio and the measles, mumps, and rubella shot. And in Montana, the Republican governor recently signed into law a new bill that forbids businesses, including hospitals, from enforcing any vaccination requirements as a condition of employment. (Facher, 11/17)

Some still resist mandates, as other organizations step them up —

Health News Florida: Florida Lawmakers Reassure Businesses That Federal Vaccine Requirements Will Not Stand 
One question before Florida lawmakers this week is whether businesses will have to choose between following a proposed state policy governing coronavirus vaccination requirements or a federal rule. The U.S. Occupational Safety and Health Administration issued a rule last month requiring workers at businesses with 100 or more employees to get vaccinated against COVID-19 by Jan. 4. As part of the state’s efforts to block the rule, Gov. Ron DeSantis called the Legislature into special session to adopt policy that would give workers more ways to opt out of getting vaccinated. The special session is scheduled to end Thursday but could last through Friday. (Crowder, 11/16)

Health News Florida: Health Professionals Call On Lawmakers To Reject DeSantis' Request To Ban Vax Mandate 
Physicians and other health professionals issued a call Monday for Florida lawmakers to reject any bans on COVID-19 mask and vaccine mandates. New legislation is forthcoming even as Florida has logged more than 60,000 deaths from COVID-19. The legislature has convened a special session at Gov. Ron DeSantis’ request to craft laws designed to ban such mandates. "We are deeply concerned that he is using this week's session as a platform to raise his political profile by promoting policies that his base may appreciate, but which we as doctors can say without a doubt will put people in danger," said Miami cardiologist Dr. Bernard Ashby, Florida lead for the Committee to Protect Health Care, which hosted the media event via Zoom. (Jordan, 11/16)

AP: Idaho Lawmakers Advance Vaccine Worker Comp Legislation
A bill making it easier for Idaho residents to get worker compensation if they become ill after taking an employee-mandated vaccine sailed through the House and headed for the Senate on Tuesday. The measure passed the House on a 67-3 vote. It was among seven COVID-19-related bills that the chamber pushed through with expedited voting and sent to the Senate. Supporters said workers are getting sick after being vaccinated for COVID-19, and some are having problems receiving compensation. The bill tilts the field toward employees for compensation of hard-to-prove claims such as illnesses caused by vaccines, backers said. (Ridler, 11/17)

ABC News: NYC Sanitation Workers Suspended Without Pay Over Alleged Fake COVID Vaccine Cards
Several dozen New York City sanitation workers have been accused of submitting falsified vaccination cards to satisfy the city's COVID-19 vaccine mandate, and they've been suspended without pay, according to a city official. The city's Department of Investigation is looking into the allegations, with spokesperson Diane Struzzi adding: "DOI is aware of allegations involving the issuance of bogus vaccination cards and declines further comment." (Agarwal and Katersky, 11/16)

Houston Chronicle: MD Anderson Cancer Center The Latest Healthcare Facility To Mandate Vaccines For Employees
New year, new rule. Officials at the University of Texas MD Anderson Cancer Center are mandating that all of its employees be fully vaccinated shortly after 2022 begins unless they submit a medical and religious exemption for review by internal committees of physicians, ethicists and religious experts, according to a release statement. (Welch, 11/16)

Modern Healthcare: Doctors In Congress: 20 Of 23 Currently Serving Belong To GOP
In one moment, Rep. Andy Harris (R-Md.), an anesthesiologist, is holding a news conference advising people to get vaccinated. He’s even helped administer COVID-19 shots in his eastern Maryland district. But in another moment, Harris is on the radio talking about his disappointment that he couldn’t find a pharmacy that would fill a prescription he wrote for ivermectin—an antiparasitic—to treat a patient with COVID-19, a viral infection. (Hellman, 11/16)

KHN: Congressional Doctors Lead Bipartisan Revolt Over Policy On Surprise Medical Bills
The detente that allowed Congress to pass a law curbing surprise medical bills has disintegrated, with a bipartisan group of 152 lawmakers assailing the administration’s plan to regulate the law and medical providers warning of grim consequences for underserved patients. For years, people have faced these massive, unexpected bills when they get treatment from hospitals or doctors outside their insurance company’s network. It often happens when patients seek care at an in-network hospital but a physician such as an emergency room doctor or anesthesiologist who treats the patient is not covered by the insurance plan. The insurer would pay only a small part of the bill, and the unsuspecting patient would be responsible for the balance. (McAuliff, 11/17)

On covid —

The Baltimore Sun: Rep. Andy Harris, An Anesthesiologist, Says Complaint Was Filed Against Him For Prescribing Ivermectin To Treat COVID-19
Andy Harris, a Maryland congressman and anesthesiologist, says a complaint has been filed against him with a physicians board for prescribing ivermectin to treat COVID-19. Ivermectin is used to treat parasites in humans but is not authorized for treating COVID-19 by the Food and Drug Administration, which says the medication can be dangerous in large doses. Often citing its use overseas, ivermectin supporters have pushed the drug as an inexpensive treatment for COVID. But researchers so far have been unable to prove the drug is effective. (Barker, 11/16)

The Hill: Greene Says She's Accumulated $63K In House Mask Fines And Is Not Vaccinated
Rep. Marjorie Taylor Greene (R-Ga.) said Tuesday that she has accumulated $63,000 in fines for refusing to wear a mask on the House floor, with additional fines likely to be imposed as she continues to defy the chamber's mask requirement during the COVID-19 pandemic. "I'm up to $63,000," Greene told The Hill outside the House chamber while not wearing a mask and confirmed that the fines are automatically "deducted out of my check." Greene also volunteered that she is not vaccinated against COVID-19 after declining to disclose her vaccination status for months. (Marcos, 11/16)

Stat: Fauci Calls Out ‘Insanity’ Of Threats He Gets For Promoting Covid-19 Vaccines
Anthony Fauci, the country’s top infectious disease expert who himself has become something of a Rorschach test for people’s views on the pandemic, warned that the politicization of the Covid-19 response threatens the country’s ability to withstand future health emergencies, even at a time of great scientific progress. “How do you change a mindset in a country that is completely antithetical to a response to an outbreak?” Fauci said Tuesday at the STAT Summit. “If ever there was any phenomenon that required people pulling together in a society, it’s an outbreak that’s killing hundreds of thousands of people. I don’t know how we’re going to get that divisiveness behind us.” (Joseph, 11/16)

And in other health care news from the Hill —

The Hill: Duckworth Touts Drinking Water Infrastructure Funds In Bipartisan Bill
The bipartisan infrastructure package signed Monday by President Biden contains a bill streamlining funding for water infrastructure projects, a provision that its sponsor, Sen. Tammy Duckworth (D-Ill.), hopes will mean “a difference made in people’s lives every day.” In an interview with The Hill Tuesday, Duckworth called the measure in question, the Drinking Water and Wastewater Infrastructure Act of 2021, “the backbone of all the water infrastructure in this larger bill.” The provision includes $15 billion in direct payments to the Drinking Water State Revolving Fund for Lead Service Line Replacement, which Duckworth told The Hill is “historic.” (Budryk, 11/16)

Prescription Drug Watch: For more news on rising drug costs, check out our weekly roundup of news coverage and perspectives of the issue.

Stat: The Prices Of 7 Drugs Were Hiked Without Proof Of New Benefits
During 2020, drug makers raised prices on seven widely used medicines by substantial amounts without any new clinical evidence to justify the increases, leading patients and health insurers in the U.S. to spend an additional $1.67 billion last year, according to a new analysis. Much of the added spending was attributed to just one drug – AbbVie’s (ABBV) Humira treatment for rheumatoid arthritis and other ailments. The price rose by 9.6%, after rebates and discounts, which led to an extra $1.4 billion in spending had the price not been raised, according to the analysis by the Institute for Clinical and Economic Review, a nonprofit that mostly assesses the cost effectiveness of new medicines. (Silverman, 11/16)

Modern Healthcare: Unsubstantiated Drug Price Hikes Cost $1.67B Last Year
Pharmaceutical companies continue to increase the prices of their most profitable drugs despite minimal year-over-year improvements, according to a new report. Seven of the top 10 drugs that inflated U.S. healthcare spending in 2020 due to price increases did not offer substantial clinical benefits, the Institute for Clinical and Economic Review's analysis found. The price hikes of those seven drugs increased healthcare spending by an estimated $1.67 billion last year, with AbbVie's rheumatoid arthritis biologic accounting for $1.4 billion alone. (Kacik, 11/16)

Axios: Viatris' Biosimilar Insulin Semglee Is Priced Almost The Same As Lantus 
Drug company Viatris has priced its new generic insulin, called Semglee, at almost $270 per vial, a mere $20 cheaper than the longstanding competitor that has existed for years. The rollout of Semglee highlights the specific warped incentives within the insulin market, where diabetes patients have struggled to afford their insulin for years. (Herman, 11/17)

On network contract matters —

KHN: Patients Get Stranded Out Of Network As Insurer-Hospital Contract Talks Fall Apart
In September, when Shelly Azzopardi went to Wellstar Kennestone Hospital with abdominal pain, she didn’t worry about her insurance. Doctors said she had a case of appendicitis. But she also tested positive at the hospital in Marietta, Georgia, for covid-19. Physicians decided not to do surgery and treated her with antibiotics and painkillers. Azzopardi, 47, went home after a couple of days in the hospital, feeling better. But in October, the appendix pain again flared. Her husband took her to the same hospital, where surgery was performed successfully. This time, though, she ran into a snag with her insurance. (Miller, 11/17)

In other industry news —

The Wall Street Journal: GE Pounces On Surging Healthcare Demand With Spinoff
In spinning off its healthcare business, General Electric Co. GE -3.11% is betting on the fast-growing diagnostic-imaging-equipment market, a sector facing disruption from artificial intelligence and growing competition from startups as well as established players. GE Healthcare—which makes MRI, ultrasound and other healthcare equipment—will be spun off in early 2023, with GE planning to retain a 19.9% stake in the new firm. Already dominant in the sector, as a stand-alone it would be able to move faster and have more capital to scoop up companies and technologies, analysts said. (Kantchev, 11/16)

Modern Healthcare: SCAN Group Launching In-Home, Virtual Medicare Advantage Provider
SCAN Group announced Tuesday it's launching a new medical group specializing in virtual and in-home primary care for Medicare Advantage members, many of whom will be covered under its own health plan subsidiary. Long Beach, California-based SCAN, whose holdings include the Medicare Advantage plan SCAN Health Plan, said the new company will be called Welcome Health. SCAN Group, which will be Welcome's majority owner, said the for-profit provider will offer affordable care to members of SCAN Health Plan and other Medicare Advantage plans. (Bannow, 11/16)

AP: Northern California Kaiser Permanente Pharmacists Reach Deal
Kaiser Permanente reached a tentative agreement on a three-year contract with pharmacists in its Northern California region early Monday, the company said. “In light of this, the Guild for Professional Pharmacists has canceled the strike that was expected to begin November 15 and our pharmacies will return to normal operations later today,” Kaiser Permanente said in a statement. (11/15)

Reuters: Gilead Sues Lupin Over Proposed Generic Of Symtuza HIV Drug
Gilead Sciences Inc has said an Indian generic drugmaker's proposed version of the HIV drug Symtuza infringes its patents, in a lawsuit in Delaware federal court. Gilead accused Lupin Pharmaceuticals of infringing two patents with its Abbreviated New Drug Application for the generic in a complaint entered on Tuesday. ANDAs, which companies file for U.S. Food and Drug Administration approval of generic drugs, assert that the relevant drug patents are invalid or that the generic wouldn't infringe, and open the applicant to infringement claims from the patent owner. (Brittain, 11/16)

Reuters: Roche Walks Away From Atea Partnership To Develop COVID-19 Pill
Roche Holding AG has ended a partnership with Atea Pharmaceuticals Inc to jointly develop a COVID-19 antiviral pill, the Swiss drugmaker said on Tuesday, a month after the drug failed to help patients in a small study. Boston-based Atea's shares fell 11% to $10.08 in extended trading, set to add to the 72% slump this year. Many companies are racing to develop an oral pill as it can be taken as an early at-home treatment to help prevent COVID-19 hospitalizations and deaths, a promising new weapon in the fight against the pandemic. (11/16)

Modern Healthcare: LifePoint Health Launching Health Tech Incubator
LifePoint Health is teaming up with venture studio 25madison and Apollo Global Management to launch a startup incubator for health tech in Nashville, according to a news release Tuesday. Dubbed 25m Health, the new venture will kick off with $20 million in seed funding. The companies hope combining LifePoint’s healthcare knowledge with 25madison’s startup experience will help spawn a wave of innovative companies, products and services to improve healthcare quality, access and patient outcomes and lower costs at the same time. (Brady, 11/16)

Stat: Nancy Hopkins Wins STAT Biomedical Innovation Award
Nancy Hopkins, an MIT professor who has made significant strides in molecular biology and a tireless advocate for gender equity in science, was named the recipient of STAT’s 2021 Biomedical Innovation Award on Tuesday. “It’s very easy to forget how much progress there has been because we haven’t arrived where we’d like to be. So we see the problems that still lie ahead. But you periodically have to pause and say, ‘Oh, my gosh, look how far we came,’” said Hopkins at the 2021 STAT Summit, where she was honored for her work. (Cueto, 11/16)

In news on antibiotic resistance —

CIDRAP: Scottish Report Shows 5-Year Decline In Human Antibiotic Use
A report today from Scotland highlights reduced antibiotic use in the country since it adopted a One Health approach to combatting antimicrobial resistance (AMR). The report, from Antimicrobial Resistance and Healthcare Associated Infection (ARHAI) Scotland, shows that total antibiotic use in people was 19.2 defined daily doses per 1,000 population per day in 2020, a 17.1% reduction since 2016. The report notes that the 11.8% reduction from 2019 to 2020 likely reflects the impact of the COVID-19 pandemic, which affected antibiotic use in all healthcare settings. (11/16)

CNBC: Antibiotic Resistance Could Be The Next 'Hidden Pandemic': UK Experts
The coronavirus pandemic grabbed the world’s attention in early 2020 and has failed to let go ever since, but U.K. experts are warning that antibiotic-resistant infections, often described as a “hidden pandemic,” should be the next big concern. One in five people in the U.K. with a bloodstream infection in 2020 had an antibiotic-resistant one, according to the U.K Health Security Agency, and that was even after a decline in the number of antibiotic resistant infections recorded in 2019. There are now fears that, as winter approaches and we slowly emerge from the global Covid-19 outbreak, antibiotic resistance could increase again. (Ellyatt, 11/17)

Also —

Modern Healthcare: Studies Show Less Staffing, More Surprise Bills After Private Equity Takeovers
Plenty of lawmakers, consumer advocates and others are leery of private equity’s growing presence in the healthcare sector. They worry investors will cut corners when it comes to staffing, supplies or safety in the name of saving a buck. There have been examples of private equity firms eliminating less profitable service lines after buying providers. On the revenue side, private equity has paid tens of millions of dollars to settle allegations that it fraudulently oversold products or services, including to the government. (Bannow, 11/16)

The Washington Post: Post-ABC Poll: Abortion Rights Have Broad Support As Supreme Court Weighs Texas, Mississippi Laws
The lopsided support for maintaining abortion rights protections comes as the court considers cases challenging its long-term precedents, including Dec. 1 arguments over a Mississippi law banning abortions after 15 weeks of pregnancy. The Post-ABC poll finds 27 percent of Americans say the court should overturn Roe, while 60 percent say it should be upheld, attitudes that are consistent in polls dating to 2005. More broadly, three-quarters of Americans say abortion access should be left to women and their doctors, while 20 percent say they should be regulated by law. (Clement, Bishop and Barnes, 11/16)

KHN: California Plans For A Post-Roe World As Abortion Access Shrinks Elsewhere
With access to abortion at stake across America, California is preparing to become the nation’s abortion provider. Democratic Gov. Gavin Newsom and legislative leaders have asked a group of reproductive health experts to propose policies to bolster the state’s abortion infrastructure and ready it for more patients. Lawmakers plan to begin debating the ideas when they reconvene in January. Abortion clinics are already girding themselves for a surge in demand. (Bluth, 11/17)

KHN: Texas Abortion Law Harms Survivors Of Rape And Incest, Activists Say
The Safe Alliance in Austin, Texas, helps survivors of child abuse, sexual assault and domestic violence. Before Texas’ new abortion law took effect, the organization counseled a 12-year-old who had been repeatedly raped by her father. Piper Stege Nelson, chief public strategies officer for the Safe Alliance, said the girl’s father didn’t let her leave the house. “She got pregnant,” Nelson said. “She had no idea about anything about her body. She certainly didn’t know that she was pregnant.” The girl eventually got help, but if this had happened after Sept. 1, when the state law took effect, her options would have been severely curtailed, Nelson said. (Lopez, 11/17)

ABC News: Catholic Bishops Debate Denying Communion To Biden, Other Pro-Abortion Rights Politicians
The question of whether President Joe Biden and other Catholic politicians who publicly support abortion rights should receive Holy Communion is at the center of a controversial draft document the U.S. Conference of Catholic Bishops is expected to vote on Wednesday. The vote is the culmination of year-long debate between America’s largely conservative bishops and the Vatican about whether punitive measures should be taken against public officials who contradict the church’s teaching on abortion. (Vann, 11/17)

The Philadelphia Inquirer: Penn Finds That Using Automated Texts To Monitor COVID-19 Patients At Home Saved Lives
Just two weeks after COVID-19 shut Philadelphia down in March 2020, Penn Medicine had already reengineered a program designed to monitor lung disease patients so that its staff could keep tabs on those suffering from the new virus at home. Doctors quickly realized there was a “huge swath” of patients who had tested positive but were not sick enough for the hospital — yet, said Krisda Chaiyachati, medical director of Penn Medicine OnDemand. By then, it was clear that people with COVID-19 who at first seemed fine could deteriorate rapidly. As a result, many were already extremely sick — sometimes too sick — by the time they got to the emergency department. (Burling, 11/16)

CIDRAP: Death Rate 68% Lower In COVID Outpatients Sent Text Message Check-Ins
An automated text messaging system for adult COVID-19 outpatients developed at Penn Medicine saved two lives a week during the first US pandemic surge, and users were 68% less likely than controls to die, finds a study today in the Annals of Internal Medicine. The text messaging system, COVID Watch, sent twice-daily automated text check-ins to outpatients who tested positive for COVID-19 from Mar 23 to Nov 30, 2020, at the Penn Medicine health system. Patients could report worsening symptoms to a small team of registered nurses 24 hours a day, 7 days a week. (11/16)

CIDRAP: IDSA Issues Advice For COVID-19 PPE Use In Healthcare Workers
An Infectious Diseases Society of America (IDSA) guideline panel published eight evidence-based recommendations for the use of personal protective equipment (PPE) to protect healthcare workers against COVID-19, according to a paper yesterday in Clinical Infectious Diseases. The panel, led by a University of Washington at Seattle researcher, conducted a systematic review of the literature to determine the standards of PPE use in conventional, contingency, and crisis situations. The panel recommended that healthcare personnel caring for patients with confirmed or suspected COVID-19 don a medical/surgical mask or N95 respirator and eye protection but made no recommendation about the use of double gloves or shoe covers. (11/16)

CBS News: First Human Trial Of Alzheimer's Disease Nasal Vaccine To Begin At Boston Hospital
Brigham and Women's Hospital will test the safety and efficacy of a nasal vaccine aimed at preventing and slowing Alzheimer's disease, the Boston hospital announced Tuesday. The start of the small, Phase I clinical trial comes after nearly 20 years of research led by Howard L. Weiner, MD, co-director of the Ann Romney Center for Neurologic Diseases at the hospital. (Reardon, 11/16)

CNN: Your Morning Cups Of Coffee And Tea Could Be Associated With Lower Risk Of Stroke And Dementia 
The cup of coffee or tea you reach for in the morning -- OK, maybe it's a few -- may be associated with a lower risk for stroke and dementia, according to a new study. Among more than 360,000 participants studied over a period of 10 to 14 years, those who drank 2 to 3 cups of coffee, 3 to 5 cups of tea, or a combination of 4 to 6 cups of coffee or tea a day had the lowest risk of stroke and dementia, according to researchers from Tianjin Medical University in Tianjin, China. (Holcombe, 11/16)

On telehealth —

Modern Healthcare: Telehealth May Prevent Detecting Drug Misuse, Providers Warn
Three-fourths of physicians said they believe telemedicine visits limit their ability to determine whether patients are at risk for or are currently misusing prescription drugs, according to a new study. Providers are concerned that substance abuse issues are slipping through the cracks in virtual care, as patients experience more stress and mental illness, according to the 2021 Quest Diagnostics Health Trends report released in November. (Devereaux, 11/16)

Stat: Can Telehealth For PTSD And Bipolar Disorder In Rural Areas Be Scaled Up?
A multiyear effort to pipe big-city mental health providers to rural communities over video accomplished a trifecta of telehealth victories: It reached people who wouldn’t otherwise have access to mental health care; it tackled difficult diagnoses that don’t have simple answers; and it stretched how many people the most skilled providers can treat. Now comes the inevitable question that follows any technology breakthrough: Does it scale? (Aguilar, 11/17)

Also —

The Hill: Two 'Forever Chemicals' More Toxic Than Previously Thought: EPA Drafts
The drafts found the safe levels of ingestion for chemicals perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) are much lower than the agency had found in prior assessments. The agency also found that PFOA is “likely” carcinogenic to humans. This is a step up from before, as it has previously said that there is “suggestive” evidence that the substance can cause cancer. Both PFOA and PFOS can be found in drinking water, as well as other substances. PFOA has been used in nonstick cookware, flame repellants and cosmetics. PFOS has been used in water- and stain-resistant products. (Frazin, 11/16)

ABC News: Eating Disorder Hospitalizations Doubled During COVID-19 Pandemic, New Data Shows
The number of people who were hospitalized for eating disorders in the United States doubled during the COVID-19 pandemic, new research shows. The increase in in-patient treatment for eating disorders came as early as May 2020, according to researchers from the University of Pennsylvania, whose study was published Monday in the Journal of the American Medical Association. (Kindelan and Joseph, 11/16)

CNN: Using Cannabis In Pregnancy Linked To Aggression And Anxiety In Children, A Study Suggests
More and more women are using weed in pregnancy but they may want to think twice. Researchers have found a link between marijuana use by expectant mothers and autism and childhood psychosis. Now, a small study has shown how cannabis use can affect the placenta and may be linked to higher levels of anxiety, aggression and hyperactivity in children. (Hunt, 11/16)

Modern Healthcare: Catching Up To Sci-Fi: Innovations In Transplant Care
As a young trainee decades ago, Dr. Mikel Prieto, a transplant surgeon at Mayo Clinic, said the one-year success rate for a donor organ could be as low as 25%. Now most short-term success rates for organ transplants are in the 80s or 90s, he said. Although there are still issues of equity and access, organ transplantation has become safer and more routine due to major developments in the field. (Devereaux, 11/16)

CBS News: Mississippi Capital Under Boil Water Notice After Suspected Bad Batch Of Chemicals Found At Water Treatment Plant
City officials in Jackson, Mississippi, are asking residents to boil their water as "complications" at a water treatment plant are addressed. Some residents in parts of the city have low water pressure or none at all, according to a press release from the city. The issues began over the weekend when a worker discovered a problem at the O.B. Curtis Water Treatment Plant. According to CBS affiliate WJTV, city engineer Dr. Charles Williams said they were forced to shut down a portion of the plant and empty the water after what was believed to be a bad batch of chemicals was put into the water. (Reardon, 11/16)

AP: Many In Mississippi's Capital Left With Little Or No Water
Residents of Mississippi’s capital city are being warned to boil water before using it because of low pressure in the aging water system. The citywide alert was issued after a problem occurred during the weekend at one of Jackson’s water treatment plants, WAPT-TV reported. Charles Williams, the city’s chief engineer, said the issue was resolved but it had drained the storage tanks. Pressure dropped after the city cut off treatment at one of the plants after a worker discovered a bad batch of treatment chemicals were used, WLBT-TV reported. The worker found the problem Sunday, but the pressure did not drop below the threshold until Monday evening. (11/16)

On smallpox samples —

CNN: Vials Labeled 'Smallpox' Found At Vaccine Research Facility In Pennsylvania, CDC Says 
Several vials labeled "smallpox" have been found at a vaccine research facility in Pennsylvania, the US Centers for Disease Control and Prevention said Tuesday. "There is no indication that anyone has been exposed to the small number of frozen vials," the CDC said in a statement emailed to CNN. "The frozen vials labeled 'Smallpox' were incidentally discovered by a laboratory worker while cleaning out a freezer in a facility that conducts vaccine research in Pennsylvania. CDC, its Administration partners, and law enforcement are investigating the matter and the vials' contents appear intact," the CDC added. (Fox, 11/16)

Also —

Axios: U.S. Premature Births Decline Despite Racial Disparities 
The overall rate of premature births in the U.S. declined for the first time in six years between 2019 and 2020, despite increases in preterm births among Black Americans and Native Americans or Alaska Natives, according to a report published Monday by the nonprofit March of Dimes. A tenth of births in the U.S. were premature in 2020, according to the Centers for Disease Control and Prevention. These infants face a higher chance of having to deal with health risks, like breathing problems, difficulties feeding, and vision and hearing problems. (Saric, 11/16)

CIDRAP: Multistate E Coli Outbreak Linked To Organic Spinach Sickens 10
The Centers for Disease Control and Prevention (CDC) yesterday announced an Escherichia coli O157:H7 outbreak linked to Josie's Organics fresh baby spinach that has sickened 10 people from 7 states. No one has died, but two people have required hospitalization, the CDC said. The outbreak is concentrated in the Midwest, with cases reported in Minnesota, Iowa, Missouri, South Dakota, Michigan, Indiana, and Ohio. Illness-onset dates range from Oct 15 through Oct 27. (11/16)

The Hill: Petition Launched In Oregon To Decriminalize Sex Work
A philanthropist filed a petition with the Oregon Secretary of State Shemia Fagan to decriminalize sex work in the state, The Associated Press reported. Chief petitioner Aaron Boonshoft filed the Sex Worker Rights Act on Tuesday. Organizers have said the Sex Worker Rights Act will end criminal penalties for those participating in consensual adult sex work, add health and safety protections, and will maintain laws against human trafficking, according to the AP. (Oshin, 11/16)

ProPublica: One Major Reason The U.S. Hasn’t Stopped Syphilis From Killing Babies
In public health, a “sentinel event” is a case of preventable harm so significant that it serves as a warning that the system is failing. The alarms are now blaring. A growing number of babies are being born with syphilis after their mothers contract the sexually transmitted disease and the bacteria crosses the placenta. These cases are 100% preventable: When mothers who have syphilis are treated with penicillin while pregnant, babies are often born without a trace of the disease. But when mothers go untreated, there is a 40% chance their babies will be miscarried, be stillborn or die shortly after birth. Those who survive can be born with deformed bones or damaged brains, or can suffer from severe anemia, hearing loss or blindness. (Chen, 11/16)

NPR: Colleges Are Turning to Science to Limit Suicide Contagion and Help Heal Campuses
Ethan Phillips was 13 years old when he first heard the term "suicide contagion." It's the scientific concept that after one person dies by suicide, others in the community may be at higher risk. (Pattani, 11/16)

Bloomberg: WHO Reports Tobacco Use Fall, Urges Help For People To Stop Smoking Cigarettes
Tobacco use around the world is on a downward trend and governments need to keep investing to help their populations quit, global health officials said. The number of tobacco users has fallen by 200 million to 1.3 billion since 2015, and will probably drop another 2.3% by 2025, according to a report from the World Health Organization. Some 37% of men and 8% of the world’s women made up the world’s tobacco users last year. (Gretler, 11/16)

The Washington Post: Transgender Athlete Eligibility Will No Longed Be Based On Testosterone, IOC Says
The International Olympic Committee is moving away from a focus on individual testosterone levels in transgender and intersex athletes as a way of determining those athletes’ eligibility for competition. In new guidelines for inclusion on the basis of gender identity, the IOC is encouraging policies that require evidence that transgender athletes have a competitive advantage. In guidance released Tuesday, the IOC pushes responsibility for making gender policies to the global governing bodies of individual sports while offering to give those organizations assistance in creating fair rules. (Carpenter, 11/16)

Reuters: North Carolina Attorney General Launches Probe Into E-Cigarette Maker Puff Bar
North Carolina Attorney General Josh Stein on Tuesday launched a state-wide investigation into e-cigarette maker Puff Bar, citing concerns over kid-friendly flavors and youth marketing. Stein also filed a lawsuit against Juul Labs Inc founders James Monsees and Adam Bowen, seeking civil penalties and damages, alleging they personally participated in Juul's marketing strategy of attracting young users to their product. The probe also takes aim at other companies that manufacture tobacco-free cigarettes and at retailers across the state that sell flavored e-cigarettes, including many located near schools. (11/16)

Elsewhere around the nation —

San Francisco Chronicle: S.F. Working To Open Supervised Drug Use Site By Spring, Possibly In Building Near The Tenderloin
San Francisco Mayor London Breed is pushing to open a site as early as the spring where people can use drugs under the supervision of medical professionals, and she’s working to acquire a building near the Tenderloin that could house the program. Even though supervised consumption sites are currently illegal under federal and state law, Breed is trying to open one in San Francisco. The move comes as she faces increased pressure to address the city’s overdose crisis, which has killed a record number of people since last year. (Thadani, 11/16)

AP: Corrections Boss Defends Care Provided In Arizona Prisons
Arizona’s corrections chief testified at a trial on Tuesday over the quality of medical and mental health care in state prisons that incarcerated people often have greater access to health services than people who aren’t locked up. The defense by Corrections Director David Shinn of the health care system for prisoners came after the state has faced years of complaints about poor health care behind bars and has been fined $2.5 million for not complying with a settlement over the issue. (Billeaud, 11/16)

Dallas Morning News: Texas Board Rejects Proposed Sex Ed Materials For Middle And High Schoolers
The ongoing battle over “inappropriate content” in Texas public schools raged on Tuesday as the State Board of Education declined to preliminarily adopt middle and high school health instructional materials that addressed such topics as contraception, gender identity and self-harm. The decision could leave school districts to fend for themselves on how best to address new health curriculum standards approved just a year ago — in a less fevered environment. (Smith, 11/16)

On covid —

AP: DC To Drop Most Indoor Mask Requirements Next Week
The District of Columbia will lift its indoor mask requirement starting next week, as local COVID-19 infection cases continue to trend downward. Starting Monday, Nov. 22, masks will no longer be required in many indoor spaces. A statement from the city Health Department announced that masks will still be required in certain settings, including schools, libraries, public transportation, ride-share vehicles and group-living facilities like nursing homes, dorms and jails. Private businesses will still be able to require customers to wear masks. (Khalil, 11/16)

: Pa. Court Says School Mask Order Will Expire Dec. 4, But Health Secretary Could Impose New Requirement
Pennsylvania’s Commonwealth Court on Tuesday said it would lift a stay on its order voiding the state’s school mask mandate, but not until Dec. 4 — when Gov. Tom Wolf’s administration could implement a new requirement, according to the court. It wasn’t clear Tuesday evening what the court’s decision would mean for the future of the school mask requirement, which has been hotly debated in a number of communities. (Hanna, 11/16)

WUSF Public Media: Parents' Bill Of Rights Could Be Strengthened To Include Bans On School Mask Mandates 
During a special legislative session this week to push back against pandemic-related mandates, Republican lawmakers also aim to expand an existing law known as the “Parents' Bill of Rights” to include a ban on school mask requirements. State lawmakers approved the Parents' Bill of Rights during the 2021 legislative session this spring, and Gov. Ron DeSantis signed the measure in June. (Dailey, 11/16)

AP: Florida Woman Who Sued For Ivermectin Dies From COVID
A Florida teacher hospitalized with COVID-19 has died after her husband unsuccessfully sued to force doctors to treat her with ivermectin, a drug popular among some skeptics of accepted coronavirus treatments despite a lack of studies proving its effectiveness. Tamara Drock died Friday, 12 weeks after being admitted to Palm Beach Gardens Medical Center, Ryan Drock told the Palm Beach Post. He sued the hospital last month in an attempt to require doctors to administer ivermectin, a drug used to treat conditions caused by parasitic worms. The U.S. Food and Drug Administration has not approved the drug to treat COVID-19, saying it hasn’t proved effective in pre-clinical trials. (11/16)

Dallas Morning News: Doctor In Ivermectin Lawsuit Resigns From Houston Hospital Following Suspension
The doctor involved in a lawsuit over ivermectin treatments for a Fort Worth coronavirus patient has resigned from a Houston hospital after the hospital suspended her last week. Dr. Mary Talley Bowden, a private-practice ear, nose and throat doctor who had provisional privileges to practice at Houston Methodist Hospital, was suspended Friday after spreading COVID-19 misinformation, the hospital said. (Prosser, 11/16)

Bloomberg: Mexico To Begin Vaccinating Some Teenagers Against Covid-19
After dragging its feet and falling behind regional peers, Mexico’s government will finally vaccinate some teenagers, and one state will even begin sending minors to the U.S. to get shots. During a press conference on Tuesday, the nation’s virus czar Hugo Lopez-Gatell announced that vaccinations will now be available to kids from the ages of 15 to 17 without underlying health conditions. (Villamil, Gonzalez and Navarro, 11/16)

AP: Coalition Launched To Provide School Lunches To Global Needy
Over 60 governments and 50 U.N. agencies and organizations have joined forces to press for the restoration of school lunches for all 388 million primary school children who were receiving the meals before the COVID-19 pandemic. They also will push for school meals to be started for 73 million vulnerable youngsters who weren’t getting them before the coronavirus struck in early 2020. Led by France and Finland, the School Meals Coalition was officially launched at a U.N. event Tuesday with a longer-term goal of ensuring that every needy child in the world gets a nutritious school meal by 2030. (Lederer, 11/17)

Elsewhere around the world —

Bloomberg: Ireland Reimposes Some Covid Restrictions As Coronavirus Cases Surge
Ireland has reintroduced some Covid-19 restrictions as it grapples with surging infections and a rising number of hospitalizations. Starting Thursday, people should work from home where possible, Prime Minister Micheal Martin said in a national address, while bars and restaurants must close by midnight. Cinemas and theaters will now require proof of vaccination, he said. (Flanagan, 11/16)

AP: Belgium To Make COVID-19 Shots Mandatory For Health Workers
Health workers in Belgium who don’t want to get vaccinated against COVID-19 will face losing their jobs. Amid a surge of coronavirus cases that has led hospitals in Belgium to reserve half of their 2,000 ICU beds for COVID-19 patients, Belgium’s federal government finalized a draft bill late Monday to make vaccinations mandatory for health care workers. (Petrequin, 11/16)

Reuters: Russia Reports Record Daily COVID-19 Deaths
Russia on Wednesday reported a new record one-day death toll of 1,247 from COVID-19, a little over a week after most of its regions emerged from a week-long workplace shutdown designed to curb the spread of the virus. The government coronavirus task force also reported 36,626 new coronavirus cases nationwide in the last 24 hours, including 2,966 in Moscow. (11/17)

AP: South Korea Pushes Booster Shots As COVID-19 Spread Worsens
South Korea on Wednesday reported 3,187 new cases of the coronavirus, nearly matching a one-day record set in September, a worrisome development in a country that eased social distancing rules in recent weeks to lessen the pandemic’s economic impact. The Korea Disease Control and Prevention Agency said more than 2,550 of the new cases came from the greater capital area, including a record 1,436 in Seoul. The country’s death toll is now 3,137, after 21 deaths were reported on Wednesday, the 16th consecutive day of double-digit fatalities, including a record 32 on Saturday. (11/17)

Bloomberg: China Covid Infections Fall To Single Digits In Latest Outbreak
China reported eight Covid-19 infections on Wednesday, all in one province, as the country’s new cases dropped to single digits for the first time in its latest delta outbreak. All of the locally transmitted cases were found in northeastern Liaoning province, according to the National Health Commission. The number of new infections has fallen for three consecutive days, after peaking at more than 100 daily during the broadest outbreak it’s experienced since Covid first emerged two years ago. (11/17)

Politico: Dems’ Plan To Limit Drug Price Inflation Faces Test In Senate
Democrats managed to strike a compromise on drug prices to advance their sweeping social spending bill. But as the House prepares to send the package to the Senate, the way the plan would extend price controls beyond Medicare to private health coverage is stoking another battle over the package. At issue is Democrats’ push to penalize drugmakers if they hike prices of medicine faster than inflation, a provision Republicans and the drug industry see as government overreach — and, they say, a violation of the Senate’s parliamentary rules for considering the bill because it’s a non-budgetary item. (Miranda Ollstein and Wilson, 11/13)

Bloomberg Government: Industry Groups Fault Drug Pricing Measure
Democrats are facing pressure from a host of health care industry groups to make key changes to their drug pricing proposal before voting on it in coming weeks, Alex Ruoff reports. Generic drug companies are telling Democrats their legislation to empower the government to negotiate lower drug prices would cut into their profits and make it harder to bring low-cost versions of pricey medicines to market. “It would greatly effect the rate of return for a generic,” Jeff Francer, senior vice president for the Association of Accessible Medicines, said. Their ask: exempt medicines from negotiations if a generic version is on the way. (Lee and Ruoff, 11/15)

KFF: Potential Costs And Impact Of Health Provisions In The Build Back Better Act
Congress is considering a broad package of health, social, and environmental programs supported by President Biden, called the Build Back Better Act. The total cost of the original package had been pegged at $3.5 trillion (much of which would be offset by savings and new revenue), though the legislation has since changed in ways that will likely reduce the total. This brief summarizes major health provisions as of the bill reported to the House Rules Committee on November 3, 2021, which, at the time of publication, has not yet received a CBO score. Negotiations are ongoing and there may be future changes. Here, we walk through 10 of the major health coverage and financing provisions of the Build Back Better Act, with discussion of the potential implications for people and the federal budget. We summarize provisions relating to the following areas and provide data on the people most directly affected by each provision and the potential costs or savings to the federal government. (Cox, Rudowitz, Cubanski, Pollitz , Musumeci, Ranji, Long, and Freed, 11/16)

AP: Alzheimer's Drug Cited As Medicare Premium Jumps By $21.60
Medicare’s “Part B” outpatient premium will jump by $21.60 a month in 2022, one of the largest increases ever. Officials said Friday a new Alzheimer’s drug is responsible for about half of that. The increase guarantees that health care will gobble up a big chunk of the recently announced Social Security cost-of-living allowance, a boost that had worked out to $92 a month for the average retired worker, intended to help cover rising prices for gas and food that are pinching seniors. (Alonso-Zaldivar, 11/12)

The New York Times: Biden Chooses Robert Califf To Lead F.D.A., Despite Drug Industry Ties
President Biden announced on Friday that he would nominate Dr. Robert M. Califf, a former commissioner of the Food and Drug Administration, to lead the agency again. His decision ends nearly a year of political wrangling as the White House vetted then dropped several candidates after complaints that some were too close to the pharmaceutical industry. In the end, White House officials might have concluded that they could not find a suitable candidate with no industry ties. Dr. Califf, 70, a respected academic and clinical trial researcher who ran the agency during the last year of the Obama administration, has long been a consultant to drug companies and ran a research center at Duke University that received some funding from the drug industry. (Gay Stolberg and Kaplan, 11/12)

Stat: California Wants To Revoke An OptumRx Pharmacy License For Lapses
The California Board of Pharmacy is seeking to revoke or suspend a pharmacy license held by OptumRx, which is one of the largest pharmacy benefit managers in the U.S., for a series of prescribing failures that allegedly jeopardized patient health. The infractions, which occurred between 2016 and 2020, involved failures to refill prescriptions promptly; substituting a medicine without written consent; telling a patient his health insurer denied a refill due to cost; and dispensing a generic version of a drug with a costly co-pay when the customer had no co-pay for the brand version, according to the complaint, which was filed in August but shared online recently by the agency. (Silverman, 11/16)

New Jersey 101.5: NJ Looks To Take On Prescription Drug Costs With New Review Board
Among the ideas advancing in the final months of the legislative session is the creation of a state board that would study and potentially cap prescription drug prices. Legislation creating the Prescription Drug Affordability Board advance in the Assembly back in June and through the Senate health committee last week, despite concerns from business groups that it would lead pharmaceutical companies to move their work to the states. (Symons, 11/15)

Oregon Public Broadcasting: Oregon Pharmacies Are Short On Staff And Drug Price Managers Have Something To Do With It
Customers all around Oregon have reported standing in line for hours at pharmacies and waiting weeks for prescriptions to be filled. ... Explaining the pharmacy problemKevin Russell spent 28 years working in community pharmacies and is now the Central Oregon Regional Director on the Oregon State Pharmacy Association board.Russell told OPB that intermediary companies called Pharmacy Benefit Managers have too much control over the prices of prescription drugs, and that causes a ripple effect. (Cuthill, 11/13)

San Francisco Chronicle: You're Paying Too Much For Prescription Drugs. Biden's Bill Will Lower Costs - Unless Lobbyists Prevent It
It doesn’t have to be this way. Most other countries have successfully implemented price controls. President Biden’s reconciliation bill, currently in Congress, proposes some control — allowing Medicare to negotiate drug prices with manufacturers. These negotiations would lower prescription drug costs for 48 million Americans on Medicare. The bill would also stipulate that this lower price would be available to those with private plans. The Congressional Budget Office estimates this could reduce federal spending by $456 billion and increase revenues by $45 billion over 10 years. (Tom Handley, 11/10)

Kaiser Health News: People Want Lower Drug Prices. Why Are Democrats Settling For Less?
Democrats and Republicans are crystal clear in polls that they want government to be allowed to negotiate down high drug prices. Americans pay nearly three times as much for drugs as patients in dozens of other countries. In the past two years, numerous Democratic candidates — including President Biden — have campaigned on enacting such legislation. (Elisabeth Rosenthal, 11/16)

Brookings: Addressing The Trade-Off Between Lower Drug Prices And Incentives For Pharmaceutical Innovation
The fundamental dilemma in prescription drug policy is often understood to be the tradeoff between establishing incentives for innovation that produces new cures through high product prices and the fact that high prices can and do strain the ability of consumers and taxpayers to afford the high prices to support that innovation. This is also the tradeoff posed by the Congressional Budget Office’s (CBO) recent cost estimate of one of the leading proposals to control drug pricing, H.R.3. That bill proposes new negotiation authority be extended to the Secretary of Health and Human Services to establish drug prices and imposes limits on drug price inflation. The implementation of these policies is estimated to save the public sector almost half a trillion dollars a decade – yet at the same time declining pharmaceutical industry revenues are estimated to result in 30 fewer drugs over multiple decades. Thus, the dilemma facing policymakers is perceived to be that controlling drug prices now necessarily means fewer new drugs tomorrow. The trade-off between prices and innovation need not be this stark and, in fact, is likely avoidable. (Rena Conti, Richard G. Frank, and Jonathan Gruber, 11/15)

Stat: Personalized Medicine Goes Far Beyond Genetics 
Since the Human Genome Project was completed in 2003, most public considerations of personalized medicine have focused on genetically targeted treatments. As The New York Times recently reported, genetic testing and targeted therapies have, for example, introduced a “totally different world” that replaces one-size-fits-all chemotherapy with tailored treatment options for individuals with certain genetically defined breast and lung cancers. (Christopher J. Wells, 11/16)

The New York Times: Why Is It So Dangerous To Be Pregnant In America? 
The United States has one of the highest maternal mortality rates in the developed world. To understand why, look at the states. One out of every five women of reproductive age in Southern states live in counties with a high risk of death and other poor maternal health outcomes, such as post-partum hemorrhage, pre-eclampsia and preterm birth, according to new data from Surgo Ventures. (Sema Sgaier and Jordan Downey, 11/17)

Kansas City Star: Missouri Women Would Be In Danger With Texas Abortion Law 
“There were a number of women who would come in periodically to the emergency room after failed or botched abortions, either self-induced or by some back-alley provider. These women would come in with major sepsis (an infection in the abdominal cavity). In the absence of antibiotics, we had to place four quadrant drains, which would drain pus out of the abdominal cavity, and hopefully save them for the ability to have children later on. Some would end up sterile simply because of infections which affected their fallopian tubes. Some we were able to save but it was hard work … it was intensive care. There was an abortion ban, but it was a matter of access. If you were white and had financial resources, there was never any problem getting an abortion if you needed one. If you were not white and did not have money, you had to go to the back alley to get it done.” (Stacey Newman, 11/17)

The CT Mirror: Keep The Windham And Sharon Hospital Maternity Wards Open
When did our expectations that hospitals exist to serve the public good drop so low? Was it around the time we normalized millions in compensation to CEOs? Or is it now, when we accept the fact that hospitals are denying the women they serve the most basic human healthcare need — the right to deliver a baby in safety? At least two Connecticut hospitals — both with long histories of caring for patients, including expectant mothers — now claim they can’t afford to continue this service. (State Reps. Anne Hughes and Susan Johnson, 11/17)

Los Angeles Times: Despite Our Efforts To Convince Them, Too Many Pregnant Patients Won't Get The COVID Vaccine 
In our high-risk pregnancy clinics there are three vaccine conversations that we have with patients regularly. First, there are patients who are vaccinated for COVID-19 and counting down the days until they can schedule a booster shot. Then there are patients who will accept vaccines for influenza and Tdap (tetanus, diphtheria, pertussis), but not COVID-19. The third conversation is with expectant mothers who not only decline a COVID-19 vaccination but also other vaccines recommended in pregnancy. (Alyssa Stephenson-Famy and Linda Eckert, 11/17)

The New York Times: When Will The Covid Pandemic End? 
On Nov. 15, 2020, in the United States, as the most devastating wave yet of coronavirus infections was beginning to crash over the country, about 1,148 Americans were dying of Covid every day. A year later, that number is 1,129. To call the statistic sobering would be an understatement. And yet many parts of the country are not in the same place, epidemiologically speaking, as they were last year. In New York City, where I live, and where 87 percent of adults have received at least one vaccine dose, restaurants and bars and theaters fill with people every night. Cases have ticked up once again in recent weeks, but hospitalization and deaths continue to decline — for now, at least. (Spencer Bokat-Lindell, 11/16)

Bloomberg: Covid Vaccine Booster Shots Should Be Available To Everybody
It looks as though the White House may have finally figured out the obvious: It’s time to roll out Covid-19 booster shots to everyone, ASAP. Medical specialists are still debating the extent to which boosters are strictly necessary, given that one- and two-dose vaccine regimens seem to be protecting people against life-threatening disease. And there’s an ethical debate about whether it's fair to give Americans third shots when lots of people in other parts of the world are still awaiting their first. (Scott Duke Kominers, 11/16)

Stat: Are Authorized/Approved Covid Vaccines The Best Ones? We Don't Know
Pfizer/BioNTech. Moderna. Johnson & Johnson. AstraZeneca. These are the marquee names that spring to mind when you think of the vaccine companies at the forefront of the global fight against Covid-19. And for good reason: together they have manufactured the majority of the estimated 7 billion-plus Covid vaccine doses administered to date around the world. But as regulators in the U.S., Europe, and around the world mull the most responsible way to expand vaccine eligibility to an even larger share of their populations — including to younger children, as the Food and Drug Administration (FDA) and Centers for Disease Control (CDC) have done this month by greenlighting Pfizer’s vaccine for kids 5 to 11 years of age — it’s time to confront an uncomfortable reality: The global health community still doesn’t know which of the hundreds of Covid vaccines currently in clinical and preclinical development are truly “the best.” (Mike Rea, 11/17)

CNN: Rescuing Our Kids From Covid Trauma Is Vital For Healing America 
Now that the Pfizer vaccines have been authorized for emergency use in children ages 5 to 11, I, like so many parents across the US, am breathing a sigh of relief that my little ones can finally be protected against Covid-19. We still have a lot of work to do to ensure we emerge from this pandemic as soon as possible, but as a pediatrician and the Surgeon General of California, I recognize that reining in the virus can't be the end of the story. If we're going to truly heal from the impacts of Covid-19, we need to once again let medicine lead our decision making and recognize the role that trauma caused by the pandemic and other cumulative stressors plays in both personal and public health — particularly when experienced during childhood. (Nadine Burke Harris, 11/16)

The Atlantic: The Upside Of COVID Hygiene Theater 
We are now more than a year and a half into the coronavirus pandemic, and we are once again hand-wringing about “hygiene theater,” the various public displays of sanitation and cleanliness that critics attack as unnecessary, wasteful, and even counterproductive. But if detractors mock these measures—temperature checks before concerts, QR codes instead of paper menus at restaurants, outdoor mask wearing—for being useless and performative, it’s worth remembering that not everything we do need necessarily have a use, and that not everything performative is without merit. (Colin Dickey, 11/16)

The Washington Post: How To Assess The Covid-19 Risk From Holiday Gatherings? Here Are Four Things To Consider
After weeks of steady decline, covid-19 cases are on the rise again. Much of the United States is in the highest-risk category for transmission, according to the Centers for Disease Control and Prevention. As Thanksgiving, Christmas and other winter holidays approach, here are four factors to consider when assessing risk to decide which gatherings to attend. (Leana S. Wen, 11/16)