HHS Has Been Deluged With Comments Over PBMs And Drug Rebates. Who Is Stoking That Fervent Response?

Stat: A Drug Pricing Mystery: Who's Behind All The Outrage Over Rebates?
The Department of Health and Human Services has already received 18,000 comments on its proposal to end the system of rebates insurers and middlemen use to negotiate drug prices. That is not normal. That’s six times more comments than HHS received on the entire drug pricing plan it released last May. And I’m even more suspicious because almost all the big groups in town — the trade associations, the individual drug companies, the pharmacy benefit managers, and the consumer advocacy groups — told me they haven’t yet submitted their comments, which aren’t due till next month. (Florko, 3/19)

Stat: States Advance Efforts To Import Drugs From Canada, With Florida The Latest
Amid the heated debate over the cost of medicines, various state lawmakers are pushing ahead with legislation that would allow Americans to import drugs from Canada. In Florida, a bill is making its way through the legislature that would establish two programs, one of which would permit the state to import drugs from Canada for Medicaid and state prisoners, while the other would be available to state residents, although these would be administered by different state agencies. (Silverman, 3/18)

The Associated Press: Group With Consumer-Friendly Vibe Pushes Drugmakers’ Message
As ominous music plays in the background, the narrator of a radio ad warns that a Trump administration proposal to apply international pricing to certain Medicare drugs would be a nightmare for seniors. The one-minute spot is the handiwork of the Alliance for Patient Access, a nonprofit group that gives off a consumer-friendly vibe but is bankrolled by the powerful pharmaceutical industry. It’s also closely aligned with a Washington lobbying and public relations firm, Woodberry Associates, whose president, Brian Kennedy, is the nonprofit’s executive director. (Lardner, 3/18)

The Associated Press: Outside Political Groups Not Always What They Appear
As ominous music plays in the background, the narrator of a radio ad echoes objections from drugmakers by warning that a Trump administration proposal to apply international pricing to certain Medicare drugs would be a nightmare for seniors. The one-minute spot is the handiwork of the Alliance for Patient Access, a nonprofit group that gives off a consumer-friendly vibe yet is bankrolled by the powerful pharmaceutical industry. It's also closely aligned with a Washington lobbying and public relations firm, Woodberry Associates, whose president, Brian Kennedy, is the nonprofit's executive director. (3/18)

Modern Healthcare: Insurers Should Move To Biosimilar Drugs, FDA's Gottlieb Says
Insurers must be willing to take a short-term financial loss to get long-term savings from adopting biosimilars, outgoing Food and Drug Administration Commissioner Scott Gottlieb said Tuesday. There are major commercial obstacles to getting biosimilars onto the market to replace pricey biologics, Gottlieb said at a Brookings Institution event. Even though the FDA has approved 16 biosimilars, very few are on the market. Gottlieb will leave his post as commissioner early next month to spend more time with his family. (King, 3/19)

Politico Pro: Drugs With A Single Manufacturer Drive Medicare, Medicaid Spending Increases, CMS Says
Drugs for which there is only one manufacturer are responsible for the biggest spending increases in Medicare and Medicaid even when a range of treatments are available for a particular disease, according to updated data CMS released today. The figures raise questions about why there isn't more price competition among branded products, a solution commonly embraced by Republicans and some Democrats in Congress. (Karlin-Smith, Owermohle and Boschma, 3/14)

Reuters: Sanofi Says Working On CEO Succession Plan
Pharmaceuticals group Sanofi is working on a plan to find a new CEO in agreement and consultation with current chief executive Olivier Brandicourt, a spokesman for the French drugmaker told Reuters on Monday. Sanofi has an age limit of 65 for its CEO. Brandicourt will be 65 in February 2021. (3/18)

Stat: Catalyst Says Pricey Drug Doing 'Better Than Expected' Despite Anger
A new and pricey rare-disease drug that angered many patients — and prompted Sen. Bernie Sanders (I-Vt.) to protest its cost — is showing signs of becoming a hit on Wall Street. In a call with analysts, Catalyst Pharmaceuticals (CPRX) chief executive Patrick McEnany disclosed that about 250 patients are being treated with Firdapse, which is used to combat Lambert-Easton myasthenic syndrome, or LEMS, and has a list price of $375,000.  He also reported most patients are paying $10 a month, thanks to assistance programs, and payers are responding “better than expected.” (Silverman, 3/19)

Stat: Can Compounding Make Vasopressin Affordable Again? It's Up To The Courts
When a sepsis patient goes into vasodilatory shock — that is, blood stops flowing to the brain and other vital organs — the intensive care unit springs into action. Alarms blare and frenzied doctors and nurses rush to find a crash cart, scrambling through its contents for a decades-old drug: vasopressin. Until recently, the drug was so vital and so cheap that hospital staffs kept it stashed in every corner of the ICU. In 2011, a box of 25 tiny vials cost less than $200. But after the Food and Drug Administration granted an Endo Pharmaceuticals subsidiary the exclusive right to make the drug in 2014, the price spiked: the same box, now bearing the brand name Vasostrict, cost over $4,000 in 2018. (Florko, 3/15)

Bloomberg: One In Five U.S. Adults Ask Doctor For Lower Cost Medication 
Over one third of U.S. adults aged 18-64, without health insurance, did not take their prescription medication as prescribed in the past 12 months in order to reduce costs, according to data released by the Centers for Disease Control and Prevention. Among, all adults, including those with insurance, on Medicaid and the uninsured, about one in five asked their doctor for alternative medication to lower the cost. (Tanzi, 2/19)

The Hill: Survey: About 1 In 10 US Adults Rationing Medicine In Effort To Lower Costs 
New survey data shows that 11.4 percent of U.S. adults did not take their medication as prescribed in an effort to reduce costs. The survey from the Centers for Disease Control and Prevention finds that those adults, aged 18 to 64, either skipped doses, took less medicine than prescribed or delayed filling a prescription because of the cost of the drugs in the past 12 months. (Sullivan, 3/19)

Modern Healthcare: AbbVie Sued Over Humira Patents Blocking Competition
Drugmaker AbbVie is facing a putative class-action lawsuit over its array of patents shielding the blockbuster drug Humira from U.S. competition until 2023. The complaint, filed Monday in a U.S. District Court in Illinois, alleged the company has "abused the patent system." Seven additional manufacturers are co-defendants in the case because of their patent settlements with AbbVie that delayed competitive products from entering the market. (Luthi, 3/19)

Stat: Tiny PhaseBio Gets The NEJM Spotlight. Can Its Shares Rebound? 
PhaseBio, a small biotechnology firm based in Malvern, Pa., is not loved by investors. Its shares are down 25 percent from their October 2018 initial public offering, and the company has a market capitalization of just $89 million. So it’s a bit of a surprise to see the company’s experimental drug highlighted in the New England Journal of Medicine. The study, also being presented here at the annual meeting of the American College of Cardiology, tested PhaseBio’s drug, PB2452, as a way to reverse the effects of Brilinta, an AstraZeneca drug that is used to prevent blood from clotting in heart patients, including those who have received stents to prop open clogged arteries. (Herper, 3/17)

Bloomberg: Biotech Investors Zero In On Gene Therapy As Next Big Frontier 
Biotech investors are bullish on the market for gene therapies, even though actual sales of a few existing drugs have so far failed to impress some Wall Street analysts. Fund managers and venture capitalists discussed their outlook for the technology in interviews in Boston, where investors gathered for the Cowen health-care conference. Investor interest in gene-therapy stocks is high, as investing has paid off this year. Roche Holding AG and Biogen Inc. recently snapped up a pair of drug developers, boosting speculation of more deals. (Darie, 3/15)

Stat: Vivek Ramaswamy Finds Success With Overactive Bladder Drug
Vivek Ramaswamy, the hedge fund manager turned biotech entrepreneur, has raised billions of dollars to create a constellation of “Vant” companies that license and develop drugs from other firms. Five years and one spectacular Alzheimer’s drug blowup later, Ramaswamy finally notched a late-stage clinical trial win. It comes courtesy of Urovant, the urology-focused spinout from his Roivant Sciences mothership. On Tuesday, Urovant said its lead pipeline drug, vibregon, achieved all the treatment goals in a Phase 3 clinical trial involving patients with overactive bladder. (Feuerstein, 3/19)

Miami Herald: Legacy Recalls 43 Lots Of Losartan For NMBA Impurity
In two different recalls Friday, Legacy Pharmaceutical Packaging recalled 43 lots of heart and hypertension medication losartan for the presence of possible carcinogen NMBA. This especially affects those who you get their medication at Walmart, Sam’s Club or pharmacies in supermarkets owned by the Kroger, Co.: Kroger, Ralphs, City Market, Dillons, Fred Meyer, Fry’s, King Soopers, QFC, Harris Teeter and Smith’s Food and Drug. (Neal, 3/16)

The Associated Press: More Charges In $50M State Benefits Prescription Drug Probe
A police officer and three firefighters were among seven people indicted this week in an alleged $50 million prescription drug scheme involving public employees, the latest charges in an investigation that has already produced nearly two dozen guilty pleas. A 50-count indictment unsealed Friday by the U.S. attorney's office in Camden, New Jersey, charged the seven with health care fraud, wire fraud and conspiracy. Twenty-three people already have pleaded guilty in connection with the investigation, according to the U.S. attorney's office. (3/15)