FDA To Overhaul Its Oversight Of Tobacco, Nicotine Products

Roll Call: FDA Plans Oversight Changes After Critical Tobacco Report
The Food and Drug Administration on Friday announced a series of actions meant to improve its oversight of tobacco and nicotine products, most notably e-cigarettes. FDA Commissioner Robert Califf outlined plans for better communication and transparency on product reviews, increased use of the tobacco advisory committee and intra-agency meetings on enforcement. (Clason, 2/24)

Stat: FDA's Top Tobacco Official Talks Benefits Of E-Cigs Over Cigarettes
The head of the FDA’s tobacco center wants to do more to tout the health benefits of switching from cigarettes to e-cigarettes, now that youth vaping rates are declining. “With the reductions in [youth vaping rates] that we’ve seen, we’ve got an opportunity to ramp up our efforts related to the continuum of risk,” said Brian King, director of the FDA’s Center for Tobacco Products, at a Friday event. “I am wholly open to enhanced efforts by the Center for Tobacco Products to message not only on the continuum of risk, but also misperceptions related to nicotine.” (Florko, 2/24)

On marijuana use —

Fortune: Daily Marijuana Users Are More Likely To Take This Health Hit, A New Study Finds
Those who use marijuana daily are about a third more likely to develop coronary artery disease than those who’ve never used the recreational drug, according to a new study. “There are probably certain harms of cannabis use that weren’t recognized before, and people should take that into account,” Dr. Ishan Paranjpe, a physician at Stanford University and lead author, said in a news release about the study, which will be presented in early March at the American College of Cardiology conference. (Prater, 2/24)

St. Louis Post-Dispatch: Smoking Weed Is Legal In Missouri Now. But Your Surgeon May Not Approve
Expect to be asked more about cannabis use — what type, how much and how often — when preparing for an upcoming surgery as researchers learn more about complications associated with marijuana and anesthesia. New U.S. guidelines released in January say all patients undergoing procedures that require going under should be asked details about their marijuana consumption. That’s because regular users may require more anesthesia and experience worse pain and nausea after surgery, according to research gathered as part of developing the first-ever guidelines for anesthesiologists when it comes to patients’ cannabis use. (Munz, 2/26)

In other pharmaceutical news —

Fox News: Biden Admin To Limit Telehealth Prescriptions For Some Controlled Drugs
The Biden administration is moving to require patients to be evaluated by a physician in person before receiving prescriptions for some controlled medications, including Adderall and OxyContin. The proposal would reverse a policy enacted during the coronavirus pandemic that allowed doctors to prescribe these medications through telehealth appointments. The move will make it more difficult for Americans to access some drugs used for treating pain and mental health disorders. (Mion, 2/26)

Stateline: Addiction Treatment May Be Coming To A Pharmacy Near You
Despite an overdose epidemic that killed 107,000 people last year, nearly 9 in 10 Americans who need medication to treat their addiction to deadly opioids aren’t receiving it. Surprising new results from a first-of-its-kind study in Rhode Island could hold a key to getting addiction medication to more people who need it: allowing patients to get prescriptions at their local pharmacy rather than a doctor’s office. The change would particularly help those with low incomes who lack housing and transportation, the study found. (Vestal, 2/24)

The Wall Street Journal: Pfizer In Talks To Acquire Seagen In Deal Likely Valued At More Than $30 Billion 
Pfizer Inc. is in talks to acquire biotech Seagen Inc., according to people familiar with the matter, the latest potential deal for a big drug company aimed at adding a promising class of targeted cancer therapies. The talks are at an early stage and there is no guarantee there will be a deal, the people said. A number of hurdles would need to be overcome, including the potential for a stringent antitrust review of any proposal. If there is a deal, it would be big: Seagen has a market value of some $30 billion and would be expected to command a premium over that. (Hopkins and Rockoff, 2/26)

Stat: U.S. Trade Rep Urged Not To Sanction Countries If They Sidestep Patents On Vertex Cystic Fibrosis Drugs
Several leading advocacy groups are asking the U.S. trade representative not to sanction or pressure four countries — Brazil, Ukraine, South Africa, and India — if the governments grant requests from cystic fibrosis patients to sidestep or revoke patents on a pricey medicine. (Silverman, 2/25)

KHN: After Capping Insulin Copays, Colorado Sets Its Sights on EpiPens
Almost four years after becoming the first state to cap insulin prices, Colorado may limit what consumers pay for epinephrine autoinjectors, also known as EpiPens, which treat serious allergic reactions. A proposed state law would cap out-of-pocket copayments at $60 for a two-pack of epinephrine autoinjectors. In 2007, the wholesale price of a single EpiPen was about $47. Today, two brand-name autoinjectors cost just under $636 at a Walgreens in Denver, according to GoodRx. At some pharmacies a generic pen sells for $100 to $200, which is still expensive for many people. (Santoro, 2/27)

Stat: Little Transparency, Lots Of Waste: NIH Funds Pediatric Research, But Many Trials Results Go Unpublished
The National Institutes of Health provided $362 million in grants for clinical trials that enrolled at least 41,000 children over a recent three-year period — but many results were never published, a new analysis found. The results are a worrisome sign of a lack of transparency that can lead to wasted research funding. (Silverman, 2/24)