Morning Briefing
Summaries of health policy coverage from major news organizations
White House Faces Pressure To Ban Menthol Cigarettes
Menthols, which are known for their minty taste, are easier to smoke and harder to quit. According to the Centers for Disease Control and Prevention, they are the choice of 81% of Black smokers, compared to 34% of white smokers. The White House Office of Management and Budget is currently reviewing an FDA proposal to prohibit menthol cigarettes and on Monday, local leaders called on the Biden administration to finalize those rules quickly. (Fan, 11/6)
Former law enforcement officials say Biden's proposed menthol cigarette ban will lead to a host of problems, including Mexican cartels saturating the U.S. black market. The Food and Drug Administration (FDA) proposed rules prohibiting menthol cigarettes and flavored cigars in April 2022. At the time, Health and Human Services Secretary Xavier Becerra said the action would protect children and benefit adult smokers. (Schoffstall, 11/6)
In other pharmaceutical news —
Novo Nordisk has refuted a Louisiana woman’s claim that her doctors weren’t properly warned of the side effects of the company’s blockbuster drug Ozempic, saying the vomiting and pain she alleged to have experienced are documented side effects included on the drug's label. The Danish drugmaker filed a motion to dismiss Jaclyn Bjorklund’s lawsuit against the company on Friday in Louisiana federal court. Bjorklund said that while taking the drug for Type 2 Diabetes she developed gastroparesis, a slowdown in the emptying of the stomach into the small intestine, that led to her vomiting and pain. (Jones, 11/6)
Astellas on Saturday presented study results showing an increased treatment effect over time for its approved medicine for a common type of vision loss. The new data are probably enough to convince the Food and Drug Administration to remove restrictions on the drug’s use, but they still don’t measure up to a competing treatment from Apellis Pharmaceuticals. (Feuerstein, 11/6)
Bristol Myers Squibb has acquired Orum Therapeutics' experimental therapy to treat a type of blood cancer for a total value of up to $180 million, the privately held company said on Monday. The therapy, ORM-6151, which helps degrade a specific protein hard to treat previously, has received the U.S. Food and Drug Administration's (FDA) clearance for an early stage study. (11/6)
A U.S. appeals court on Monday gave Viatris' Mylan Pharmaceuticals another chance to prove that its proposed generic of Johnson & Johnson unit Actelion's cardiovascular drug Veletri would not violate J&J's patent rights and should be allowed to go to market. The U.S. Court of Appeals for the Federal Circuit said that a West Virginia court interpreted a key part of the patents incorrectly and sent the case back for reconsideration. (Brittain, 11/6)