Morning Briefing
Summaries of health policy coverage from major news organizations
Drugmaker Sues FDA Over Right To Promote Off-Label Drug Use
The New York Times: Drugmaker Sues F.D.A. Over Right To Discuss Off-Label Uses
Drugmakers have long argued they should have the right to talk to doctors about unapproved uses for their products, as long as they are being truthful. And in some cases, courts have agreed. But the federal government still frowns on the practice and, in recent years, has fined drug companies billions of dollars for talking to doctors about so-called off-label uses for their medications. (Thomas, 5/7)
The Wall Street Journal's Pharmalot: Drug Maker Sues FDA Over Free Speech Right To Promote Off-Label
In a move that may have broad ramifications for the pharmaceutical industry, a small drug maker called Amarin has filed a lawsuit against the FDA to argue that its right to distribute information about unapproved uses of a medicine is protected by the First Amendment. Amarin wants to be able to provide doctors with clinical trial data that does not directly pertain to the approved uses of its Vascepa prescription fish-oil pill, the lawsuit states. The FDA endorsed drug to treat people with very high levels of triglycerides, a type of fat in the blood that can lead to heart disease. (Silverman, 5/7)
Los Angeles Times: California Supreme Court Revives Generic Cipro Lawsuit
The California Supreme Court on Thursday revived a class-action lawsuit that accuses German pharmaceutical giant Bayer of paying another drug company to delay introducing a generic version of a Bayer antibiotic. The practice is known as “pay to delay” and can violate antitrust law, according to a 2013 U.S. Supreme Court decision. (Dolan, 5/7)
The Associated Press: California Court Sides With Consumers In Generic Drug Fight
In a win for consumers, the California Supreme Court ruled Thursday that settlement agreements between pharmaceutical companies that keep cheaper, generic drugs off the market may be illegal if they include excessive cash payments. (Thanawala, 5/7)
Also in the news, Actavis' plan to switch out an older version of its Alzheimer's drug could cost Medicare Part D millions -
The Wall Street Journal's Pharmalot: Actavis And Its Forced Switch Could Cost Medicare $288M This Year: Study
If Actavis were allowed to discontinue sales of an older Alzheimer’s pill and steer patients toward a newer version in order to blunt generic competition, the move could cost Medicare Part D as much as $288 million during the last six months of 2015, according to a new government analysis. The analysis comes as a federal appeals court panel decides whether to permit Actavis to conduct a so-called forced switch. As reported previously, the drug maker planned to prematurely end sales of its older, twice-a-day Namenda IR in favor of a newer, once-daily Namenda XR. The patent on the older pill expires in July, while the patent on the newer version does not expire until 2025. (Silverman, 5/7)
Earlier KHN coverage: Battle Over Dementia Drug Swap Has Big Stakes For Drugmakers, Consumers
And draft guidelines for the 340B discount drug program are moving forward -
CQ Healthbeat: Drug Discount Program Guidelines Near Unveiling
New draft guidelines for the 340B discount drug program are under review at the White House Office of Management and Budget, a final step needed before the Obama administration reveals the much anticipated oversight framework. Administrators of many hospitals and drugmakers have been at odds about expanding program. Hospitals, clinics and other participants saved about $3.8 billion on the cost of medicines in fiscal 2013. The program was created in the 1990s with a goal of helping hospitals that treat many people living in poverty. Participants have complained about a lack of transparency about drugmakers' prices, while others have criticized a lack of rules on who should benefit from the discounted medicines. (Young, 5/7)
