Morning Briefing
Summaries of health policy coverage from major news organizations
2 Generics Makers Settle With Justice Department Over Price-Fixing Charges
Politico: Generic Drug Giants Settle Federal Price-Fixing Charges
Two generic drug giants agreed Monday to settle long-running criminal price-fixing charges with the Justice Department, including the unusual move to sell off the drugs involved. The U.S. arms of Israel-based Teva and India-based Glenmark are paying $225 million and $30 million, respectively, according to court filings. The companies agreed to enter into deferred prosecution agreements, a resolution in which charges are suspended but a company must admit wrongdoing. It can later face charges if it does not follow the terms of the deal. (Sisco, 8/21)
A German drugmaker is suing the U.S. over drug price negotiations —
Reuters: Boehringer Latest To Sue US Over Drug Price Negotiation Plan
Boehringer Ingelheim sued the U.S. government in an attempt to block a program that gives the Medicare health insurance plan the power to negotiate lower drug prices, joining other drugmakers and business groups claiming that it would stifle development of new medicines. In a complaint filed on Friday in federal court in New Haven, Connecticut, the privately-held German drugmaker said the program violates the U.S. Constitution by giving federal regulators too much power to dictate drug prices. (Pierson, 8/21)
In other pharmaceutical industry news —
Reuters: Indivior To Pay $30 Million To Settle Health Plans' Suboxone Claims
Indivior has agreed to pay $30 million to settle a class action lawsuit filed in a U.S. court by health plans accusing the drugmaker of illegally suppressing generic competition for its opioid addiction treatment Suboxone. The settlement, disclosed on Saturday in a filing by lawyers for the health plans in federal court in Philadelphia, must still be approved by a judge. Indivior is still facing claims by drug wholesalers that bought Suboxone from the Virginia-based company directly, with a trial scheduled in October. (Pierson, 8/21)
Reuters: US FDA Puts Gilead Sciences Blood Cancer Drug Studies On Hold
Gilead Sciences said on Monday the U.S. health regulator placed a clinical hold on studies of its blood cancer drug, just a month after the company scrapped a late-stage trial due to efficacy concerns. (8/21)
Stat: FDA Advisory Panel To Debate High Blood Pressure Devices
An advisory committee to the Food and Drug Administration will convene on Tuesday to evaluate the benefits of renal denervation, a one-time surgical procedure that works to reduce blood pressure. The promise — and the potential market — is enormous, but the data on how well the procedure works remains contentious. (Lawrence, 8/22)
Stat: Intellia Plays Down Concerns On Accidental Germline Transmission
Earlier this month, Intellia Therapeutics announced it was scrapping plans to include U.S.-based sites in one of its mid-stage CRISPR trials after the Food and Drug Administration requested additional data to support including female patients of childbearing potential. The move left many researchers wondering whether the specter of accidental germline transmission — which haunted early gene therapy trials — had now risen over the field of gene editing. (Molteni, 8/21)
