Morning Briefing
Summaries of health policy coverage from major news organizations
FDA Launching Website To Call Out Pharma Companies Accused Of Deterring Development Of Generics
Stat: FDA To Name Companies Accused Of Hindering Generic Drug Development
On Thursday, the Food and Drug Administration plans to start publishing the names of pharmaceutical companies that have been accused of withholding samples of drugs from generic manufacturers, Commissioner Scott Gottlieb told STAT. This is part of the Trump administration’s broader plan to bring down drug prices by fostering competition. In a speech Monday, Secretary of Health and Human Services Alex Azar highlighted this forthcoming action by the FDA as one way to “call out the manufacturers who may be abusing the rules that built our free market for drugs.” (Swetlitz, 5/14)
CQ: FDA Acts To Target Drugmakers Accused Of Not Sharing Samples
The website will initially display the names of about 50 brand-name drugs that generic companies have complained about getting, with more to be added as generic companies petition the FDA for help. Generic companies need the samples in order to replicate them in lower-cost products. “Branded companies are on notice that there will be a website at FDA that’s going to identify when multiple generic entrants are having trouble getting access to their physical samples,” Gottlieb said Tuesday at a briefing with reporters. (McIntire, 5/15)
Modern Healthcare: FDA Explores Requiring Drug Price Disclosures In Commercials
Drug companies on Tuesday claimed the Trump administration may not have the legal authority to make them disclose their products' prices in consumer advertising. Both President Donald Trump and HHS Secretary Alex Azar have cited the policy proposal as a key strategy to rein in drug prices. The U.S. Constitution's free speech protections raise legal questions about whether the Food and Drug Administration can compel drugmakers to disclose prices in ads, said Lori Reilly, an executive vice president of the Pharmaceutical Research and Manufacturers of America, said at a health reform panel Tuesday. (Dickinson, 5/15)
CNBC: FDA's Gottlieb On Lowering US Drug Prices: Europe Needs To Pay More
U.S. allies' drug pricing strategies are not sustainable for long-term success, and that's adversely leading to higher prescription costs at home and abroad, FDA Commissioner Dr. Scott Gottlieb told CNBC on Tuesday. Europeans "do underpay relative to us for branded drugs and that's in part because they do put price controls and utilization restrictions on those drugs," Gottlieb said in a "Squawk Box" interview. "But they're overpaying relative to us on generic drugs." "That's not a system for success in the long run," he argued. "So, I don't think they're set up for long-term success." (Lovelace, 5/15)
