Morning Briefing
Summaries of health policy coverage from major news organizations
Naming Names: FDA Calls Out Drugmakers For Blocking Generics To Shame Them Into Better Behavior
The Associated Press: FDA Names Drugmakers Accused Of Blocking Cheaper Generics
U.S. drug regulators are publicizing information on brand-name drugmakers that use what government officials call "gaming tactics" to block cheaper copycat versions. The Food and Drug Administration's new webpage names the makers of more than 50 brand-name drugs, many carrying five- or six-figure annual price tags, who are under scrutiny. The agency also lists inquiries it has received from generic drugmakers requesting FDA's help in getting access to the brand-name drugs though not all the complaints have been verified. (Johnson, 5/17)
The New York Times: F.D.A. Names And Shames Drug Makers To Encourage Generic Competition
Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, calls this “gaming the system,” and has vowed to stop it as part of the government’s campaign to lower drug prices. On Thursday, the F.D.A. took a new tack and began posting a list of makers of brand-name drugs that have been the target of complaints, to persuade them to “end the shenanigans,” in the commissioner’s words. Dr. Gottlieb calls it transparency, but this approach is better known among ethicists as naming and shaming. (Kaplan, 5/17)
The Wall Street Journal: FDA Calls Out Drug Makers That Improperly Block Generic Competition
“We hope that this increased transparency will help reduce unnecessary hurdles to generic drug development and approval,” Dr. Gottlieb said in a statement. The FDA plans to update the list twice a year. Companies on the FDA’s list include midsize and larger drugmakers like AstraZeneca PLC and its heart drug Brilinta, Biogen Inc. and its multiple sclerosis drug Tecfidera, and Bayer AG’s cancer drug Nexavar. Biogen said it is the company’s practice to comply with requests from generic companies for drug samples. Bayer also said its practice is to “provide samples upon request, in full accordance with applicable laws and regulations.” AstraZeneca said it wasn’t aware of any outstanding requests for samples of Brilinta by any generic manufacturers. (Burton, 5/17)
Stat: FDA Calls Out 39 Drug Companies For Allegedly Blocking Access To Generics
Thursday’s announcement from the FDA focuses on branded companies that may be trying to delay competition from a generic competitor by blocking access to product samples the other company needs to test its own version of the drug — “gaming tactics,” as FDA Commissioner Scott Gottlieb said Thursday. Generic companies need somewhere between 1,000 and 5,000 doses of a drug to complete the studies that prove their product is equivalent with the branded one. (Mershon, 5/17)
Bloomberg: U.S. Names Drugmakers ‘Gaming’ Safety System To Shield Profits
Celgene, maker of one of the world’s biggest brand-name cancer treatments, Revlimid, has been frequently accused of using safety programs to forestall cheaper versions of its drugs. Revlimid, which costs more than $100,000 a year, had sales of $8.19 billion in 2017. According to the database, generic drugmakers contacted the FDA 31 times to say they were unable to obtain samples of a Celgene drug. The complaints were divided among three drugs, with 13 instances pertaining to Revlimid, which is also the subject of a legal battle over its intellectual property. (Koons and Edney, 5/17)
