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F.D.A. Names and Shames Drug Makers to Encourage Generic Competition
Key Excerpts from Article on Website of New York Times
Posted: May 21st, 2018
https://www.nytimes.com/2018/05/17/health/drug-prices-generi...
Pharmaceutical companies that spend billions of dollars to develop new drugs do not want competitors to profit from inexpensive generic copies of blockbuster medicines. To avoid rivals, they ... sometimes prevent generic drug companies from obtaining samples. Dr. Scott Gottlieb, the commissioner of the Food and Drug Administration, calls this gaming the system, and has vowed to stop it. 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 commissioners words. Congressional efforts to force the companies to hand over samples of their drugs to generic competitors have not been successful. Generic drug developers usually need between 1,500 to 5,000 units of the brand drug to develop their product and test it. Both the F.D.A. and the Federal Trade Commission say securing the samples can be difficult. The F.D.A.s new list includes drug companies the agency said may be pursuing gaming tactics to delay generic competition. Along with the name of each business, the agency noted how many inquiries it received from generic drug companies seeking supplies. Celgene, [which makes drugs to treat cancer and immune-inflammatory diseases], tops the list. Other companies ... included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals.
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