FDA names and shames top drugmakers
Commissioner wants to encourage more generic competition
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 fight for patent extensions, seek new uses for old products and, 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 as part of the federal government’s campaign to lower drug prices.
On Thursday, the FDA 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.
Gottlieb calls it transparency, but this approach is better known among ethicists as naming and shaming.
Congressional efforts to force the companies to hand over samples of their drugs to generic competitors have failed. Recent proposals to ensure generic access to drug samples would save the federal government $3.8 billion over 10 years, according to the Congressional Budget Office, partly by lowering Medicare and Medicaid spending on prescription drugs.
The Federal Trade Commission has also been investigating the practice.
Some brand-name makers say the legislation is not needed. The FDA has been speeding up approval of generic drugs, and nearly 90 percent of prescriptions are filled with generics.
But others point to the ways in which pharmaceutical giants have managed to keep patents on certain expensive drugs for years longer than necessary.
Generic drug developers usually need between 1,500 to 5,000 units of the brand drug to develop their product and test it, to show it is effective and can be absorbed at the same rate as the brand drug, the agency says.
Both the FDA and the Federal Trade Commission say securing the samples can be difficult, because major drug firms can invoke safety concerns — real or unreal — to avoid providing the materials.
The FDA’s new list includes 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 companies seeking supplies. The names of the generic companies were not provided.
While Celgene tops the list, other companies that the FDA named as the subject of complaints included GlaxoSmithKline, Pfizer, Valeant Pharmaceuticals International, BioMarin Pharmaceutical, Gilead Sciences and Novartis Pharmaceuticals. Also on the list is Actelion Pharmaceuticals, a Johnson & Johnson company.
Greg Geissman, a spokesman for Celgene, said the company had not prevented generic companies from obtaining their products.
The FDA’s list of shame notes three inquiries from companies trying to get access to Mylan’s Amnesteem (isotretinoin), used to treat severe cystic acne that has not responded to antibiotic treatment.