FDA names, shames drugmakers to boost generics
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 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 not been successful. 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 drugmakers 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 generic drugs. But others point to the ways in which major pharmaceutical companies 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 that it is effective and can be absorbed at the same rate as the brand drug, according to the agency.
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 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. 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.
Celgene, which makes drugs to treat cancer and immune-inflammatory diseases, was named as the subject of 31 inquiries from companies seeking access to Revlimid (lenalidomide), its treatment for multiple myeloma and related diseases; Pomalyst (pomalidomide); and Thalomid (thalidomide).
Celgene has been embroiled in lawsuits for several years with companies seeking access to the drugs. It recently sued Dr. Reddy’s Laboratories Ltd., an Indian company, to block it from selling
generic copies of Revlimid, the company’s biggest product, and has been fending off an attempt by Mylan to also get into the generic Revlimid business.
At a court hearing last year, a lawyer for Mylan, Jonathan M. Jacobson, told a federal district judge that the drug costs dying patients $20,000 a month — a price that would decline if generics were available.
Greg Geissman, a spokesman for Celgene, said the company had not prevented generic companies from obtaining their products.
“We have sold and will sell our groundbreaking products to generic manufacturers for the purposes of bioequivalence testing, subject to reasonable safetyrelated and business requirements,” Geissman said.
Geissman also said that Celgene supports federal efforts to promote access to samples at reasonable prices, as long as there is appropriate safety and liability protection for the seller.