When he served as commissioner of the Food and Drug Administration (FDA), Dr. Scott Gottlieb pressed for lower prescription drug prices by speeding development of generic alternatives. His successor is following his example.
Acting FDA Commissioner Dr. Ned Sharpless has announced that the agency is moving forward on plans to streamline the development and approval process of high-quality generic drugs. Generics made up about 90 percent of prescriptions dispensed in the U.S. in 2017. The FDA approved or tentatively approved more than 2,000 generic drug applications in 2017 and 2018.
Generic drugs are usually significantly cheaper than their name brand counterparts since more than one manufacturer can make them. Sharpless said the FDA’s efforts have been directed at getting more competitors into the marketplace so prices will come down.
Gaming the system
Last year, the FDA accused several drugmakers of blocking development of generics by throwing up delay after delay. The agency said major pharmaceutical companies have deployed “gaming tactics” to keep competitors from creating cheaper versions on their off-patent drugs.
“One example of such gaming is when potential generic applicants are prevented from obtaining samples of certain brand products necessary to support approval of a generic drug,” the FDA said. “The inability of generic drug companies to purchase the samples they need slows down, or entirely impedes, the generic drug development process -- leading to delays in bringing affordable generic alternatives to patients in need.”
When he assumed office, Gottlieb was confronted with a backlog of nearly 4,000 generic drug applications. Before leaving office in April, Gottlieb presided over FDA approval of naloxone, the first generic version of an opioid addiction drug; a generic version of valsartan, a high blood pressure drug that was recalled for impurities; and the first generic naloxone hydrochloride nasal spray -- Narcan -- which can often counter the effects of an opioid drug overdose.
With Gottlieb’s departure, Sharpless says the FDA is still reducing approval times and enhancing the efficiency of certain aspects of the submission process for generic drug applicants.
“We also are striving to provide the industry with greater transparency in order to provide greater certainty around timing of market entry and empower more informed decisions on how to prioritize their resources,” Sharpless said.
Sharpless also said the agency is making it easier for generic applicants to challenge existing drug patents before they expire on the grounds that the patent is invalid or unenforceable. In recent years, some critics have charged drug manufacturers of extending patents by slightly changing a drug’s formulation and applying for a new patent.