FDA Commissioner Scott Gottlieb said the agency may expedite applications for some generic drugs in an attempt to bring more price competition to the US market, Bloomberg reported. "We know the most significant savings to consumers comes when there are three generics on the market," Gottlieb remarked.
Gottlieb was confirmed by the US Senate last month to head the FDA, and has previously highlighted a need for the regulator to play a larger role in controlling drug pricing. For related analysis, read ViewPoints: Trump eschews unpredictability by tapping Gottlieb to head FDA.
According to Gottlieb, the point at which prices start to fall significantly is when there are three manufacturers for a particular generic drug on the market. An analysis by the FDA suggests that the first generic version of a medicine to reach the market will "only slightly lower" the price compared to the branded product. Meanwhile, the introduction of a second generic version will cut the price by almost half of the originator, with subsequent approvals slashing the cost to 20 percent of the branded version.
The FDA is also considering whether to publish a list of the 180 branded drugs that no longer have patent protection and still don't face any generic competition, 150 of which the agency has never received an application from a generic drugmaker to review. Gottlieb said publishing it "might create a more compelling business opportunity."
Last month, Gottlieb unveiled several proposals aiming to increase the FDA's ability to influence drug pricing and increase generic competition. Among these, Gottlieb indicated that the agency is looking at ways to eliminate the backlog of 2640 generic drug applications within a year.
Previously, Gottlieb postulated that the FDA could take steps to stop brand-name manufacturers from preventing generic drugmakers from obtaining samples of their drugs for testing by restricting distribution. "Getting access to 3000 tablets can be hard unless the branded companies are going to facilitate the ability of the generic companies to get the drug," Gottlieb noted, adding "they can't just go into the market and buy it readily."
Additionally, the FDA Commissioner stated he wants to implement measures to hasten the approval of complex generic drugs, particularly those that combine a medicine with a delivery device .Gottlieb said he expects that the agency will release "a whole series" of documents to advise industry on the issue, while a number of the ideas will be discussed at a public hearing expected to be held in the next several months.