FDA commissioner offers efforts to address high drug prices and facilitate competition in market

In an interview with Kaiser Health News, current Food and Drug Administration commissioner Scott Gottlieb expresses hopes to increase access to lower-cost alternatives to drugs by reducing roadblocks to competition in the drug market.

One of the FDA's considerations is the 180-day exclusivity period generic manufacturers. Following the expiration of a branded drug's patent, one generic manufacturer can be granted a period of 180 days in which no other generic alternative can enter the market. In some cases, brand-name manufacturers and generic manufacturers can strike deals in which the former pays the latter to not enter the market at all. The brand-name manufacturer can earn profit that exceeds the amount paid, and other potential generic competitors are still blocked from entering the market. As a result, the original manufacturer extends the period during which no competition exists for its drug.

The FDA is also looking into the possibility of generic manufacturers purchasing drugs from the European market without having to perform bridging studies. Bridging studies are done to prove the European drugs are the same as those in the American market. Generic manufacturers need to purchase large quantities of branded drugs in order to develop alternatives, but brand-name manufacturers often prevent generic companies from doing so. Turning to the European market may help generic companies circumvent this issue.

The FDA also aims to increase the rate at which new drugs are approved for market entry. In 2017, 46 new drugs were approved - the highest figure in 21 years. However, when drugs are approved quickly, the degree to which these newer drugs can improve quality of life or extend lifespan is more questionable. Still, the FDA commissioner believes that a high standard for new drugs can be maintained while avoiding more extensive and costly development processes.

By encouraging a free market for competition, helping to facilitate the drug development process, and increasing the rate at which drugs are approved, the FDA aims to address the issue of extremely high pricing of prescription drugs.