FDA Moving to Boost Generic Competition, Lower Drug Prices


The FDA is taking steps to increase the number of generic drugs on the market as part of its overall plan to increase competition and lower drug prices.

The Food and Drug Administration June 27 said it is implementing a new policy to expedite the review of generic drug applications until a given drug product has three approved generics.

The agency also published a list of off-patent, off-exclusivity branded drugs that lack generic competition, which is intended to spur manufacturers to develop generic versions of these drugs. The list includes Pyrimethamine, which is sold under the brand name Daraprim. Martin Shkreli, the former chief executive officer of Turing Pharmaceuticals AG, purchased Daraprim in 2015 and increased the price from $13.50 to $750 per tablet. Daraprim is used to treat toxoplasmosis, a parasitic infection that can be life-threatening for people with HIV/AIDS, cancer, and other conditions that cause compromised immune systems.

The FDA’s actions are part of the agency’s Drug Competition Action Plan, announced by FDA Commissioner Scott Gottlieb June 21. The more generic drug competition a particular drug has, the lower its price.

The agency’s moves come as drugmakers are under heavy scrutiny by lawmakers, consumers, medical professionals, and President Donald Trump for their pricing practices. The increased focus on drug prices was spurred by companies, like Turing Pharmaceuticals, that significantly hiked the prices of older pharmaceutical products that lacked competition.

Premier Inc. said in a June 28 statement that while it supports the FDA’s actions, more needs to be done. Premier is a health-care improvement company, uniting an alliance of about 3,750 U.S. hospitals and more than 130,000 other provider organizations.

“While we applaud these important actions by the FDA to address issues that are helping to cause high drug prices and shortages, we recognize that more needs to be done. Premier recently released nine policy recommendations Congress and the administration should take to create healthier and more competitive pharmaceutical markets, and drive toward the goal of achieving a high-quality, cost-effective pharmaceutical industry,” Premier said.

Read my full article here.

Stay on top of new developments in health law and regulation with a free trial to the Health Law Resource Center.

Learn more about Bloomberg Law and sign up for a free trial.