Grassley, FDA Focus on Increasing Generic Drug Competition


The Food and Drug Administration should expand generic drug access as a way to lower prescription drug prices, a key senator said.

Sen. Chuck Grassley (R-Iowa), chairman of the Senate Judiciary Committee, in a June 19 letter asked FDA Commissioner Scott Gottlieb to look at ideas in proposed legislation as the agency forms a plan to address high prescription drug prices.

Meanwhile, Gottlieb said in a June 21 blog post that his agency is working on an action plan to increase competition in the market for prescription drugs through the approval of lower-cost generics.

Gottlieb said as part of the action plan, the FDA will hold a public meeting July 18 on federal rules being used to thwart generic competition, and added the FDA will look at how it can coordinate with the Federal Trade Commission to identify and publicize practices that stifle competition.

Drugmakers are under heavy scrutiny by lawmakers, consumers, medical professionals, and the president for their pricing practices. The increased focus on drug prices was spurred by companies significantly hiking the prices of older pharmaceutical products that lacked competition.

David Balto, an antitrust lawyer in private practice and former policy director at the FTC, told me June 21 the FDA’s action plan “is a crucial first step. Regulation can be a tool to strengthen competition but it can also be abused to limit access to the market.”

“The FDA is not a competition agency and the FTC is not a regulatory agency so it’s vital for the two of them to go and educate each other about how the regulatory process can be abused to deter competition,” Balto said.

Read my full article here.

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