Generic Drugs Achieve Record FDA Approvals, Aim to Lower Prices

Jack O'Brien, December 12, 2017

As the FDA continues to approve generic drugs at a record clip, patients see the potential for reducing costs while nonprofits hope for increased availability of generics during a nationwide shortage.

FDA Commissioner Scott Gottlieb, MD, released the latest data last week on approvals of generic prescription drugs. Through November, the FDA has granted 929 approvals or tentative approvals for generic drugs, at an average rate of 84.5 per month this year. This past month saw 107 generics earn approval, besting the previous all-time high of 101, a record the FDA had just set one month prior.

The FDA has seen its generic approvals record reset in recent years, rising from 726 in 2015 to more than 800 in 2016. The agency says the approval of multiple generics to an existing brand-name drug encourages a competitive marketplace to ensure lower prices for consumers.

President Donald Trump has named lowering prescription drug costs among his goals in office, as have leaders on Capitol Hill.

Typically, generics drive down drug prices by as much as 80%, according to the Commonwealth Fund. That saved Americans $253 billion last year and saved the U.S. healthcare system $1.67 trillion from 2007 through 2016, according to the Association for Accessible Medicines 2017 report on generic drug access and savings.

Understanding the process and its changes

The current FDA approval process for generic drugs is based on a comparison with the brand-name drug to ensure the new product “demonstrates bioequivalence.” FDA approvals are not based on price considerations, though Gottlieb has indicated a willingness to move proactively against anti-competitive behavior by approving lower-cost generics.

Jack O'Brien

Jack O'Brien is an associate editor at HealthLeaders Media. 

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