Generic drug approvals haven't significantly increased, despite FDA's efforts, study finds

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Though the FDA has said it will approve more generic drugs as a strategy to increase competition and combat drug shortages, a study published by JAMA Network Open found that the number of generic approvals has remained steady.

From July 2016 to December 2018, the FDA approved 1,832 generic drugs. Of those approved generic drugs, 20.4 percent had limited competition at the time of approval and 39.1 percent faced a shortage within the last five years.

In recent years, the FDA has taken steps to try to increase the number of generic drug approvals, such as releasing a list of generics with limited or no competition, prioritizing reviews of applications with less than three approved generics and creating a competitive generic therapy designation. However, JAMA's study found that the number of generic approvals hasn't increased significantly as a result of those measures.

The authors of the study noted that it takes time for generic drugmakers to prepare applications as well as up to a year for regulatory review. Since the policies started in 2017, it could take time for results to appear.

Recently released FDA data also indicates generic approvals may be increasing faster since the start of 2019. Twenty-seven priority applications for generic drugs were filed in the first quarter of 2019, which rose to 52 in the second quarter and 48 in the third quarter. In addition, the number of drugs given competitive generic designation rose from 48 in the first quarter to 84 in the third quarter.

Erin Fox, PharmD, a co-author of the study published in JAMA who is the director of drug-information service at Salt Lake City-based University of Utah Health, told STAT the FDA could increase generic approvals if it prioritized approvals for products that will actually be sold.

The "FDA approves many applications for things that never actually are sold or on the market," Dr. Fox told STAT. "This makes it look like there are more products than there actually are if you just look at FDA's site, but it doesn’t help with competition or access if these products are never sold."

Read the full article here.

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