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# FDA Should Make Off-patent Drugs Affordable: Researchers
- URL: https://www.fdaweb.com/fda-should-make-off-patent-drugs-affordable-researchers/
- Published: 2016-01-04T12:00:00.000Z
- Updated: 2026-09-15T02:24:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5134300

> Three Johns Hopkins researchers say that because FDA approves the generic products that establish competitive markets, the agency should have a more active role in ensuring that patients have access to essential drugs that have been affordable for many years. Writing in a *Journal of the American Medical Association* [Viewpoint](http://jama.jamanetwork.com/article.aspx?articleID=2480263&utm%5Fsource=Silverchair%20Information%20Systems&utm%5Fmedium=email&utm%5Fcampaign=JAMA%3AOnlineFirst01%2F04%2F2016), the three say there has been significant concern in HHS and Congress recently over the off-patent drug market with limited or no competition. “Several pharmaceutical companies have developed a novel business strategy of dominating noncompetitive markets for older drugs and then increasing the price substantially,” they write.  
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> While in competitive markets another manufacturer could begin to produce and offer a product at a lower price when a price is too high, the article says, this can happen under the FDA approval process to ensure bioequivalence and quality manufacturing only at the speed of agency review.  
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> The report notes that FDA continues to work its way through a significant backlog of generic drug applications and that even with the greater resources provided by the Generic Drug User Fee Act it will take years to review all the applications. Although there have been calls for the agency to change its standards, the researchers say that a better solution would be for it to prioritize review of applications for essential drugs that can have a major effect on competition and market affordability.  
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> The article also says that during the six to 12 months of a priority review, FDA should evaluate temporary measures to restore affordability and access, including considering temporarily permitting compounding of a drug at issue, and temporarily permitting the importation of drug products reviewed by competent regulatory authorities and approved for sale outside the U.S.  
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> “Congress should continue its investigation to illuminate the business strategies that are distorting the market for generic drugs,” the article concludes, “with a focus on eliminating price gouging. At the same time, FDA should act under its existing authority to protect the public. Moving forward would signal FDA’s commitment to protecting the competitiveness of the generic drug market. Doing so would also invalidate the business case for cornering markets on older, essential medicines and reaffirm the role of high-quality affordable generic drugs for clinical use in the United States.”