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Although the Food and Drug Administration has maintained that additional generic approvals should promote competition and alleviate shortages, the proportion of approvals for drugs that could address those concerns has actually remained steady, according to a new report.

From July 2016 to December 2018, the total number of generic drug applications approved by the agency gradually increased during most quarters, from 133 to 262. Of the 1,832 generics approved during that time, 20.4% faced limited competition at the time of the approval, and 39.1% had experienced a shortage in the previous five years.


“Our results suggest that there have not yet been noticeable effects of the FDA’s initiatives to expand approvals for generic drugs at risk for price spikes and shortages,” the authors wrote late last week in a JAMA Network Open research letter.

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  • Ah, and there is the nub, right at the end – “but it doesn’t help with competition or access if these products are never sold” – companies seem to be stockpiling applications without intention to manufacture or sell. Perhaps waiting for a more favorable price environment?

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