Why Did New Drug Approvals in the U.S. Plunge This Year?

December 15, 2016, 11:05 PM UTC
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Photograph by Douglas Sacha - via Getty Images

Last year, the Food and Drug Administration approved a whopping 45 new drugs, one of the highest numbers since 1996. In 2016, that number’s fallen to a dismal 19 (as of Dec. 9). But why?

The latest annual report from the FDA’s Office of New Drugs approves drugs provides some insights into the sharp drop-off. (For some context: “new” drug approvals only refer to genuinely new therapies, and wouldn’t include, for example, an existing cancer drug that was already approved to treat melanoma and then gained an additional indication to treat lung cancer.)

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From 2011 to 2015, the agency significantly ratcheted up its pace of drug approvals, green lighting an average of more than 36 new drugs annually over that five-year period. And the most recent year that the FDA approved less than 20 new treatments was all the way back in 2007, an era that’s widely considered a nadir of successful biopharma drug development.


Office of New Drugs Director Dr. John Jenkins cites three reasons for the decline:

1) There were five new drug applications that weren’t supposed to be processed until 2016 that the agency approved ahead of schedule in 2015, simultaneously inflating last year’s total and deflating this year’s number.

2) In general, biopharma companies filed fewer applications for new drugs.

3) The FDA issued more rejections (potentially temporary) than usual, citing manufacturing concerns at plants developing experimental treatments.

Drug approvals tend to swing on a pendulum. The FDA was criticized for not aggressively moving new drugs to the market a decade ago. Now, some critics have argued that the pendulum has swung too far in the opposite direction, and that the agency has been clearing treatments that haven’t necessarily been proven effective.

And it’s entirely possible that the 2016 drug approval decline will reverse itself in the coming years given the recent passage of the 21st Century Cures Act. The legislation was overwhelmingly supported by Congress and nearly every health special interest group (patient advocates and big pharma alike) since it aims to speed up the drug and medical device approval process, especially for diseases with unmet medical needs. But critics argue that it could also lower the FDA’s standards and allow unproven therapies to reach American patients.

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