New drug OKs fell off a cliff in 2016 and the FDA wants you to know why
The FDA’s John Jenkins has one more annual review on new drug approvals before he retires as director of the Office of New Drugs. And it’s not a pretty picture.
After tracking surging new drug approvals for much of the past 5 years, which helped alleviate concerns about the industry’s overall R&D productivity rate, the agency posted only 19 new BLAs and NDAs in 2016 — a low the agency hasn’t seen since the bad old days of 2007.
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