Nature Medicine | Spoonful of Medicine

FDA on track for a record-high number of drug approvals this year

Although the year is barely half over, the US Food and Drug Administration (FDA) is about to hit a year-end milestone: topping its number of drug approvals from 2010. The goal shouldn’t be too tricky as the agency only green-lighted 21 drugs last year, the lowest level in a decade.

Congressional leaders — who are deciding whether to reauthorize the Prescription Drug User Fee Act, which requires drug companies to pay fees to fund FDA staff and technology — weren’t too happy about this low approval number. According to LillyPad, a blog from the Indiana-based drugmaker Eli Lilly, House Energy and Commerce committee Chairman Fred Upton, a Republican from Michigan, blamed inefficiency and unpredictability at the FDA for “stifling American innovation, costing American jobs, and hurting American patients.” So he summoned one of the FDA’s top brass to a hearing yesterday to evaluate the agency’s drug approval process.


However, Janet Woodcock, head of the FDA’s drug division, wasn’t going to put up with that trash talk. The agency approves two-thirds of new drugs within 6–10 months and meets 90% of its deadlines, she said. In her staunch defense, Woodcock blamed the drop in approvals on drug companies and their shoddy products, not FDA regulations, for the low number of approvals last year.

Congressional subcommittee battles aside, the FDA has approved some promising drugs this year. The first lupus drug approved in a half century, Benlysta (belimumab), received a thumbs-up in March, and later that month, the melanoma drug Yervoy (ipilimumab) passed through the FDA with flying colors. And in May, the FDA also approved Merck’s Victrelis (boceprevir) and Vertex Pharmaceutical’s Incivek (telaprevir) for Hepatitis C.

Maybe we ought to cut Woodcock some slack. A typical year doesn’t have that many drug approvals — 25 and 24 in 2009 and 2008, respectively — and, at the rate things are going, 2011 may top them all.

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