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BioPharm Executive: FDA, Faster Than Ever?


7/25/2011 3:57:23 PM

FDA, Faster Than Ever?

At the recent BIO annual convention in Washington, D.C., Biotechnology Industry Organization president Jim Greenwood offered up a legislative blueprint to revamp the mission of FDA's (we previewed it briefly last month). Among the proposals were to make FDA an independent agency of government--rather than arm of the Department of Health and Human Services -- and to make promotion of innovation part of its mission. BIO is even seeking to change the agency's system of basing approval decision on two well-controlled clinical trials. The proposal would instead have approval hinge on the "weight of evidence."

All bold stuff, if unlikely to find much traction in Congress anytime soon. But BIO's bold reform initiative is at least in part an expression of industry frustration with the current state of FDA, which they say is approving too few drugs, too slowly, with too many strings attached.

Then, lo and behold, comes testimony from Drug Division director Janet Woodcock that FDA is on track to approve more drugs in 2011 than it has in 20 years! In the first half of the year, she said, the agency has already approved 20 new molecular entities--versus 21 for all of 2010. "We’re seeing a lot of innovation, much more than in recent memory," she told the House Energy and Commerce's health subcommittee. A subsequent article in the Wall Street Journal predicts a period of productivity through 2019 exceeding anything in the history of the industry.

How could this be? Is BIO speaking out too soon against bureaucratic stagnation at FDA? Or is this year just a fluke, with the large number of approvals coming in part from chance and in part from drugs previously delayed?

It seems likely that it's a little bit of both. FDA is governed by politics, and like other political entities it gets far too much blame for things that go wrong. (Presidents, at least, get to balance all the angry finger-pointing with largely undeserved credit for what goes right, but I'm not sure FDA enjoys that benefit.) Approvals correlate more highly with innovation and R&D efficiency than they do with FDA's perceived risk-tolerance, and right now we may be finally starting to see the fruits of more rational approaches to drug discovery born in the late 1990s and early 2000s. It takes that long, after all, for drugs to make it from the lab bench to the market. That, at least, suggests that we may really see a prolonged period of above-average approvals for innovative new products. Here's hoping!

-Karl Thiel

Read the BioPharm Executive online newsletter July 2011.

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