FDA plots better foreign inspections

The FDA just can't win. Even as it answers one set of critics, it's attracting new ones. Today, the agency said it would post food and drug inspectors overseas permanently in an attempt to darn its foreign-product safety net. Good; the FDA's foreign enforcement is seriously lacking, as we all learned last fall. The FDA troops would then train foreign inspectors so that enforcement doesn't fall only on the U.S.

Meanwhile, a barrage of Vytorin-related criticism from Congress and news that the diabetes med Avandia will get new warning labels in the EU are reviving questions about just how thorough the FDA's drug-approval process is. For instance, should the agency allow drug makers to use "surrogate markers"--e.g., blood sugar levels in diabetes and cholesterol levels in heart disease--as proof that a drug works? Or should it demand actual outcomes studies before drugs are approved? Should the FDA at the very least prevent companies from touting their drugs to consumers before outcomes studies are complete?

Big questions that could have big consequences for pharma. Already frustrated by the slow pace of new drug approvals, drugmakers would gnash their teeth at tougher scrutiny, which might add years to development times and millions to development costs. But pharma isn't doing itself any favors with Vioxx/Avandia/Vytorin scandals. Finding middle ground won't be easy, and even then, it's likely to be an unhappy medium.

- read the foreign inspection report from the New York Times
- read about the FDA approval pile-on in the Wall Street Journal
- here's a Q&A with FDA Commissioner Andrew von Eschenbach