Tuesday, December 14, 2010

Hamburg's FDA Getting Tough?

A website called FDAzilla, designed to assist industry in "working smarter with the FDA," says that the FDA is getting tougher under Commissioner Margaret Hamburg:

  • A commitment to go personally after Pharma execs who violate the law around marketing off label drugs, rather than just slap the company with a fine. A former Glaxo lawyer has been indicted for lying to the FDA in such a case.
  • Doing away with the Bush administration practice of demanding that warning letters sent to companies first have to go through a review by the Legal department--which turned out to massively slow down the process of issuing such letters.
  • Increasing foreign inspections in the wake of scandals regarding unsafe imported chemicals, and making moves to hold US companies responsible for shoddy imported ingredients.
Says their blogger, "A lot of people talk about how the FDA has hired a ton (hundreds?) of new inspectors and that the FDA FY11 budget is almost 2x that of FY08. I think a lot of that just comes with an increasingly complex world (both with science and with globalization). But make no mistake about it, the FDA under Hamburg will only get more aggressive. While she has already instituted a lot of changes, changing an organization the size and complexity of the FDA takes time. So, expect a lot more in the next few years."

Some say it's about time.

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