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Wajert-Bexis Published On FDA Shift Away From Internal Oversight

By James M. Beck and Mark Herrmann

Proving they can do more than just blog, Dechert's two longest-running bloggers, Bexis and Sean Wajert (who writes the Mass Tort Defense Blog), along with associate Vince Gallo, recently wrote a "Legal Backgrounder" for the Washington Legal Foundation analyzing the FDA's decision to do away with the vetting of its Warning Letters by actual lawyers before such letters are issued.

The predictions:  (1) more warning letters about less important things; (2) poorer quality and more mistakes as FDA employees apply their own subjective standards concerning what's a violation and what isn't; (3) increased liability risks as the folks on the other side of the "v." pick up on letters suffering from defects (1) and (2); and (4) a greater likelihood of warning letters that improperly curtail the First Amendment rights of regulated entities.

If that kind of stuff interests you, take a look.

Full post as published by Drug and Device Law on January 21, 2010 (boomark / email).