Consumer Law

The FDA: Run by Colonel Klink?

By Andy Hoffman

Just in time for the Washington Post to expose yet another example of the FDA?s Sargent Schultz-like willingness to ?know nothing? when it comes to unfavorable drug trials that big pharma is trying to bury,  The Wall Street Journal?s ?Health? blog is reporting that FDA Deputy Commissioner Frank Torti recently released a kind of ?shut up, or else? memo to his staff.  In it, the tempestuous Mr. Torti warns against leaking ?internal memoranda, letters, and e-mail to and from employees within FDA? or risk ?disciplinary sanctions and/or individual criminal liability.?

Of course all of this begs the question: does Washington Post columnist, Michael Kinsely read his own paper?and if so, what makes him so eager to make the FDA the sole ?decider? when it comes to approving new drugs and medical devices?

Whatever the case, Steve Nissen, a Cleveland Clinic cardiologist who often advises members of Congress and their staffs about pharmaceutical problems and the FDA shared in our dismay.  ?I?m a little stunned that the FDA would send this [memo] out at this time,? said Nissen, noting that he feels agency leaders disclose ?too little? about their interactions with industry lobbyists and lawyers.  ?I wonder what some of the people on the Hill think.?

Whatever they think, we sure hope they take it into consideration when it?s time to vote on the Medical Device Act.

Full post as published by ThePopTort on March 19, 2009 (boomark / email).