Keystone compliance cops
09/01/2003
The Food and Drug Administration's right hand doesn't know what the left is doing, and despite the validity, the bureaucracy-mired agency recoils when questions abound.
Adven Medical Inc. (Lubbock, Texas) has worked closely with the FDA in what CEO Mark Aldana describes as cordial rapport aimed at ensuring cleaning, sterilization and validation protocols fell in line with current good manufacturing practices (cGMPs).
Aldana, to put it mildly, was sucker-punched with an FDA press release full of "false and inflammatory" information that sparked him to issue his own statement, a rather believable haymaker revealing apparent agency deception and incompetence. (See story, page 26.)
He certainly makes a case, and this isn't the first instance of FDA bullying.
The FDA action against Adven reeks of impropriety. A medical device re-processor, one that continually sought FDA feedback, was backstabbed by a self-effacing agency, where communication between offices seems to be non-existent. Moreover, actions against Adven do not mesh with the risk- and science-based goals outlined in the FDA mission to revamp cGMPs.
Life sciences companies are already weathering economic and political storms, and it is time to hold the FDA accountable for being the port that it has promised it would be.
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Mark A. DeSorbo
Associate Editor