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September 17, 2008
Caste of Characters
by Peter Pitts
The House Energy & Commerce Committee needs to help fix the problem, not the blame.
Statements coming out of the committee like -- “The FDA has refused to take meaningful regulatory action despite the fact that, for the past three years, it possessed credible information that Ranbaxy had engaged in a pattern of fraudulent behavior regarding its generic drug applications and records pertaining to good manufacturing practices.” -- is not being fair to an agency that at the time under debate and yet today is under-funded and under-staffed.
But when the committee says -- “The FDA, for example, conducted preapproval inspections for only 17 percent of the Ranbaxy applications approved since January 2005. It also allowed Ranbaxy to perform the key bioequivalence studies for generic drug approvals in facilities owned by the firm and conducted by clinicians employed by the firm.” – they’re right. The same rule that holds true for innovator companies must also applied to generic drug manufacturers – otherwise the public’s queasiness about the quality and character of generic drugs will continue.
But Representative John Dingell, who chairs the committee, goes to far when he says, “The heparin fiasco made it clear that the FDA had compromised the policies that were put in place during the last generic drug scandal to protect the public from fraud. This latest Ranbaxy announcement further confirms that those protective policies are in shambles. The FDA is not doing its best to protect the medicines that Americans depend on for their health.”
That’s not true. It’s not fair. And it’s not helpful.
Posted by peterpitts at September 17, 2008 08:12 AM
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