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COMMENTARY

Questioning Authority with Questionable Tactics

A drug company's efforts to turn up the heat on an FDA official backfires.

PETER J. PITTS

The Burrill Report

“Private investigators working for a drug company gathered information on a high-ranking official at the FDA-unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand.”

To repeat that quote from Theodore Roosevelt, “When you’re in a hole, stop digging.” Note to Amphastar Pharmaceuticals—stop digging.
Back in August Amphastar was so dissatisfied with the way the U.S. Food and Drug Administration was dealing with its file for generic Lovenox, it decided to claim unfair treatment at the hands of the agency’s Center for Drug Evaluation and Research Director Janet Woodcock.

Amphastar claimed that its rival, Momenta, had a “leg up” and was getting “special access.”  And yet both companies were in the same place in the regulatory process and both companies are being asked for the same data sets.  And this is unfair why?

According to Amphastar, it's unfair because Woodcock co-authored a paper with one of Momenta's founders, MIT biological engineering professor Ram Sasisekharan, on how the FDA taskforce (on which they both served) identified and contained the cause of contaminated Chinese heparin imports.

To nobody’s surprise, the inspector general of the U.S. Department of Health and Human Services has cleared Woodcock of all allegations of conflict of interest.

Not satisfied to acknowledge a boner of monumental proportions, Amphastar's general counsel Jason Shandell said that the FDA narrowly tailored its review to legal issues. “We never asserted she got any money—that would be illegal. Our focus was on the appearance of impropriety and its impact on the approval system.”
Remove foot from mouth, right?

Um—not so fast. According to Politico: “For more than two months in late 2008, private investigators working for a drug company gathered information on a high-ranking official at the FDA—unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand.”
Politico reported that Amphastar paid “more than $100,000 to Kroll, the New York-based private investigative firm, to uncover the information about Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, who oversees the agency’s new-drug approvals.”

And it gets worse. At one point, the investigators hired a freelance reporter to file Freedom of Information Act requests, using her status as a journalist, to request Woodcock’s emails, phone records, voicemails, calendar and expense reports, among other documents—without mentioning that she was being paid for her efforts by a private investigative firm. Oops.

And worse.

“On behalf of the drug company Kroll also investigated a second FDA official—Moheb Nasr, director of the FDA’s Office of New Drug Quality Assessment, creating a file on him that included his birth date, the price he paid for his home, and details of his education and professional background,” Politico reported.

Amphastar’s general counsel Shandell defended the companies actions. “I feel like as a citizen you have a right to question your government and a right to look at public information,” he said. “There was no impropriety here.”

A lesson in why you should not let your lawyer act as spokesperson.

To make matters worse for Amphastar, they’re now squarely in the crosshairs of Senator Max Baucus (D, MT), who said it was “an outrage,” and has demanded that Kroll tell him how often private detectives target public officials.

“Pharmaceutical companies should be focusing on getting their drugs approved based on health research and science rather than wasting their resources hiring private investigators to snoop around the lives of FDA regulators and their families,” said the Senator.
An apology is in order.


Peter J. Pitts is President of the Center for Medicine in the Public Interest and a former FDA Associate Commissioner.


April 03, 2010
http://www.burrillreport.com/article-questioning_authority_with_questionable_tactics.html


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COMMENTS


Jarvis April 05, 2010

Why should they apologize? For doing the same thing that resulted in the 1989 generic scandal being brought to light? Personally, I believe their suspicions are right on target, and it is Amphastar that is owed an apology. There is much good reportage on this mess, better than this miserably one-sided article. If you truly wish to learn something of what is happening here, do a little digging and read the articles pieced together by Andrew Zajac and Alicia Mundy. Until then, kindly get your facts straight before launching gratuituous attacks on others.


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