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 unsatisfied with the way the FDA was dealing with their file for generic Lovenox, they decided to claim unfair treatment at the hands of CDER Director Dr. 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 CDER Director, Dr. Janet 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.
Well, to nobody’s surprise, the inspector general of the Department of Health and Human Services has cleared Janet 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 Food and Drug Administration – unearthing details about her husband, two daughters, and in-laws, and re-tracing her steps on a business trip she took to Thailand.
The drug company, Amphastar Pharmaceuticals Inc., 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.
According to Politico, “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.”
And here’s a lesson to all of you drugwonks out there – do NOT let your lawyer act as spokesperson.
“I feel like as a citizen you have a right to question your government and a right to look at public information,” said Amphastar’s general counsel, Jason Shandell. “There was no impropriety here.”
So now the conversation has moved Amphastar’s boner. Solid PR.
And to make things even 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.
