Drug firm investigated FDA officials - Eamon Javers - POLITICO.com:
Drug firm investigated FDA officials
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 retracing 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.
At stake for Amphastar, a generic drug maker, was whether the FDA would allow it to bring to market a version of a prescription drug for blood clots and gain access to a market worth more than $3 billion.
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.
Amphastar says the investigation was done in order to find out if Woodcock or Nasr was unfairly favoring a competitor in the drug approval process and that it did nothing wrong.
“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.”
Shandell said the investigation was limited to public records, database searches and other information available to the general public.
But the case has attracted the attention of investigators working for Senate Finance Committee Chairman Max Baucus (D-Mont.), who said it was “an outrage” and has demanded that Kroll tell him how often private detectives target public officials. He also had harsh words for Amphastar.
“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,” he said.
The details of the drug company investigation, which came to light after committee investigators requested documents from Amphastar last fall, offer a rare glimpse inside the world of high-stakes corporate detective work.
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 e-mails, phone records, voice mails, calendars and expense reports, among other documents — without mentioning that she was being paid for her efforts by a private investigative firm.
“I am making this request as a journalist and this information is of timely value,” Melanie Haiken, a San Francisco-based freelance reporter, wrote to the FDA. “As a journalist, I am primarily engaged in disseminating information.”
Haiken did not disclose that she was working for the private investigators at the time. In an e-mail explaining its fees, Kroll told Amphastar that the expenses related to the FOIA covered “the cost of the person we are using to make the requests untraceable to you, the client.”
“I am wondering if this is an isolated instance or if Kroll is using journalists, who purport to be working in the public interest, to file FOIA requests on behalf of clients in order to take advantage of reduced fees and expedited processing,” Baucus wrote in a letter to Kroll CEO Ben Allen.
Woodcock and Nasr did not respond to requests for comment. Neither did the FDA.
Amphastar turned to Kroll in late 2008, after becoming increasingly frustrated that the FDA was dragging its feet in approving the company’s generic-drug application for low-molecular-weight heparin. In addition, the company’s executives became worried that the FDA was favoring a competitor, Massachusetts-based drug manufacturer Momenta Pharmaceuticals, and suspected that Woodcock, the official they blamed for the delays, was somehow allied with Momenta.
As evidence, Amphastar pointed to a paper Woodcock had co-authored with Momenta co-founder Ram Sasisekharan. And, it noted, Woodcock had been a featured speaker along with him at the Shangri-La Hotel in Bangkok in 2007.
Collusion between FDA officials and drug companies has happened before — a history Amphastar was well aware of when it launched its investigation.
In 1989, three FDA officials pleaded guilty to taking bribes and two companies said they had submitted false information to the government in a scandal that rocked the pharmaceutical world. And that scandal came to light only because an aggrieved drug company had hired private investigators to dig into suspicious relationships.
According to a document titled “Suggested Items for Investigation,” Kroll’s plan for investigating Amphastar included digging up information on “[Janet Woodcock] and her relatives and friends; J.W.’s financial status and lifestyle change since 2004; any entities ... that JW, her relatives or friends partially own or are affiliated with in the U.S.”
Other objectives included determining if Woodcock or any of her family members maintained any Swiss or Cayman Islands bank accounts or companies.
By the end of October 2008, Kroll had completed an “interim report” on Woodcock and Nasr. In it, Kroll detailed Woodcock’s birth date, the state in which her Social Security number had been issued, the identity of her husband, Roger Miller, their home address and the value of her Brookeville, Md., home. Kroll also uncovered similar details about Nasr.
But Kroll had come up empty — finding little evidence of an improper connection.
“To date, Kroll has identified no reports indicating that Woodcock’s relationships with Nasr [and another individual] are anything but of a professional nature,” Kroll concluded. “Kroll has identified no personal or business links with the Sasisekharan family other than Woodcock and Ram Sasisekharan’s well-publicized, jointly authored reports.”
But despite the report, Amphastar in April 2009 filed a complaint with the FDA, alleging that Woodcock and Momenta had an improper connection.
“Sure, we don’t have a smoking gun,” Shandell said, “but there appears to be some relationship between these two that goes beyond the typical FDA relationship.”
The FDA’s legal counsel, however, said in February that Woodcock’s interactions with Momenta did not constitute a conflict of interest.
Rick Shea, the chief financial officer for Momenta, also said his company acted properly in its interactions with the FDA. “There certainly was no inappropriate relationship between anybody at Momenta or anybody associated with Momenta and anybody at the FDA,” Shea said.
Haiken, the freelance journalist, confirms that she filed the FOIA on behalf of Kroll. But Haiken said her intent was journalistic and that she hoped the FOIAs would yield an interesting story. “I’m not really an investigator, I’m a health writer,” she said. “I have a right to get a story tip from somebody, even if it’s somebody at Kroll.”
Individual investigators inside Kroll billed for their time like lawyers, with rates ranging from $125 to $390 per hour. By the end of November, the company had charged Amphastar more than $100,000. Its invoice included $596.25 for “calls to Thailand regarding Woodcock’s hotel stay. Further research on … conference participants and board members. Further research on Woodcock schedule prior to and after the conference.”
Kroll also sent Amphastar a memo titled “Woodcock/Miller Family Members.” That document detailed the biography of Woodcock’s husband and information about the couple’s two daughters.
An outside public relations consultant for Kroll issued a statement in response to POLITICO’s questions about its investigation.
“We have received Senator Baucus’s letter and will review the request, bearing in mind our obligations to our client and client confidentiality,” Kroll said.
© 2010 Capitol News Company, LLC