By EAMON JAVERS | 3/30/10
Politico
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, is one of two officials Amphastar Pharmaceuticals paid to have investigated.
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.
Politico
Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, is one of two officials Amphastar Pharmaceuticals paid to have investigated.
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.