FDA Bowed to Drug Company Pressure in Reassigning ReviewerFeb 8, 2008 | Parker Waichman LLP
There is more evidence that pharmaceutical companies are interfering with the Food & Drug Administration (FDA). Senator Charles Grassley (R-Iowa) has charged that the FDA did not exercise scientific objectivity when it reassigned an agency veterinarian based on unsubstantiated claims by the drug company, Wyeth. These charges are the latest in a series of complaints over the FDA's safety review of drugs and industry influence on the agency. Dr. Victoria Hampshire, the veterinarian who was accused, said Thursday that the agency was "so gullible, and they bent so far...to appease this company." Although vindicated, Hampshire said other FDA staff, having seen how she was treated, might now hesitate to challenge a powerful drug company.
Grassley made his charges in a letter Wednesday to the heads of the FDA and its parent, the Department of Health and Human Services (HHS) and was reporting findings of a Senate Finance Committee investigation, on which he is ranking Republican. In his letter, Grassley said the committee findings made him "concerned that the scientific process is being compromised internally" at the FDA and wrote that the case also brings into question "the processes that FDA uses in response to industry allegations of wrongdoing by FDA employees."
The congressional inquiry looked at how the FDA dealt with Wyeth’s conflict-of-interest accusations against Hampshire, who was helping to review the safety of its lucrative pet drug, Proheart 6, a heartworm drug injected into dogs. Proheart 6 was pulled from the market by Wyeth in 2004 following FDA pressure. Prior to the Proheart 6 withdrawal, Hampshire linked Proheart 6 to deaths in dogs. Wyeth had argued that Hampshire was biased, saying she was focused on selling competing drugs through her own Web site, according to Grassley’s letter and the FDA staffers involved.
Hampshire was reassigned to another job within the agency and the FDA referred her case to a U.S. attorney's office for possible criminal prosecution. Prosecutors quickly dropped the case, and in 2006, the U.S. Public Health Service named Hampshire veterinarian of the year.
Congressional investigators discovered that the FDA referred Hampshire's case to prosecutors on the basis of mistaken allegations about her Web site that could have been easily verified. Apparently, the site did little business and sold Wyeth's product. Hampshire said that, given the chance to handle the situation differently, "I would find a new job before my managers had a chance to buckle to industry pressure." Hampshire still works within the FDA.
Wyeth spokesman Doug Petkus said its actions in the case "have always been appropriate and responsible" and claimed that Wyeth merely wanted to ensure the FDA was aware of Hampshire's connection with the Web site and "asked them to review the information we provided in order to assess whether there was a conflict of interest."
In his letter to HHS Secretary Michael Leavitt and FDA Commissioner Dr. Andrew von Eschenbach, Grassley demanded fuller recording and disclosure of FDA meetings with drug companies and recommended more care in managing internal investigations and provisions to postpone scientific advisory committee meetings when there are accusations against FDA staff.
An agency advisory panel voted to keep Proheart 6 off the market after Hampshire’s reassignment.