KETEK FALLOUT MAY BE JUST THE BEGINNING OF DRUG REVIEW SCRUTINY
The FDA may be facing increasing pressure on Capitol Hill due to its handling of Ketek, as a former agency official turned whistleblower is working with activists and a key Senate critic to take the FDA to task.
David Ross, one of the primary Ketek reviewers, testified at a Dec. 15 advisory committee hearing that the agency has become a place where dissent is discouraged, transparency is shunned and drug reviewers are pressured by their superiors. However, the agency denies this is the case.
Ross, who resigned from the agency Nov. 11, is now working with the Government Accountability Project (GAP), a whistleblower protection group, and Sen. Chuck Grassley (R-Iowa) to illustrate how the agency mishandled Ketek and pressured its staff. As part of that effort, many of Ross' internal emails concerning the agency's Ketek decisionmaking have been turned over to the senator, he said.
Lawmakers will likely increase their oversight of the agency's drug review processes, using Ketek as a prime example of problems, Mark Cohen of GAP said. Congress may address issues such as what information the agency is required to provide to its advisory committees and standards for proving a drug's efficacy, he added.
Drug reviewers were pressured to review Ketek, despite questions about validity of the data, Ross said. The agency also purposefully hid concerns about clinical trial data from committee members, both during the public meeting and later in private, he said. Furthermore, despite what the FDA says, the agency relied numerous times on this questionable data in approving the drug, according to Ross.
Ross alleges that superiors reprimanded him when he spoke to drug reviewers in the anti-infective office about his concerns with the drug and the agency's review of it. He was told not to speak to reviewers any further, he said.
This move speaks to a major problem at the agency, he said. "Open debate is part of a healthy, scientific culture. It's not to be feared."