More Sharp Knives Cut and Slash at FDA

WINSTON-SALEM, N.C., Oct. 9 -- With the echoes of the Institute of Medicine's unrestrained critique of the FDA last month still resounding, two more broadsides advocating major reform were fired today at the beleaguered agency.

The New England Journal of Medicine delivered an editorial that gave a ringing endorsement to the IOM's scathing indictment of the FDA. At the same time, a paper in the Archives of Internal Medicine paper pushed the FDA reform chorus loudly.

Curt D. Furberg, M.D., Ph.D., a professor of public health sciences at Wake Forest, and lead author of the Archives paper, said he and his co-authors, in addition to defining the problem, and recommending changes, "put the blame on Congress for much of the current mess."

Dr. Furberg, is a member of an FDA advisory committee with a term that expires in May 2007. His co-authors are all current or former members of the same committee.

The paper outlines specific marching orders for Congress, but Dr. Furberg said it unlikely that Congress would act on an FDA overhaul before the end of the year, especially because lawmakers are preoccupied with next month's election.

But he was optimistic that the new Congress will take action early in 2007. If not, he said, he would be willing to resign his seat on the Drug Safety and Risk Management Advisory Committee as public expression of his disagreement with current FDA policy.

Dr. Furberg said that he and his co-authors developed their plan for "sweeping changes" at the FDA independent of the IOM "although we do agree with the IOM report.

He said Congress shortchanged the FDA by withholding both the necessary funds and the legal clout to guarantee the safety of prescription drugs. For example, Dr. Furberg said, according to a report issued by the FDA, since 1997 drug companies committed to 1,231 post-marketing safety studies that are still incomplete, and they included 797 studies that were never started.

Dr. Furberg and colleagues recommended that Congress:

• Give the FDA direct legal authority to pursue violations.
• Authorize adoption of a conditional drug approval policy for selected drugs.
• Provide additional financial resources to support safety operations.
• Mandate a reorganization of the FDA with emphasis on strengthening the evaluation and proactive monitoring of drug safety.
• Require boarder representation of safety experts on the FDA advisory committees.

Congress needed to step in to take the necessary action to "clean up the current mess," Dr. Furberg said "because we don't believe that the FDA can do much on its own since these problems have evolved over a decade and in that time the FDA has done very little to fix the problems."

He pointed out, for example, that in news coverage of the IOM report, FDA administrators defended the agency saying that it had top quality researchers and safety experts.

"We agree," Dr. Furberg said. "The FDA staff is top quality. The problem isn't the FDA staff, the problem is the FDA leadership."

The leadership, he said, has nurtured an agency culture that "encourages a state of denial and makes it difficult for insiders to recognize the problems."

The answer, he said, would be for an "an outside entity-Congress-to put the screws to the FDA leadership" as an instrument of change.

Dr. Furberg and colleagues also identified eight problems with current system, including:

• Failure of initial review to detect serious adverse drug reactions.
• Reliance on the Adverse Event Reporting System to identify postmarketing problems, even though this system has no teeth to enforce reporting rules.
• Relying on a subjective threshold for action in response to adverse drug reaction reports.
• Failure to adequately control the post-marketing safety studies required under current law.
• Lack of legal authority to hold accountable drug companies that violate FDA recommendations and/or suppress or delay unfavorable trial data.
• An internal conflict created by the requirement that the Center for Drug Evaluation and Research, which reviews and approves drugs, also monitors postmonitoring safety problems, so that it is charged with second-guessing itself.
• Reliance on user fees from the industry it regulates.
• Shortage of FDA expertise in drug safety and public among those who serve on FDA advisory committees.