Waxman Thrusts, FDA Parries, No One Wins

A June 26 report issued by Rep. Henry Waxman took FDA to task for what it cited as a dramatic decline in enforcement activity during the past five years. The Agency's reply was official yet defensive.

By Heidi Parsons, Managing Editor, Digital Media

In the latest skirmish in the ongoing battle between the FDA and its longstanding critic, Henry A. Waxman (D-Calif.), the congressman issued a June 26 report that lambasted both the Agency and the Bush Administration for what it deemed a “precipitous” drop in enforcement activity since 2001. The Agency mounted a less-than-forceful defense that avoided addressing some of the report’s sharpest criticisms. Whether Waxman achieved his aims or not is questionable, but it was the general public that lost, as rhetoric trampled truth and clarity.

The report, "Prescription for Harm: The Decline in FDA Enforcement Activity," was prepared by a division of the U.S. House of Representatives’ Committee On Government Reform, based on its 15-month investigation of FDA’s enforcement actions since 2001. The report drew three major conclusions:

  1. FDA enforcement actions have declined under the Bush Administration.


  2. FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff.


  3. FDA’s recordkeeping and case tracking are inadequate.

The report noted that the number of warning letters issued by the agency for violations of federal requirements has fallen by over 50%, from 1,154 in 2000 to 535 in 2005. During the same period, the number of seizures of mislabeled, defective, and dangerous products has declined by 44%.

Peter Pitts, who served as FDA Associate Commissioner for External Relations from 2002 to 2004, expresses frustration with both Waxman and the Agency. On one hand, he says, Waxman is putting politics in front of public health with his report. “The FDA’s [inspection] system, while not perfect, is the most effective, most transparent system in the world,” Pitts maintains. “But it’s awfully hard to move forward when people are throwing darts at you. What has he [Waxman] done other than call names? His report suggests the FDA is under-funded, but did he introduce a bill to increase that funding?”

The answer to that question is no, of course. Now Senior Vice President for Health Affairs at Manning, Selvage & Lee and co-founder of Center for Medicine in the Public Interest — with its DrugWonks.com blog — Pitts defends the FDA’s enforcement actions but not its communication tactics.

“Warning letters are not a metric of drug industry compliance,” he says. “Warning letters and product seizures have decreased because FDA’s people are doing a better job earlier in the process and the industry is in better compliance.” However, he asserts, “If I were back at FDA, I’d have been much more forceful and blunt in responding to Waxman’s report. Unfortunately, the FDA’s communication efforts are hindered by having an Acting [i.e. unconfirmed] Commissioner.”

To access the 24-page PDF document, "Prescription for Harm: The Decline in FDA Enforcement Activity," click the Download Now button below.

To read letters solicited by Waxman to support the credibility of the report's findings, click the following links:

  • Jerry Avorn, M.D.,
  • Professor of Medicine at Harvard Medical School and Chief, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston
  • Michael Wilkes, M.D., Ph.D.,
  • Professor of Medicine and Vice Dean, Medical Education, School of Medicine, University of California, Davis
  • Sammie R. Young,
  • retired 29-year FDA official with 17 years' enforcement experience, including various positions at CDER and Director of the Division of Compliance in the Bureau of Biologics


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