Waxman Criticizes FDA's Enforcement Record

June 26, 2006
Pharmaceutical Technology Editors

Coinciding with the 100th anniversary of the US Food and Drug Administration (Rockville, MD), Representative Henry A. Waxman (D-CA) released a statement this week expressing his concern over ?an agency that is adrift and floundering.?

Coinciding with the 100th anniversary of the US Food and Drug Administration,(Rockville, MD, www.fda.gov),Representative Henry A. Waxman (D-CA) released a statement this weekexpressing his concern over "an agency that is adrift and floundering."FDA is in a state of "decline" and in the past five years "has seen itspowers wither and its reputation plummet," he said. Waxman claimed thatalthough the agency is "built on it scientific strength," it has"ignored and twisted science to reach pre-ordained outcomes" and itsenforcement presence has been "crippled," declining by 50% from 1154Warning Letter violations in 2000 to 535 in 2005, and the number ofseizures of "mislabeled, defective, and dangerous products has declinedby 44%."

The congressman also released a report (available at www.democrats.reform.house.gov)concluding that FDA headquartered inspectors "routinely reject theenforcement recommendations of career field staff." As evidence, thereport points to a 15-month investigational review of "internal agencydocuments" that show that FDA "overruled field inspectors and failed tobring enforcement actions" in at least 138 cases in the past five yearsinvolving drugs and biological products. Some cases also involved deathand serious injury.

The report also calls FDA's recordkeeping and case-tracking practices"inadequate," stating that the agency is "unable to track and maintainadequate records of agency-enforcement decisions, an apparent violationof the Federal Records Act." The Act and agency procedures require FDAto keep records that document agency enforcement decisions. Accordingto the report, however, "FDA officials explained that FDA could notprovide prompt and complete responses [to House Government ReformCommittee requests for relevant enforcement documents] because theagency lacks a system that enables it to track enforcementrecommendations from field offices."

Although the report may have the support of other agency critics, someare also admitting that it will result in little, if any, change in FDA'senforcement practices. They point out that Waxman does not have theauthority to call for oversight hearings to further investigate thereport claims. Other politicians allege that Waxman is using thisreport to attack the Bush administration and is politicizing anonpolitical issue.

Meanwhile, the Pharmaceutical Research and Manufacturers Association(PhRMA, Washington, DC, www.phrma.org) is reportedly "rejecting Waxman's allegations." ContrastingWaxman's conclusion that "The agency needs to chart a new direction,"Alan Goldhammer, PhRMA's associate vice-president for regulatoryaffairs told the Drug Industry Daily (June 28, 2006) that theorganization sees nothing in the report "that would lead patients toquestion the safety and efficacy of the medicines that are prescribedto them."