House Republicans Challenge FDA On Warning Letter Appeal Process

Senior Republicans on the House Energy & Commerce Committee are challenging FDA on the fairness of its warning letter appeals process, questioning whether the agency "really provides a good-faith option of appeal."

In an April 18 letter to FDA Commissioner Andrew von Eschenbach, Reps. Joe Barton, R-Tex., and Ed Whitfield, R-Ky., suggest that FDA is taking unfair advantage of a regulation that allows it to pursue enforcement action for conduct cited in warning letters while an appeal is pending before the FDA commissioner.

Barton, ranking member of Energy & Commerce, and Whitfield, ranking member of the Oversight and Investigations subcommittee, say the appeal process "potentially weakens FDA's credibility with the courts."

An Energy & Commerce staffer said the letter stemmed directly from concerns over the case of TMJ Implants. The Golden, Colo.-based dental implant maker's version of an ongoing three-year dispute with the agency matches almost exactly a theoretical case described in the letter.

Personal-care marketers and OTC drug and dietary supplement firms, as well as prescription drug and food and beverage companies, all are subject to the warning-letter appeal process the letter questions.

According to the letter, when "a company disputes the basis of a warning letter to an FDA product center," the firm's appeal is denied, but it is told it "can appeal the decision to the FDA Commissioner."

"While the appeal is supposedly pending ... FDA imposes an enforcement action such as civil money penalties and moots the appeal," the authors write.

Reps. Barton and Whitfield express special concern about FDA's imposition of enforcement actions before the commissioner appeal step in light of the fact that federal courts have supported the dictate that firms cannot sue FDA over warning letters.

"The rationale for the holding has been the availability of relief within the agency, especially the FDA regulation providing appeals to the FDA Commissioner," they write.

"However, if these appeals to the FDA Commissioner do not in practice materialize ... we question whether relief is really available," the congressmen conclude.

The letter asks von Eschenbach to provide information from the past 10 years on how many FDA warning letters have been appealed, how many rulings FDA made in favor of the company, how many requests for a commissioner review have not been granted due to an "intervening enforcement action" and how many civil penalties the agency has imposed.

The representatives also inquired whether there is an internal deadline for FDA's response in granting a commissioner review and, if not, whether FDA would "implement a 30-day deadline" to deny or grant a request for appeal. They also asked for the commissioner's criteria for denying appeals and whether the office can delegate authority to handle appeals.

The letter requests a response by April 30, but as of May 9 the agency said it was still drafting its reply.

FDA is seeking about $600,000 in fines from TMJ for not submitting required adverse event reports even after being advised of the need to do so in a 2004 warning letter.

TMJ maintains that the adverse events in question do not constitute "serious injury" that would make them reportable under Medical Device Reporting regulations. TMJ requested an appeal to the agency commissioner after CDRH staff rejected the company's argument in late 2004.

In July 2005, FDA filed a complaint seeking the monetary penalties. The company said it did not hear from the commissioner's office on its appeal.

An administrative law judge convened a cross-examination hearing on the case April 16, but a ruling is not expected until both FDA and TMJ issue post-hearing briefs, which are due June 15.

TMJ President Robert Christensen said he is confident FDA will drop the case. "Having gone through the court session with them, they have nothing," Christensen said.

- David Filmore ([email protected])