FDA’s Warning Letter Appeals Process Questioned by Congress, Company

A medical devicemaker is ready to take the FDA’s dispute resolution process to court, and congressional leaders are supporting the firm.

Reps. Joe Barton (R-Texas) and John Shimkus (R-Ill.) are going to bat for Colorado-based TMJ Implants in an ongoing four-year dispute with the FDA. In a letter to FDA Commissioner Andrew von Eschenbach last week, they questioned the agency’s practice of telling companies they can appeal a decision when it intends to proceed with enforcement actions.

“We do not believe there is ever a situation where the FDA should be given a license to lie to regulated industry,” they write.

Barton and Shimkus ask von Eschenbach to explain the agency’s February response to a request for information on its dispute resolution process.

That request from Barton and Rep. Ed Whitfield (R-Ky.) stemmed from the dispute between TMJ Implants and the FDA over several warning letters and a fine for medical device reporting violations.