Several House Democrats have taken off their gloves in the escalating partisan fight over reauthorization of the Medical Device User Fees Act (MDUFA). Democratic representatives Henry A. Waxman (CA), Diana DeGette (CO), and John D. Dingell (MI) sent a letter recently requesting hearings to examine dangerous medical devices to Republican leaders Fred Upton, Cliff Stearns, and Joseph Pitts, chairmen of the Committee on Energy and Commerce, Subcommittee on Health, and the Subcommittee on Oversight and Investigations, respectively. Although the hearing request singles out surgical mesh for pelvic prolapse and the weight-loss Lap-Band device, it represents a larger divide on Capitol Hill regarding conflicting views of the current medical device regulatory approval process and environment.

Following on the heels of a similar request in October for hearings on controversial brain stents and metal-on-metal hip implants, this letter questions the efficacy of existing medical device regulation and whether FDA has sufficiently ensured patient safety. "The Committee has failed to schedule the hearing we requested in our October 12 letter, and we remain concerned that the Committee's previous hearings on medical devices have presented a skewed and inaccurate picture of the importance of appropriate medical device regulation," the letter states. "We hope you will reconsider your approach so that the Committee can have a fuller understanding of these critical issues as we prepare to reauthorize the Medical Device User Fees Act."

A fuller understanding, according to the authors, can be gained through such information as the safety of medical devices currently on the market, marketing tactics employed for these devices, and the relation between these marketing strategies and increased risk. "The Committee's reauthorization of the Medical Device User Fee Act is an important opportunity to improve the efficiency of the FDA's review process while, at the same time, strengthening assurances of safety and efficacy," the letter concludes. "Obtaining information about devices like the Lap-Band and intravaginal mesh will be critical to informing members of the Committee on an issue that has this far been absent from the Committee's record."

The current MDUFA II expires on September 30.