Mark’s Memo: FDA Updates and News Briefs | 09/24/10

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Mark Mansour, Partner, Bryan Cave, LLP

Industry, Consumer Advocates Differ in Views of MDUFMA User Fee Negotiations

While consumer advocates are pushing the FDA to increase user fees as part of its next round of negotiations under the Medical Device User Fee and Modernization Act (MDUFMA), industry has indicated that it does not support an increase in such user fees because the FDA has thus far failed to meet its goals put forward in the last round of negotiations. The Medical Device Manufacturers Association has indicated that it is not pleased with the FDA’s progress in meeting its goals, including increased collaboration, predictability, and timeliness, under the MDUFMA and is calling on the agency to work harder toward meeting those goalsbefore it further increases user fees. The agency has indicated that it intends to release draft recommendations regarding user fee reauthorization in about a year’s time and then hold another public meeting. Final recommendations are due to Congress by January 2012. Agency officials have indicated that the changes that the agency is considering with regards to the 510(k) process will also have implications for user fees.

Members of Congress Introduce Bill for Inspection Parity

Four House Democrats in the House of Representatives have released draft legislation that aims to create parity in foreign and domestic inspections of drug manufacturing sites. The legislation would also provide the FDA with mandatory recall authority over drugs.

FDA Seeks Comments on Parallel Review of Medical Products

The FDA and the Centers for Medicare and Medicaid Services (CMS) have indicated that they are considering establishing a process for overlapping evaluations of premarket, FDA-regulated medical products when the product sponsor and both agencies agree to such parallel review. This process is intended to reduce the time between FDA marketing approval or clearance decisions and CMS national coverage determinations (NCDs). The agencies are seeking public comment on what products would be appropriate for parallel review by the two agencies, what procedures should be developed, how a parallel review process should be implemented, and other issues related to the effective operation of the process. The agencies also intend to create a pilot program for parallel review of medical devices. More information is available here.

Mark Mansour is a partner in the firm, Bryan Cave, LLP

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