August 6, 2012 ~ The U.S. Food and Drug Administration (FDA) has a renewed source of funding for the review of medical devices, at least for the next five years.
On October 1, 2012 the Medical Device User Fee Amendments of 2012 or MDUFA III will go into effect. It will expire October 1, 2017.
The medical device industry, makers of defibrillators, surgical mesh, and catheters is taxed when a company is established or it registers a product for approval with the FDA. MDUFA It is an agreement between the agency and medical device industry with industry paying for its own regulation.
The MDUFA III authorization allows the FDA to collect about $595 million over five years from industry with the funding to partially go to hire about 200 full-time workers over that time period, according to the FDA's website, here.
User fees were established by Congress in 2002 and are set under the Food Drug & Cosmetic Act, depending on each different type of submission.
However consumer groups argue that MDUFA III gives medical device companies a fast track avenue to approvals for some products in exchange for the higher user fees.
Consumer Union’s Safe Patient Project (here) argued that the politically powerful medical device industry successfully blocked much needed patient protections from the House and Senate versions of MDUFA. See background story here.
Consumers Union also supported a timely post-market requirement that 522 safety review studies begin no later than 15 months after they are ordered. The FDA does have the authorization to order a postmarket study if a medical device begins to show complications and typically requires the manufacturer to begin monitoring patient injuries after they’ve been implanted with the device. As it now stands there is a rather casual attitude toward manufacturers who get to their study plan on their own schedule.
The bill also gives the FDA authority to stop clinical trials if they pose too great a risk to the public.
What the bill doesn’t do
It doesn’t allow the FDA to reject an application for a new device if the agency suspects a device will not be approved based on a questionable history. A device maker may apply for an Investigational Device Exemption and now the agency cannot reject that application.
The bill also weakens standards that attempted to prevent conflict of interest on FDA panels that review medical devices and prescription drugs. That is a reversal from what was adopted by Congress five years ago.
Rep. Edward Markey’s Sound Devices Act was defeated in the House before MDUFA was ever approved. Background story here.
It would have disallowed a defective and recalled medical device to serve as a predicate upon which to approve future devices.
The ProteGen vaginal mesh served as a predicate device for almost every synthetic vaginal mesh on the market. Unfortunately the Boston Scientific polypropylene mesh was recalled from the market for safety concerns in 1999. That recall didn’t stop it from continuously being named as the device that new ones seeking approval named as a “substantial equivalent”- the requirement under the FDA’s 510(k) approval process.
What did survive in MDUFA III was an ability by the FDA to reclassify problem devices once the agency realizes there is a problem with a defective device. That also means the future applications of a similar medical device will be more heavily scrutinized.
Also still alive is a requirement that the FDA issue regulations within six months to establish a Unique Device Identification (UDI) System for life sustaining implantable medical devices. The UDI system must be implemented within two years of finalizing the regulations.
It is not unlike a VIN number on your vehicle that allows a car manufacturer to alert you if there is a recall and to track the car to see if the necessary improvements have been made. #