The Food & Drug Administration is asking the Institute of Medicine for a $1.3 million review of the 510(k) process. Is this a good or a bad way to review this agency’s work product?
Many have criticized the FDA’s process as being less than rigorous, for Class II devices in particular. Some Class III devices have reached the market without undergoing the full approval process; the one that sparked recent attention is the Menaflex knee device marketed by ReGen Biologics. According to principal deputy commissioner Joshua Sharfstein, “there were numerous departures from processes, procedures and practices, and problems with the review process for the device.”
Yet Sharfstein says that consumers shouldn’t worry if the Menaflex device was implanted in their knee. That’s quite a contradiction!
The study is slated conclude in March 2011, and will address two questions:
- Does the current 510(k) process protect patients and promote innovation in support of public health?
- If not, what legislative, regulatory or administrative changes are recommended to achieve the goals of the 510(k) process?
If the answer to the first question is “yes,” the IOM will make no recommendations to change the course of the FDA’s review. But how many oversight bodies have you known to give any organization it’s examining an “A-OK?” While I applaud the study, its worth will depend substantially upon how committee members are selected and whether or not real public and industry input is considered. This will determine how fair and well-balanced the process will be.
And the new FDA commissioner, Margaret Hamburg, has made it clear that changes are needed, especially in the compliance area. Given that agenda, it’s very likely she welcomes this report as one way to initiate such changes.
One frequest FDA critic, Rep. Henry Waxman (D-Calif.), chairman of the House Energy and Commerce Committee, often stands on his soapbox to inveigh against the agency. Waxman was quoted as saying that he’s long been concerned about the uncertain safety of too many devices on the market.
But if he’s been so concerned, why has nothing ever been done by Congress? True, some congressional members are “investigating” ReGen’s overreaching lobbying effort. But the FDA asked for the IOM review, not Congress. In fact, when it comes to the Menaflex imbroglio, some of the criticism stems from members of Congress allegedly interfering with the FDA review process.
The goals of the FDA 510(k) clearance process are to make devices safe and effective for consumers and to promote innovation. These goals are not mutually exclusive. There have been six Class II device recalls this year — a far cry from the “hundreds” cited by Waxman. In a majority of those instances, the manufacturer found the problem (with labeling, or with an alarm system, or with a cardiac device). The industry does police itself and shares the FDA’s goals.
It might be a good idea to review 510(k) devices every five years. Some argue that there are useless devices on the market that do not show effectiveness; there’s no mechanism to establish whether that’s true. The 510(k) process is the front end of the FDA’s mandate. Once a device is on the market, it’s the mandate of the industry, physicians and consumers to identify issues that may need attention. The alleged problems with the ReGen device notwithstanding, voluntary recalls are the best defense against having bad products on the market that might hurt or offer no benefit to consumers.
