After listening to medical device industry advocates such as Minneapolis attorney Mark DuVal, it's easy to conclude that the U.S. Food and Drug Administration is on the verge of implementing draconian regulations that will bankrupt small- to mid-sized companies and bring behemoths like Medtronic to their knees.
The reality is that no big changes are imminent, according to Dr. Jeffrey Shuren, acting director for the FDA's Center for Devices and Radiological Health. Instead, the FDA is taking some measured, overdue steps toward updating its device clearance process -- steps that the industry should welcome because the agency's current process is vague, nontransparent and apparently favors deep-pocketed companies that can get politicians to lean on FDA bigwigs if firms don't like regulators' decisions.
It's ridiculous to think that improvements aren't in order after scandal roiled the FDA's device regulation division earlier this year. A much-publicized report from the nonpartisan General Accounting Office in January criticized the agency for continuing to clear a small number of high-risk medical devices through what's known as the "510 (k)" process. Designed for products similar to existing ones on the market, the 510 (k) emphasizes expediency and may not require expensive clinical trials.
A Wall Street Journal story published March 6 brought the problem to light. It chronicled how the agency cleared a product called Menaflex, a small rubbery pad implanted in damaged knees as a shock absorber. ReGen, the New Jersey-based manufacturer, was told repeatedly by the FDA that Menaflex needed to go through a more rigorous approval process before it could be sold. ReGen disagreed. It not only took its case to the FDA's top officials, but also enlisted the help of four Democratic lawmakers from its home state, including both U.S. senators. After top FDA officials "personally" took charge of the process and deviated from standard procedures, Menaflex was cleared for use through the 510 (k) process. Since then, former FDA commissioner Andrew von Eschenbach has admitted that the agency "fumbled" the decision.
The FDA's response to all this has been eminently sensible. It asked an outside body, the prestigious Institute of Medicine, to review its device approval process and make a recommendation. That report is due in 2011. The agency also launched an internal "working group" to scrutinize its process, and is seeking public and industry input. Minimizing political interference in decisionmaking is one consideration. Clarifying regulations and making the process more consistent are other priorities.
These types of changes were welcomed by a number of Twin Cities device firms contacted this week. Executives said current regulations are muddy and it's often difficult to understand why some products go through the more rigorous approval method while others get the nod for 510 (k). Risk categories for devices within the 510 (k) process also need clarity and improvement.
The challenge for the FDA is to strengthen its process without stifling new products and putting an undue regulatory burden on device companies, which are struggling to find venture capital in today's economy and potentially face a hefty new tax to fund health reform. Shuren, on Friday, reiterated the FDA's commitment to facilitate safety and innovation. Menaflex and the GAO report are not justification for jettisoning the 510 (k) process. Members of Congress tempted to legislate hasty new regulations for political gain need to stand back and let the thoughtful process launched by the FDA unfold.