The U.S. Food and Drug Administration made a move this month that show a tougher regulatory agency—at least one that is erring on the side of patients, rather than pharmaceutical companies. The FDA revoked its approval for Menaflex Collagen Scaffold, a mesh that was intended to facilitate the regrowth of knee meniscus tissue after orthopedic surgery. The FDA had given ReGen Biologics 510(k) approval to manufacture and sell the surgical mesh for knee repair surgery in December 2008. However, the review process and approval were marred by controversy. Even Congress chimed in on in the Menaflex case as an example of how the the FDA’s 501(k) approval process may not be stringent enough to ensure patient safety. Many industry professionals view the FDA’s vote to pull ReGen’s approval as a sign of a different kind of FDA.
Those that predict stricter requirements for the FDA approval process cite the almost simultaneous decision pull sibutramine (Meridia) from the market. While Abbott Laboratories’ decision to pull the weight loss drug from shelves was considered voluntary, the pharmaceutical company’s letter to healthcare providers clearly states that it does not agree with the FDA’s decision that Meridia is unsafe for patients.
Some have suggested that the new climate at the FDA is based on the political atmosphere in Washington. The either years of the George W. Bush administration saw a relaxation in the positions of various regulatory agencies, including the FDA. Now that Democrats control the White House and both houses of Congress, there is a general move toward tighter regulation, including the process by which drugs and medical devices show safety and efficacy to the FDA in order to gain approval.
While it does appear that the 510(k) vehicle for approval is going to disappear, it is entirely conceivable that the requirements to demonstrate that a product is “substantially similar to predicate drugs/devices” will be more rigorously applied and enforced. At least until the pendulum swings the other way in Washington.
