The Wall Street Journal‘s Alicia Mundy chronicles how political lobbying can overcome scientists’ objections and influence the FDA approval process. At issue is a fast-tracked product aimed to better treat meniscus tears.
The FDA’s internal dissent over Menaflex … is straining a government agency that oversees a quarter of the U.S. economy. Some senior FDA staff members complained in documents that the handling of Menaflex, made by ReGen Biologics Inc., shows how political and industry pressure can influence scientific conclusions.
After being rejected for special status both in 2006 and 2007 and against the recommendations of FDA scientists, Menaflex was fast-tracked and approved under a process meant to expedite products similar to those already available, Mundy reported, even though there weren’t really any similar devices on the market.
Dr. Schultz, the FDA official who signed off on Menaflex, says he found ReGen “adversarial” and “extremely aggressive” but didn’t let the company’s pressure affect his decision.
A ReGen representative said the firm needed to be “aggressive” and “adversarial” because if it hadn’t “confronted” delays caused by the FDA, “ReGen would have been out of business and a very valuable device would have been unavailable to patients.”
