A business article published yesterday by The New York Times alerts us to a profound worry: FDA over-regulation of the medical device industry is driving companies in this business overseas to countries like China, India and Brazil. The approval process for new medical devices is not only more difficult and time-consuming in the U.S. than it is in Asia and Latin America, the article points out that it is even harder than in the notoriously regulation-obsessed European Union. Yet, as a study by PricewaterhouseCoopers recently emphasized, the E.U. does not have a higher product recall rate. So, it isn’t even succeeding in its aim of doing a more thorough job of keeping unsafe products off the market.
But in consequence of these policies, some U.S. patients are now going abroad so they can get newer and better devices implanted. Other bad news: U.S. venture capital funds for the industry are diminishing even as domestic venture capital funding for start-up firms is picking up again.
ACSH's Dr. Gilbert Ross says that the FDA is speaking out of both sides of its mouth when the agency claims that it’s working toward an expedited device approval process. “They’re actually taking a precautionary approach to innovation and preventing improved products from appearing on the market. But they want to seem like they’re open to change.” How then to explain that Dr. Jeffery Shuren, the director of the agency’s medical device division, told reporters that the F.D.A. would not relax its standards, arguing that Europe’s system might be too lax? .
