Regulatory Joke: If the Food and Drug Administration OKs It, It's Obsolete

Article excerpt

In the April 9 Op-Ed article, "The FDA's reform hoax," Dr. Henry I. Miller makes an excellent case that the Food and Drug Administration's claims of progress and reinvention of government notwithstanding, the process of regulatory reform at that agency has not progressed very much at all.

One significant area that Dr. Miller doesn't mention is the FDA's review of medical devices. Critics of the FDA have long claimed that the agency takes too long and that lives are being lost because Americans don't have access to state-of-the-art technology and medicines. Dr. Keith Lurie of the University of Minnesota observes that because of the FDA's delays, "We don't get the equipment we need to save lives."

Because of these criticisms and reform proposals, the agency has fought back, claiming that shortened approval time. But to date, its efforts on medical devices haven't amounted to much in terms of results.

Recent congressional hearings make this point clearly. In February, in testimony before the House Commerce Committee, Stephen Ferguson, chief operating officer of the Cook Group, the largest privately held manufacturer of medical devices in the world, painted a dismal picture. …