June 27, 2006 -- The senior Democrat on the House Government Reform Committee, Congressman Henry A. Waxman of California's 30th District, issued a report today sure to stir controversy in the already volatile topic of government regulation of the healthcare industry. Waxman's 15-month investigation into enforcement actions undertaken by the U.S. Food and Drug Administration (FDA) found that last year the Agency issued 535 warning letters to medical device or pharmaceutical companies -- this was compared to the year 2000, when 1,154 letters were issued -- a 54 percent decline and the lowest number in 15 years -- Waxman terms this "a precipitous drop in FDA enforcement actions".

Of concern to Waxman was that this was not a sign that the companies were doing better with compliance. Rather, the number of problems reported to or uncovered by investigators at the Agency remained constant but, as he states (emphasis is his):

"FDA headquarters officials have routinely rejected the enforcement recommendations of career field staff. Internal agency documents show that in at least 138 cases over the last five years involving drugs and biological products, FDA failed to take enforcement actions despite receiving recommendations from agency field inspectors describing violations of FDA requirements."

Besides warning letters, more direct actions, such as seizure of defective or dangerous products were also down by 44 percent.

Of specific interest to readers of Angioplasty.Org is that, even with the highly-publicized recalls and problems seen over the past few years, most recently in the heart rhythm device area, the biggest decline in enforcement actions occurred in the medical device area -- down by 65 percent.

Commentary from a variety of sources in an article appearing in today's New York Times demonstrates the spectrum of opinions, from David. K. Elder, director of the F.D.A. Office of Enforcement, who defended his Agency's actions as "prompt, targeted and aggressive", to Dr. Sidney M. Wolfe of Public Citizen and long time critic of the F.D.A., who stated the the Agency is funded partially by the $380 million a year in fees from drug makers and that sets up a conflict of interest.

Part of the reduction in enforcement was tied by several former F.D.A. officials to budget cuts, according to the New York Times article, which quotes former general counsel of the Agency, Peter Barton Hutt:

"This is a tragedy. Congress has failed to realize that our single most important government agency is being systematically dismantled."

related stories:
Prescription for Harm: The Decline in FDA Enforcement Activity --Committee on Government Reform Minority Office
Top Democrat Finds F.D.A.'s Efforts Have Plunged --Gardiner Harris, New York Times

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