I wrote extensively about federal preemption in the Capitol Observations Section. However, the New York Times recently carried an excellent story by Gardiner Harris and Alex Berenson on federal preemption and how it protects the drug manufacturers. Because of the seriousness of the issue, the article warrants mention here. After decades of being dismissed by courts, federal preemption could be on the verge of becoming the law. As a payback for huge campaign funding, the Bush Administration has worked hard for the doctrine. They claim the FDA is the only agency with enough expertise to regulate drug makers and that its decisions should not be second-guessed by courts. The U.S. Supreme Court is to rule on a case next term that could make preemption a legal standard for drug cases. More than 3,000 women and their families have sued Johnson & Johnson, asserting that users of the Ortho Evra patch suffered heart attacks, strokes and even death. From 2002 to 2006, the FDA received reports of at least 50 deaths associated with the drug. The agency did not warn the public of the potential risks until November 2005 — six years after the company’s own study showed the high estrogen releases. At that point, the product’s label was changed, and prescriptions fell 80%, to 187,000 by last February from 900,000 in March 2004.

As we have reported, the FDA is poorly organized, scientifically deficient and woefully short of money. In February, the agency’s commissioner, Andrew C. von Eschenbach, admitted that the FDA faces a crisis and may not be “adequate to regulate the food and drugs of the 21st century.” The Times article pointed out that the FDA doesn’t even test experimental medicines. Instead, the agency relies on drug makers to report the results of their own tests completely and honestly. Even when companies fail to follow agency rules, officials rarely seek to penalize them. The FDA receives a tremendous amount of money each year from the drug companies – the very companies it is supposed to be regulating – which is part of the problem. Lawyers for Johnson & Johnson say that patients should not be allowed to sue the company because the FDA approved the patch and its label. When you consider the FDA’s poor record of approving drugs that turned out to be extremely dangerous and had to be withdrawn from the market, it’s difficult to have any confidence in the agency’s ability to regulate a politically powerful industry. That’s why preemption is so bad for people and so good for the drug industry.

Source: New York Times

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