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| Paulson & Nace

The AP has reported that nine FDA scientists have written a letter to the Obama Transition Team that FDA decisions are not always based on facts:

"The purpose of this letter is to inform you that the scientific review process for medical devices at the FDA has been corrupted and distorted by current FDA managers, thereby placing the American people at risk," said the letter, dated Wednesday and written on the agency’s Center for Devices and Radiological Health letterhead.

The center is responsible for medical devices ranging from stents and breast implants to MRIs and other imaging machinery. The concerns of the nine scientists who wrote to the transition team echo some of the complaints from the FDA’s drug review division a few years ago during the safety debacle involving the painkiller Vioxx.

According to the AP,

In their letter the FDA dissidents alleged that agency managers use intimidation to squelch scientific debate, leading to the approval of medical devices whose effectiveness is questionable and which may not be entirely safe.

"Managers with incompatible, discordant and irrelevant scientific and clinical expertise in devices…have ignored serious safety and effectiveness concerns of FDA experts," the letter said. "Managers have ordered, intimidated and coerced FDA experts to modify scientific evaluations, conclusions and recommendations in violation of the laws, rules and regulations, and to accept clinical and technical data that is not scientifically valid."

This is particularly troubling given recent Supreme Court Opinions and Bush Administration efforts to "preempt" state tort laws under the guise that the FDA and other federal agencies regulate industries such as the medical device industry.

The FDA scientists’ letter calls out for a strong civil justice system. If consumers cannot rely upon the federal government to protect them from dangerous products, then the civil justice system remains the only check on corporate greed.

Consumers need to rely either on the government or the civil justice system to assure that only safe products are marketed. According to at least nine FDA scientists, we certainly can’t rely on the FDA.

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