FDA Commissioner Says Pending Lawsuits Threaten Patient Safety

hamburg-FDAThe commissioner of the Food and Drug Administration told physicians in Boston today that two lawsuits challenging the regulatory authority of the FDA could jeopardize patient safety, and hinder innovation and medical progress.

FDA Commissioner Margaret Hamburg, MD, said that if the plaintiffs in the lawsuits prevail, many companies will be able to promote products as beneficial without the benefit of adequate evidence. She added that companies whose products are truly beneficial “would have trouble penetrating the confusion” in the marketplace.

The FDA’s only avenue to protect patients would be legal action after the products hit the market, where the agency would have to prove that product claims were false and misleading, she said.

Hamburg was speaking at the annual Shattuck Lecture, sponsored by the Massachusetts Medical Society and the New England Journal of Medicine.

One of the lawsuits she discussed challenges the FDA’s authority to review the validity of marketing claims by drug and device makers. The other, filed by two tobacco companies, is trying to overturn the agency’s authority to regulate tobacco products.

Hamburg said that if the FDA is prohibited from reviewing the marketing claims of tobacco products, the country will see a repeat of the “low-tar fiasco” of previous years, when some lower-tar cigarettes were successfully marketed as being healthier than regular cigarettes, “when there was never any evidence that it provided any medical advantage.”

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