FDA: previous failures and potential powers

Although the Food and Drug Administration touts on its website its task is "protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics and products that emit radiation," the past few years have exposed an underfunded and understaffed organization that has been slow to react, or taken no protective action at all, in response to potential dangers.

Recent examples of contaminated food products, destructive dietary supplements and harmful homeopathic remedies and drugs have highlighted the need for a more proactive, tougher FDA regulatory agency.

The new FDA commissioner, Dr. Margaret A. Hamburg, is taking the lead in trying to facilitate a strengthened regulatory agency for American consumers. Until now, the FDA has been a more reactive agency with limited powers as shown in the past few years with normal household products on the market hurting Americans who purchase and use them.

Fortunately, Dr. Hamburg said that to oversee the increasing flood of imported foods, medical devices and drugs, the F.D.A. would have to create far more partnerships with foreign regulators. “Under my leadership, we’ll see a somewhat more aggressive posture with respect to enforcement,” she said. Unanimously confirmed by the Senate in May, praised by conservative Republicans and liberal Democrats alike, Dr. Hamburg maintains wide support among a diverse and often fractious set of industry, consumer and patient advocacy groups.

The FDA has already made strides, but I expect to see tougher regulations and restrictions on companies producing dietary supplements, homeopathic remedies, medical devices, pharmaceuticals, food, tobacco, and plastics. Currently, the FDA does not regulate dietary supplements or homeopathic remedies (highly diluted drugs made from natural ingredients), which are taken by more than half of Americans and have grown into an estimated $25 billion industry, causing consumers to be guinea pigs to companies’ recipes for healthier life. The sector remains one of the least regulated under current laws: the Dietary Supplement Health and Education Act of 1994 requires that the manufacturer of a dietary supplement, not the FDA, ensure its safety before it is marketed. The FDA is responsible only for taking action against any unsafe product after it's on the market.

U.S. District Court Judge Jack Weinstein in ruling on one Zyprexa case in 2008 said

"Compared to its peer agencies in other parts of the world, the FDA has arguably failed consumers and physicians by over-relying on pharmaceutical companies to provide supporting research for new drug application. The result of such claimed governmental failures arguably causes overuse and overpricing of pharmaceuticals, resulting in mass litigations such as this one for Zyprexa."

Let’s hope the new FDA Commissioner stands by her word and allows Americans to consume safer products, food, and medical devices.