Regulatory: Food and Drug Safety Under the Obama Administration

The Obama Administration has taken aggressive steps to address perceived weaknesses in the food and drug safety area. Many of these problems arose from the Food and Drug Administration's (FDA) slow response to the internationalization of supply chains.

Transforming Food Safety. FDA is developing a modern food import program to evaluate food safety programs in supplier countries and enhance its oversight and surveillance programs for imported foods. To help prevent foodborne illnesses, the agency will issue binding standards for inspection of produce and other food products and for analysis of samples. The FDA has also adopted a new process to assess the risks of imported foods as they enter the country and target shipments that pose the greatest risk for closer attention. Its priorities include imports of seafood and fresh produce and foods produced in China. These steps will allow the agency to better hold companies responsible for the performance of their global supply chains.

FDA is preparing new rules that will require menu disclosure of the calorie content and other nutritional information by chain restaurants and at vending machines. It also has played an important role in assuring the safety of seafood from the Gulf of Mexico after the Deepwater Horizon explosion.

Protecting Pharmaceutical Consumers. FDA is upgrading consumer protection programs intended to assure the safety of drugs, medical devices, vaccines (especially vaccines against flu viruses), and the nation's blood supply. This initiative also has a large international component, as 40 percent of the drugs and 80 percent of the active pharmaceutical ingredients for drugs consumed in the United States are from foreign sources. The agency now has three offices in China, three in Central America, and two in India that are intended to produce better quality controls at the point of production through cooperation with the home country regulator and more aggressive FDA surveillance and enforcement actions.

On the supervisory front, FDA has overseen a highly visible recall of Children's Tylenol for failure to comply with good manufacturing practices. The agency also is carefully reviewing unapproved drug claims that companies make on their websites and other forms of product advertising.

Improving Regulation of Medical Devices. In response to public criticism about the scientific and regulatory rigor of the medical device approval process, the FDA is adopting a more conservative and demanding regulatory approach that will make approval more difficult, costly, and time-consuming.

This multifront campaign to adapt the food and drug safety program to the era of globalization ultimately will require a larger budget and additional user fees by companies whose products are subject to FDA review.

John F. Cooney is a partner in the Washington, D.C., office of Venable.

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John Cooney

John F. Cooney is a partner in the Washington, D.C., office of Venable.

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