FDA Bill Would Strengthen Agency's Regulatory Authority

Rep. John Dingell, D-Mich., has reintroduced the FDA Globalization Act of 2009, H.R. 759, (at the THOMAS Web site, type "H.R. 759" in the search bar after selecting "Bill Number") thus taking a "critical step toward equipping the FDA with the authority and funding it needs to regulate what is now a global marketplace for food, drugs, devices and cosmetics," according to Adam Benson, press secretary for Dingell.

Dingell, a long-time critic of the FDA, has believed for some time that the agency lacks the resources and the manpower to adequately protect the public against contaminated food and pharmaceutical products, said Benson. The recent outbreak of salmonellosis traced to peanut products contaminated with Salmonella serotype Typhimurium was another example of the FDA's failure to safeguard the public's health and well being.

"H.R. 759 is a recognition by Rep. Dingell that the FDA lacks sufficient resources, personnel, information systems and authority to protect the public health in an increasingly global marketplace," said Benson.

The legislation, now pending in the House Energy and Commerce Committee, would require domestic and foreign pharmaceutical and device companies that ship products into the United States to register with the FDA and to pay a registration fee determined by HHS to cover the cost of drug and device inspections. The legislation also would require companies to provide country-of-origin labeling and would give the FDA the capacity to monitor foreign facilities.

Domestic food facilities operating in the United States or foreign food facilities shipping food into the country would be required to pay an annual registration fee and would have to provide country-of-origin information on their products.

The fees will generate additional revenue, enabling the FDA to hire more personnel and to increase the number of inspections, among other things, said Benson.

Ken Johnson, senior vice president of the Pharmaceutical Research and Manufacturers of America, or PhRMA, said in a prepared statement that PhRMA is currently reviewing the bill. He pointed out, however, that the FDA and others have said the agency's responsibilities have increased dramatically in recent years, but its resources have been unable to keep up with these increasing demands.

"This is why we believe it is in the best interest of the public health and safety for Congress to significantly increase appropriated resources to help the FDA carry out its vital mission," Johnson said.