Beefing Up the FDA: Lawmakers Seek to Give agency More Authority and Funding

To implement its plans, the FDA is looking to fill more than 1,300 science and medical positions, nearly tripling the number of people it hired from 2005 to 2007. The agency is holding job fairs around the country to recruit biologists, chemists, medical officers, statisticians, and investigators. “It takes a large pool of talented people for the FDA to protect and promote the public health,” says John Dyer, the FDA’s deputy commissioner for operations and chief operating officer.

ChinA: Improving Take-Out

The FDA also wants to enhance the safety of food and animal feed products exported from China to the United States. In December, Michael Leavitt, secretary of the Department of Health and Human Services, negotiated an agreement for enhanced registration and certification requirements, information sharing, and faster access to food production facilities in China. But, as of press time, the U.S. was still waiting for the Chinese to grant approval for FDA offices in Beijing, Shanghai, and Guangzhou.

In addition to being a major food and food products exporter, China is the world’s largest supplier of active pharmaceutical ingredients (APIs), producing 14% ($4.4 billion) of the $31.0 billion total in 2005. By 2010, its share is expected to grow 17.2% annually to 21.5% ($9.9 billion) of the world’s $46.0 billion API market, according to the Chemical Pharmaceutical Generic Association. After opening offices in China, the FDA hopes to open facilities in India, another major API supplier, and in Central America, because of the increase of fruits and vegetables being imported from that region.

But the FDA needs statutory authority to implement the more significant changes proposed in its Food Protection Plan. The agency has already requested authority from Congress to require food facilities to renew their FDA registrations every two years; to authorize the FDA to accredit “highly qualified” third parties to conduct voluntary food inspections; to require new re-inspection fees from facilities that fail to meet current Good Manufacturing Practices; to allow the FDA to issue mandatory recalls if voluntary recalls are not effective; and to give the agency greater access to food records during emergencies.

Agres is a freelance writer based in Laurel, Md. Reach him at [email protected].