FDA to Open Offices Abroad for Product Safety Checks

By: Gerri L. Elder

As part of a broad plan to insure the safety of imports, the Food and Drug Administration will establish its first office in China.

The FDA office in China will open before the end of this year and more than 60 food and drug regulators will be placed worldwide over the next year. FDA Commissioner Andrew von Eschenbach said that there will be a particular focus on regulation in India, Latin America and the Middle East, according to the Associated Press.

The FDA staffers located in offices across the globe will work to inspect foreign facilities and provide guidance on U.S. quality standards. There are also plans to eventually begin training local experts to conduct facility inspections on behalf of the FDA.

This year, the initial FDA office will open in Beijing and the FDA plans to have eight U.S. staffers in China next year. Also in 2009, additional FDA offices will open in Shanghai and Guangzhou.

The FDA will also send 10 U.S. staffers to India in 2009.

Currently, the FDA sends inspectors to foreign facilities on individual assignments. However, with a growing number of safety concerns about imported products, through the placement of international offices, the agency plans to send a clear message to manufacturers about standards of quality.

Health and Human Services Secretary Michael Leavitt says that manufacturers will have to meet FDA safety and quality standards in order to have continued access to the U.S. market. Leavitt oversees the FDA and other federal health agencies.

As domestic producers shift operations overseas to cut costs and foreign manufacturers continue increasing the import of their products to the U.S., the safety of imported food and drugs has been questionable. Recently, the FDA has been blamed for failing to ensure the safety of imported products.

In 2008, a contaminated blood thinning drug that was made in China made its way into the country and peppers tainted with salmonella were imported from Mexico. These incidents, among others, were responsible for preventable injuries, illnesses and deaths in the United States. Many blame the FDA and its lax inspection policies for these product safety issues.

It will cost approximately $30 million over the first year to implement the FDA's plan. Most of the money will be spent in setting up the international offices and hiring new staff members. Foreign nationals who will report back to the FDA will also be hired.

The FDA will obviously not have enough internationally-based staff members to inspect the thousands of food and drug manufacturing plants around the world that are under the agency's responsibility. The FDA hopes that the manufacturers will voluntarily pay for inspections by independent parties to prove that their plants meet U.S. safety standards. However, here at home a similar program has not been a huge success. Companies generally don't want to shell out cash for their own regulation.

In foreign countries, Leavitt believes the FDA will have more leverage when asking companies to voluntarily participate in - and pay for - the independent certification. Imports that have been independently inspected will make it to the U.S. market faster with expedited entry. Manufacturers that do not have their imports independently inspected will be subjected to increased scrutiny.

According to a Government Accountability Office report issued earlier this year, the FDA is currently inspecting less than 11 percent of the plants on its own list of high-priority sites.