Washington Editor

WASHINGTON - The FDA will open an office in China before the end of the year as part of a plan to ensure the safety of imported drugs and food, Secretary of Health and Human Services Secretary Michael Leavitt said.

The agency also plans to open overseas offices in India, Europe and Latin America before year-end, with a fifth office in the Middle East to follow by mid-2009, Leavitt announced.

The FDA expects to place a little more than 40 employees overseas under its initial plan at a cost to taxpayers set at about $30 million, with $20 million annually thereafter, said HHS spokesman Kevin Schweers.

Leavitt said the FDA over the past year has upgraded labs and equipment, hired additional personnel and begun implementing product safety agreements with key trading partners, including China, as part of its plan. "Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products," Leavitt said in a statement.

The FDA no longer will need to send personnel to foreign nations to work with regulators and industry there to improve oversight because "we'll have staff living there and working on the ground 365 days a year," FDA Commissioner Andrew von Eschenbach said.

The FDA will open its initial office in China this year in Beijing, with other offices set to open next year in Shanghai and Guangzhou, with eight FDA employees stationed in that country.

Leavitt said he plans to travel to China next month to meet with health officials there to review mutual efforts to ensure the safety of food and medical products consumed by both nations.

The FDA's initial office in India will be housed in New Delhi, with plans for at least one additional office in a yet-to-be determined location to follow in 2009, with about 10 FDA employees stationed in that country.

Officials said that the FDA personnel stationed overseas will work with local authorities and industries that ship food and medical products to the U.S. to improve safety efforts by providing technical advice, conducting additional inspections and working with government agencies and private-sector entities interested in developing certification programs.

Leavitt said that HHS officials also are working to conclude agreements involving import safety issues with Belize, Costa Rica, the Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua and Panama.

Officials noted that more than $2 trillion worth of products had been imported into the U.S last year from about 825,000 foreign companies.

That volume, officials said Thursday, is projected to rise sharply over the coming years as the scale and complexity of international trade multiplies.

U.S. regulators currently rely on inspections at the border to ferret out unsafe products - an approach officials said has not kept up with the exponential growth in global commerce.

The Bush administration has been seeking new powers from Congress authorizing the FDA to accredit third parties to evaluate whether foreign facilities are complying with U.S. requirements and the ability to refuse admission of imports from firms that delay, limit or deny U.S. regulators access to the foreign companies' facilities.

Reps. John Dingell (D-Mich.), Bart Stupak (D-Mich.) and Frank Pallone (D-N.J.) have proposed legislation that would overhaul the FDA's inspection processes for food, drugs and devices. (See BioWorld Today, Feb. 25, 2008, April 21, 2008, April 23, 2008, April 25, 2008, and May 5, 2008.)

The lawmakers want the FDA to require U.S. manufacturers and those that import their products here to be listed in a registry and pay fees to cover the costs of inspections of foreign facilities.

Under the bill, the FDA would be required to conduct inspections of foreign facilities every two years. Manufacturers of drugs and ingredients also would be required to test their products for contaminants.

The FDA has been under increased pressure this year from Congress after nearly 100 people died and several hundred more were sickened after being exposed to tainted heparin that was traced to a production facility in China.

GAO: Biolabs Lack Safety Controls

Two of the nation's five biosafety level (BSL)-4 laboratories, sites where the world's most dangerous biological agents and diseases are studied and stored, significantly lack security controls to protect against unauthorized access or theft, the Government Accountability Office (GAO) reported last week.

The GAO did not reveal the names of the labs, citing security reasons. However, the Associated Press Thursday identified the locations as Atlanta and San Antonio. The nation's other three BSL-4 labs are located in Bethesda, Md., Fort Detrick, Md., and Galveston, Texas.

The GAO report was requested by Reps. Dingell and Joe Barton (R-Texas), the chairman and ranking member of the House Energy and Commerce Committee, and Stupak and John Shimkus (R-Ill.), chairman and ranking member of the Oversight and Investigations Subcommittee.

Congressional investigators noted in their report that the Centers for Disease Control and Prevention, the agency that regulates BSL-4 labs, does not require the labs to have specific perimeter security controls, which the GAO said results in significant differences in the level of perimeter security among the five labs.

While three labs had perimeter barriers, roving armed-guard patrols and magnetometers in use at lab entrances, two of the labs demonstrated a significant lack of those controls, investigators said.

The two labs with fewer security controls lacked both visible deterrents and a means to respond to intrusion, and one lab even had a window that looked directly into the room where BSL-4 agents were handled, the GAO reported.

"In addition to creating the perception of vulnerability, the lack of key security controls at these labs means that security officials have fewer opportunities to stop an intruder or attacker," investigators stated.

The GAO recommended that CDC Director Julie Gerberding take immediate action to implement specific perimeter controls for all BSL-4 labs "to provide assurance" that each lab has a strong perimeter security system in place.

Lawmakers questioned why the CDC had not suspended the permits for the two labs with the security failures. "No fortress is impregnable, but CDC cannot allow these biolabs to remain this vulnerable to intruders and attackers without accepting a level of risk that is intolerable," Barton charged.

Dingell noted that six more high-containment labs currently are under construction. He renewed a request he made in August for President Bush to suspend the design and construction of the labs until the problems at the existing labs are resolved. (See BioWorld Today, Aug. 18, 2008.)

The Energy and Commerce Committee over the past year has been conducting an investigation into the risks associated with the proliferation of BSL 3 and 4 labs since the Sept. 11, 2001, attacks on the U.S.

As part of the investigation, lawmakers have probed the Department of Homeland Security's plan to replace the Plum Island Animal Disease Center, which resides off the coast of Long Island, N.Y., and houses hazardous viruses and other diseases, with a new mainland facility. The committee held hearings Oct. 4, 2007 and May 22, 2008 to examine the safety and security of BSL labs. (See BioWorld Today, May 27, 2008.)