FDA in the Global Village : Part 2

by Food and Drug Administration (FDA)

(Page 2 of 2)

Help to Countries in Need

In addition to conducting foreign inspections, FDA lends technical assistance to many countries that need scientific advice or training.

For three years, FDA consumer safety officer Edwin Rivera-Martinez practically lived out of his suitcase, traveling around Latin America to train officials of those countries in proper drug manufacturing practices, quality control, and inspection techniques.

With funding from the Pan American Health Organization, Rivera-Martinez, then stationed in FDA's San Juan district, helped set up five month-long training courses in Guatemala, Colombia, Costa Rica, Brazil, and Equador for nearly 250 officials. The students then used their training to teach others what they'd learned.

"I think the project had a dramatic impact," Rivera-Martinez said. "Whenever an FDAer goes abroad, his or her presence is perceived in a positive way."

The agency has also traveled overseas in times of emergency.

In the past year, FDA has given advice on food safety to South American countries hit by a cholera epidemic. An FDA official traveled to Russia to review vaccine-making capabilities in light of that country's recent political upheaval. And the agency has worked with Egypt and Saudi Arabia to help them establish better quality control methods in vaccine manufacturing.

"By and large, we will work with all countries except those in which there are government restrictions, such as Iraq or Libya," says Batts. "However, we evaluate requests carefully to weigh the impact on FDA resources against the contribution to our mission and U.S. government policies."

FDA officials have traveled to Cuba, for instance, to work on medical device regulations. They have gone to Taiwan, a country not officially recognized by the United States, and to India and Thailand, even though relationships with those countries are strained by disagreements over copyright and patent laws.

In 1991, FDA brought 600 foreign visitors to the United States, from high-level health officials eager to talk about FDA policy to laboratory technicians who needed hands-on training.

By way of a computerized communications link through the Department of State and regular mailings to embassies and foreign health officials, FDA also informs and receives information from other countries about recalls, new policies and regulations, and health hazards.

International Harmonization

Inspections and technical assistance are not FDA's only international concerns, however. The agency is also working to establish standard regulations worldwide for products it regulates. Among negotiators, this effort is called "international harmonization."

Regulations governing food, drugs and medical devices now vary widely among countries. International harmonization may speed new drug and medical device approvals, help FDA use its resources more efficiently, and ease trade restrictions between nations.

For example, FDA has agreements with some countries to exchange data from drug testing so that scientists don't have to duplicate efforts. Recently, the United States and Canada worked together to evaluate DDI, a drug to combat the AIDS virus. Both countries approved the drug in record time and on the same date.

FDA is negotiating especially with Japan and the European Community to harmonize drug testing requirements, since 90 percent of drugs come from those countries and the United States.

FDA employees also participate in international conferences sponsored by the World Health Organization, and in a number of international trade negotiations.

"It's important for us to be involved in the trade talks to make sure FDA's mandate isn't compromised," says Batts, FDA's primary negotiator at the North American Free Trade Agreement talks between Canada, Mexico, and the United States.

FDA welcomes the opportunity to participate in trade negotiations. However, it doesn't intend to relax standards on the products it regulates to improve trade at the expense of public health.

"Clearly," Batts adds, "FDA's mandate is to protect the public health from unsafe, ineffective, or poor-quality products."

Future International Affairs

The future of FDA's international activities, particularly concerning international harmonization, is currently under study by an agency task force. Although the task force's recommendations were not complete when this article went to press, proposals to improve FDA's monitoring of the increasing amount of imported food, drugs and medical devices will likely be among them.

The agency's international affairs staff has increased from two people only handling foreign visitors in the late 1970s to a staff of 16 today. Some industry groups have suggested that FDA station employees in Europe and Mexico to coordinate regulatory issues and technical cooperation overseas.

In any event, the task of harmonizing international regulations, says Batts, will give lasting benefits to FDA and the American public.

"[With harmonization], we can make better use of information from other countries, approve products faster, and regulate imports more effectively," Batts says.

"In the future, FDA is going to be much more involved in activities with other countries and international organizations."

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.