Regulatory process in the United States

FDA's role poised for enhancement

The US Food and Drug Administration (FDA) engages in many international efforts regarding medical product approval. These efforts are intended primarily to ensure that products imported to the United States meet safety and efficacy standards and are manufactured in ways that guarantee reliable production. In addition, the FDA has played a role in the regulation of global health products. FDA's cooperation with foreign health ministries and international agencies devoted to diseases endemic to the developing world is important and can contribute to efforts to deliver on US commitments to global health.

The FDA has valuable skills and resources that can assist other countries seeking to enhance their regulatory capacity. With appropriate enhanced authority and resources, the agency is well-positioned to strengthen its role and partnerships with global regulatory stakeholders such as the WHO, as well as with developing country regulatory authorities reviewing global health technologies.

Sharing expertise, bolstering access

To encourage requests for review of vaccines that may be used both in the United States and developing countries, FDA published a guide for developers that includes information on the use of data collected outside the United States.

In addition, recent legislation sponsored by Sen. Brownback passed as an amendment to the Department of Agriculture Fiscal Year 2010 appropriations. The legislation directs the FDA to convene two new review groups, one of which is mandated to recommend appropriate regulatory positions and solutions for the prevention, diagnosis, and treatment of neglected diseases in the developing world.

By building upon this opportunity—and in creating others—policymakers can ensure that US expertise is provided where it can help most.

For more information on the above data, see:

Department of Agriculture Fiscal Year 2010 appropriations bill (316.67 KB PDF)