August 15, 2013


 FDA to increase oversight of imported drugs

Posted July 31, 2013 

The Food and Drug Administration plans to increase oversight of the rising portion of pharmaceuticals and pharmaceutical ingredients made outside the U.S.

About 40 percent of drugs and 80 percent of active ingredients are imported, according to the agency.

“The globalization of the pharmaceutical market has created tremendous challenges for FDA, including dramatic increases in drug imports, complex and fragmented global supply chains, and increasing threats of fraudulent and substandard drugs,” the FDA said in a June 19 Federal Register notice.

That notice was published in advance of a meeting July 12 during which the FDA hoped to receive ideas on how to develop standards for admitting drugs into the U.S. as well as how to develop standards on collecting information from importers, registering them, and establishing preferred importer practices. In expanding oversight, the agency is citing authority gained through passage of the Food and Drug Administration Safety and Innovation Act in July 2012.

The meeting notice indicates the FDA is determining the kind of proof that should be required of importers to show sufficient inspection by their home governments and the safety and effectiveness of their products, what practices importers should be required to follow, and what importer registration is needed. For example, the FDA questioned whether importers should be required to provide certificates that ensure the identity of drug components as well as to prove the certificate issuers are reliable. The notice also includes questions from the FDA on how the agency could allow expedited importation of drugs from companies deemed to be reliable.

Christopher C. Kelly, a spokesman for the FDA, said in early June the agency was reviewing comments on the planned increase in oversight, and agency officials did not know when draft regulations would be available.

Information on the subjects under consideration are available in the meeting notice here. ​