Bush Administration Seeks Expanded Overseas Authority for the FDA

HHS Secretary Mike Leavitt supports a Republican congressman’s efforts to give the FDA jurisdiction over criminal Federal Food, Drug and Cosmetic Act (FDCA) violations occurring outside the U.S.

In a recent letter to House Energy and Commerce Committee Ranking Member Joe Barton (R-Texas), Leavitt writes that amending the FDCA to provide the agency with such jurisdiction is consistent with “the principles of due process” and would better enable the FDA to deal with overseas criminal conduct.

“Foreign firms can often deny U.S. officials access to their facilities without any adverse consequences,” Leavitt says in the letter. “Current law has not kept up to date with modern technology and global marketing realities. The lack of explicit jurisdiction for [FDCA] offenses can hamper FDA’s ability to investigate the overseas offenders, . . . whose conduct occurs entirely outside the territorial jurisdiction of the U.S.”

Providing the FDA such powers under the FDCA was recommended to Congress by the Justice Department in 2000 when Patricia Maher, then deputy assistant attorney general in the Civil Division, testified before the House Oversight and Investigations Subcommittee asking lawmakers to modify the law so Justice and the FDA could fight counterfeit drugs more effectively.

Barton and Rep. John Shimkus (R-Ill.) wrote a letter to Leavitt last December supporting recommendations by the president’s Interagency Working Group on Import Safety that the FDA be given authority to block imports of products it regulates if the agency is denied access to the manufacturing facilities or warehouses where those products are made and stored.