White House Wants to Widen FDA Authority over Imports

Health and Human Services Secretary Mike Leavitt said the Bush administration supports legislation giving the Food and Drug Administration explicit authority over unsafe food or drugs made overseas with the intent of shipping them to the U.S.

The FDA has been hobbled in its enforcement of imports even as the number of products entering the U.S. has skyrocketed. The agency, for example, had trouble at first getting its investigators into Chinese factories involved in last year's pet-food recall. And recently, some have questioned how the FDA failed to inspect a Chinese plant that supplies much of the active ingredient for Baxter International Inc.'s blood thinner, heparin, which has been linked to hundreds of bad reactions and four deaths.

"Foreign firms can often deny U.S. officials access to their facilities without any adverse consequences," Mr. Leavitt wrote in a letter to two Republican lawmakers. "Such an amendment would better enable FDA to address criminal conduct that occurs entirely outside of the United States and threatens the health and safety of consumers within the United States." Mr. Leavitt said he will work with Congress to pass the legislation. "This change would be another arrow in our quiver for FDA's ability to investigate overseas offenders that violate the FDCA," or the federal Food, Drug, and Cosmetic Act, said HHS spokeswoman Christina Pearson.

The letter marked the first time the HHS, the FDA's parent agency, supported the effort to give the agency such authority. Earlier, the administration's cabinet-level import-safety panel, which Mr. Leavitt heads, had proposed increasing penalties and other enforcement power over imports and importers, and the Justice Department has supported the amendment for a number of years.

Mr. Leavitt's letter came in response to a December 2007 letter from Reps. Joseph Barton of Texas and John Shimkus of Illinois, prominent Republicans on the House Energy and Commerce Committee. They and other Republicans have pushed since 2000 for such a change amid rising concerns about imports, such as tainted or counterfeit drugs.

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