Lawmakers Consider New Legislation to Prevent FDA from Enforcing Ban on Rx Drug Reimportation

Rep. Bernard Sanders (I-Vt.) and other lawmakers are considering offering an amendment to the fiscal year 2002 agricultural appropriations bill that would "prevent the FDA from enforcing a ... ban" on the reimportation of prescription drugs, CongressDaily/AM reports. Last year, the House passed amendments introduced by Sanders, Rep. Jo Ann Emerson (R-Mo.) and Rep. Marion Berry (D-Ark.) to ease restrictions on reimporting drugs and to allow consumers to purchase drugs made in the United States and shipped overseas for sale at a cheaper price as part of the fiscal year 2001 agricultural spending bill. The Senate also passed legislation. But according to Sanders, the measures were "amended so much along the way that neither the Clinton administration then nor the Bush administration now felt that it could meet the bill's standards" for guaranteeing safe reimportation (Fulton, CongressDaily/AM, 6/21). In January, then-HHS Secretary Donna Shalala decided not to implement the reimportation law passed by Congress late last year, concluding that it had "serious flaws" (Kaiser Daily Health Policy Report, 1/2). A Democratic aide said that the "goal" of adding an amendment to this year's spending bill would be to "reopen the debate" and "fix the loopholes the Republicans added to the original legislation." Sanders added, "We want to offer this amendment to get the debate going, so later in the (appropriations) process we can get a regime that can be implemented." At a hearing this month, however, FDA Associate Commissioner Bill Hubbard expressed the agency's concerns about allowing reimportation, saying, "U.S.-made drugs that are reimported may or may not have been stored under proper conditions, or may not be the real product, because the [United States] does not regulate foreign distributors or pharmacies." Supporters of reimportation say that such fears "have been exaggerated" (CongressDaily/AM, 6/21).