Working Group Releases Summary on Product Safety Efforts
In the wake of safety concerns over tainted heparin and the push to ensure the safety of pharmaceuticals, the Interagency Working Group on Import Safety has issued a progress report updating initiatives to enhance the safety of imported goods.
The report, Import Safety — Action Plan Update, highlights how agencies and the private sector have worked to ensure the safety of imported goods since the release of the working group’s Action Plan for Import Safety last November. The new report comes roughly a week after the U.S. signed a three-year, renewable memorandum of understanding with Vietnamese officials that calls for cooperation in sharing information, developing workshops and training and establishing best practices in clinical trials.
President Bush established the Interagency Working Group in July 2007 and appointed HHS Secretary Mike Leavitt as chairman. The group was charged with identifying actions to promote the safety of imported products, including pharmaceuticals.
The group’s November report contained 14 recommendations and 50 specific short- and long-term action steps to protect consumers and enhance the safety of imports entering the U.S.
Proposals in the action plan affecting the FDA include creating incentives to ensure that drug manufacturers importing products into the U.S. meet agency standards. The plan also recommends allowing the destruction of medical products that have been refused admission into the country to prevent reimportation.