SENATE COMMITTEE DEBATES RISKS OF ALLOWING IMPORTED PHARMACEUTICALS

Witnesses at a Senate hearing debated the costs and risks of allowing imported pharmaceuticals, with some saying a proposed bill would cause "a flood" of dangerous counterfeit drugs into the country and others claiming it would improve safety.

The bipartisan "Pharmaceutical Market Access and Drug Safety Act of 2007," S.242, would allow U.S. citizens to import drugs from FDA-approved and inspected Canadian facilities at lower prices. However, some witnesses at a Senate Committee on Commerce, Science and Transportation hearing March 7 debated whether the potential dangers were worth the savings.

Randall Lutter, FDA deputy commissioner for policy, said legalizing importation would increase the risk of counterfeit or otherwise dangerous drugs entering the country, compromising consumer safety. The FDA recently warned consumers about ordering drugs online after several Americans who bought drugs off websites instead received products containing the antipsychotic haloperidol.

PhRMA CEO Billy Tauzin agreed, saying that "bodies are piling up all over the world," due to deaths from counterfeit drugs. The proposed bill has no real control over exporters and where the drugs come from, he said, adding that even if products come to the U.S. from Canada, they may originally be from another country.

Sen. Olympia Snowe (R-Maine), a sponsor of the bill, emphasized it covers every issue to ensure only safe products enter the country. The legislation requires that all facilities be approved, registered and inspected by the FDA at least 12 times a year, far more frequently than national facilities, Snowe said. The bill also includes a pedigree system to track medications, she added.

"There is no reason why we can't accomplish this bill," Snowe said, noting that both the Congressional Budget Office and a former FDA commissioner said the resources provided in the bill would be sufficient to support all of its programs. She added that she expected both sides of Congress to embrace the legislation, but could not provide a timeline for a vote on the bill.

( http://www.fdanews.com/did/6_48/ )