Debate over reimportation continues

According to the Pharmaceutical Research and Manufacturers of America, Washington, eleven former Food and Drug Administration commissioners - who have served presidents from Lyndon Johnson to Bill Clinton - have written to members of Congress that the reimportation of prescription drugs poses grave risks for American patients. Currently, there is legislation pending before a House and Senate conference committee that would allow the reimportation of pharmaceuticals from countries where they are sold at lower prices into the United States.

The letters, from consecutive former commissioners and acting commissioners dating back to 1969, warn that removing the protections in current law regarding reimportation of drugs could expose U.S. patients to dangerous, counterfeit or adulterated medicines.

Alan F. Holmer, president of the Pharmaceutical Research and Manufacturers of America, said these warnings from former Food and Drug Administration Commissioners should act as a red flag to members of Congress.

"Congress should heed these warnings from people who know the dangers of counterfeit and adulterated drugs and stop this legislation before it can harm American patients," he said.

A change of endorsement

Less than a month after PhRMA released its letters, U.S. Sen. Byron Dorgan (D-ND) released a letter from former FDA Commissioner David Kessler that seemed to endorse the reimportation amendment. Kessler was one of the eleven commissioners that PhRMA said were opposed to the amendment.

Kessler wrote that the fact that the Senate plan "allows only the importation of FDA-approved drugs, manufactured in approved FDA facilities and for which the chain of custody has been maintained, addresses my fundamental concerns. The requirement that the importer maintain a written record of the chain of custody and batch testing to ensure that the product is both authentic and unadulterated provides an important safety net for consumers."

If Congress gives the FDA the resources necessary to enforce the safety requirements of the plan, Kessler believes that "the importation of these products could be done without causing a greater health risk to American consumers than currently exists."

"He's modified his position somewhat," said Jeff Trewhitt, a spokesperson for PhRMA. "He still says there needs to be a new regulatory program with significant extra funding going to the FDA before the Jeffords amendment will work, but he says if that happens then the Jeffords amendment will work and it can be passed."

Trewhitt said he believes that Kessler modified his statement due to his work with Vice President Al Gore's presidential campaign. PhRMA still maintains that the amendment will not guarantee the safety of reimported pharmaceuticals whether the Food and Drug Administration is given additional funding or not. PR