THE BUREAU OF NATIONAL AFFAIRS: DAILY REPORT FOR EXECUTIVES - JULY 11, 2002
HEALTH CARE POLICY REPORT - JULY 15, 2002
Imported, Reimported Drug Dangers Cited by FDA Official at Senate Hearing
Allowing pharmaceutical imports, as well as reimports of U.S.-made drugs, would pose a threat that counterfeit, and possibly dangerous, medications would end up in the hands of American consumers, a senior official of the Food and Drug Administration said in July 9 Senate testimony.
FDA's William K. Hubbard outlined current problems that the FDA and U.S. Customs Service have with monitoring all imports, and said that these problems would be exacerbated by proposals to allow imported drugs into the country. Hubbard, the senior associate commissioner for policy, planning and legislation for the FDA, testified before the Senate Special Committee on Aging.
Sen. John Breaux (D-La.), chairman of the committee, said that, based on the testimony, he would not support reimportation/importation. "I'm against the reimportation of drugs into this country until such time as it could be assured that they are as safe as American-made drugs. As it was stated here today, that is not possible."
In a prepared statement, Hubbard said allowing importation or reimportation would create "a wide inlet for counterfeit drugs and other dangerous products that can be injurious to the public health and a threat to the security of our nation's drug supply."
Drug importation has become an important issue, as some claim that the increased competition could drive down prices of prescription drugs in the United States. In 2000, Congress passed an appropriations bill allowing for reimportation of U.S.-made drugs, but then-Health and Human Services Secretary Donna Shalala decided not to implement it, citing cost and safety concerns. Current HHS Secretary Tommy G. Thompson also chose not to implement the law.
Canada Exemption Debated. Sen. Byron L. Dorgan (D-N.D.), a long-time advocate for importation and reimportation, proposed in April a bill to allow for reimportation through Canada (S. 2244), and Senate Majority Leader Thomas Daschle (D-S.D.) said June 19 that it might be added as an amendment to a Senate Medicare prescription drug bill.
Hubbard also dismissed the idea that allowing imports only from Canada would eliminate the dangers, noting that it would "encourage unscrupulous individuals to devise schemes using Canada as a transshipment point for dangerous products from all points around the globe."
Barry E. Piatt, a spokesman for Dorgan, disputed the assertion that allowing reimportation from Canada would be dangerous. "The reimported drugs would have been made under FDA supervision and subject to the same identical chain of custody requirements," said Piatt. "It's a diversionary argument."
Also testifying at the hearing were Elizabeth G. Durant, executive director of trade programs at the U.S. Customs Service; Rick Roberts, an AIDS patient; and John Theriault, vice president of corporate security for Pfizer Inc.
BY ALEX PARKER
