Rx DRUG COSTS II: Reimportation Measure Raises Doubts
While House and Senate negotiators approved prescription drug reimportation legislation last week, "[d]oubts are growing" among government and drug industry officials about the effectiveness and safety of the measure, the New York Times reports. The compromise bill, which would allow pharmacists and wholesalers to reimport prescription drugs that meet federal safety standards, "was not thoroughly examined" by any congressional committee and instead attached to an agriculture appropriations measure. At a press conference yesterday, Chris Jennings, health policy coordinator at the White House, said, "As currently structured this provision is unworkable and would not achieve its goal." A drug industry lobbyist agreed, adding, "I doubt that anyone will realize a penny of savings from this legislation." Even some supporters of drug reimportation legislation, such as Sen. Byron Dorgan (D-N.D.) and Rep. Marion Berry (D-Ark.), expressed disappointment over the compromise bill. "I don't think consumers will get much benefit," Berry said. Two senior House members, Reps. Tom Bliley (R-Va.) and John Dingell (D-Mich.), also warned that the measure would likely increase the amount of "counterfeit or adulterated" drugs flowing into the United States. While the FDA initially had "grave reservations" that the measure would "endanger the safety of consumers," the Clinton administration later endorsed a bill passed by the Senate, although President Clinton has not agreed to sign the compromise legislation.
Building the Bureaucracy
Still, the FDA said that the agency would need $23 million to ensure the safety of reimported drugs under the legislation, and Congress provided the additional funding -- but only for the first year. According to confidential budget documents, the FDA's costs will likely "explode" in later years, because the agency will have to hire an estimated 500 new employees and spend more than $90 million annually to test and regulate imported drugs. The FDA also expects that "criminal activity will increase," which will cost the agency $3.5 million per year in criminal investigations. In addition, the U.S. Customs Service, which has "already struggl[ed] with a flood of drug imports, including many counterfeit products," will have increased responsibilities under the measure, although the office received no additional funding.
Read the Label First
The prescription drug reimportation legislation stipulates that imported products must meet labeling requirements which apply to pharmaceuticals manufactured and distributed "exclusively in the United States," and many will "need to be relabeled," the Times reports. For example, AstraZeneca PLC's Prilosec, an ulcer medication, sells outside the United States as Losec, but importers cannot distribute the drug under that name in America. In addition, foreign drug labels might be written in a foreign language or allow uses of products for purposes not approved in the United States. FDA Commissioner Dr. Jane Henney said, "[N]othing in the bill requires a manufacturer to give the approved label to an importer" or to allow an importer the use the label. According to Rep. Henry Waxman (D-Calif.), "The bill is full of loopholes. It tells U.S. pharmacists that they can import cheaper foreign drugs, but then denies them access to the FDA approved labels that must be on the drugs. The bottom line is that very few, if any drugs, can be imported into the United States under this legislation" (Pear, New York Times, 10/11).