Panel says drug imports too costly

Safety measures would eliminate savings, group says

? Making imported drugs safe for Americans would be so expensive that U.S. consumers would see a price break of only about 1 percent, a Bush administration advisory task force said Tuesday.

The task force also warned that legally importing prescription drugs from countries with price controls, such as Canada, would cut drug company profits, which are used to fund research and development, resulting in three or four fewer innovative, new drug approvals each year.

Supporters of imported drugs expressed dismay with the findings of the 13-member panel, which is led by Surgeon General Richard Carmona and includes representatives of several government agencies that have long opposed importation. Among the panelists were acting FDA Commissioner Lester Crawford, Medicare Administrator Mark McClellan and representatives from the Justice Department, U.S. Customs and the Drug Enforcement Administration.

The Bush administration is opposed to drug imports, which growing numbers of Americans use to reduce their drug costs. The task force report gives the White House added ammunition as it tries to head off congressional support of legalized drug importation.

In a joint letter to congressional leaders, Health and Human Services Secretary Tommy Thompson and Commerce Secretary Donald Evans warned that, in light of the findings, they or their successors would recommend that President Bush veto any drug import bill “that does not address the serious safety concerns.”

They also would recommend a veto of any bill that “significantly discourages (drug company) innovation or stifles competition and the lower prices and greater access to drug treatments that result from competition and innovation.”

To win Bush’s signature, according to Thompson and Evans, a bill legalizing drug imports would have to track the manufacture, storage and shipment of drugs; restrict imports to only licensed commercial wholesalers and distributors; limit importation to high-use drugs with no generic equivalent; involve only foreign countries with top-notch regulatory systems and impose no price controls.

The FDA allows individuals to import prescription medications for personal use, although it’s technically illegal. No such exception is made, however, for prescription drugs imported for retail sale. A growing number of states, including Kansas, Minnesota, Michigan, Wisconsin and Rhode Island, as well as some local governments, have established or sought to establish drug-import programs, mainly from Canada.

Peter Rost, a vice president of marketing at Pfizer Inc. and the first drug-industry executive to dispute publicly that drug importation is unsafe, rejected the administration’s arguments about minimal cost savings.

“If importation didn’t work, you wouldn’t have had it in Europe for 20 years. This is so wrong,” Rost said of the report.

The panel’s conclusion that there would be just a 1 percent savings presumes that imports would have to be handled by large-scale commercial wholesalers to assure the integrity of drugs. It also assumes that wholesalers’ profits and regulatory costs would reduce consumer savings. Assuring the safety of drugs personally imported by U.S. consumers via mail order and the Internet, the report estimated, would cost about $3 billion a year.

Lawmakers who support importation, including Reps. Gil Gutknecht, R-Minn., Jo Ann Emerson R-Mo., Bernard Sanders, I-Vt., and Sherrod Brown, D-Ohio, issued a joint statement rejecting the report as “one-sided” and saying that it relied on “scare tactics employed by the pharmaceutical companies themselves.”

“It is ironic that two weeks after the HHS announcement that millions of flu vaccine doses will be imported from Germany, HHS is releasing a report creating major roadblocks to drug importation,” the statement said. The lawmakers vowed to push for new import legislation in 2005.