Ex-FDA head endorses plan for importing prescriptions

Senate proposal contains adequate safeguards, Kessler tells lawmakers

April 20, 2005|By Ricardo Alonso-Zaldivar | Ricardo Alonso-Zaldivar,LOS ANGELES TIMES

WASHINGTON - A Senate plan that would allow Americans to import lower-cost prescriptions from abroad got a significant endorsement yesterday from former Food and Drug Administration Commissioner David A. Kessler.

Safeguards proposed in recent legislation by Sens. Olympia J. Snowe, a Maine Republican, and Byron L. Dorgan, a North Dakota Democrat, would protect consumers from substandard and counterfeit drugs, Kessler told the Senate Health, Education, Labor and Pensions Committee. He had criticized earlier proposals as too weak on safety.

Drug import legislation is considered a political wild card in Congress. The powerful pharmaceutical industry is strongly opposed, and the Bush administration has raised many objections. But some lawmakers say solid majorities probably would support legislation if it comes to a floor vote.

Americans import an estimated 10 million shipments of medicines from abroad each year in an unregulated and technically illegal market.

"We already have a system of importation of drugs that jeopardizes public health," said Kessler, a doctor who led the FDA from 1990 to 1997 under Republican and Democratic administrations. He is now medical school dean at the University of California, San Francisco.

"I believe Congress has the responsibility to fix this serious problem. ... The American public will be safer with a regulated system than with the current system of uncontrollable risk."

Committee Chairman Michael B. Enzi, a Wyoming Republican, said he intended to move ahead with a bill of his own in an attempt to work out a compromise between Snowe and Dorgan and some of their critics.

As a result of government controls, brand-name drugs in Europe and Canada commonly are priced 35 percent to 55 percent below U.S. market prices.

Dorgan said Bush would be hard-pressed to veto a bill amid widespread concerns about the cost of the Medicare prescription drug benefit scheduled to take effect next year.

A study published yesterday in the journal Health Affairs concluded that middle-income elderly beneficiaries with chronic health problems would face disproportionately high out-of-pocket costs for medications despite the new benefit.

The Snowe-Dorgan bill would allow individual consumers to order brand-name drugs on an FDA-approved list directly from Canada. U.S. pharmacists would be able to import medications not only from Canada, but also from Europe, Australia, New Zealand and Japan.

Pharmacists and drug wholesalers would have to register with the FDA and be licensed to participate in the program. Inspectors from the agency would have access to foreign production and distribution facilities.

Wholesalers would pay a 1 percent fee on sales, which would finance administration of the program and enforcement of consumer safeguards.

The legislation creates "a validated system, a safe system, for drug importation," said Kessler.

A spokesman for Enzi said the committee chairman thought there are 60 votes in the Senate to pass a drug import bill.

But there are dozens of complicating factors. For example, legislation that limits U.S. consumers to imports from Canada would not produce much savings. And some pharmaceutical companies might try to undermine the intent of the legislation by limiting supplies to foreign wholesalers who deal with U.S. pharmacies and consumers.

The Los Angeles Times is a Tribune Publishing newspaper.

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