Former FDA Chief Backs Drug Import Plan

A Senate plan that would allow Americans to bring in lower-cost prescription drugs from outside the United States got a significant endorsement Tuesday from a former Food and Drug Administration commissioner, Dr. David A. Kessler.

Safeguards proposed in legislation by Sens. Byron L. Dorgan (D-N.D.) and Olympia J. Snowe (R-Maine) 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 to the plan, and the Bush administration has raised many objections. But some lawmakers say solid majorities would probably support legislation to permit drug imports if it came to a floor vote.

Because of government controls, brand-name drugs in European nations and in Canada are commonly 35% to 55% cheaper than in the United States. Americans annually import an estimated 10 million shipments of medicines from abroad in an unregulated and technically illegal market.

“The choice before you is not the choice of imports or no imports,” said Kessler, now dean of the medical school at UC San Francisco.

“We already have a system of importation of drugs that jeopardizes public health,” said Kessler, who led the FDA from 1990 to 1997 under Republican and Democratic administrations. “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.”

Sen. Michael B. Enzi (R-Wyo.), the committee chairman, said Tuesday that 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.

“I will work to deliver a bill that will allow for safe importation,” Enzi said.

Dorgan said he thought President Bush would be hard-pressed to veto a drug importation bill amid widespread concerns about the cost of the Medicare prescription drug benefit scheduled to take effect next year. A study published Tuesday in the journal Health Affairs concluded that even with the new benefit, middle-income elderly beneficiaries with chronic health problems would face disproportionately high out-of-pocket costs for medications.

The Dorgan-Snowe 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 most countries in the European Union, Switzerland, 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% fee on sales, which would be used to finance administration of the program and enforcement of consumer safeguards.

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

Mexico is not on the list of countries that would be approved for wholesale pharmacy sales and Internet purchases, but the legislation would not repeal a law that allows Americans traveling to the country to buy a 90-day supply of prescriptions for personal use. “If you’re going to Mexico, you can continue to do so, but there will be a lot of other alternatives that may save you the trip,” said Barry Piatt, a spokesman for Dorgan.

A broadly similar bill has been introduced in the House of Representatives by Rep. Gil Gutknecht (R-Minn.). However, the Dorgan-Snowe legislation goes further in requiring various kinds of FDA inspections and setting up a fee system to finance them. A companion to the Gutknecht bill has been introduced in the Senate by Republican David Vitter of Louisiana.

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

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