Public support fuels latest reimportation push in Congress

Washington -- With a little push from every Tom, Dick and ... Homer, lawmakers have introduced new legislation that would require the Food and Drug Administration to implement measures enabling reimportation over agency officials' safety warnings.

A recent episode of the television cartoon "The Simpsons" reflects how deeply the issue has been absorbed into popular culture and the high level of public support. When the family's drug benefit is canceled due to the rising cost of health care coverage, Homer, father of the Simpson clan, travels to Canada for cheaper medications.

While the episode is a comical depiction of Americans, perhaps numbering in the millions, who travel across the border every year for low-cost prescription drugs, the portrayal of straightforward bargain-hunting is not far from the truth.

Public support is also reflected in recent opinion polls. For example, a Kaiser Family Foundation survey found that 73% of Americans think Congress should change the law to allow reimportation. Only 21% oppose such measures. Sixty-nine percent said legalizing the practice would make medicines more affordable without sacrificing safety.

"People are not that concerned about the safety issue," said Harvard University professor Robert Blendon, MD, PhD, who helped conduct the Kaiser survey. "At the moment, they feel comfortable with drugs from Canada."

As long as people see a familiar label on their Canadian drugs, they think the medications are the same as they would get from their corner pharmacy, said Marvin Shepherd, PhD, professor of pharmacy at the University of Texas.

Winning votes

Politicians are responding to that continuing public pressure.

By the end of last year, three reimportation bills had been introduced in Congress. The House passed one, but Senate leadership blocked efforts to hold hearings and floor action on similar measures.

As of press time, two reimportation bills had already been introduced this year, and a third was expected by the end of the month. Sponsors of the bills hope the situation will be different this time around.

"We are determined to pass drug importation legislation in the Senate this year in order to put downward pressure on prescription drug prices," said Sen. Byron Dorgan (D, N.D.). He announced that he had secured a promise from Senate leadership to hold committee hearings on a bill he plans to introduce with Sen. Olympia Snowe (R, Maine).

The Snowe-Dorgan legislation is expected to require the FDA to take measures that would reduce the risk of counterfeit and otherwise tainted medicines making their way into the country. But unlike previous reimportation measures, it won't require the FDA to sign off on the safety of the practice.

Instead, the bill is expected to mandate that the agency oversee registered exporters, who in turn would be required to document their chain of supply and to use counterfeit-resistant measures to ensure the drug's authenticity. Agency oversight would be funded, at least partially, by registration fees.

Another bill, which was simultaneously introduced in both bodies, is sponsored in the House by a bipartisan group, including Reps. Gil Gutknecht (R, Minn.) and Rahm Emanuel (D, Ill.). The measure (HR 328/S 109) is similar to one offered last year, which passed in the House.

A third bill (S 184) was also introduced in the Senate last month by Sen. Judd Gregg (R, N.H.).

Both these bills contain provisions designed to ensure safety and authenticity of drugs entering the country.

Bills face obstacles

Critics said the legislation amounts to blatant politics.

Politicians are offering the public a simple solution to the very complex problem of high prescription drug costs, said Peter Pitts, senior fellow for health care studies at the Pacific Research Institute in San Francisco and spokesman for the Partnership for Safe Medicines.

Ultimately, the measures fall short, Dr. Shepherd said. Counterfeiters have become very adept at faking drug labels, even those with holograms and other sophisticated imaging techniques, he said. Once the system of drug distribution is opened up to the international market, more counterfeit and bogus drugs will come into the country, Dr. Shepherd added.

Reimportation policy recently adopted by the AMA calls for the distribution chain to remain closed and for all drugs to be subject to reliable electronic track-and-trace technology. The policy also recommends that Congress give the FDA the authority and resources to ensure the authenticity and integrity of imported drugs.

"Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients," said AMA Trustee Edward L. Langston, MD.

The FDA's reimportation task force found that to satisfactorily limit the risk in importing prescription drugs, any new system would have to include multiple anti-counterfeiting techniques, including high-tech labels, microchips and pedigrees. However, those measures are expensive to implement.

Reimportation measures also face other obstacles.

Two of the bills include penalties to be levied against drug manufacturers that attempt to cut off supplies to importers or otherwise limit the flow of drugs from other countries. But legislation cannot mandate international cooperation, which is rapidly becoming a larger obstacle than drug companies' attempts to restrict drug supplies to Canadian pharmacies.

The Canadian government itself has begun taking steps to shut down the export of drugs from that country. Experts expect that when that happens, other developed nations, such as those of the European Union, would quickly follow suit to preserve their drug supplies, and prices, for their own citizens.