22 May 2004

Pressure grows to allow drug imports

WASHINGTON - Election-year pressure is mounting for a change in federal law that would make it legal to import prescription drugs from Canada and perhaps other countries, but it's still unclear whether a consensus can be built on how to regulate what has grown into a huge gray market.

Although the House has already approved an importation plan, and several bills have been introduced in the Senate this spring, the pivotal man on the issue is Sen. Judd Gregg, R-N.H., chairman of the Senate's health committee, who has been ordered by Republican leaders to come up with an action plan.

Gregg won't unveil his bill for a few more weeks, but he suggested during a hearing on re-importation this week that he is looking to maximize protection for American consumers while giving them greater access to brand-name drugs that can cost hundreds of dollars less across the border than in the United States.

Name brand drugs sold in Canada and the European Union typically cost 40 percent to 60 percent less than in the United States, and the savings are drawing a increasing number of individuals, as well as health plans run by local and state governments, to rely on imports.

"We want to make sure that they also are able to have certainty and a level of confidence that what they're purchasing isn't going to hurt them," Gregg said.

Currently under federal law, only drug companies can legally import drugs. But several million Americans, most of them seniors, are thought to be buying their medicines outside the country, either in person, through the mail or on the Internet.

Officials estimate that some 20 million packages containing prescription drugs are shipped into the country each year, a trade worth more than $3 billion and growing, but still just a fraction of the $184 billion medicine market in the United States last year.

Congressional experts calculate that 10 percent to 15 percent of the drugs sold in the country might come from imports if the trade were made legal.

"People are either going to do it in the sunshine, in a regulated environment, or they're going to do it underground," Sen. Barbara Mikulski, D-Md., said of the drug imports.

Allowing drug importation is strongly opposed by pharmaceutical manufacturers and the Food and Drug Administration, which contends it can't ensure the safety of the pharmaceuticals.

"The theory of good American drugs being in Canada and coming back sounds good, but in the real world we work in, we see a lot of dangers out there that have to be controlled," said William Hubbard, FDA associate commissioner for policy and planning, appearing before Gregg's committee.

While drugs prescribed from most Canadian pharmacies are well-regulated by Canadian health officials, Hubbard and others argue that little or no attention is paid to drugs that are shipped through Canada destined for patients in other nations.

The potential for counterfeit or improperly formulated drugs soars when drugs are sold over the Internet. FDA spot checks last year found that 88 percent of drug shipments intercepted did not meet federal standards because they were either not FDA-approved or were improperly packaged, dosed or labeled.

In addition, many Internet orders are filled without a prescription or consulting with a doctor, increasing the danger to patients from drug interactions, overdoses and other complications.

Among those appearing before Gregg's committee were Tim and Margaret Malone, parents of a 24-year-old college student who died from a mixture of pain relievers, muscle relaxants and anti-anxiety medications obtained from Internet pharmacies, primarily in India or Pakistan. "There needs to be accountability from these entities," Malone told the senators.

Gregg expressed particular concern about the difficulty of regulating Internet pharmacies, but along with other senators, he said any importation plan would include a requirement that prescriptions would have to come from a patient's doctor and be verifiable.

Various proposals for imports so far all envision importation only of FDA-approved drugs made in plants certified by the FDA. Individuals, licensed pharmacies and wholesalers would be allowed to buy the drugs, with the commercial entities getting special licenses and paying fees to the FDA to support regulation.

Aides to Gregg said his plan may be somewhat more cautious, possibly requiring American consumers to go through an American pharmacy to obtain imported drugs bought directly or online, but that the details must still be worked out.

On the Net: www.fda.gov

http://health.senate.gov/calendars/all.html

www.aarp.org/bulletin/prescription/Articles/a2004-05-12-buycanadian.html

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