Spending bills would allow drug importation

Washington -- Congress passed two spending bills just before its August recess that would expand Americans' access to imported prescription drugs. Both measures, however, still need the other chamber's approval.

A provision in the House version of the 2008 Agriculture appropriations bill effectively would allow individuals, pharmacists and wholesalers to import Food and Drug Administration-approved prescription drugs. The bill, which passed Aug. 2 by a 237-165 largely party-line vote, next heads to the Senate for consideration.

Meanwhile, the Senate passed (89-4) a Homeland Security appropriations bill July 26 with language that would prevent U.S. Customs and Border Protection or the Dept. of Homeland Security from stopping individuals from importing prescription drugs from Canada to the U.S., including via mail order. As of now, Americans are effectively able to carry only a 90-day supply of pharmaceuticals from Canada. The provision, however, would continue enforcement for biologic drugs and controlled substances.

At press time, the future of these two importation provisions was unclear. The Bush administration said the president would veto both bills based on concerns about excessive spending but that it also opposes the bills' drug importation provisions because it would be impossible for the FDA to track counterfeit drugs.

Similar legislative attempts in recent years have been nullified by amendments or removed during House-Senate negotiations. For example, in early May, the Senate considered the FDA Revitalization Act, which included language that would have allowed drug imports from several industrialized countries. But an amendment by Sen. Thad Cochran (R, Miss.) negated this provision by requiring the Health and Human Services Dept. to certify the safety of and savings resulting from drugs purchased outside the U.S. -- something HHS says is not feasible. The amendment was approved May 2 with a 49-40 vote, with 14 Democrats supporting it and 11 Republicans in opposition. The overall bill, including that amendment, was passed a week later by a 93-1 vote and now awaits House action.

Even without legislation, Americans' access to imported drugs has increased. Last October, after numerous complaints from Americans about seized drugs, the U.S. border agency announced that it would stop confiscating mailed packages of imported drugs from Canada as long as they contain noncontrolled, FDA-approved medications and do not look suspicious. The policy change did not legalize such imports.

Therefore, lawmakers such as Sen. David Vitter (R, La.), sponsor of the importation amendment to the Senate 2008 Homeland Security spending bill, continue to press the issue. "This amendment will provide more access to affordable prescription drugs for residents of Louisiana and other states that aren't close to the Canadian border," Vitter said.

The measure next heads to a conference committee to resolve differences with the House version, which doesn't have a similar provision. It passed June 15 by a 268-150 vote with 45 Republicans supporting it.

American Medical Association policy supports drug importation, but only if all drugs are FDA-approved, drugs can be tracked electronically and traced back to their original source, and the FDA receives additional funding to monitor drug imports.

Canada might not cooperate

If Congress adopts any significant drug importation legislation, there's a chance the Canadian Parliament would ban exports of its price-controlled prescription drugs.

The Canadian Pharmacists Assn. opposes exports to the U.S. because Canada needs to make sure it has enough drugs for its citizens, said spokeswoman Louise Crandall. "We're not the drugstore for the United States," she said. "Our drug supply is for 32 million Canadians and not for 300 million Americans."

Others share this position. As early as last November, Colin McMillan, MD, president of the Canadian Medical Assn., responded to Democrats' 2006 campaign promises to legalize drug importation. In a Nov. 22, 2006, letter, he asked Canadian Minister of Health Tony Clement to consider adopting a system to improve tracking of prescription drugs in Canada. He also called for legislation restricting drug exports. In return, Clement assured Dr. McMillan that current U.S. purchases pose no imminent threat to the Canadian supply and that any U.S. policy legalizing mass exports to the U.S. would take at least six months to implement, providing ample time for Canada to react.

Meanwhile, although patient safety is a major concern in regard to the drug importation issue, physicians and patients in one border state haven't witnessed a rash of fraudulent prescription drugs.

For the last few years, the Maine Medical Assn. has endorsed patients filling prescriptions in Canada to help reduce the cost of drugs. Safety hasn't been an issue, said Gordon Smith, MMA's executive vice president. "We've just not experienced that in the reports that we've heard from our members," he said. But the MMA doesn't endorse buying drugs over the Internet, he said.

In another border state, the situation is less clear. The Michigan State Medical Society hasn't tracked the issue closely and doesn't have a formal policy. But the MSMS is considering the AMA policy on the issue.