Drug reimportation plans undaunted despite Bush task force concerns

Washington -- Doctors likely won't see a drop in the volume of patients getting reimported drugs via state programs or by their own initiative even now that the Bush administration has officially weighed in with strong reservations about the practice.

The Dept. of Health and Human Services' task force on reimportation issued a final report last month that details myriad safety and cost concerns. The document nevertheless stops short of calling for federal action against entities or people who are getting drugs from outside the United States.

Such a move is not surprising to physicians, given that federal officials have not been as effective as many doctors would like in shutting down other questionable drug operations, said Michael Reineck, MD, president of the Wisconsin Medical Society.

The Food and Drug Administration, for instance, has been slow in stamping out dietary supplement advertising that makes false statements about clinical effectiveness, he noted.

"We're very skeptical as to how federal regulation can stop people from getting their drugs from overseas when it can't control the country's internal trade," said Dr. Reineck, an orthopedic surgeon in West Bend, Wis. He reported that many of his patients have been importing drugs that he prescribes and predicted that most patients would continue to do so.

The AMA maintains that patient safety is the most important factor in determining whether the United States can set up a national drug reimportation program. While opening the door for possible support of federal legislation in the future, the group remains opposed to personal reimportation over the Internet.

"While we are still reviewing the [HHS report], we are pleased with the report's focus on ensuring access to drugs that are safe and effective, as well as affordable," said AMA Trustee Edward L. Langston, MD. "Patient safety must remain the overriding concern as we work to make prescription drugs more available and affordable for patients."

HHS' task force, chaired by U.S. Surgeon General Richard H. Carmona, MD, MPH, revealed that roughly $700 million in drugs came into the country from Canada alone in 2003. An equivalent number of products flowed from other nations during that year.

While many of the purchases are by individuals who visit foreign pharmacies or import drugs via overseas vendors, some are facilitated by state governments aiming to look past borders to find lower costs.

Illinois, for instance, set up a program named I-SaveRx in October 2004 that allows its citizens to use a standard order form to obtain medicines from Canadian and European pharmacies. With no apparent legal or regulatory threat to the initiative from the HHS report, the state plans to continue offering the service, which has expanded to include Kansas, Missouri and Wisconsin.

"I don't think that the report changes the FDA's options in reference to our program or similar programs, and they have never taken action in the past," said Abby Ottenhoff, spokeswoman for Illinois Gov. Rod Blagojevich. "We can't imagine why they would take action against our particular program, but if they choose to take the program to court, we'll be prepared to go and defend it."

Federal officials releasing the task force report nevertheless warned that states should not become complacent just because they haven't yet attracted the government's full attention.

"We will continue to look at how to enforce the law in a way that applies our priorities," said Amit K. Sachdev, FDA deputy commissioner for policy. "In this case, our enforcement policy is to look at those products that present the greatest risk and to try to focus on the higher risks first."

Giving reimportation a wide berth

Backers of I-SaveRx suggest that it avoids many of the possible safety concerns that accompany drug reimportation by individuals. All of the foreign pharmacies that serve patients in the four participating states underwent inspection by Illinois drug regulators.

But some physicians' groups remain wary about participating in such initiatives.

The Missouri State Medical Assn., for example, recently recommended that its physician members decline to fill out a health questionnaire that might accompany prescription orders to I-SaveRx. The possibility that the federal government or another entity might seek legal action against the program in the future raises concerns that participating doctors could face liability as well.

"I don't think any physician's going to sign the form," said C.C. Swarens, executive vice president of the association. "A physician here today can give a prescription to a patient, and that patient can take the prescription wherever they want. So if they want to take it and attach it to this [reimportation] form, that's up to the patient."

Physicians in Wisconsin are following a similar tack, notifying their patients of the safety concerns and avoiding any involvement in where individuals take their prescription orders. Dr. Reineck noted that doctors could face lawsuits from patients if they arrange for reimported drugs that prove dangerous.

"I've already been approached by [foreign] pharmacies about supplying joint injection medication," he said. "If I stick that in somebody's knee and it's contaminated, who am I going to blame for that?"

The HHS task force report does not address the liability that doctors may currently face if their patients are buying foreign drugs through a state program, but it acknowledges that lawsuits could become a problem if Congress legalizes reimportation nationally.

"Allowing prescription drug importation would have uncertain effects on the litigation exposure of manufacturers, distributors, doctors and pharmacists," the document states. "The primary factor in determining litigation risk -- the number and severity of injuries -- is not amenable to analysis at this time."

State medical associations largely are remaining neutral on specific programs in their areas. The Illinois State Medical Society, for instance, officially defers to the American Medical Association position when it comes to patients finding less expensive drugs overseas.