Drug reimportation supported if safety of patients is assured

Atlanta Tackling the continued rise in drug costs could require bold actions from health policy-makers, but those changes must not be dangerous.

That was the message American Medical Association delegates expressed during this year's Interim Meeting, where for the first time the group offered its conditional support for prescription drug reimportation. The ability of pharmacies and wholesalers to buy U.S.-made drugs back from other nations is a promising way to lower prescription prices, provided the system meets rigorous safety requirements, the delegates said.

AMA leaders hailed the policy as a major sign of doctors' commitment to getting patients access to affordable care, but they echoed the caution in the adopted language.

"This clearly is an advocacy position for our patients," said AMA Trustee Edward L. Langston, MD. "We're trying above all to advocate patient safety and appropriate medications for them when prescribed."

An acceptable reimportation system is one in which a closed distribution chain allows the Food and Drug Administration to vouch for drugs' authenticity and safety at any point along the way, the delegates said. The practice of patients importing cheaper medications from Internet pharmacies doesn't fit this definition, and the Association will oppose it.

Congressional reimportation backers could get a boost from the AMA endorsement. But the same concerns prompting the group to temper its language have prevented federal officials from embracing the practice.

The Dept. of Health and Human Services under Presidents Clinton and Bush has refused to certify that U.S. drugs coming back into the country would be safe.

Patient safety issues dominated debate on the Board of Trustees report that contained the recommendations. Concerns that an AMA endorsement would encourage doctors to back risky practices prompted delegates to add language stating that the Association would work to educate members about reimportation's risks, as well as possible benefits.

Meeting attendees crafted the final policy with the knowledge that the nation's doctors are deeply divided on the issue. In an AMA survey of more than 6,000 members before the event, respondents were evenly split on supporting and opposing reimportation.

Although the questionnaire did not attempt to distinguish members who would support the practice if the federal government was able to certify its safety, some physicians see the prospect as a hazardous proposition about which many of their colleagues are poorly educated.

Many attendees warned that doctors should not assume that federal officials could control a reimportation system as well as they regulate drug distribution within the nation.

"We are very sheltered in the U.S. by the FDA," said Susan Edelman, MD, a delegate from California.

The AMA report cited recent well-publicized "blitzes" in which the agency seized and examined foreign prescription drug shipments. A majority of the inspected packages failed to meet FDA specifications. They contained drugs that were illegal here or that were manufactured improperly.

Such spot checks, which involved a small percentage of total drug shipments, indicate that inspectors are already unable to handle the large volume of questionable drugs, said Maureen Casey, a vice president with Giuliani Partners in New York City. The FDA hired the firm to examine whether reimportation could be safe.

"The [AMA] report is very consistent with what we have found," Casey said. "Non-approved drugs are already getting into our system."

Delegates acknowledged that the FDA has its hands full. The new policy says the AMA will support a reimportation measure only if Congress also grants the agency added resources.

A closing window of opportunity?

Some physicians warned that the AMA's conditional support for reimportation could be undermined by recent events.

Several delegates pointed to reports that the U.S. pharmaceutical industry is already moving to cut off supplies to foreign pharmacies that are selling drugs back to U.S. consumers at deep discounts. Some Canadian health officials are also taking steps to preserve dwindling drug supplies for patients in Canada.

"This issue may become somewhat moot," said vascular surgeon Richard M. Peer, MD, an alternate delegate from New York.

Increasing price pressures on overseas drug exporters could mean that patients aren't going to receive much of a discount after all, some delegates said. Consumers could decide that a relatively small price break is not worth the potential health risk.

"This will not create the kind of savings needed," said William Pease, MD, alternate delegate speaking on behalf of the American Assn. of Neuromuscular and Electrodiagnostic Medicine.

Patients already have access to price discounts that don't carry reimported drugs' risks, but many are unaware of the opportunities or choose not to take them, said Paul Antony, MD, MPH, chief medical officer for the Pharmaceutical Research and Manufacturers of America.

The AMA could revise its policy after reviewing a forthcoming HHS report on reimportation. The report was due in December but was delayed.