Drug reimportation dilemma: Drug safety vs. access

As more patients get their medications from across the border, doctors are caught between a rock and a hard place.

By Joel Finkelstein, AMNews staff. July 5, 2004.

If drug reimportation is the answer, then what's the question? For patients, it's easy: How can I get affordable drugs? But for physicians, it's more complicated.

The drive toward importation of U.S.-manufactured drugs back across the border has left many doctors asking themselves whether it's more important that their patients are able to pay for their prescriptions or that their drugs are safe.

"It may be a penny-wise approach to get the patient the medicine right now because there's no other way they're likely to afford it, but it may prove to be a pound-foolish approach as we see problems emerging with the quality of the products," said Richard Roberts, MD, professor of family medicine at the University of Wisconsin.

"Reimportation seems like an easy answer, but I think it's an answer that, over time, will be fraught with difficulties," he said.

Among those difficulties is the potential for reimportation to swell the already existing flow of counterfeit drugs into the United States. "We are concerned because when patients go outside the country to purchase their drugs, there is no way for physicians to be certain that the drugs we prescribe for them are the drugs they are going to receive," AMA Trustee Rebecca J. Patchin, MD, testified at a May listening session held by the federal Task Force on Drug Importation.

Safety concerns also have motivated the Food and Drug Administration to oppose past attempts to legalize reimportation.

"When it comes to buying drugs absent our existing regulatory procedures, the FDA has consistently concluded that it is unable to endorse a buyer-beware approach," John Taylor, FDA associate commissioner for regulatory affairs, testified at a May Senate hearing on reimportation.