Drug re-importation: Risks worth the rewards?

Congress not taking a firm stand — yet

It’s illegal, it may undermine international treaties, and there are warnings that patient safety is at risk — but for many, the cost savings of buying re-imported drugs outweighs all the arguments against it.

Pressure is on Congress to enact legislation that would make it easier for consumers to purchase prescription drugs from Canadian pharmacies. Many of the pharmacies are selling the drugs that were imported from the United States — thereby, "re-importing" U.S.-made drugs.

Pharmaceutical manufacturers, who have federal law on their side at the moment, are reacting by refusing to sell their products to Canadian pharmacies that sell to American consumers.

The U.S. Food and Drug Administration (FDA) is watching closely, not yet ready to prosecute individual consumers buying prescription pharmaceuticals for personal use, but not saying it won’t.

Just recently, American Medical Association (AMA) delegates attending the AMA’s Interim Meeting offered conditional support to measures that would permit U.S. consumers to buy re-imported drugs, provided it was through a "closed system" that would ensure FDA oversight.

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 AMA delegates said.

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

Laws not stopping some

"It is legal for pharmaceutical manufacturers to re-import their own drugs, but the importation of drugs by others, technically, is illegal," says Crystal Rice, public affairs specialist for the FDA’s Center for Drug Evaluation and Research in Rockville, MD. "That said, FDA is not going to go after individuals who are buying drugs from other countries, but has and will continue to take action against commercial entities that are importing unapproved drugs into the U.S."

Chief among these are companies that are importing unapproved or potentially unsafe drugs and selling them to patients as brand name, approved, prescription drugs.

But individuals are not the only ones skirting the FDA. Governors in several states and mayors of some large cities in the United States have overseen the creation of programs that allow their citizens and public employees to purchase drugs from Canada, in hopes of containing the rising cost of prescription drugs.

The U.S. Department of Health and Human Services (HHS), in a report issued by a task force in December 2004, revealed that roughly $700 million in drugs came into the country from Canada alone in 2003. An equivalent number of drug products flowed from other nations during that year. While many of the purchases were by individuals who visited foreign pharmacies or imported drugs via overseas vendors, state governments aiming to look past borders to find lower costs facilitated some.

The FDA has issued a number of sternly worded letters of warning to mayors and governors, signed by FDA associate policy and planning commissioner William K. Hubbard, asking that they reconsider their administrations’ ties to prescription drug sources that might not adhere to FDA safety criteria.

Wisconsin Gov. Jim Doyle, whose administration was one of the earliest to create a web site providing Wisconsin residents with links to Canadian pharmacies, was warned of the following safety concerns by the FDA (letters available at www.fda.gov/importeddrugs):

  • The number of Canadian pharmacies that have been found lacking in safe pharmacy practices even in pre-announced initial inspections by state inspectors from Minnesota and have not been inspected by appropriate U.S. regulatory authorities.
  • The Canadian pharmacies listed on [the Wisconsin] web site that sell drugs that have not been manufactured, shipped or held within FDA oversight, and to our knowledge the State of Wisconsin has not even attempted to inspect these pharmacies to assess their safety practices.
  • The drugs listed on [the Wisconsin] web site have less expensive FDA approved, generic versions available in the United States. Consequently, Wisconsin citizens, on [the web site’s] recommendation, may pay more for foreign drugs than they could pay in the United States for a FDA-approved generic version.
  • The fact that [the Wisconsin] web site continues to include disclaimers that place the "sole responsibility for any purchase from the Canadian pharmacies listed" on Wisconsin citizens using the web site, while the state "expressly disclaims any and all liability from such importation." [The] disclaimer stands in stark contrast to our current U.S. prescription drug regulatory system that assures the safety and efficacy of all FDA-approved drugs.

Rice says the FDA has not yet taken any action against a state or municipality over facilitating U.S. residents in purchasing re-imported drugs, "but we have not said that we would not take action against a city or state. We have not sued one up to this point, although it is an option."

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

The AMA report cited recent FDA seizures of imported drug shipments containing drugs that are illegal here or were manufactured improperly, and questioned the ability of the FDA to oversee increased numbers of shipments of imported drugs.

Boom may be its own undoing

But the re-importation boom may be its own undoing. U.S. pharmaceutical companies have responded to the violations of the law on re-importation by refusing to supply foreign pharmacies that sell drugs back to U.S. consumers. This has led to a shortage of some drugs in other countries, driving those prices higher than prices for the same drugs sold in the United States.

Until re-importation to consumers becomes clearly legal, some patients may have trouble finding physicians who will knowingly assist them in obtaining prescription medications from overseas or, if the medicines require injection or intravenous use, to help them take the medications.

Physicians in Wisconsin are notifying their patients of the safety concerns and avoiding involvement in directing their patients to pharmacies.

The HHS report warns that lawsuits could become a problem even if Congress legalizes re-importation 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."

No federal action against individuals

The HHS report specifies numerous safety and cost concerns associated with re-importing drugs, but does not urge federal action against individuals who are purchasing their drugs from outside the country.

The AMA’s support for a national policy on re-importation would come with hefty safety restriction. To get the AMA’s backing, delegates said, a proposed system would need to approve only FDA-approved and regulated drug products, with all products distributed through a closed chain subject to reliable electronic tracking, and with necessary resources and authority from Congress to allow the FDA to ensure the safety of the products.

The HHS warns of another potential effect of legalized re-importation — the HHS re-importation task force estimates that research and development incentives will be lowered by legalized re-importation, resulting in between four and 18 fewer new drugs introduced each decade. This is based on the theory that if revenues fall for pharmaceutical companies, their research and development spending also would fall.

While the FDA is not currently prosecuting individuals who purchase re-imported drugs, it is offering tips to help consumers make safe choices. Chief among those warnings is that individuals check with the National Association of Boards of Pharmacy [www.nabp.net, (847) 698-6227] before ordering from a pharmacy on-line, to make sure the pharmacy is in good standing.

Sources/Resources

  • Edward L. Langston, MD, Trustee, American Medical Association. Phone: (765) 448-4511.
  • Crystal Rice, Public Affairs Specialist, Center for Drug Evaluation and Research, U.S. Food and Drug Administration. Phone: (301) 827-1673. E-mail: ricec@cder.fda.gov.
  • Center for Drug Evaluation and Research, web site: www.fda.gov/cder.
  • U.S. Food and Drug Administration, "Buying Prescription Medicines Online: A Consumer Safety Guide." Available on-line at www.fda.gov/cder/drug/consumer/buyonline/guide.htm.