The Medicare Prescription Drug Improvement and Modernization Act of 2003, signed by President George W. Bush in December, contains language allowing prescription drug importation from Canada … with an important safety caveat: The Department of Health and Human Services (HHS) must certify that drugs can be safely imported before imports will be allowed. As was true of importation-allowing provisions in legislation signed by past administrations, the language is expected to act as an effective legal barrier to drug importation schemes.
HHS has opposed the legalization of importation, which HHS officials believe would increase the risk of counterfeit and tainted prescriptions entering the U.S. drug supply. Even Health Canada, that country’s counterpart to HHS, has stated it cannot guarantee the safety of drugs sold out of Canada.
The Medicare reform measure, which allows imports from Canada only, requires HHS to certify the safety of reimportation, all but assuring the practice will remain illegal. The decision to give HHS veto power over importation has spurred proponents to turn attention back to stand-alone legislation sponsored by Rep. Gil Gutknecht (R-Minnesota).
The Gutknecht bill would allow importation from Food and Drug Administration (FDA)-approved facilities in 25 industrialized countries and would require the use of technology to prevent counterfeiting.
Safety concerns have kept the American Medical Association and other physician groups from supporting drug importation as a way to improve access to medications.
“Those who choose to ignore [the importation ban] do so at their own risk,” said Jeff Trewhitt, spokesman for the Pharmaceutical Research and Manufacturers of America. “The United States already has a small domestic counterfeit problem, but it cannot compare to the scale of international counterfeiting rings that would gain a foothold if borders were opened by reimportation.”
Risk Is Real
Just before passage of the Medicare reform measure, the Senate Commerce, Science and Transportation Committee examined the importation issue. The committee’s chair, Senator John McCain (R-Arizona), said, “Demand for lower prices should not lead us to sacrifice the health and safety of our citizens. That is why any legislation that permits the freer importation of pharmaceuticals must contain safeguards that protect American consumers from tainted or counterfeit prescription drugs.”
“Even if it isn’t apparent, the harm is still real,” said Carmen A. Catizone, executive director of the National Association of Boards of Pharmacy. “Injuries resulting from patients receiving wrong or counterfeit drugs may not manifest themselves in the health care system until sometime later, when the patient’s condition worsens and requires emergency treatment or hospitalization,” he noted.
It’s also an issue of knowing exactly where the drugs are coming from, Trewhitt pointed out. “Prescriptions from Canada may largely be safe and genuine, but many counterfeiters use the Canadian postal system, which is not well monitored, to funnel bogus and expired drugs into the U.S. market,” he explained.
John Graham, director of health and pharmaceutical policy research at the Fraser Institute in Vancouver, Canada, also thinks in terms of safety. Said Graham, “Drug manufacturers have strong incentives to play a significant role in preventing counterfeiting, other types of fraud, and activities that threaten the integrity of the distribution chain that connects factories to customers.
“But,” warned Graham, “they only have that incentive if you allow them to manage the distribution chain and to keep the markets differentiated. If you say to the manufacturer it is against the law for him to have input into the distribution chain, and it is against the law for him to profit from managing the distribution chain, then the manufacturer loses all interest, or a significant amount of his interest, in combating the counterfeiting problem.”
In Harm’s Way
To date, 12 states continue to ignore public safety and the law, demanding the federal government’s permission to import drugs for state entitlement programs like Medicaid and state employee benefit plans. So far, warnings from the FDA have kept states from importing prescription drugs themselves, but they are finding ways to circumvent the law.
Minnesota, for example, has established a special office and Web site to guide patients though the purchase of prescriptions from registered Canadian pharmacies. Illinois State Senator Chris Lauzen (R) has helped launch a similar Web site in that state.
Illinois Governor Rod Blagojevich (D) said the new Medicare law gives HHS the authority to waive the rules against bringing in drugs from outside the country in order to establish a pilot program. Shortly before Christmas, Blagojevich sent a letter to HHS Secretary Tommy Thompson requesting such a waiver and asking for a decision in 30 days. The response was almost instant, and Blagojevich was told HHS will not authorize his pilot program.
Bill Pierce, spokesperson for HHS, said Thompson cannot certify the safety of imported prescription drugs because they “pass outside the FDA’s scrutiny during manufacture or shipment.” Pierce added, “Canada has great standards, but we have U.S. standards. Our law is very specific. It’s not a ‘will not.’ It’s a ‘cannot’.”
FDA Associate Commissioner Peter Pitts said importation is a “gimmick” and “not a solution to a difficult problem” because the practice “leads to unapproved, possibly counterfeit, mislabeled, expired, improperly packaged, illegal, unsafe medications.”
Conrad F. Meier is managing editor of Health Care News. His email address is [email protected].
For more information …
Video clips and transcripts of presentations delivered at an October 23, 2003 National Symposium on Drug Importation are available on The Heartland Institute’s Web site at http://www.heartland.org/Article.cfm?artId=13270.