Rx for the Prescription Drug Battle

By M.K. Gaedeke Roland

This article first appeared in Buffalo Business First.

For the uninsured and elderly in the United States, Canada might provide a solution to obtaining more affordable prescription medications. On December 8, 2003, President George Bush signed into law the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—a complex, broad overhaul of the Medicare system that includes provisions for the importation of prescription drugs from Canada. Unfortunately, before importation is permitted, the Food and Drug Administration ("FDA") must take several actions. For instance, the FDA must certify to Congress that importation will not pose additional risks to public health and safety and that U.S. citizens will experience significant prescription drug savings as a result. Given the FDA’s longstanding opposition to importation of Canadian prescription medications, this may prove to be a significant hurdle. In addition, the FDA must also promulgate regulations that permit individual patients as well as pharmacists and pharmaceutical wholesalers to import drugs from Canada. Any regulations the FDA issues must still comply with existing requirements under the federal Food, Drug, and Cosmetic Act.

Currently, in almost all cases, it is illegal for any U.S. citizen to buy Canadian or other foreign prescription medications for use in the United States. Even with a prescription signed by a Canadian physician, obtaining medications in Canada for U.S. citizens violates both U.S. and Canadian laws. To make matters worse, there is no guarantee the medication dispensed in Canada is identical to the medication that would be dispensed in the United States. The FDA has turned up its law enforcement efforts against anyone involved in bringing drugs from foreign countries like Canada into the United States. In fact, the FDA said it will enforce action against physicians who write prescriptions to be filled for U.S. citizens in Canada, any pharmacy filling such prescriptions, and anyone in between, such as those who run "store-fronts" and Internet sites for this purpose.

Admittedly, for now, the FDA has said it does not intend to criminally prosecute consumers such as the elderly for trying to obtain affordable medications for personal use. Having said this, keep in mind this is purely the FDA’s present enforcement policy, and it could change at any moment.

Everyone agrees the high price of prescription medications is one of the greatest health problems in the United States. Senior citizens and the uninsured are particularly hard hit because they must pay for their medications in full without the benefits of the discounts and co-payments that insurance coverage may provide. Often people are forced to choose between their medications and heat—or even food.

Looking for a solution, many U.S. citizens, especially those in border states like New York, have turned to Canada. Medications purchased in Canada are generally less expensive than their counterparts purchased in the United States—often a lot less expensive. Nonetheless, U.S. citizens cannot yet legally purchase drugs from Canada by mail, in person, or through the Internet. The only current exception is the FDA’s Personal Importation Policy, which permits certain experimental drugs to enter the United States even though not yet approved here, but only if the FDA has reviewed and approved a drug’s use for a specific patient.

The FDA has taken a great deal of political heat for its policy and enforcement efforts. In fact, the city of Boston and the state of New Hampshire boldly announced they will purchase prescription medications in direct violation of the FDA’s directive. The FDA never budged from its position that drugs imported from Canada are not subject to its strict quality standards, may have different strengths, are more prone to counterfeiting, may contain untested substances, and may have improper labeling, all of which could seriously and adversely affect the health of millions of U.S. citizens. How long will it take the FDA to move forward under the new Medicare Prescription Drug, Improvement, and Modernization Act of 2003?

When prescription drugs eventually may be imported from Canada, the effects will be far reaching. Some will be positive and some may be negative. For instance, patients in international border areas who can buy their medications in Canada may experience savings. The cost of prescription drugs also may be lower for patients in the Midwest or South, if their pharmacies can purchase from less expensive Canadian wholesale sources and pass their savings on to their customers. In addition, employers could benefit if they find their costs of health care coverage lowered, permitting some to offer better health insurance coverage—or even permitting smaller businesses to offer coverage for the first time. But some effects may not be beneficial. For instance, many fear opening the borders will increase the risk of counterfeit or contaminated medications. Still others predict that if pharmaceutical manufacturers’ profits are adversely affected, there will be less research and development of new medications that save or improve the quality of U.S. citizens’ lives. Pharmaceutical pricing may also become more uniform among all countries and the hoped-for savings might never be realized.

M.K. Gaedeke Roland is a member of Hodgson Russ LLP’s Health Law Practice Group. Her practice emphasizes compliance and reimbursement matters, fraud and abuse, FDA regulatory affairs, and HIPAA. Ms. Roland is also a pediatric and adult nurse practitioner.