Executive Briefing Series (formerly The Food & Drug Letter)

In light of mounting concerns over the cost and availability of prescription drugs in the U.S., government officials and the pharmaceutical industry are facing intense pressure on the drug importation front. The spotlight on importation has grown particularly bright in recent months, as there has been a strong movement by American consumers, as well as states and municipalities, to use Canadian internet pharmacies to fill their Rx drug needs. Advocates for the pharmaceutical industry have argued that importation isn’t the answer to affordability and accessibility concerns and will only leave the U.S. more vulnerable to safety and counterfeiting dangers. Many state and local governments, meanwhile, are aggressively pursuing importation plans to provide residents with easier access to low-cost Canadian drugs much to the dismay and opposition of federal officials and the U.S. drug industry. On the other side of the border, Canadian drug suppliers and pharmacies have started expressing concerns about the Canadian drug supply, arguing that the increase in prescription orders from the U.S., combined with increasingly tight supply restrictions being imposed by some pharmaceutical companies’ supply policies will prevent Canadian demand from being met. These concerns have brought forward the HHS Drug Importation Task force, chaired by U.S. Surgeon General Richard Carmona, to explore how drug importation might be conducted safely and its potential impact on the health of American patients, medical costs and the drug development pipeline.

Government officials are faced with the daunting task of finding a solution to rising Rx drug prices while maintaining public safety and perpetuating a positive and fruitful working relationship between the pharmaceutical industry and regulatory agencies.

State and local governments have jumped on the bandwagon for the importation of Rx drugs from Canada in attempts to lower drug spending and bypass regulatory agencies’ long and concentrated paper trails.

Merck and Novartis are planning to offer assistance — including free drugs — to some low-income seniors under the new Medicare discount drug program set to take effect in June.

GlaxoSmithKline (GSK) Canada has begun to restrict shipments of prescription medicines to certain internet pharmacies in Canada known to export drugs to the U.S. and elsewhere.

In the latest development on the importation front, a bipartisan group composed of some of the Senate's most powerful and influential members introduced new importation legislation April 21, which its sponsors contend provides for a method of securing safe and effective Rx drugs from other countries.