Officials from NABP, HHS, Schools of Pharmacy Voice Concerns Over Efforts to Illegally Import Prescription Medicines

October 21, 2003 12:00 am

Proposal Would Bypass US Safeguards and Threaten Safety of Patients Most in Need

Boston, MA, October 21, 2003 — Leading regulators and health officials appeared together today at a press conference on Beacon Hill to address the ongoing efforts of Springfield Mayor Michael Albano to illegally import prescription drugs from Canada despite prohibition of the practice by federal and state law. The press conference was called to respond to issues raised by Albano as he and several state representatives began a statewide bus tour to raise support for the illegal effort.

Mayor Albano's efforts have been hailed by many as the panacea for lowering the cost of prescription medicines. "We understand that people are worried about the cost of their prescriptions," said Carmen A. Catizone, NABP Executive Director/Secretary. "But illegally importing medicines from Canada is not a legitimate solution."

"If Mayor Albano continues with his program in Springfield and convinces other towns to join, the safety of the medication system will be further challenged and more problems will arise than it will resolve. Because the source and safety of these medicines cannot be guaranteed, unknowing patients may become ill due to unapproved medications, incorrect dosages, and improperly stored and shipped medications. Patients may save on their prescription costs, but the trailing hospital, emergency room, and additional prescription costs will more than negate any savings," stated Catizone.

Joining Catizone at the press conference were Brian Cresta, Regional Director for Department of Health and Human Services and Dennis Lyons, Director of Government Affairs at the Massachusetts College of Pharmacy and Health Sciences.

According to Brian Cresta, Regional Director for the Department of Health and Human Services, "Secretary Thompson has the authority to allow these medications to be imported from Canada but he has refused to do so because of concerns about the safety of the imported medicines. He is following the lead of his predecessor, Donna Shalala, Secretary of HHS under President Clinton, who also refused to certify Canadian importation because of safety concerns. We continue to feel that the best and most appropriate way to make prescription medicines affordable to our nation's seniors is through a comprehensive Medicare drug benefit."

The groups participating in today's press conference strongly expressed their concern that expanding Albano's proposal would circumvent the U.S. Food and Drug Administration's (FDA) approval and safety processes. FDA Commissioner Mark McClellan has warned that the proposal "creates a wide channel for large volumes of unapproved drugs and other products to enter the United States that are potentially injurious to public health and pose a threat to the security of our Nation's drug supply."

"Our purpose is to make sure the medications that the people take are safe and that patients and pharmacists interact appropriately," said Dennis Lyons of the Massachusetts College of Pharmacy and Health Sciences. "The FDA has proven that many of the drugs being imported are not adequately labeled with instructions for proper use, have inappropriate packaging, require careful dosing to avoid serious side effects, and can cause harmful interactions with other drugs consumers may be taking. This can be dangerous, especially for elderly patients not strong enough to handle the incorrect medicines. Importing from Canada also deprives patients of the prescription management, drug interaction review, and counseling functions of licensed US pharmacists, increasing the risk of dangerous interactions."

A recent letter signed by 53 US Senators, including Massachusetts Senator Ted Kennedy (D), to members of the Medicare Conference Committee charged with ironing out differences in a Medicare prescription drug benefit states, "[D]rug importation is opposed by the FDA, two Secretaries of HHS from both Republican and Democratic Administrations, the US Customs Service, and the Drug Enforcement Administration (DEA), even if it is limited only to Canada. . . . We urge you to oppose efforts to weaken current law that requires the Secretary of Health and Human Services to demonstrate that implementation of drug importation will pose no additional risk to the public's health and safety."

Renee Renganathan