Leading Health Care, Business, Labor and Advocacy Groups Join
Together to Oppose Drug Importation as Part of the Prescription
Drug User Fee Act (PDUFA)

Importation Undermines Drug Safety Protocols, Could Lead to Influx of Dangerous Counterfeit Drugs

Washington, D.C. (May 21, 2012) – In a letter sent today to members of the U.S. Senate, the Partnership for Safe Medicines (PSM), a public health group comprised of more than 65 organizations committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines, joined with leading patient, health care, business and advocacy groups in strongly opposing any amendments that would permit legal importation as part of the Prescription Drug User Fee Act (PDUFA). If allowed to move forward, importation would unnecessarily expose patients to increased risk of dangerous and potentially life-threatening counterfeit medicines making their way into the United States.

Among the organizations included in the letter: the American Pharmacists Association, the Kidney Cancer Association, the National Association of Manufacturers, the Pharmaceutical Industry Labor Management Association (PILMA) and the U.S. Chamber of Commerce.

“Despite the United States having the most secure drug supply chain in the world, recent incidents such as the discovery of fake Avastin prove we must remain ever vigilant,” said PSM Chairman Marvin D. Shepherd, PhD. “Contrary to claims made by importation advocates, there is no regulation for products trans-shipped through ‘safe’ countries such as Canada and the United Kingdom. Americans would be put at great risk and importation would erode the FDA’s ability to regulate prescription medicines, opening the door for more criminals to operate bogus online pharmacies that prey upon our citizens.”

Letter image

Leading Health Care, Business, Labor and Advocacy Groups Join
Together to Oppose Drug Importation as Part of the Prescription
Drug User Fee Act (PDUFA)

Importation Undermines Drug Safety Protocols, Could Lead to Influx of Dangerous Counterfeit Drugs

Washington, D.C. (May 21, 2012) – In a letter sent today to members of the U.S. Senate, the Partnership for Safe Medicines (PSM), a public health group comprised of more than 65 organizations committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines, joined with leading patient, health care, business and advocacy groups in strongly opposing any amendments that would permit legal importation as part of the Prescription Drug User Fee Act (PDUFA). If allowed to move forward, importation would unnecessarily expose patients to increased risk of dangerous and potentially life-threatening counterfeit medicines making their way into the United States.

Among the organizations included in the letter: the American Pharmacists Association, the Kidney Cancer Association, the National Association of Manufacturers, the Pharmaceutical Industry Labor Management Association (PILMA) and the U.S. Chamber of Commerce.

“Despite the United States having the most secure drug supply chain in the world, recent incidents such as the discovery of fake Avastin prove we must remain ever vigilant,” said PSM Chairman Marvin D. Shepherd, PhD. “Contrary to claims made by importation advocates, there is no regulation for products trans-shipped through ‘safe’ countries such as Canada and the United Kingdom. Americans would be put at great risk and importation would erode the FDA’s ability to regulate prescription medicines, opening the door for more criminals to operate bogus online pharmacies that prey upon our citizens.”

PSM believes legalizing importation would break a crucial link in the supply chain, as the FDA has no legal jurisdiction over foreign supply chains. Furthermore, the number of rogue online pharmacies would likely skyrocket, as an unregulated importation market would give criminals carte blanche to prey upon American citizens.

“Instead of undermining nearly two decades of progressive drug safety policy by allowing importation, the Senate should soundly reject any and all importation amendments,” said Shepherd. “PSM remains committed to the fight against unsafe medicines, and we and our partners will continue to vigorously oppose any legislation that threatens Americans and our drug supply.”

PSM’s Board includes Dr. Marv Shepherd; Bryan A. Liang, MD, PhD, JD, Vice President, Partnership for Safe Medicines, Executive Director, Institute of Health Law Studies, California Western School of Law and Director, San Diego Center for Patient Safety, University of California San Diego School of Medicine; and Thomas T. Kubic, Treasurer, Partnership for Safe Medicines, President & CEO, Pharmaceutical Security Institute and Deputy Assistant Director, FBI (Ret.)

Read the joint letter from PSM, its members and allies to the Senate here.