Sen. Vitter’s Proposed Amendment Raises Drug Safety Concerns
[The Senate is marking up the House's Agricultural Appropriations Bill (HR 2112). They are considering an amendment (#769) proposed by Senator Vitter which would allow for drug importation. The Partnership for Safe Medicines sent this letter to all members of the Senate today to urge them to oppose importation.]
As a public health group whose outreach and operations extend to Brazil, China and India, and whose membership is comprised of more than 65 organizations committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines, we are deeply concerned that the proposed amendment to the Agricultural Appropriations Bill by Senator Vitter will undermine America's existing and proposed drug safety protocols by allowing drug importation.
Drug importation advocates believe that drugs purchased from countries such as Canada and the United Kingdom are safe because of their strict health regulations. Unfortunately, this is simply not true. There is a lack of regulation for products trans-shipped through "safe" countries such as Canada and the United Kingdom. In a letter issued in 2009, FDA Commissioner Margaret Hamburg outlined the agency's concerns with drug importation, arguing that the importation of FDA-approved drugs from countries like Canada could endanger the U.S. medicine supply because of the lack of FDA jurisdiction over foreign supply chains. "In establishing an infrastructure for the importation of prescription drugs, there are two critical challenges in addressing these risks. First, FDA does not have clear authority over foreign supply chains…. Second, FDA review of both the drugs and the facilities would be very costly."
In 2006 the European Commission conducted a study into the parallel trade of medicine. In response to the study, E.U. Commissioner Guenter Verheugen said "parallel trade brings a considerable risk for the safety of the patients. The reasons for that are numerous – there are problems with the packaging and labeling of the products, as well as with product recalls, the complexity of distribution channels and the supply. And finally it is difficult to effectively enforce the law."
This proposed amendment will undermine nearly two decades of drug safety policy. Large volume importation of prescription drugs could be permitted under current law only if the Health and Human Services (HHS) Secretary was willing to certify that imported drugs "pose no additional risk to the public's health and safety, and result in a significant reduction in the cost of covered products to the American consumer." Recent HHS Secretaries have not been willing to make this certification of "no risk." This means that throughout the past 18 years and under three Administrations, no HHS Secretary (Democrat or Republican) has certified a drug importation plan-a clear indication of the extreme safety concerns associated with drug importation and the challenges with ensuring safety of the globalized drug supply.
We urge Congress to focus on creating substantive programs that protect the nation's drug supply to maintain access to safe medicines. The risks of policy failure fall upon this country's most vulnerable and traditionally underserved minorities.
With very best regards,
Marv Shepherd, PhD
President, Partnership for Safe Medicines
Director of Pharmacoeconomics, University of Texas School of Pharmacy
Bryan A. Liang, MD, PhD, JD
Vice President, Partnership for Safe Medicines
Executive Director, Institute of Health Law Studies, California Western School of Law
Director, San Diego Center for Patient Safety, University of California San Diego School of Medicine
Thomas T. Kubic
Treasurer, Partnership for Safe Medicines
President & CEO, Pharmaceutical Security Institute