Partnership for Safe Medicines Opposes Legislation to Undermine Drug Safety Enforcements

Public Health Group Urges Senators to Prevent Influx of Counterfeit Medicines and Ensure Patient Safety by Opposing Vitter Importation Amendment

Washington, D.C. (October 19, 2011) – Legislation that would prohibit the US Food and Drug Administration (FDA) from stopping the importation of potentially unsafe medicines, including those sold over the Internet, would raise the risk of dangerous counterfeits harming millions of American patients, the Partnership for Safe Medicines (PSM) said in a letter today urging members of the US Senate to oppose an amendment offered by Senator David Vitter (R-LA). PSM, a public health group comprised of more than 65 organizations that are committed to the safety of prescription drugs and protecting consumers against counterfeit, substandard or otherwise unsafe medicines, is deeply concerned that this proposed amendment would unnecessarily put America's secure drug supply, and patients' health, in serious jeopardy.

"The proposed amendment will undermine nearly two decades of drug safety policy, and put Americans at significantly greater risk for harm – or even death – from counterfeit medicines," said Marv Shepherd, PhD, who serves as both Director of Pharmacoeconomics, University of Texas School of Pharmacy and as President of the Partnership for Safe Medicines. "As it stands today, FDA does not have jurisdiction over foreign supply chains, and allowing importation of medicines from even seemingly safe countries like Canada would add to FDA's already overburdened and underfunded responsibilities. This is a short-sighted amendment with unintended consequences that will harm American consumers."

This broadly written amendment would have a far-reaching impact by allowing American consumers to obtain unlimited prescription medications without a prescription, even over the Internet, from abroad. PSM has been actively fighting the proliferation of the sale of counterfeit medicines by fake online pharmacies and social networks, which are the venues of choice for criminals who wish to make a quick buck while putting American consumers at risk. This amendment would only make it easier for criminals, both online and offline, to sell their counterfeit medicines to unsuspecting American consumers, while making it much harder for the FDA to protect the health and safety of American patients.

"The United States is fortunate to have one of the safest drug supplies in the world, allowing our citizens a high level of confidence in the safety of the medicines they take every day. Any legislation that puts that level of safety in jeopardy is bad public policy," Shepherd added. "On behalf of our members, PSM strongly urges Senators to oppose the Vitter amendment and help keep Americans safe from counterfeit medicines."

Three members of the PSM Board submitted today's letter on behalf of the organization – 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.)

For a full copy of the letter, see:

About PSM: Comprised of more than 65 non-profit organizations, the Partnership for Safe Medicines is a public health group committed to the safety of prescription medicines and protecting consumers against counterfeit, substandard or otherwise unsafe medicines. PSM can be found on Facebook (, Twitter (@safemedicines), and the web at

Media Contact: Teresa Schofield +1-202-347-7947