Over 30 Groups Nationally Oppose Drug Importation

Recently, conversations and debate about drug importation has reached a fever pitch. Partnership For Safe Medicines’ many coalition members want Congress to know about our concerns for the safety of American patients. The secure American drug supply chain protects American consumers from dangerous counterfeit, substandard and unsafe medicines. Any effort designed to bypass FDA controls tears open the safe, closed supply chain and exposes U.S. patients to serious risk.

December 1, 2015

Dear Senator,

As a coalition whose outreach and operations involve educating health care workers and patients in all fifty states, and whose membership is comprised of more than 60 organizations committed to the safety of prescription drugs and protecting U.S. consumers against counterfeit, substandard or otherwise unsafe medicines, we are deeply concerned that importation proposals will undermine America’s existing and proposed drug safety protocols.

Whether offered broadly or for a narrow set of medications, there’s never a good time to sacrifice safety. No patient is served well by a drug from an unknown source, that has been stored under unknown conditions, and which contains unknown ingredients because it passed through unlicensed, foreign middlemen who operate beyond U.S. law. 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 no regulation for products trans-shipped through “safe” countries such as Canada and the United Kingdom and thus, Americans would be put at great risk.

Proposals allowing importation would 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.” We urge you to focus on creating substantive programs that protect the nation’s drug supply to maintain access to safe medicines.

With very best regards,

Marv Shepherd, PhD President, Partnership for Safe Medicines, Director of Pharmaeconomics, University of Texas School of Pharmacy

Thomas T. Kubic President & CEO, Pharmaceutical Security Institute Deputy Assistant Director, Criminal Division, FBI (retired)

Jim Dahl Assistant Director, FDA Office of Criminal Investigations (retired) Board member, Partnership for Safe Medicines

Additional signers

• Edith A. Rosato, RPh, IOM Chief Executive Officer, Academy of Managed Care Pharmacy
• Louise F. Jones, Executive Director, Alabama Pharmacy Association
• Brian Kennedy Executive Director, Alliance for Patient Access
• Kelly Fine Ridgway, RPh. Chief Executive Officer, Arizona Pharmacy Association
• Todd Gillenwater Executive Vice President, Advocacy and External Relations California Life Sciences Association (CLSA)
• William E. Arnold, Community Access National Network (CANN)
• Chester “Chip” Davis, Jr., President and Chief Executive Officer, Generic Pharmaceutical Association
• John M. Gray President and Chief Executive Officer, Healthcare Distribution Management Association
• Steve Issenman Sr. Vice President, HealthCare Institute of New Jersey
• Mary R. Grealy President, Healthcare Leadership Council
• Garth K. Reynolds, RPh Executive Director, Illinois Pharmacists Association
• Michael R. Cohen, RPh, MS, ScD (hone), DPS (hon) Institute for Safe Medication Practices
• Bob Barchiesi President, International AntiCounterfeiting Coalition
• Robert L. McFalls Executive Director/CEO, Kentucky Pharmacists Association
• William P. Bro, President, CEO, and Patient-Survivor Coordinator, Kidney Cancer Association
• Todd Brown MHP, R.Ph. Executive Director, Massachusetts Independent Pharmacists Association
• Brandon Leonard, MA Director, Strategic Initiatives, Men’s Health Network
• Larry Wagenknecht, Pharmacist Chief Executive Officer, Michigan Pharmacists Association
• Ron Fitzwater, CAE, MBA Chief Executive Officer, Missouri Pharmacy Association
• Rebecca P. Snead Chief Executive Officer, National Alliance of State Pharmacy Associations
• Carmen A. Catizone, MS, RPh, DPh Executive Director/Secretary, National Association of Boards of Pharmacy
• Tom O’Donnell Vice President, Federal Government Affairs, National Association of Chain Drugs Stores
• Charlie Cichon Executive Director, National Association of Drug Diversion Investigators
• Joe Trauger Vice President, Government Relations, National Association of Manufacturers
• Douglas Liptak President, National Biopharmaceutical Security Council
• Joni Cover, J.D. Chief Executive Officer, Nebraska Pharmacists Association
• Rich Sagall, MD President, NeedyMeds
• Elise M. Barry, M.S., CFRE Chief Executive Officer, New Jersey Pharmacists Association
• Ernest Boyd, Pharm.D (hon), MBA Ohio Pharmacists Association
• Debra Billingsley, JD Executive Director, Oklahoma Pharmacists Association
• Patricia A. Epple, CAE Chief Executive Officer, Pennsylvania Pharmacists Association
• Tim Dickson Executive Director, Pharmaceutical Industry Labor Management Association (PILMA)
• Thair Phillips President, RetireSafe
• Craig M. Burridge, M.S., CAE Chief Executive Officer, South Carolina Pharmacy Association
• Bruce Josten Executive Vice President, Government Affairs, US Chamber of Commerce
• Thomas J. Berger, Ph.D. Executive Director, The Veterans Health Council of Vietnam Veterans of America
• Timothy S. Musselman, Pharm.D. Executive Director, Virginia Pharmacists Association
• Richard Stevens, Executive Director, West Virginia Pharmacists Association