Consumer Protection Group Announces Principles for Drug Safety

Partnership for Safe Medicines establishes drug safety principles to protect the pharmaceutical supply chain, regulate online drug sellers, and fight counterfeit drugs.

July 28, 2008 (FPRC) -- WASHINGTON - Following on recent reports about a substantial increase in the number of counterfeit drug incidents worldwide, the Partnership for Safe Medicines has developed a set of drug safety principles to form the basis for a national strategy to strengthen the U.S. distribution system and curtail the criminal counterfeit drug trade.

'In today’s global environment, it doesn’t matter if you live in United States, Spain, Australia, or Ghana—everyone is at risk from counterfeit drugs,' said Marvin D. Shepherd, Ph.D., president of the Partnership for Safe Medicines and the Director of the Center for Pharmacoeconomic Studies and Chairman of the Pharmacy Administration Division at the University of Texas at Austin’s College of Pharmacy. 'There needs to be better cooperation between government agencies here within the United States, as well as with our counterparts around the world, in order to stop the unscrupulous counterfeiters who do not hesitate to use foreign, even toxic, materials in their products.'

As a coalition of organizations and individuals dedicated to protecting consumers from counterfeit medicines, the Partnership created the Principles for Drug Safety. The principles are aimed to address the urgent need for progress in the fight against counterfeit drugs, encourage policymakers to enact stronger safety measures, and enable law enforcement to deal with problems at their source. Specifically, the Partnership’s principles addresses ways to protect the pharmaceutical supply chain, regulate online drug sellers, and fight counterfeit drugs, including:

Protect Our Supply Chain
• We believe there is strong need for strict, rigorous regulatory oversight of imported pharmaceuticals, including the regulation of the storage throughout the distribution system of imported pharmaceuticals.
• We support a dramatic and sustained increase in funding for the FDA in order to increase inspections of foreign facilities that manufacture drug products or components of drug products sold in the United States. Additionally, the FDA should be empowered to inspect distribution facilities.
• We endorse establishing permanent FDA field offices in China, India and other key exporting countries staffed with both inspectors and criminal investigators.
• We advocate the development and implementation of a standardized drug pedigree program at a national level.

Regulate Online Drug Sellers
• We value the rigorous oversight and standards that govern traditional pharmacies in the United States and believe all online drug sellers should be held to the same standards.
• We endorse the full Verified Internet Pharmacy Practice Site (VIPPS) accreditation program created by the National Association of Boards of Pharmacy.
• We believe all Internet drug sellers, regardless of which state or country in which they are based, must comply with the pharmaceutical licensing and survey requirements for every state they sell pharmaceuticals.
• We advocate that no one should be able to purchase prescription drugs, including controlled substances, over the Internet without a valid prescription and physician oversight.

Unify in the Fight Against Counterfeit Drugs
• We believe the United States needs to be a leader in the global fight against counterfeit drugs.
• We recognize that counterfeit drugs, tainted medicines, and rogue online drug sellers are a global problem that requires an international solution.
• We advocate for international cooperation between government agencies around the world in order to prosecute the unscrupulous counterfeiters who do not hesitate to use foreign, even toxic, materials in their products.
• We support increasing criminal penalties against the perpetrators of counterfeit medicines to reflect the gravity of their offenses.
• We endorse granting the FDA authority to destroy unapproved drugs entering the United States rather than returning them to the criminals who sent them here.

'Counterfeit drugs are a global public health hazard that requires an international solution,' Dr. Shepherd continued. 'If we want to avoid more deadly incidents both here in the United States and around the world, we need to take this opportunity to work together as a global community to address the vulnerabilities threatening the safety of our prescription drugs.'

In addition to the Principles for Drug Safety, the Partnership offers several online resources to help consumers ensure the safety of their prescription drugs, including guides to safely purchasing medicines online and how to save money without compromising drug safety. To learn more about why counterfeit drugs are unsafe at any cost, visit

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About the Partnerships for Safe Medicines
The Partnership for Safe Medicines is a group of organizations and individuals that have policies, procedures, or programs to protect consumers from counterfeit or contraband medicines. To join us in our stand against counterfeit drugs or obtain a copy of the Principles for Drug Safety, please visit

For more information contact Deborah Danuser of The Partnership for Safe Medicines  (

Keywords: Counterfeit drugs, on line pharmacy, drug safety

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