US drug safety lacking, finds study

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A white paper by the Pew Health Group, the product health and safety arm of the Pew Charitable Trusts, found US drug safety sorely lacking. The study, titled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” concluded that international supply chains and a greater reliance on medicines produced in developing countries have increased the likelihood of fake and low quality drugs ending up on store shelves. The US Food and Drug Administration (FDA) estimates 40% of finished drugs and 80% of active ingredients currently come from overseas.

“Today’s prescriptions are being produced under last century’s oversight,” said Allan Coukell, Director of Medical Programs at the Pew Health Group.

Compared with a decade ago, pharmaceutical supply lines stretch around the world and out to a complex web of suppliers. Regulators and industry players must modernize supervision of the manufacturing process to ensure the drugs we consume are safe. The After Heparin white paper identifies links in the supply chain that government and business should strengthen.

“After Heparin” was based on public information, including FDA documents, US Government Accountability Office reports, congressional testimony, peer-reviewed journals and interviews with more than 50 supply chain experts and stakeholders. It included several case studies involving heparin (a blood thinner) manufactured with substandard ingredients in China, counterfeit vials of the anemia drug Epogen and stolen insulin.

The study also made several recommendations for improving drug safety, particularly:

  • Comprehensive systems ensuring quality and safety. Drug companies must take responsibility for their entire supply chains.
  • Improved distribution security. National standards for oversight of drug wholesalers would help prevent counterfeit and stolen medication from entering distribution chains.
  • The FDA’s authority to address issues must be increased. Congress should ensure that FDA can order the recall of substandard drugs, similar to the agency’s authority for food and medical devices. In addition, the agency needs the authority to subpoena documents and witnesses and an improved set of enforcement tools, such as strengthened penalties for certain violations.