Keeping the public safe in an age of global pharmaceutical sourcing requires improved safety testing standards, greater industry oversight of contract manufacturers and suppliers, and expanded enforcement authority for FDA backed by stronger penalties and clearer accountability, says a new report from the Pew Charitable Trusts.
The study, released last week on Capitol Hill, looks at risks posed to consumers by the increasingly global nature of the pharmaceutical supply chain. It focuses on the challenges of quality management, barriers to FDA oversight, and the potential for crime in drug distribution.
The report also includes a raft of policy recommendations.
Titled “After Heparin: Protecting Consumers from the Risks of Substandard and Counterfeit Drugs,” Pew’s report presents case histories of drug adulteration, including the heparin recall of 2008, and statistics illustrating a steep rise in the number of overseas pharmaceutical suppliers to the U.S. According to Pew, 80% of active ingredients and bulk chemicals used in drugs in the U.S. are currently imported.
Tougher regulations and more stringent oversight on the part of manufacturers are required “to remove the competitive advantage of noncompliance, which currently exists for companies able to flout the law beyond FDA’s reach,” said Deborah Autor, compliance director at FDA’s Center for Drug Evaluation & Research, in her remarks to the forum.