Thank you for the opportunity to present comments and to participate today in this important discussion. My name is Allan Coukell. I am a pharmacist and director of the Pew Prescription Project – an initiative established by The Pew Charitable Trusts to represent consumer interests on a range of drug safety issues, including the risk of adulterated medicines.
Protecting consumers against the risk of adulterated products is, of course, the original mission of the FDA.1 Today, the vast majority of pharmaceutical products sold in the United States today are not adulterated, but an increasingly complex supply chain creates new challenges and new risks – as recent events demonstrate.
Economically motivated adulteration includes the potential for contaminated, sub-potent or counterfeit medication to enter the supply chain at several levels, from the production of raw ingredients through to the point of retail sale.
The true prevalence of such adulteration is unknown. The severity of reactions associated with heparin in 2007 and 2008 made it likely that the contamination would be detected, albeit too late. However, a less toxic contaminant or an inert or sub-potent formulation would be more likely to escape notice.
In recent years, the pharmaceutical supply chain has become increasingly complex, extending beyond our shores in unprecedented ways. By one widely-cited 1998 estimate, nearly 80% of all active pharmaceutical ingredients now originate outside the United States, a trend that can only have increased in the past decade.2 Americans now consume pharmaceuticals that originate in thousands of manufacturing facilities in developing nations outside the formal jurisdiction of FDA.
Even an adulteration rate of less than 1 percent, could equate to millions of American consumers exposed each year.3
To protect the supply chain, regulatory activity occurs at multiple levels:
Download the PDF to read the complete testimony from Alan Coukell.
Pew sent a comment letter to the Senate Committee on Health, Education, Labor and Pensions on the Pharmaceutical Compounding Quality and Accountability Act. This bill takes steps toward clarifying state and federal oversight of compounding, including an important increase in FDA supervision of certain activities—specifically, the compounding of sterile medicines that are shipped interstate.
More infoRepresentative Edward Markey, a Democrat from Massachusetts, on Thursday became the latest lawmaker to propose legislation that would give the U.S. Food and Drug Administration greater regulatory authority over drug compounding.
More infoOn Thursday, May 23, the House Energy & Commerce Subcommittee on Health held a hearing, entitled "Examining Drug Compounding." Gabrielle Cosel, a drug safety expert, testified on the need to clarify oversight of compounding pharmacies on the state and federal level.
More info
Public health and consumer advocacy groups are attacking Senate legislation designed to tighten oversight of specialized pharmacies such as the one at the center of this past fall’s deadly meningitis outbreak, saying it does not adequately address health risks.
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