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:
- Promulgation of good manufacturing practices and related standards
- Compliance reviews, including inspections of manufacturing facilities
- Review of pharmaceutical imports at the point of entry to the United States
- Oversight of pharmaceutical distribution within the United States
1 Created through the Food and Drugs Act of 1906.
2 U.S. Government Accountability Office. (2007, November). Drug Safety: Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers. (Publication No. GAO-08-224T)
3 An estimate by FDA officials of the prevalence of counterfeit drugs in the US – one specific kind of economically motivated adulteration. Rudolph, PM and Bernstein, IBG. “Counterfeit Drugs” N Engl J Med. April 1, 2004. Vol. 350: 1384-1386