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December 06, 2011

By Gary A. Puckrein, PhD


06 December 2011

National Minority Quality Forum Statement regarding the Counterfeit Drug Penalty Enhancement Act of 2011 

The National Minority Quality Forum applauds the Counterfeit Drug Penalty Enhancement Act of 2011, legislation that addresses one of the front-end, underlying factors that compromise quality health care and subvert efforts to incentivize the innovations necessary to increase the effectiveness of the American health care delivery system. This legislation is a step in the right direction – taking steps to remove fraudulent, and potentially harmful or ineffective drugs from the market without restricting access to legal, necessary and effective health care services.

According to a January 2010 Fact Sheet (No 275) issued by the World Health Organization (WHO), SFCCs (spurious/falsely-labeled/falsified/counterfeit) drugs can be defined as medicines that are deliberately and fraudulently mislabeled with respect to identity and/or source. Use of these counterfeit branded or generic medicines poses a public health risk because their content can be harmful, or they can lack the necessary active ingredients. As WHO notes, unlike substandard medicines where there are problems with the manufacturing process by a known manufacturer, counterfeit medicines are made by those with the intent to mislead – and, we might add, depending upon the nature of the counterfeit, the willingness to do harm to those whose health and lives depend upon the product.

Unlike the counterfeit consumer merchandise we encounter in the form of clothing, electronics and other non-essential items, the production and distribution of counterfeit medicines preys upon those whose health and longevity depend upon consumption of the product. The National Minority Quality Forum believes that this reprehensible practice must be stopped.

Support of the Counterfeit Drug Penalty Enhancement Act of 2011 by the Pharmaceutical Research and Manufacturers of America, in our view, reflects not only an appropriate and necessary protection of the business interests of their members, but, more significantly, is a harbinger of the implicit promise of this legislation — that passage will avert revenue losses linked to counterfeit drugs and the concomitant cost increases that are passed on to patients and their families. Further, the unproductive costs to manufacturers associated with protecting their financial interests against encroachment squander private sector resources that could be invested in forward-looking research and innovation.

The Counterfeit Drug Penalty Enhancement Act of 2011, sponsored by U.S. Senators Pat Leahy (VT) and Charles Grassley (IA) and U.S. Representatives Patrick Meehan (PA) and Linda Sanchez (CA) is an exemplar of bipartisan and bicameral engagement of our Federal government in a national action to protect the health and welfare of the American public. We laud their efforts and anticipate more such proactive initiatives. The National Minority Quality Forum encourages Congress to pass the Counterfeit Drug Penalty Enhancement Act of 2011.

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About The Forum

The National Minority Quality Forum (NMQF) is a 501(c)(3) not-for-profit, non-partisan, independent research and education organization. The vision of NMQF is a health services research, delivery and financing system that provides quality and effective health services to the biodiverse American general population of the 21st century. NMQF helps assure that national and local quality improvement initiatives are informed by scientific evidence, and place a priority on the quality of care and patient outcomes in all populations.