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IOM Report: Countering the Problem of Falsified and Substandard Drugs (2013) Minimize

Institute of Medicine Press Release


Countering the Problem of Falsified and Substandard Drugs

Released: February 13, 2013

Type: Consensus Report

Topic: Global Health

Activity: Understanding the Global Public Health Implications of Substandard, Falsified, and Counterfeit Medical Products

Board: Board on Global Health


 Falsified and substandard medicines provide little protection from disease and, worse, can expose consumers to major harm. Bad drugs pose potential threats around the world, but the nature of the risk varies by country, with higher risk in countries with minimal or non-existent regulatory oversight. While developed countries are not immune, – negligent production at a Massachusetts compounding pharmacy killed 44 people from September 2012 to January 2013 – the vast majority of problems occur in developing countries where underpowered and unsafe medicines affect millions.

It is difficult to measure the public health burden of falsified and substandard drugs, the number of deaths they cause, or the amount of time and money wasted using them. The FDA asked the IOM to assess the global public health implications of falsified, substandard, and counterfeit pharmaceuticals to help jumpstart international discourse about this problem. At the international level, productive discussion relies on cooperation and mutual trust. This report lays out a plan to invest in quality to improve public health.

Read or Download the IOM Report, Click Here...






Bennet, Burr React to IOM Report: "Countering the Problem of Falsified and Substandard Drugs" Minimize

Bennet, Burr React to IOM Report: 
"Countering the Problem of Falsified and Substandard Drugs"


“The release of today’s Institute of Medicine’s report “Countering the Problem of Falsified and Substandard Drugs” calling for a national track and trace system underscores the urgency of Congress taking steps to improve the integrity of our pharmaceutical distribution supply chain for America’s patients. We remain committed to working with our colleagues to enact bipartisan legislation this year to put in place a uniform, national traceability framework built on the principle of advancing workable traceability informed by risk-based circumstances surrounding suspect and illegitimate prescription drugs.”





FDA Press Release Minimize


For Immediate Release: Feb. 13, 2013
Media Inquiries: Gloria Sanchez-Contreras, 301-796-7686,
[email protected];
Sarah Clark-Lynn, 301-796-9110,
[email protected]
Consumer Inquiries: 888-INFO-FDA


FDA Commissioner Margaret A. Hamburg’s Statement on the Institute of Medicine’s Report “Countering the Problem of Falsified and Substandard Drugs”


The U.S. Food and Drug Administration commends the Institute of Medicine (IOM) for its thorough discussion and recommendations outlined in its report, Countering the Problem of Falsified and Substandard Drugs.” The report identifies causes and public health consequences of substandard and falsified drugs and recommends a range of strategies to address the problem and to promote global dialogue and action.

The IOM report spotlights a critical global public health issue. Falsified and substandard medicines adversely affect the lives of millions around the world, and the issue must be elevated to the highest levels of international discourse.

In order to meet the challenges of today’s global marketplace, the FDA is transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world. In this context, many of the IOM recommendations support actions and efforts already underway at the FDA, including advancing technology, strengthening global regulatory capacity, strengthening surveillance, developing science-based standards and engaging in global dialogue.

The FDA engages in numerous efforts to combat substandard, falsely-labeled and counterfeit medical products globally. These include overseas presence in 12 countries in seven regions; active engagement with the World Health Organization’s new Member State Mechanism; and participation in the Asia Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) roadmap aimed at improving global medical product quality and supply chain integrity. In 2011, the FDA added to these efforts by commissioning the IOM to undertake the study released today.

The FDA recognizes that all countries need to work together to ensure safe medicinal products for their citizens due to the increasing complexity of the global economy. The FDA remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products.

For more information:

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.



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