New Institute of Medicine Report on Illegitimate Drugs: A Moral Tragedy

March 21, 2013

Todd Summers
Senior Adviser

The U.S. Institute of Medicine at the National Academy of Sciences recently released a new report on Countering the Problem of Falsified and Substandard Drugs.  Commissioned by the U.S. Food and Drug Administration, it raises important, indeed frightening, concerns about the quality and reliability of medicines in the U.S. and other developed nations, as well as in low- and middle-income countries that often have weaker capacities, and proposes concrete steps in response.

Leading the expert panel that authored the report was Larry Gostin, a public health law and policy expert at the Georgetown University Law School.  At a public release event last month (video here), Professor Gostin laid out his panel’s key findings and recommendations.  The focus was on medicines that are either fake (what’s on the label is not what’s in the bottle) or substandard (the quality of what’s in the bottle can’t be guaranteed), collectively referred to as “illegitimate drugs.”

The problem, says Professor Gostin, is global and has significant and sometimes tragic consequences:

• Drugs with insufficient levels of active ingredients lead to sub-optimal dosing that limits therapeutic benefit and promotes drug resistance;

• Poorly manufactured or adulterated drugs can be toxic, causing illness rather than treating it;

• Bad drugs erode consumer confidence in medicines, in health care, and in their ability to rely on their governments to ensure the safety and authenticity of medicines;

• Profits from selling bad drugs attract and fuel criminal enterprises that are adept at exploiting weak regulatory and enforcement systems; and

• Precious funds are wasted on medicines that don’t work or even cause harm.

In the developing world, proliferation of illegitimate drugs is exacerbated by:

• Inadequate capacity to manufacture drugs in compliance with stringent international standards and lack of investment capital needed by companies to build suitable production facilities;

• Lack of investment by governments to strengthen their regulatory and enforcement capacities; and

• A chronic deficit of skilled personnel.

The panel’s report includes a range of detailed recommendations targeting a range of actors:

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  Additional investment is needed to bolster public and private sector capacity.

  • The World Bank and others need to increase access to the investment capital needed by the private sector to improve the quality and reliability of drug manufacturing facilities.

  • Developing country governments, which ultimately hold responsibility for oversight, need to strengthen their regulatory and enforcement capacity with better planning, higher investment, and enhanced authority.

• Technical support is needed:

  • The FDA, World Health Organization, and others need to provide more of the technical support needed to strengthen regulatory capacity, including training of the various tiers of pharmaceutical experts needed.

• Distribution and manufacturing systems need development:

  • Drug distribution systems need to be strengthened so that they can ensure secure delivery of products from manufacturers to patients.

  • Private sector capacity, especially in the retail sale of medicines, needs to be expanded.

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  Global standards must be developed:

  • In the absence of an effective treaty, an international code of practice needs to be developed by a range of public, private, and civil society stakeholders.

  • This code needs to encompass the full range of surveillance, regulatory, and law enforcement standards required to ensure a safe drug manufacturing and delivery system.

• Innovations are available:

  • Amazing new tools are available to identify, track, and trace drugs to identify quickly those that are illegitimate, and they need to be put to use quickly and at scale.

  • These need to be part of a broader system of regulation and law enforcement so that there are effective responses when problems are detected.

• Consumers need information:

  • Effective communications are needed to raise awareness about the proliferation of bad drugs, and to build consumer and civil society demand for improved national and international responses.

Here at the CSIS Global Health Policy Center, we’re fortunate to have a great relationship with FDA Commissioner Peggy Hamburg, who’s been outspoken on this issue.  In the past, she’s talked with us about the safety of food and drug imports, and more broadly about FDA’s expanding role in the global arena, so we’ll ask how FDA and other U.S. global health and development agencies are responding to the report’s recommendations. 

I work a lot with the Global Fund, which is a major funder of drug procurement, especially for anti-tuberculosis and anti-malaria drugs cited in the IOM report as particularly at risk.  While it has policies on procurement, pharmaceutical quality control, and related capacity building, its procurement team is also looking to see what more proactive role it can play, so we’ll check in with them on progress.

Let us know how you see this issue, and how you think CSIS can help.

Read more posts by Todd Summers