Regulatory Focus™ > News Articles > IOM Report Calls on Global Regulators to Work Together to Address Threat of Counterfeits

IOM Report Calls on Global Regulators to Work Together to Address Threat of Counterfeits

Posted 13 February 2013 | By Alexander Gaffney, RAC

A new report just published by the US Institute of Medicine (IOM) and sponsored by the US Food and Drug Administration (FDA) finds that global regulators and regulatory systems need to do more to combat the rising tide of falsified and substandard medicines.


Though the two terms-falsified and substandard-are often used interchangeably, there is an appreciable difference. A falsified medicine is one that claims to be one substance, but is fact another entirely. A substandard medicine, meanwhile, is one that is what it claims to be, but is not manufactured correctly, and may be diluted or contaminated with other excipients, or may have been manufactured to the incorrect standards. Often, drugs fall under both categories.

That distinction is not necessarily well-known or appreciated, though some researchers, including the American Enterprise Institute's Roger Bate, have pushed for broader recognition of it for years. In a May 2012 paper entitled, "Counterfeit or Substandard? The Role of Regulation and Distribution Channel in Drug Safety," Bate found that out of 1,437 units of the antibiotic ciprofloxacin obtained from 18 low- to middle-income countries, 9.8% could be defined as "counterfeit," a broader category encompassing both falsified and substandard. Of those samples, 41.5% were falsified, and the remaining 58.5% were substandard (defined as containing less than 80% of the intended active ingredient).

Bate's study noted that the problem is one that is particular pernicious to developing countries, where regulatory authorities often lack the know-how or resources to catch counterfeit products before they make it to market. In western countries, like the US and those in the EU, just 1.1% of products on the market are counterfeit.

Developing countries fared far worse in Bate's testing. Products registered with the World Health Organization (WHO)'s prequalification program passed Bate's testing at a 98.5% rate, while products registered with local authorities passed at a 93.5% rate. Unregistered products only passed 69.8% of the time, showing the powerful effects a regulatory authority can have on product quality and identity.

A Lack of Attention

And regulatory authorities have been doing just that over the past year. China, for example, has instituted tougher excipient regulations meant to cut down on fly-by-night manufacturers who substitute approved ingredients for cheaper, potentially dangerous ones. In Pakistan, the country has for the first time launched a drug regulatory authority in response to a huge number of counterfeit drug products, including cough syrup that had killed dozens.

But, as FDA explained in an October 2012 article in the medical journal Public Library of Science, the problem of ensuring drug quality is solved equally in actions and awareness.

"The lack of attention to medical product regulatory systems in low- and middle-income countries is a significant gap that needs to be bridged," wrote Charles Preston, Mary Lou Valdez and Katherine Bond, all employees of FDA's Office of International Programs. They explained further in that article that they hoped that strengthening regulatory systems and their supply chains would "become a global health priority."

Now, those same FDA authors are getting some support in the form of a lengthy IOM report entitled, "Countering the Problem of Falsified and Substandard Drugs," which makes the case that counterfeit drugs are of enormous public health consequence, and that regulatory authorities have a prominent role to play in reducing their proliferation and effects.

A Role for Regulators

The report concedes that measuring the deleterious effects of substandard and falsified drugs is difficult, and notes that the problem is "disproportionately felt in the developing world."

"Lack of clarity of the magnitude of the falsified and substandard medicines market holds back coordinated international action," it explains, adding that no global surveillance system yet exists despite the World Health Organization's (WHO) ongoing efforts.

The authors of the report said they hope that such a system will one day link the various pharmacovigilance databases, and recommended that FDA and other regulators work to "establish or strengthen systems to detect substandard, falsified and unregistered medicines."

But there's more that regulators can do than just that, the report explains. Regulators in low- and middle-income countries should use the International Conference on Harmonisation's (ICH) Common Technical Document (CTD) to better harmonize review and registration procedures and save costs. The same model is already used in the US, EU and Japan, as well as a number of non-ICH member countries.

Those same regulators should also be engaged in developing strategic plans for compliance with quality and manufacturing standards on a standardized basis. Even FDA is not immune from such criticism, as the report takes note of its recent failures to protect the public against substances compounded at the New England Compounding Pharmacy (NECC), whose products were found to be contaminated with fungal meningitis.

The report also calls on FDA to collaborate with state licensing boards to establish a public database to trade and share information on drug wholesalers, especially those whose licenses have been suspended or revoked for selling or distributing falsified or substandard medicines, and for the US National Institute of Standards and Technology (NIST) to develop a "central repository" for technologies and techniques to detect counterfeit medications.

Private Sector Problems

Other problems will be better left to the private sector, the report states. One problem in particular is the ability of companies to recoup investments in quality manufacturing. While those incentives usually -though not always-exist in western countries, they don't always exist in third-world settings, where costs have the potential to far exceed eventual returns. Thus, many companies seek to maximize profits by cutting corners, resulting in the proliferation of substandard and even falsified drugs. The report calls for the creation of investment vehicles to help finance pharmaceutical manufacturers who want to meet international manufacturing standards.

But not just suppliers are to blame for quality failures. Purchasers, such as aid procurement agencies, must do a better job at ensuring all products meeting international standards, such as those put forth by the WHO's Model Quality Assurance System (MQAS), the report says.

FDA Response

In a statement, FDA Commissioner Margaret Hamburg praised the report, noting that FDA is "fully prepared to help ensure product safety and quality within a globalized world," and is already engaged through its own efforts in enacting many of the report's recommendations.

"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," Hamburg wrote. "The FDA remains committed to engaging with multiple stakeholder groups to advance global solutions and minimize exposure of consumers to unsafe products."

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