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FDA's Role in the WHO’s Member State Mechanism on Substandard and Falsified Medical Products

In October 2012, the World Health Assembly established the World Health Organization’s Member State Mechanism on Substandard and Falsified Medical Products (the Mechanism), to serve as a global forum that would convene, coordinate, decide, and organize activities addressing the twin public health scourges of substandard and falsified (SF) medical products. 

As defined by the World Health Organization, substandard products are authorized but fail to meet their quality standards or specifications. Falsified medical products are those that deliberately or fraudulently misrepresent their identity, composition, or source — they may contain no active ingredient, the wrong active ingredient, or the wrong amount of the correct active ingredient. They commonly contain corn starch, potato starch, or chalk. 

SF products have been identified in all main therapeutic categories, including medicines, vaccines, and in vitro diagnostics. The products may cause harm to patients, fail to treat the diseases for which they were intended, and lead to loss of confidence in medicines, health care providers, and health systems — and they affect every region of the world.  

Among its objectives, the Mechanism seeks to:  

  • identify major needs and challenges, make policy recommendations, and develop tools in the areas of prevention, detection methodologies, and control of substandard and falsified medical products; 
  • work to strengthen national and regional capacities in order to ensure the integrity of the supply chain;
  • provide for the exchange of information and best practices at national, regional and global levels; 
  • identify actions, activities and behaviors that result in substandard and falsified medical products; and  
  • strengthen the regulatory capacity and quality control laboratories at national and regional levels, particularly for developing and least developed countries. 

Data collection to better identify the scope of the problem has been one of the goals of the Mechanism since its founding. The Mechanism is aligned with the WHO’s Global Surveillance and Monitoring System (GSMS) to encourage countries to report SF incidents in a structured and systematic format and to help develop a more accurate and validated assessment of the problem. When a report is received by the WHO, it is automatically uploaded to a secure database and is immediately compared against all other existing reports. Any matches are identified, and details are shared with the reporting Member State. 

The GSMS provides technical support in emergencies; links incidents between countries and regions; issues WHO medical product alerts; gathers a validated body of evidence to more accurately demonstrate the scope, scale, and harm caused by SF medical products; and identifies vulnerabilities, weaknesses, and trends. Hundreds of regulators in 141 countries have been trained to detect and respond to SF products, and 1,500 SF products have been identified and reported to the system by a network of “focal points” that include health agencies such as the FDA, as well as manufacturers, donor organizations, and other stakeholders. The WHO also monitors media reports for SF medical product incidents. Since 2013, the WHO has issued 35 global medical product alerts — as well as many regional warnings — and has provided technical support in more than 100 cases.  

Over the years countries have begun to adopt screening technology, such as handheld detectors that can quickly identify SF products. The Mechanism has a chair supported by 11 vice chairs, representing the six regions of the WHO. The FDA is actively engaged in the Mechanism, including the WHO’s Americas Regional Network for Substandard and Falsified Medical Products, which it co-chairs.  

The Mechanism meets every October to set policy and decide on its two-year work plan that lays out prioritized activities. Once the Mechanism agrees to the list of prioritized activities, work in each activity is then led by, either a Member State or by the Secretariat. In October 2021, the Mechanism’s Steering Committee accepted an FDA proposal to set up a work group on informal markets — the market stalls, push carts, and small retail shops found in low- and moderate-income countries that dispense medicines when pharmacies or health care facilities aren’t available. These loosely regulated markets often sell the medication by the pill or in small amounts that are devoid of any packaging, an approach that would be illegal in pharmacies or informal markets with packaging restrictions. 

The FDA’s involvement with the Mechanism is part of a multipronged approach to shield patients and consumers from the unlawful sale and distribution of unsafe drugs. The agency’s efforts include a combination of enforcement, compliance, and voluntary actions, as well as outreach, education, and collaboration with stakeholders. 

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