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FDA and industry support global framework and collaborations to secure the supply chain.
As concerns mount around the world regarding adulterated and counterfeit drugs and medical products, FDA is joining manufacturers and other regulatory bodies to take more aggressive action against “fake pharma” operators. There were more than 2000 incidents of pharmaceutical crime in 2014, according to the Pharmaceutical Security Institute (PSI); these involve diversion, theft, and counterfeiting in more than 100 countries, primarily in Asia.
Illegal drug websites drive such activities, as seen in the latest international crackdown on these operations: the June 2015 Operation Pangea VIII. Led by INTERPOL, the action netted more than 1000 websites selling unapproved and illegal medicines and medical devices worldwide and led to FDA warning letters to approximately 400 websites. Similarly, reports of unauthorized foreign versions of Allergan’s Botox in the United States made headlines, along with the arrest of members of a Miami crime ring for allegedly distributing $200 million in illegally diverted drugs to treat cancer, HIV, and psychological disorders. In April 2015, FDA sent more than 300 letters alerting physicians against purchasing unapproved drugs from Gallant Pharmaceutical International, the target of a vast investigation of illicit sales.
Growing international concerns about a global pandemic in substandard drugs are evident (1). The rise in poor quality medicines and the related increase in resistance to critical treatments for infectious diseases is examined in 17 research papers supported by the National Institutes of Health’s Fogarty International Center and the Bill & Melinda Gates Foundation. Studies sampled antimalarials, antibiotics, and TB treatments for quality and found that up to 41% had either too much or too little active ingredient and other formulation problems (2).
FDA is responding with a new strategic framework to fight illegal medicines, under the auspices of the agency’s Counterfeit Drug Council chaired by Howard Sklamberg, deputy commissioner for global regulatory operations and policy. The program is mapped out in the Global Product Safety Net for SSFFC (substandard, spurious, falsely labeled, falsified, and counterfeit) Medical Products, reported Cynthia Schnedar, director of the Office of Compliance (OC) in the Center for Drug Evaluation and Research (CDER), at a June 2015 conference on “Fighting Fakes” sponsored by the Rx-360 consortium (3). The framework aims to reduce public health risks caused by SSFFC medical products by blocking their entry into the US market, by improving detection of these products, and by developing more effective responses when such products are identified.
Enforcement efforts to catch and shut down bogus product distributors will be supported by the establishment of a more effective US drug supply chain system able to track and identify legitimate as well as illegal medical products, as required by the Drug Quality and Security Act of 2013. CDER’s Office of Drug Security, Integrity and Response (OSDIR) in the OC has been implementing product serialization requirements, and product tracking to the lot level is now in effect. By November 2017, manufacturers must have unique product identifiers on all prescription drug packages. This will support a system able to identify and verify products at the package level by 2020; a fully interoperable, electronic package level-tracing program is slated for 2023.
Achieving these goals involves establishing standards for product verification and for exchange and documentation of transactions. FDA is planning a pilot test of its ability to respond to reports of fake or illegitimate products in the supply chain. And agency scientists are examining new analytical methods for detecting harmful adulterants in pharmaceutical ingredients with an eye to creating a spectral library with profiles for qualified ingredients and suppliers.
The SSFFC framework also bolsters FDA collaborations with other US and international agencies, such as the US Department of State’s International Forum on SSFFC products and World Health Organization (WHO) actions against illegal medical products, explained OC deputy director Ilisa Bernstein at the Rx-360 conference. FDA is engaged in several US-European Union mutual reliance initiatives to make the legitimate drug supply chain safer and more secure, Bernstein noted. And FDA is working closely with the Pharmaceutical Inspection Cooperation Scheme (PIC/S); the PIC/S Permanent Forum on International Pharmaceutical Crime aims to provide more support for legitimate international drug supply chain operations.
Michael Deats, WHO group lead for surveillance and monitoring, described how WHO is expanding oversight of SSFFC products while working to gain agreement on common definitions and tracking technologies. WHO oversight in Africa has led to reports on more than 700 suspect products and 11 drug alerts, Deats reported, noting that the current surge in falsified artemisinin-based antimalarials threatens to undermine effective treatment. A particularly alarming situation, he noted, involved distribution of an ineffective vaccine for meningococcal C, following an outbreak of disease that dried up supplies of the legitimate product; difficulty in detecting lack of efficacy in a vaccine makes such fakes particularly dangerous and easily foisted on unsuspecting patients and health authorities. To build support for stronger action against such illegal actors, WHO has launched a project to calculate the harm caused by divergence and how it threatens local manufacturers, local economies, and public health.
Similarly, an Asia-Pacific Economic Cooperation (APEC) high-level steering committee has determined that poor-quality medicines threaten the economies and public health of member nations. This determination has built support for a “major initiative” to establish a Roadmap to Promote Global Medical Product Quality and Supply Chain Security under its Life Sciences Innovation Forum (LSIF). The Roadmap will be discussed further at an APEC work stream meeting in August 2015 in Korea, reported OSDIR counsel Mark Paxton. Sessions will cover a range of strategies for protecting trade in legitimate products, including good distribution practices, GMP audits, quality management systems, import and export practices, Internet dispensing practices, detection technologies, and single point-of-contact systems within each APEC economy.
The APEC August meeting follows an LSIF training program on medical product integrity and supply chain security, which took place in the Philippines in January 2015. The group anticipates that a track-and-trace pilot may further acceptance of GS1 standards for product identification, which could achieve greater efficiency in cross-border shipping, while enhancing supply chain security.
While biopharma manufacturers generally support these and other efforts to combat SSFFC medicines, the campaign could be undermined by the reluctance of some companies to acknowledge the appearance of illegal products in the supply chain for fear that will trigger recalls and discourage product use. Another problem is the limited involvement of generic-drug makers in international anticounterfeiting efforts. And most troubling is the emergence of different national drug-tracing systems that use a range of product serialization and data exchange models and requirements.
These developments point to the importance of manufacturers and regulatory authorities seeking agreement on policies for transaction data management, ownership, and access that will lead to harmonized, international drug tracking and identification systems around the world. Experts also urge brand and generic-drug firms, along with wholesalers and distributors, to develop a single voice on these issues to gain more credibility and attention from both domestic and international policymakers.
1. American Journal of Tropical Medicine and Hygiene, Supplement (June 2015), accessed July 8, 2015.
2. NIH, “Global Pandemic of Fake Medicines Poses Urgent Risk, Scientists Say,” Press Release, April 20, 2015, accessed July 14, 2015.
3. C. Schnedar, Fighting Fakes, presentation, June 2015.
Article DetailsPharmaceutical Technology
Vol. 39, No. 8
When referring to this article, please cite it as J. Wechsler., “Campaign Against Fake Drugs Gains Momentum,” Pharmaceutical Technology39 (8) 2015.