Securing the Pharma Supply Chain - Pharmaceutical Technology

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Securing the Pharma Supply Chain
Regulatory bodies, standard-setting organizations, and industry seek to tackle the problem of counterfeit drugs and securing the flow of pharma ingredients.


Pharmaceutical Technology
Volume 36, Issue 3, pp. 52-57

Coordinating US efforts

In March 2011, several US government agencies and departments—FDA, the Office of the Intellectual Property Enforcement Coordinator, the US Customs and Border Protection (CBP), US Immigration and Customs Enforcement, the US Departments of Justice, State and Commerce, and the Agency for International Development—issued a joint report recommending a series of items to combat the problem of counterfeit medicines entering the US (3). The report called for better data and information-sharing among government agencies and departments to address counterfeit medicines entering the US. For example, as part of a process for developing an Import Operation Strategic Plan, FDA and CBP examined the flow of imported pharmaceutical products through different ports of entry, identified available legal authorities, and worked to develop best practices to enhance collaborative enforcement efforts. (3).

CBP and FDA are engaged in ways to ensure that only compliant pharmaceuticals are imported into the US and that appropriate enforcement action is taken against illegal pharmaceuticals. For example, FDA and CBP will explore ways to ensure that, under appropriate circumstances, products are destroyed rather than returned to the sender. CBP and FDA also are exploring ways to improve targeting of counterfeit pharmaceuticals. And CBP, in coordination with FDA, will access civil penalties to deter repeat offenders of importation of counterfeit medicines (3).

Part of this effort also involved the development of a Secure Supply Chain (SSC) pilot program by FDA's Center for Drug Evaluation and Research and Office of Regulatory Affairs. The program is part of FDA's risk-based approach to ensure the safety of imported drugs. The program is designed to help expedite shipments of drugs that meet the SCC pilot criteria because FDA has greater confidence in the drugs that are imported by a company in control of its supply chain.

The Counterfeit Pharmaceutical Inter-Agency Working Group Report also called for increased measures for improving coordination among international bodies for combating counterfeit medicines, improving public awareness of counterfeit medicines, and improving government-to-government enforcement training. The report also called for continued involvement and support by FDA in the World Health Organization's International Medical Product Anti-counterfeiting Task Force (IMPACT). IMPACT brings together private and public sector experts to address the public health aspects of drug counterfeiting and is developing technical tools for countries to use and adopt to fight drug counterfeiting. These tools can be used to strengthen legislative, regulatory, technological, enforcement and communication infrastructure and build capacity for surveillance, identification, and prevention of counterfeit drugs from reaching patients. (3).

WHO and FDA are collaborating to build global rapid alert surveillance/monitoring systems for combating counterfeit and falsified medicines and risks in supply-chain security. The goals of this effort are to generate sound and reliable evidence of where the incidence of falsified medicines is most serious, and promote exchange of information (e.g., case reports and descriptions of actions taken) and expertise between countries to stimulate action. Also, FDA and WHO are partnering to make available a system to be used for collecting and disseminating information based upon the requirements shared by all partners (3).


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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