FDA Maps Strategy to Counter Supply-Chain Threats - Rising imports, overseas production spur collaboration and realignment of enforcement activities. - BioPharm International


FDA Maps Strategy to Counter Supply-Chain Threats
Rising imports, overseas production spur collaboration and realignment of enforcement activities.

BioPharm International
Volume 24, Issue 7, pp. 14-17


In response, FDA proposes a more collaborative regulatory approach, somewhat along the lines of the International Civil Aviation Organization, which promotes common global standards for aviation safety. Another model is information sharing, promoted by the International Criminal Police Organization (Interpol). Access to international data on manufacturers, pharmaceutical suppliers, and regulatory operations would help FDA identify potential risks that can be monitored and addressed before they lead to public harm.

Collaboration between regulatory counterparts is not new. FDA and EMA have launched extensive information-sharing activities involving new drug applications, drug safety reports, orphan medicines, and field inspections. A joint FDA–EMA pilot with Australian regulators aims to coordinate inspections of API manufacturers in third countries. Another FDA–EMA pilot involves joint oversight of clinical-research sites.

Although FDA has been engaging foreign regulatory counterparts in collaborative initiatives, such as those being refined by the International Conference on Harmonization and the Pharmaceutical Inspection Co-operation/Scheme, these partnerships "are not sufficient" to deal with an increasingly complex global environment, the report concedes. What is needed are "global coalitions of regulators" that allow countries to maintain sovereignty in setting standards and making decisions, but rely more on the work of other regulators and encourage the pooling of resources to manage the global pharmaceutical inventory. Increased information sharing with trusted counterparts would be easier if FDA did not need to redact all trade secret information from documents, for example, a process that seriously stymies the communications process.

Such collaboration reflects FDA's recognition that its own inspectors cannot reach the growing volume of foreign sites: The average cost of a foreign-plant inspection is $52,000, more than twice the $23,000 outlay for a domestic site visit. More than 54% of foreign drug making facilities went uninspected from 2002 to 2007, and the record is even worse for foreign medical device producers. Even though FDA increased foreign-drug inspections by 27% between 2007 and 2009 and opened a series of international offices, that still falls hopelessly short of covering the field.

The good news is that collaborative initiatives are proliferating as regulators seek to conserve their own resources. Mexico and Costa Rica, for example, are accepting FDA medical-device review decisions. FDA recently put a company on import alert based on an inspection report from a European agency, and is exploring other ways to streamline operations. EMA reliance on "qualified persons" employed by drug manufacturers to verify the quality and safety of all approved drug batches is an approach worth looking at, says OC Director Deborah Autor*. She's also interested in models for third-party audits for drugs, an option already authorized by FDA for medical devices and food imports. A shift to more reliance on outside auditors, however, requires a more sophisticated review and monitoring infrastructure that can verify the integrity of information received from other regulators and private parties.

Related initiatives aim to expand the expertise and capabilities of regulatory agencies around the world. The World Bank is providing resources for building regulatory capacity in developing economies so that less-experienced agencies can better enforce GMPs and other drug quality policies. The US Pharmacopeia similarly is providing technical assistance to help emerging-nation manufacturers comply with GMPs, along with support for regulatory authorities to establish quality drug-surveillance programs. The US Agency for International Development (USAID) funds this $35 million, 5-year program, which now is active in about 30 countries in Africa, Asia, and Latin America. A major impetus for regulatory capacity building comes from donor and health funding organizations, such as the Global Fund to Fight AIDS, Tuberculosis, and Malaria, which increasingly require the drugs they purchase to meet GMPs and World Health Organization prequalification standards.

Pharmaceutical companies also are working together to prevent product theft and adulteration and to provide more efficient ways to oversee suppliers and contractors. The Rx-360 coalition aims to ensure product quality through cooperative auditing of suppliers and contractors. More than 50 pharma, biotech and supplier companies are participating in the Rx-360 joint audit program, which uses third-party auditors to examine operations and standards at producers of active ingredients, excipients and other raw materials. A shared audit program encourages pharmaceutical companies to provide their own audits of suppliers to colleagues.

Separately, several organizations market third-party audit and certification programs for excipients. And a new track-and-trace consortium of manufacturers, distributors, pharmacists, and shippers is working with FDA to develop standards for an interoperable prescription-drug tracking system. The impetus comes from California electronic pedigree requirements, which are scheduled for implementation beginning in 2015.

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