Bilateral Co-operation
This article was originally published in SRA
Executive Summary
Senior US official explains FDA's role overseas
Senior US official explains FDA's role overseas
The US Food and Drug Administration is making concrete efforts to strengthen its oversight of imported drug products by establishing a presence overseas. Murray Lumpkin, deputy commissioner of the Office of International Programs at the FDA, told RAJ Pharma's John Hatjoullis of his recent visit to India and of the agency's aim to work with foreign counterparts at the point of manufacture to ensure the quality of products that are exported to the US.
The FDA must get beyond its borders in order to meets its responsibilities as a domestic health protection agency and move away from the old paradigm where a country's borders are its first line of defence against bad products, Dr Lumpkin said. Having a presence abroad will enable the agency to work with other national agencies and with companies in the various countries where products exported to the US originate. Products that are known to be quality-assured can then be audited in when they arrive in the US.
The current means for regulating foreign products - which includes FDA personnel flying out periodically for inspections and the agency having periodic meetings with counterpart agencies and conducting workshops for industry - is not going to be sustainable, Dr Lumpkin said. The new approach would give the FDA an opportunity to leverage the resources of its counterpart agencies and for them to leverage the FDA's resources so that each can meet its own domestic responsibilities.
India
The visit to India was an opportunity for the US delegation - Mike Leavitt, the Secretary of Health and Human Services, FDA commissioner Andrew von Eschenbach and Dr Lumpkin - to visit manufacturing facilities that are already shipping products to the US and to visit the new start-up biotech industry there.
The Indian authorities, which are currently in the process of restructuring the federal regulatory body, requested that the US agency offer some of its perspectives on the subject, to which it agreed1. Dr Lumpkin said that the FDA will now discuss with its Indian counterparts how best to offer technical assistance, and whether the concept of an FDA presence in India would be mutually beneficial. Although the implementation of an overseas programme is a long way off, Dr Lumpkin said that it may involve any of its areas of jurisdiction, including drugs, biologics, medical devices or radiation-emitting devices.
China
It is China where the concept of establishing a presence is most developed, Dr Lumpkin said. In November 2007, Mr Leavitt signed a memorandum of understanding with China's State Food and Drug Administration and the Administration of Quality Supervision, Inspection and Quarantine, regarding the safety of Chinese drug and medical device imports into the US2. This was a sign that the relationship between the US and China was ripe enough for negotiations to begin. Negotiations between the two countries are underway.
The idea of stationing staff outside the US is not exclusively focused on China and India. It is, rather, Dr Lumpkin said, part of a much bigger and broader scheme that will involve many other countries. However, last year there was a confidence crisis in products imported from China, which prompted Secretary Leavitt's subsequent visits to China and led to the signing of the US-China memorandum of understanding.
Background
The move toward establishing an overseas presence follows a recommendation from the US House of Representatives Committee on Energy and Commerce. In October 2007, as part of an ongoing investigation into the ability of the agency to protect the US public from the risks of imported drugs, the committee suggested that setting up offices overseas, particularly in China and India which are major producers of drugs exported to the US, could greatly facilitate the FDA's inspection process and improve information sharing with foreign regulatory agencies.
References
1. The Regulatory Affairs Journal - Pharma, 2008, 19(2), 126-127
2. The Regulatory Affairs Journal - Pharma, 2008, 19(2), 111-112