FDA announces New Worldwide Strategy on GMP Supervision and Importation

On 20 June, the FDA announced on their News Page the announcement of a new worldwide strategy on Safety and Quality of imported products. The publication, released in a report form, is entitled "Pathway to Global Product Safety and Quality" and relates not only to raw material, intermediate steps and APIs required for the manufacture of finished medicinal products but also to products from the Industry regulated by the FDA, i.e. products from the food industry and medicinal products.

The introduction of the report deals with the tremendous increase of goods which are manufactured in worldwide networks, transported and imported into the USA. Since the FDA has to supervise all these products, they have to face one of the greatest challenges of their history. The report cites FDA Commissioner Margaret A. Hamburg: "Global production of FDA-regulated goods has exploded over the past ten years.  In addition to an increase in imported finished products, manufacturers increasingly use imported materials and ingredients in their U.S. production facilities...There has been a perfect storm - more products, more manufacturers, more countries and more access.  A dramatic change in strategy must be implemented." Further, she says: "FDA regulated imports have quadrupled since 2000. The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face."

The report describes the development of imports, the growing globalisation of goods flows, the progression of public health costs in the most important economies as well as the expenses and costs of FDA's inspection activities, who cannot keep up with these evolutions any longer. One of the report Highlights is based on four core building blocks which concretely define FDA's change in strategy:

1. FDA, in close partnership with its foreign counterparts, will assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world.

2. With these coalitions, the FDA intends to develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets.

3. FDA will continue to expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities.

4. FDA will effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.

The fourth point reveals to be particularly interesting concerning the collaboration of the FDA with accredited Third Parties who perform audits (for example in APIs facilities) which are accepted by the Agency. The FDA intends to build a (not yet described in detail) Review and Audit Infrastructure which should help to verify the integrity of information contained in audit reports from Third Party Organisations. In this way, the Agency hopes to assure a better balance of her human resources, and if needed, quicker introduction of regulatory sanctions. Such a programme for medicinal products had already been established in 2002 shortly after the adoption of the Medical Device User Fee Modernization Act.

Almost helpless, the American Public Health Agency has to regulate enormous flows of products coming from the globalised drug and food industry. This situation has aroused concerns - not only among experts. In its edition from 20 June, the "New York Times" reported in detail about the topic and referred to one of its articles from 2008 in which already at that time government investigators estimated that the FDA would need 13 years to perform inspections at each drug manufacturing site abroad, 27 years to inspect all drug products manufacturers and 1900 years to inspect all food producers. With regard to this situation, the FDA had to take action. Moreover, this initiative has to be considered in the context of the new "Food Safety Modernization Act" (FSMA) that was signed by President Obama on January 4, 2011. This new Act contains guidance for the food industry regarding consumer protection and regulatory monitoring. The FDA Press Announcement - where you can download the full strategy report - can be found

here. You can access the NY Times' article from 20 June 2011here.

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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