The Anatomy of the Changing Supply Chain - Pharmaceutical Technology

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The Anatomy of the Changing Supply Chain
The high-profile case of contaminated heparin from a Chinese supplier has intensified the debate on the effectiveness of FDA's process for inspecting foreign drug-manufacturing facilities. The article examines proposed legislative and regulatory reforms and actions taken by the agency to improve drug-import safety.

Pharmaceutical Technology

Taking action

Intragency Working Group on Import Safety. The Interagency Working Group on Import Safety was established in July 2007, under an executive order by the Bush Administration, to conduct a comprehensive review of current import-safety practices for drug, food, and consumer products, and to determine where improvements could be made. The Working Group, chaired by Health & Human Services (HHS) Secretary Mike Leavitt, evaluated steps that could be taken in the exporting country, US importing companies, and by federal, state, and local governments to address problems regarding imported products (drugs, food, and consumer goods). On Nov. 6, 2007, the Working Group issued an Action Plan for Import Safety: A Roadmap for Continual Improvement that contained 14 broad recommendations and 50 specific short- and long-term action steps to enhance the safety of the increasing volume of imports entering the US (6). The following list highlights drug-safety measures taken by FDA since the issuance of the action plan and measures taken under FDA's "Beyond Our Borders" initiative, a multipronged approach to promote and verify compliance in medical products, food, and cosmetics (6–9):

  • FDA received approval and hired leadership for a new office in China, which will include 13 staff members (8 FDA personnel and 5 foreign nationals). The staff is responsible for building closer working relationships with FDA's Chinese counterparts, carrying out inspections, and working with Chinese inspectors to provide training.
  • FDA signed memoranda of agreements (MOAs) with China's State Food and Drug Administration to facilitate broader access to Chinese production facilities on an expedited basis. FDA held bilateral talks with Chinese regulatory agencies to work toward creation of a certification program to help ensure items exported to the US meet HHS and FDA safety standards. Additionally, these MOAs provide a streamlined process for facilitating FDA inspections conducted in China. Senior officials from China and the US will meet annually to discuss and review progress on the MOAs.
  • FDA plans to increase its field and international inspection operations. Its goals for FY 2009 include increasing foreign and domestic inspections and sampling, improving its laboratory infrastructure, continuing developing tools for rapid analysis, and enhancing its in-country presence in China.
  • FDA is working to establish collaborations with India
  • FDA accompanied an HHS delegation to Vietnam to discuss a cooperative arrangement with the Ministry of Health covering food, feed, and medical products
  • HHS announced a pilot program by FDA and its counterparts in the European Union and Australia to jointly plan, allocate for, and conduct inspections of drug-manufacturing facilities, initially focusing on API producers (10).
  • FDA is providing training on US regulatory requirements and technical assistance to foreign regulators
  • FDA is pursuing third-party certification to verify compliance with FDA requirements. These third parties may include foreign government agencies and independent agencies accredited by FDA or accreditation organizations recognized by FDA. This certification would complement, not supplant, FDA inspectional and regulatory activities.
  • FDA plans to issue guidance on good importer practices to help importer ensure product safety
  • FDA participated in the World Health Organization's International Medical Products Anti-Counterfeiting Task Force (IMPACT). IMPACT is coordinating action among countries to halt the production, trading, and selling of counterfeit medical products globally.
  • FDA is working to improve its IT infrastructure. Projects include more effective solutions to ensure the accuracy and validity of data in its registration- and import- information IT systems, including the Bio-Informatics Board's efforts to establish accurate information on firms and their products. FDA also plans to better use risk-based information from the entire life cycle of imported products. These changes will be implemented during the next two years, with certain projects implemented beyond 2010.
  • Closer cooperation with Customs and Border Protection (CBP), including plans for developing interdepartmental procedures for clearing and controlling shipments at ports of entry, colocating FDA and CBP at locations to improve coordination, and greater import–information sharing.
  • FDA is working to facilitate the adoption of track–and–trace technology to identify and track a product along the product's life cycle.


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