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


Congressional action. In April 2008, the US House of Representatives Energy and Commerce Committee issued a discussion draft on the Food and Drug Administration Globalization Act of 2008 to address the funding and authority of FDA in regulating the safety of the country's drug supply. The discussion draft was designed to stimulate discussion in Congressional hearings and serve as basis for drafting legislation. The discussion draft builds on four other bills (H.R. 3610, H.R. 3624, H.R. 3115, and H.R. 3484) and investigations conducted by the House Committee on Energy and Commerce's Subcommittee on Oversight and Investigations, a report from FDA Science Board's Subcommittee on Science and Technology, the Administration's Food Protection Plan and Import Plan, and input from other stakeholders. The proposed measures include the following:

  • Creating an up-to-date registry of all drug and device facilities operating within the US or exporting products to the US. These facilities would be required to register annually with FDA. Registration would require payment of an annual fee to cover the cost of FDA inspections.
  • Requiring FDA to inspect foreign and domestic drug and device facilities every two years. Manufacturers would be prohibited from introducing a drug, drug ingredient, or device into interstate commerce until an initial facility inspection has occurred. Registration would be suspended for refusing, impeding, or delaying an inspection.
  • Restricting entry of imports lacking certain compliance documentation. After a phase-in period, importers of drugs for commercial use who lack compliance documentation relating to identity, safety, and purity would be required to ship products only through ports of entry with federal testing laboratories.
  • Requiring manufacturers of drugs and drug ingredients to test for contaminants
  • Allowing FDA to issue fines for violations of drug-safety requirements, extending FDA's authority to recall drugs and detain unsafe drugs discovered during inspections, and allowing FDA to destroy counterfeit or adulterated commercial imports
  • Requiring drug labels to identify the source of the API and its place of manufacture and to require device labels to indicate the country of manufacture
  • Creating a dedicated foreign inspectorate within FDA
  • Prohibiting FDA from closing or consolidating any of the 13 field laboratories or 20 district offices that were operational as of Jan. 1, 2007 (11).

The draft legislation is still under consideration by Congress, as of press time.

References

1. "Petition to Request the Food and Drug Administration to Rank Foreign and Domestic Drug Manufacturing Firms Together for Purposes of the Agency's Risk-Based Approach to Inspections and Take Other Steps to Reduce the Public Health Risks Associated with Imported Drugs," Citizen Petition filed by the Synthetic Organic Chemical Manufacturers Association's Bulk Pharmaceutical Task Force to FDA (Washington, DC, 2006).

2. Synthetic Organic Chemical Manufacturers Association and European Fine Chemicals Group, "Joint Position Paper: Uneven Enforcement Leads to Sub-par Drugs and National Security Risks" (Brussels and Washington, DC, Aug. 2006).

3. M. Crosse, "Preliminary Findings Suggest Weakness in FDA's Program for Inspecting Foreign Drug Manufacturers," GAO-08-224T (GAO, Washington DC, Nov. 1, 2007).

4. M. Cross, "Preliminary Findings Suggest Recent FDA Initiatives Have Potential, but Do Not Fully Address Weakness in its Foreign Drug Inspection Program," GAO-08-710T (GAO, Washington, DC, Apr. 22, 2008).

5. GAO, "Improvements Needed in the Foreign Drug Inspection Program," GAO/HEHS-98-21 (Washington, DC, Mar. 1998).

6. FDA, "Action Plan for Import Safety: FDA Activities (November 2007–June 2008)" (Rockville, MD), http:// http://www.fda.gov/oc/initiatives/advance/imports/activities.html, accessed July 14, 2008.

7. Interagency Working Group on Import Safety, "Import Safety–An Action Plan Update" (Washington, DC, July 2008).

8. J. Woodcock, "Discussion Draft of the Food and Drug Administration Globalization Act," statement before the Subcommittee on Health, Committee of Energy and Commerce, US House of Representatives (Washington, DC, May 1, 2008).

9. A.C. von Eschenbach, "FDA Actions to Improve Safety of Medical Products with Foreign Components," statement before the Subcommittee on Oversight and Investigations, Committee on Energy and Commerce, US House of Representatives (Washington, DC, Apr. 22, 2008).

10. US Department of Health & Human Resources, "HHS Announces New International Programs to Enhance Drug and Food Safety" (Washington, DC, Jul. 9, 2008).

11. US House of Representatives Energy and Commerce Committee, "Discussion Draft of the Food and Drug Administration Globalization Act of 2008" (Washington, DC, Apr. 2008), http://energycommerce.house.gov/FDAGlobalAct-08/Dingel_60AXML.pdf, accessed July 14, 2008.


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