FDA starts pilot scheme to secure medicine imports

Medicines shipmentA US FDA pilot project aimed at enhancing the security of imported medicines has got underway.

The programme - which was announced in the Federal Register last year - should allow the agency to focus its surveillance efforts on high-risk shipments that are most likely to be adulterated or counterfeit, whilst cutting red tape and delays for low-risk imports.

The main thrust of the two-year effort is to test the approach in a selected group of companies that are certified as maintaining high manufacturing and supply chain standards and so qualify for expedited entry for shipments of imported medicines.

Among the criteria for selection is a validated secure supply chain protocol in accordance with the US Customs and Border Protection's Customs-Trade Partnership Against Terrorism (C-TPAT) programme.

The 13 pre-qualified companies accepted into the pilot and which will qualify for expedited entry of up to five products each, are:

  • AbbVie
  • Allergan
  • Astellas US Technologies
  • Bristol-Myers Squibb
  • Celgene
  • GE Healthcare
  • GlaxoSmithKline
  • Merck Sharp & Dohme
  • Mylan Pharmaceuticals
  • Novartis Pharmaceuticals
  • Pfizer
  • Teva Pharmaceuticals USA
  • Watson Laboratories

"The program … allows the FDA to focus resources on the areas with the greatest potential risk to consumers," said Carol Bennett, acting director of the Office of Compliance in the FDA's Center for Drug Evaluation and Research (CDER).

"By creating incentives for manufacturers to adopt best practices for supply chain integrity, we can enhance the quality and safety of imported drugs," she added.

Up to 40 per cent of the drugs Americans take are manufactured outside US borders, while 80 per cent of the active pharmaceutical ingredients (APIs) in those drugs come from foreign sources.

It is widely recognised that the FDA will never have the capacity to screen all imported drug shipments so the new risk-based approach should help it direct resources most effectively.

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