Co-convened by the American Society of Health-System Pharmacists, the American Society of Anesthesiologists, the American Society of Clinical Oncology, and the Institute for Safe Medication Practices on Nov. 5, 2010, the Summit released the following policy recommendations:

  • Explore expanding FDA authority to require manufacturer notification of market withdrawals.
  • Evaluate the current FDA definition of medically necessary.
  • Define and implement evidence-based and other criteria for identifying critical drug therapies vulnerable to shortages. Criteria might include such factors as availability of therapeutic alternatives, supply chain characteristics and other elements that determine products' vulnerability for shortages.
  • Explore providing incentives (e.g., tax credits) to manufacturers that produce critical drugs or upgrade manufacturing plants to meet or exceed Good Manufacturing Practices in exchange for guarantee of continued production.
  • Require confidential notification of FDA when there is a single raw material or manufacturing source, or interruption of raw material supply or production process.
  • Explore reducing user fees for review of critical generic drugs, and expedite review of applications for critically needed drugs.
  • Assess the need to establish or enhance existing processes to expedite approval of applications for new drugs or drug raw material sources, and new or altered production lines for drugs in short supply.
  • Evaluate processes for new product specifications (e.g., USP standards), including appropriateness of timeline for implementation.
  • Increase collaboration with industry, DEA and FDA to modify raw material import quotas in response to drug shortages of controlled substances.
  • Establish improved processes to extend product stability for products in short supply.
  • Require manufacturing redundancies (e.g., multiple manufacturing sites for a sole product or multiple raw material sources, when available) as part of the FDA approval process.
  • Improve communication to, among and from product manufacturers and the FDA, including detailed information on reason and anticipated duration of shortage. Also, enhance communication to supply chain entities and health care providers (e.g., Dear Provider letters)
  • Consider distribution options for products in short supply (with increased information exchange among supply chain members).