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ASCO, Partnering Organizations Issue Recommendations on Drug Shortages

Mar 14, 2011

March 2011: ASCO, the American Society of Anesthesiologists (ASA), the American Society of Health-System Pharmacists (ASHP), and the Institute for Safe Medication Practices (ISMP) issued recommendations in January to help ease the U.S. drug shortage crisis. The recommendations stem from the Drug Shortages Summit convened by the organizations in November 2010 and include:

  • Expanding FDA authority to require manufacturer notification of shortages and market withdrawals;
  • Providing incentives (e.g., tax credits) to manufacturers that produce critical drug products in exchange for guarantee of continued production;
  • Requiring pharmaceutical manufacturers to confidentially notify the FDA when there is a single active pharmaceutical ingredient or manufacturing source;
  • Establishing a modified or reduced user-fee program for FDA approval of generic drugs that would support expedited review of applications; and
  • Establishing an expedited approval pathway for those unapproved drugs that are deemed critical therapies.

The summit was convened to discuss the scope and causes of drug shortages, to shed light on the resulting harm to patients, to discuss potential changes in public policy and stakeholder practices, and to develop an assertive action plan.

Summit participants included representatives from health professional organizations, pharmaceutical manufacturers, and supply chain entities. Representatives of the FDA and the Centers for Disease Control and Prevention also attended portions of the meeting as observers. The complete report, including a list of attendees, is available at asco.org/ascoaction. Additional information will be available from the co-conveners at ashp.org/drugshortages as these plans are developed.


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