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U.S. Department of Health and Human Services

Drugs

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Center for Drug Evaluation and Research’s (CDER) Drug Shortages Action Plan

All stakeholders involved in supplying drugs for the U.S. market have a responsibility to make sure that patients can access needed medicines.  FDA works closely with industry, healthcare professionals, and patients to prevent and lessen the severity of drug shortages.  FDA does not manufacture drugs, nor does it have the authority to require companies to do so.  However, the sooner the agency learns about drug shortages, the more effective it can be in helping to notify healthcare professionals and helping to minimize the impact on patients. FDA’s Center for Drug Evaluation and Research (CDER) plans to carry out the following actions as steps that CDER can take to enhance the mitigation and prevention of drug shortages.

Enhance Communication with Manufacturers and Stakeholders

  • Remind drug manufacturers of requirements for reporting to FDA, under certain circumstances, discontinuations of sole source drugs, and encourage them to report potential supply disruptions for prescription drugs. To help facilitate this reminder, FDA is sending a letter to industry on October 31, 2011.
  • Continue to meet with trade groups representing the drug industry and individual manufacturers (first with leading sterile injectable drug manufacturers) to develop plans to ensure that drugs are manufactured in adequate supplies, including roles for back-up active pharmaceutical ingredients (API) sources and manufacturing lines. 
  • Provide more detailed instructions to manufacturers on reporting product discontinuations, supply interruptions, and potential shortages.
  • Establish direct partnerships with external experts to develop tools for communicating with patient and healthcare professional groups about shortages.

Increase Availability and Usability of Drug Shortages Information

  • Enhance content and format of FDA’s Drug Shortages webpage, as well as access points from the main FDA webpage.
  • Maximize utility of the new drug shortage database.
  • Maximize public disclosure of information regarding medical product shortages.

Enhance Staffing and Internal Collaborations

  • Implement short term plan to add staff to CDER’s Drug Shortages Program staff.  Up to six professionals who take reports of potential shortages, research their roots and coordinate activities to mitigate or prevent shortages will be added within 6-8 weeks.
  • Add two dedicated staff to CDER’s Office of Compliance to focus on expanding collaborative planning across FDA to address shortages, while maintaining quality manufacturing standards.
  • Enhance procedures for internal collaborations and communications among the offices that address drug shortages.