FDA and ISPE Seek Stakeholder Input to Improve Drug Shortage Prevention and Mitigation Strategies

FDA and the International Society for Pharmaceutical Engineering (ISPE) are both surveying stakeholders in the pharmaceutical supply chain to help shed light on the causes of drug shortages and formulate better prevention and mitigation strategies.

FDA announced in the Feb. 12 Federal Register that it is seeking public input to assist it in developing a “strategic plan” on drug shortages.  Comments will be accepted until mid-March.

An announcement two days later from ISPE stated that it will be surveying international membership to help in understanding the “technical, scientific, manufacturing, quality and compliance issues” involved.  The survey is due out later this month with anonymous responses to be tabulated by a third-party firm.  Preliminary results are expected in June.

The information-gathering efforts complement a recent publication by CDER Director Janet Woodcock and her CDER colleague Marta Wosinska, which takes a hard look at the drug quality and shortage problems plaguing the generics injectable arena and provide insight into their causes and how they are linked (IPQ “The News in Depth” Feb. 8, 2013).

[See IPQ “The News in Depth” Feb. 4 and 5 for coverage of the compliance problems and remediation efforts of two major players in the generic injectables arena – Ben Venue and Hospira, respectively – and the relationship of their situations to drug shortages.]

The Woodcock/Wosinska paper provides context for the FDA and ISPE efforts and should help sharpen the responses they receive.

FDA and other regulatory agencies have been involved in the design and content of the ISPE survey.  ISPE shared a concept paper on the effort last October and incorporated input from more than a dozen agencies and organizations in the survey design. The final results of the survey will be provided to FDA as input into its drug shortage efforts.

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