Drug Shortages Milestones

For nearly a decade, ISPE and a task force of industry leaders have been working on ways to better understand the root causes and possible mitigations for drug shortages. ISPE has engaged leaders from more than 30 major companies, regulators from 10 agencies, and regional industry associations to ensure a comprehensive approach to this critical issue affecting countless patients around the world.

Highlights

January 2017: Working with The Pew Charitable Trusts, ISPE published the results of a joint study, Drug Shortages: An Exploration of the Relationship between U.S. Market Forces and Sterile Injectable Pharmaceutical Products.

June 2016: ISPE recognizes drug shortage prevention on its Facility of the Year Awards.

February 2016: ISPE released a Drug Shortages Introductory webinar created to bring knowledge to the industry on the regulatory expectations regarding drug shortages and practical tools for use in preventing shortages.

February 2016: ISPE Chairman invited to National Public Radio’s Diane Rehm Show to speak about the impact of drug shortages on industry and patients on.

November 2015: ISPE published its Drug Shortage Assessment and Prevention Tool. The Tool provides a structured approach for industry to develop strategies and practices for each of the six drug shortages dimensions described in the ISPE Drug Shortages Prevention Plan.

October 2015: ISPE joined more than 50 delegates from other industry associations, patient group, health care providers, EMA members, National Competent Authority inspectors, and regulators from agencies such as the FDA at an EMA Stakeholder Meeting on Product Shortages to review progress and plan next steps.

November 2014: ISPE’s Drug Shortages Prevention Plan formed part of the inter-association task force’s collaborative plan, Prevention of Drug Shortages Based on Quality Manufacturing Issues.

October 2014: ISPE published its Drug Shortages Prevention Plan presenting a global and holistic response addressing shortages at both the product and process levels. The Plan lays out how industry can best prevent drug shortages from occurring by identifying the root causes of supply disruptions and creating a quality culture that will ensure a robust, resilient and reliable supply of medications.

February 2014: By request of FDA, ISPE documented the timeframes for upgrading facilities and equipment - one of the identified causes of drug shortages - in the paper Understanding Global Regulatory Filings Timelines: Upgrading Aseptic Processing Equipment or Facilities.

December 2013: ISPE was designated as moderator of an inter-association task force charged by EMA to develop a collaborative plan for the prevention of drug shortage resulting from manufacturing quality issues.

October 2013: ISPE presented highlights of its research to the EMA at an invitation-only workshop on product shortages due to manufacturing and quality problems.

October 2013: ISPE’s Report on the ISPE Drug Shortages Survey is cited in FDA's Strategic Plan for Preventing and Mitigating Drug Shortages.

June 2013: ISPE published the findings of its survey in the Report on the ISPE Drug Shortages Survey.

May 2013: ISPE met with the US FDA to discuss early survey findings. ISPE accelerated the data analysis at FDA request.

August 2012 - February 2013: ISPE developed and launched a comprehensive survey seeking information about root causes of shortages that can be attributed to technical, manufacturing and quality issues.

July 2012: Following passage of the FDA Safety Innovation Act (FDASIA), the ISPE Drug Shortages Team met with Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US FDA, and presented a concept paper concerning proposed activities aimed at helping regulators and industry understand and address the challenge of drug shortages.