Drug Shortage Initiative News
Since mid-2012, 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 also engaged leaders from more than 30 major companies, regulators from 10 agencies, and regional industry associations to ensure that ISPE is comprehensive in its approach to the problem of drug shortages – a critical issue affecting countless patients around the world.
- 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 ( 580 KB). The study examined the relationship between manufacturing, supply chain and US market forces and how they contribute to the shortage of sterile injectable products. The study also assessed the elements that influenced the decisions companies made to reduce future shortages.
- June 2016: ISPE incorporated drug shortage prevention recognition into the prestigious Facility of the Year Awards (FOYA). At the 2016 FOYA Banquet held on 7 June, ISPE recognized Baxter BioPharma Solutions located in Halle, Germany, and Janssen Vaccines AG, located in Bern, Switzerland, for excellence in several of the drug shortage prevention dimensions identified in ISPE’s Drug Shortages Prevention Plan and Drug Shortage Prevention and Assessment Tool. Baxter expanded capacity to service the CMO market of parenteral oncology and thereby accommodated the need for life saving unit dose products in multiple forms. Janssen responded to the Ebola outbreak in West Africa and committed to accelerate the development of its candidate Ebola vaccine, resulting in a launch capacity of up to 5 million doses annually.
- Feburary 2016: February 2016: Drug Shortages Introductory webinar created to bring knowledge to the industry on the regulatory expectations regarding drug shortages, ISPE Drug Shortages Prevention plan and the six dimensions, practical tools for use in preventing shortages and so much more. View the Drug Shortages Introductory Webinar today!
- February 2016: Joseph Famulare, Chairman, ISPE Board and Vice President, Global Quality Compliance and External Collaboration Genentech/Roche, Pharma Technical Operations, was a guest on The Diane Rehm Show on NPR. Famulare was one of four guests speaking about how drug shortages are impacting the industry and patients. Listen to the NPR recording.
- January 2016: Be a participant! ISPE and The Pew Charitable Trusts (Pew) launched a joint research project to explore the relationship between drug shortages of sterile injectable products and U.S. market forces. Learn more about this drug shortages study and how your company participate. Deadline for submissions is 5 February 2016.
- November 2015: ISPE debuts Drug Shortage Assessment and Tool at Annual Meeting. The Drug Shortage Assessment and Prevention Tool provide a structured approach for industry to develop strategies and practices for each of the six drug shortages dimensions.
- October 2015: EMA Workshop: ISPE Presents on Drug Shortages Prevention. Seven ISPE members joined more than 50 delegrate from other industry associations, patient group, health care providers, European Medicines Agency (EMA) members, National Competent Authority inspectors, and regulators from agencies such as the FDA, to contribute to the EMA workshop on drug shortages.
- May 2015: ISPE unveiled an early draft of the Drug Shortages GAP Analysis Tool at the Annual European Conference in Frankfurt, Germany.
- May 2015: ISPE develops Frequently Asked Questions about the Drug Shortage Initiative.View the FAQs.
- January 2015: ISPE Enters Phase III of its Drug Shortages inititave - delivering solutions based on the Drug Shortages Prevention Plan in ISPE conferences, training programs, and publications.
- November 2014: ISPE’s Drug Shortages Prevention Plan formed part of an inter-association response to the European Medicines Agency’s (EMA’s) request to industry to provide solutions to the global problem of drug shortages caused by manufacturing. Read the Prevention of Drug Shortages Based on Quality Manufacturing Issues inter-association response summary.
- October 2014: ISPE Releases its full Drug Shortages Prevention Plan and
view the Drug Shortages Prevention Plan ( 3 MB).
- August 2014: ISPE releases first look at plan to prevent Drug Shortages.
- June 2014: ISPE releases an introductory summary of its Drug Shortages Prevention Plan. Read the Introductory Summary ( 806 KB).
- April 2014: ISPE announces the development of its Drug Shortages Prevention Plan for the Pharmaceutical Industry. Read more.
- February 2014: ISPE reports to FDA the findings of its research into timeframes for upgrading facilities and equipment. Read the report ( 189 KB).
- December 2013: Two ISPE studies cited in FDA statement to congress.
- December 2013: ISPE coordinates a multi-association Task Force to deliver a collaborative plan for the prevention of drug shortages to EMA. The European Task Force is comprised of members from ISPE, PDA, EFPIA, EGA, and PPTA. The team also has participation from the EMA and six National Competent Authorities. Read more.
- November 2013: The EMA charges ISPE and other associations to develop and deliver a single, collaborative action plan a plan for the prevention of drug shortages resulting from manufacturing quality issues.
- November 2013: At the request of the US FDA, ISPE initiates deeper research into the timeframes for upgrading facilities and equipment, one of the identified causes of drug shortages.
- November 2013: ISPE presents post-survey follow up activities and its 2014 plan at the ISPE Annual Meeting in Washington, DC.
- October 2013: ISPE presents highlights of its emerging plan to the EMA as an invited guest at EMA's workshop on product shortages due to manufacturing and quality problems.
- October 2013: The report on ISPE's Drug Shortages Survey is cited in FDA's Strategic Plan for Preventing and Mitigating Drug Shortages. View press release.
- Q3 2013: The ISPE Drug Shortages Team develops plans to learn more about key issues revealed by the survey and to develop recommendations for important changes that could help mitigate shortages or reduce them altogether.
- June 2013: ISPE announces its Drug Shortages Survey initial findings to US and European audiences and publishes the highlights in a publicly available report. Read the report ( 959 KB).
- May 2013: ISPE meets with the US FDA to discuss early survey findings and ways of working together to mitigate or address key issues.
- February 2013: ISPE deploys its anonymous industry survey seeking information about root causes of shortages that can be attributed to technical, manufacturing and quality issues.
See About the Survey for more information about the survey instrument and the questions we asked.
- August 2012-January 2013: ISPE develops a comprehensive survey for industry professionals after reviewing the existing body of knowledge on the topic of drug shortages and conducting a preliminary assessment of perceived contributing factors.
- July 2012: The ISPE Drug Shortages Team meets with Dr. Janet Woodcock, Director of the Center for Drug Evaluation and Research (CDER) at the US FDA, and presents a concept paper concerning proposed activities aimed at helping regulators and industry understand and address the challenge of drug shortages.
- 2012: The Food and Drug Administration Safety Innovation Act (FDASIA) was passed granting the FDA more authority regarding drug shortages. A major addition was requiring manufacturers to notify FDA of potential discontinuations of drugs used to prevent or treat serious diseases.