November 27, 2012
ASA and FDA to Host Tele-Town Hall About Drug Shortages on Wednesday, December 5 from 10-11 a.m. (EST)
The American Society of Anesthesiologists (ASA), joined by senior officials from the Food and Drug Administration (FDA), will host a telephone town hall meeting on Wednesday, December 5 from 10 – 11 a.m. (EST). The meeting will feature a Q&A session in which ASA members will have the opportunity to pose questions to FDA officials on drug shortages.
(888) 886-6603 Ext.20584#
During the Q&A session, press 0 to ask a question.
Speakers at the telephone town hall meeting include:
- Capt. Valerie Jensen, R.Ph.,Associate Director, Drug Shortage Program, Center for Drug Evaluation and Research, FDA
- Bob A. Rappaport, M.D., Director, Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, FDA
- Arthur Simone, M.D., Ph.D., Medical Officer, Division of Anesthesia, Analgesia, and Addiction Products, Center for Drug Evaluation and Research, FDA
- John M. Zerwas, M.D., President, ASA
- Arnold J. Berry, M.D., M.P.H., Vice President for Scientific Affairs, ASA
ASA has actively led efforts to combat drug shortages on both the legislative and regulatory fronts. In March 2012, ASA surveyed its members on drug shortages. Of 3,063 anesthesiologists who responded, 97.6 percent reported that they are currently experiencing a shortage of at least one anesthesia drug, 66.7 percent of patients experienced a less optimal outcome, and 96.3 percent reported that they had to use alternative drugs. Significantly, 0.2 percent of respondents reported that the drug shortage may have contributed to the death of a patient.
In 2010, ASA co-convened a Drug Shortages Summit with stakeholders, and the Summit resulted in a report that highlighted key issues and proposed solutions to the problem. ASA presented these recommendations, along with perspectives on drug shortages from the point-of-care perspective, at a FDA public workshop on drug shortages. In addition, ASA met with Department of Health and Human Services (HHS) Secretary Kathleen Sebelius in an invitation only face-to-face meeting concerning drug shortages and spoke on the impact anesthesia drug shortages are having on patients.
ASA, continuing our call for action to alleviate drug shortages, submitted statements to the U.S. Senate Finance and U.S. Senate Health, Education, Labor and Pension Committees. In May 2012 at the ASA Legislative Conference "Lobbying Day," hundreds of anesthesiologists visited Capitol Hill urging support for drug shortage relief and highlighting the significant impact drug shortages have on the practice of anesthesia.
As a result of ASA’s and other stakeholders’ lobbying, Congress passed a law with a section dedicated solely to addressing national shortages of anesthetic and other drugs. Other major federal actions include a Government Accountability Office report on drug shortages, FDA interim final rule tightening restrictions on the reporting of drug shortages by drug manufacturers, and an Executive Order to the FDA to combat drug shortages.