November 05, 2013
FDA Releases New Actions on Drug Shortages, Recognizes ASA Efforts
The Food and Drug Administration (FDA) announced that it is taking two actions to enhance the Agency's ongoing efforts to address drug shortages.
First, the FDA released a "Strategic Plan for Preventing and Mitigating Drug Shortages," which was required under Title X of the Food and Drug Administration Safety and Innovation Act (FDASIA). In March 2013, ASA formally submitted recommendations to the FDA on the Strategic Plan. The Strategic Plan recognizes ASA's ongoing work with the FDA on drug shortages and states that the FDA will "join with other stakeholder groups, such as groups convened by the American Society of Anesthesiologists…" to develop long-term prevention strategies on shortages.
Second, the FDA issued a proposed rule requiring that manufacturers of certain drugs notify the FDA of a permanent discontinuance or a temporary interruption in manufacturing that is likely to disrupt supply. This proposed rule implements the early notification requirements in FDASIA. ASA actively lobbied to ensure that the early notification requirements applied to drugs used "during surgery" and in the "treatment of a debilitating disease or condition," which includes anesthesia and pain medications.
ASA's advocacy, alongside other key stakeholders, resulted in passage of the drug shortage provisions in FDASIA. In May 2012 at the ASA Legislative Conference "Lobbying Day," more than 500 anesthesiologists visited Capitol Hill urging support for drug shortage relief and highlighting the significant impact drug shortages have on the practice of anesthesia.
Since the passage of FDASIA, ASA has continued to work closely with the FDA to address drug shortages.
ASA is currently reviewing the Strategic Plan and the proposed rule.