March 14, 2013
ASA Offers Recommendations to FDA on Drug Shortages Task Force and Strategic Plan
On March 14, ASA formally submitted recommendations to the Food and Drug Administration (FDA) on the Agency's Drug Shortages Task Force and strategic plan. The Food and Drug Administration Safety and Innovation Act (FDASIA), a legislative package of important FDA provisions that includes a section dedicated solely to preventing and mitigating national drug shortages, directs the FDA to form a Drug Shortages Task Force to develop and implement a strategic plan for enhancing the Agency's response to drug shortages.
ASA explained that the bipartisan passage of FDASIA was an important step in helping to prevent and mitigate drug shortages, but critical anesthesia drugs are still in short supply. To help prevent and mitigate shortages, ASA recommended that the FDA:
- Offer relevant up-to-the-minute drug shortage information through an RSS-feed or similar web feed format that can be automatically posted and updated on medical societies' and patient advocacy organizations' websites;
- Establish a mechanism where physicians and patients can sign up for email updates on shortages of specific drugs or drug classes;
- Work with manufacturers to create incentives to develop smaller sized vials and alternative concentrations of FDA-approved medications.
The FDA should also adopt the remaining Drug Shortage Summit Workshop recommendations that were not addressed by FDASIA. These recommendations were produced in November 2010 by ASA, along with the American Society of Clinical Oncology, the American Society of Health-System Pharmacists, the Institute for Safe Medication Practices and the American Hospital Association. ASA previously presented these recommendations to the FDA at the Agency’s Drug Shortage Workshop in September 2011. Specifically, the FDA should:
- Work with manufacturers to develop contingency plans for critical drugs that are vulnerable to shortages and establish criteria for determining whether a drug falls in this category;
- Create incentives for firms to manufacture pre-1938 generic injectables that are essential to anesthesiologists’ ability to safely care for patients.
ASA will continue to urge lawmakers and regulators to support drug shortage relief and highlight the significant impact drug shortages have on our members and the patients they treat.