A growing number of physicians from across medical specialties and geographic regions in the country and their patients have struggled to ameliorate the adverse outcomes that result when patients are unable to access needed medication and treatment. Shortages not only impact the well-being of patients, but they increase health care costs and divert scarce resources needed to improve quality and patient outcomes. The AMA has diligently worked with impacted stakeholders to identify strategies to mitigate or avert shortages and to identify underlying causes.
On June 20, the House passed S. 3187, the "Food & Drug Administration Safety and Innovation Act," by voice vote. The Senate adopted the measure on June 26 by a vote of 92-4, and the President signed it into law on July 9, 2012.
The final version of S. 3187, which was the result of a bipartisan compromise between the House and the Senate, reauthorized the Prescription Drug User Fee Act and the Medical Device User Fee Act, and newly authorized user fees for generic drugs and biosimilars. It included several provisions that the AMA supported and worked to improve throughout the legislative process. A number of provisions are designed to address drug shortages.
AMA provided comments to the FDA on its draft guidance for Mixing, Diluting, and Repackaging Biological Products on May 20, 2015. Whilst expressing support for the FDA's goals of ensuring the quality and safety of the nation's compounded and repackaged drug supply, AMA also urged that FDA also consider the access needs of physicians and patients.
In a December 27, 2013 letter to the FDA, the AMA provided comments on FDA’s proposed rule that would require manufacturers to notify the agency of a permanent discontinuance or manufacturing interruption of a product that is likely to lead to a meaningful disruption in supply.
The AMA provided recommendations to the Food and Drug Administration's (FDA) Drug Shortages Task Force on its Strategic Plan in a March 14, 2013 letter. In its letter, the AMA highlighted physician concern and frustration with ongoing shortages, particularly of sterile injectables. In addition, AMA indicated its support of the concept of developing a qualified manufacturing partner program; and strongly supported targeted notification to physician medical specialty organizations.
Lists of Drugs in Shortage & How to Report a Shortage or Supply Issue:
American Society of Health-System Pharmacists (ASHP): Current Drug Shortages
AMA Council on Science and Public Health (CSAPH) Reports on Drug Shortages:
CSAPH Report to AMA Annual Meeting, June 2012
Drug Shortages in the Media:
Drug shortages worsen following pharmacy-related meningitis scare, AMNews, Dec. 10, 2012