Physicians from across the country and across medical specialties have experienced drug shortages that affect the health of their patients. The AMA is working with multiple stakeholders to find solutions to those shortages and the resulting adverse patient outcomes.
AMA’s involvement to reduce drug shortages
The AMA’s Council on Science and Public Health continues to evaluate the drug shortage issue and reports back at least annually to the House of Delegates on progress made in addressing drug shortages.
The AMA has been actively advocating with members of Congress, various congressional subcommittees and multiple federal agencies.
On July 9, 2012, the president signed the Food & Drug Administration Safety and Innovation Act, a bipartisan compromise that reauthorized the Prescription Drug User Fee Act and the Medical Device User Fee Act and new user fees for generic drugs and biosimilars. The Act included several AMA-supported provisions.
The AMA commented to the FDA on its draft guidance for Mixing, Diluting and Repackaging Biological Products (May 2015). While supporting its goals, the organization urged them to consider the access needs of physicians and patients.
FDA’s Drug Shortages Task Force
In December 2013, the AMA commented on the FDA’s proposed ruling requiring manufacturers to notify the agency of either discontinuance or disruption in a product’s manufacture likely leading to shortage.
Previous to that, the AMA gave recommendations to FDA’s Drug Shortages Task Force on its strategic plan. AMA commented on physician frustration with shortages, especially in terms of sterile injectables, and supported developing a “qualified manufacturing partner” program and targeted notification to medical specialty organizations.
AMA’s perspective on drug shortages
The AMA supports more efficient regulatory review of prescription drugs and greater investment in production capacity. It also encourages the HHS Secretary to speed up facilities inspections, review of manufacturing changes and drug applications. The AMA recommends greater resilience and redundancy in manufacturing to avoid disruptions caused by unforeseeable events. Comprehensive studies of the multiple causes of shortages should include federal actions, including reimbursement rates, manufacturing capacity and contracting practices.
The AMA also believes that Centers for Medicare & Medicaid Services should review its 2003 “average sales price plus 6%” reimbursement rate and consider what consequences it may have on prescription drug shortages. The AMA also urges products not be removed from market due to compliance issues unless their removal is for obvious public safety.
The AMA urges wholesalers to distribute drugs in short supply fairly based on inventory and customers’ purchase history.
Explore AMA’s legislative work on drug shortages. See the search results for "Drug Shortages" in the AMA Federal and State Correspondence Finder.
Letter to Rep. Gingrey supporting H.R. 3742, the Antibiotic Development to Advance Patient Treatment Act of 2013 (ADAPT)Letter, March 13, 2014
Letter to House Energy and Commerce supporting H.R. 3089, the Compounding Clarity Act of 2013Letter, Sept. 23, 2013
Letter to Senate HELP Committee re: substitute amendment to S. 959, the Pharmaceutical Quality, Security, and Accountability ActLetter, Aug. 8, 2013
Letter to Chairs and Ranking Members of Senate HELP Committee supporting PDUFA Reauthorization Bill (S. 3187)Letter, June 20, 2012
Letter to Senate HELP Committee on draft compounding legislationLetter, May 3, 2013
Comments to PDUFA Reauthorization Conferees, June 7, 2012 Drug shortages legislation 2nd draft comments to Senate HELP CommitteeComment Letter, April 24, 2012
Letter suggesting changes to next generation antibiotic incentives proposal in draft PDUFA reauthorization legislationLetter, April 19, 2012
Drug shortages letter to E&C Chair and Ranking MemberLetter, April 6, 2012
Senate HELP bipartisan working group's discussion draft on drug shortages: AMA commentsLetter, April 6, 2012
Drug shortages ASHP-generated sign-on letter to E&C and Senate HELPSign-On Letter, March 16, 2012
Letter to Reps. DeGette and Rooney supporting H.R. 2245, the Preserving Access to Life-Saving Medications ActLetter, Oct. 6, 2011