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Drug Shortages

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.

Legislative Activities

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.

Letter to Rep. Gingrey supporting H.R. 3742, the "Antibiotic Development to Advance Patient Treatment Act of 2013" (ADAPT), March 13, 2014

AMA letter to House Energy and Commerce supporting H.R. 3089, the “Compounding Clarity Act of 2013,” September 23, 2013

AMA letter to Senate HELP Committee re: substitute amendment to S. 959, the “Pharmaceutical Quality, Security, and Accountability Act,” August 8, 2013

AMA letter to Senate HELP Committee on draft compounding legislation, May 3, 2013

AMA letter to Chairs and Ranking Members of Senate HELP Committee supporting PDUFA Reauthorization Bill (S. 3187), June 20, 2012

AMA comments to PDUFA Reauthorization Conferees, June 7, 2012 Drug Shortages legislation 2nd draft comments to Senate HELP Committee Chair and Ranking Member, April 24, 2012

AMA letter suggesting changes to next generation antibiotic incentives proposal in draft PDUFA reauthorization legislation, April 19, 2012

Drug Shortages letter to E & C Chair and Ranking Member, April 6, 2012

Senate HELP bipartisan working group's discussion draft on drug shortages - AMA comments, April 6, 2012

Drug Shortages ASHP-generated sign-on letter to E&C and Senate HELP, March 16, 2012

Letter to Reps. DeGette and Rooney supporting H.R. 2245, the "Preserving Access to Life-Saving Medications Act," October 6, 2011

Letter to Sen. Amy Klobuchar supporting S. 296, the "Preserving Access to Life-Saving Medications Act," November 28, 2011

Regulatory Activities

In an August 30, 2016 letter to the FDA, AMA provided comments on the FDA-convened listening session concerning implementation of the Drug Quality & Security Act (DQSA)

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.

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