PRESS RELEASE: Doctors for America’s FDA Task Force Applauds Senate End of Year Package

FOR IMMEDIATE RELEASE
Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC  20009-9997

December 20, 2022

WASHINGTON, D.C. – Doctors for America’s Food and Drug Administration (FDA) Task Force is applauding leaders on Capitol Hill for including several critical patient-centered improvements to the FDA in the draft omnibus spending package agreement released today.

Doctors for America is grateful for the tireless efforts of members of Congress and their staff to find common ground on provisions that will keep our patients safe. The FDA Task Force is particularly pleased to see that the following provisions, which our task force members worked throughout the year to urge lawmakers to pass, were included in the end-of-year omnibus package:

  • A commitment to FDA actions and enforcement of diverse clinical trials to ensure that the therapies the FDA approves are proven effective in the patient population who will be prescribed them; and 
  • A reform of the accelerated approval pathway to ensure that patients and their providers find out in a timely manner whether the therapies approved through this pathway in fact have proven clinical benefit, and a clear pathway for removal if proven ineffective.

The Task Force is also heartened that legislators did not include the Pioneering Antimicrobial Subscriptions To End Up surging Resistance or PASTEUR Act in the draft omnibus package released late Monday. This legislation provides billions of dollars for antimicrobials that are newly developed without requiring that these drugs improve patient outcomes before entering the market; this would undermine the safety of patients everywhere. 

The Doctors for America FDA Task Force is thanking legislators for including measures to improve clinical trial diversity and reforms to the accelerated approval pathway, as well as prioritizing protecting patients instead of taxpayer-funded giveaways like the PASTEUR Act to drug manufacturers. We look forward to continuing to work with Congress to get the omnibus package passed in both the House and Senate and signed into law. 

For press inquiries for members of the FDA Task Force Doctors for America please contact Claire Onyechi with Continuum Health Group ([email protected]).

About Doctors for America:

Doctors for America mobilizes doctors and medical students to be leaders in putting patients over politics to improve the health of our patients, communities, and nation. We are 27,000 physicians and medical students in all 50 states, representing all areas of specialization. Our impact areas focus on access to affordable care, community health and prevention, and health justice and equity. DFA focuses solely on what is best for our patients, not on the business side of medicine, and does not accept any funding from pharmaceutical or medical device companies; which uniquely positions DFA as the organization that puts patients over politics and patients over profits. Find out more at doctorsforamerica.org and on Twitter @drsforamerica.

Learn more about the DFA’s FDA Task Force recommendations for the omnibus here.

 

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Health for All, Prescription Drugs, FDA