FOR IMMEDIATE RELEASE
Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC 20009-9997
December 5, 2022
WASHINGTON, D.C. – This week Doctors for America’s Food and Drug Administration (FDA) Task Force is meeting with leaders on Capitol Hill to ask that patient-centered improvements to the FDA be included in any final legislative agreement before the end of the year.
The FDA Task Force is following up on previous meetings with congressional leaders and reaching out to new negotiators and agency officials to discuss the need to ensure that patient-centered improvements to the FDA, which were omitted from the User Fee Reauthorization package passed in September, are passed in the 117th Congress.
In September, leaders on both sides of the aisle agreed to revisit needed reforms to the FDA during the lame-duck session, and the FDA Task Force is making sure that patients are at the core of these proposed improvements.
The FDA Task Force is urging members of congress to include the following provisions, which already passed the House, 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 asking, amid all the competing requests that legislators do not include the Pioneering Antimicrobial Subscriptions To End Up surging Resistance or PASTEUR Act in any final package this year. This legislation provides billions of dollars for antimicrobials that are newly developed, but these drugs are not required to prove clinical effectiveness before entering the market; this would undermine the safety of patients everywhere. Instead, the Doctors for America FDA Task Force is urging legislators to focus on including measures to improve clinical trial diversity and reforms to the accelerated approval pathway and prioritize protecting patients within any end of year legislative package instead of taxpayer-funded giveaways like the PASTEUR Act to drug manufacturers.
Learn more about the FDA Task Force’s recommendations for the omnibus here.
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.