FOR IMMEDIATE RELEASE
Doctors for America
PO Box 53313
1921 Florida Ave NW
Washington, DC 20009-9997
Continuum Health Group
WASHINGTON, D.C—September 27, 2022. Doctors for America’s (DFA)FDA Task Force is deeply disheartened by the proposed User Fee reauthorization agreement that is reported to be included in the Continuing Resolution.
Historically, the Food and Drug Administration (FDA) User Fee reauthorization process has allowed Congress to not only renew existing programs, but also to make much-needed reforms to the agency. As this process occurs only once every five years, it is crucial that Congress seize this opportunity to provide FDA with authority and oversight to carry out its primary responsibility of protecting the nation’s public health.
While we are grateful that an agreement has been reached ensuring that the government including the FDA will not experience any lapse in funding, we wish the proposed measure went further to put patients over industry profits. Over the last several months, DFA has been sharing the stories of our clinician colleagues and patients who are concerned over the lack of transparency and accountability at the FDA. As we have told policymakers: patients must be at the center of all therapeutic reviews and approvals.
Clinicians across all specialties look to the FDA for evidence-based guidance on prescription drugs, medical devices, and other medical treatments. In the wake of recent controversial FDA approvals that raised alarms for patients, doctors, and payers, Congress took action and included critical patient-centered riders, such as provisions that would increase clinical trial diversity and reform the accelerated approval pathway, to the FDA User Fee bill passed by the House in June. If Congress passes a “clean” reauthorization without the inclusion of these critical provisions, FDA will have their hands tied, left only with what had been pre-negotiated between the agency and the drug and device industries.
Our doctors and patients need assurance that the treatments available to them are proven safe and effective based on the highest scientific evidence. Moreover, as a nation, we need to ensure that the therapies we develop are effective and developed with a cohort of trial participants that are reflective of the nation’s population.
We know that leaders in both the House and the Senate have been working tirelessly on an agreement that considers patients and doctors. We are deeply concerned that politics once again has gotten in the way of making meaningful improvements. This is a missed opportunity.
The FDA Task Force, comprised of over 30 physicians across specialties, aims to improve the federal agency so that it can continue to provide physicians and patients with two main assurances: that therapeutic approvals are conflict-free and they rely on the highest evidentiary standards. We look forward to continuing to fight for these goals to be included in forthcoming legislative vehicles.
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.