How an Obscure Law Shapes the Way the Public Engages with the Food and Drug Administration
Every day, the executive branch of the federal government makes transformative policy changes. When federal agencies need expert input, they look to advice from external experts and interested citizens through a series of public engagement mechanisms, from public meetings to public comment. Of these, only one mechanism allows the executive branch to actively source consensus-based public advice and for external experts to directly advise policymakers, the Federal Advisory Committee Act (FACA). And it’s a law many Americans have never heard of.
FACA enables agencies to create advisory committees
Enacted in 1972, FACA governs expert and public engagement with executive branch decision making. FACA articulates rules for the establishment, operation, and termination of advisory committees (AC), groups of experts that the federal agencies establish, manage, and use to provide external advice on key policy questions. At any given moment in time, there are ~1000 active ACs across the federal government making crucial recommendations to agency leaders.
At the Food and Drug Administration (FDA), FACA is essential to the workings of the agency’s regulatory engine and public health mission. The FDA uses its ACs to provide independent advice on medical products (drugs and devices), providing a unique window for experts and the public to comment on cutting-edge medical products in the approvals pipeline. ACs capture the headlines through their “yes” or “no” votes on product approval, raising spirits or breaking hearts. Industry takes notice: medical product sponsors spend months preparing for these meetings, supported by a boutique industry geared to help them “ace” their AC meetings.
ACs need to be reformed to build public trust in the FDA
While ACs are a crucial transparency measure for an agency like FDA that is currently grappling with declining public trust, the system has been repeatedly under fire. Recent controversies include FDA’s public overruling of AC recommendations against approval for hydrocodone, an opioid pain reliever, and aducanumab, an Alzheimer’s treatment. After aducanumab approval, several high-profile resignations exacerbated the trust-issues. What’s more, FDA’s use of ACs is in decline, with the percentage of new drugs reviewed by ACs decreasing by almost 10 times from 2010-2021. These actions are in direct conflict with current whole-of-government efforts to modernize regulatory review and expand meaningful participation in the regulatory decision making process. Advancing racial equity, opening up the scientific enterprise, and broadening public engagement in regulatory decisions will require transformative policy solutions for the FDA.
To re-envision how the FDA and other federal agencies engage external scientific experts and the public to address critical challenges facing public health, FAS is diving deep into how FACA is put into action at the FDA. Over the next year, FAS will be engaging AC members on their experiences in service, understanding key evidence needs at the agency that a reformed AC system could better meet, and scoping necessary process, regulatory, and statutory changes to the AC system. This will build upon our previous efforts: FAS has participated in and provided public comment to many AC meetings and documented how ACs are slow to respond to emerging questions of regulatory concern in our ongoing work to address bias in medical innovation. FAS has also documented strategies to improve science advice for the executive branch, including FACA reform. We invite you to follow this work and join us in calling for reforms that strengthen trust in the FDA Advisory Committee system.
Calls for systematic reform are coming from leadership across the FDA, yet consensus does not yet exist on what those reforms should look like. From recommendations to get rid of voting requirements at meetings (already receiving Congressional scrutiny), to broadening membership, including to members with conflicts of interest, to increasing review timelines of sponsor materials before meetings, there is no shortage of ideas for what this new system could look like. Non-profit leaders and academic researchers have also started coming together to make recommendations that address FDA’s influence over Advisory Committee discussions and ongoing issues with agency leadership overruling the AC’s vote. There could also be clearer requirements for the FDA to respond to AC recommendations and make set public timelines for agency action. Twenty-five Attorneys General recently called on the FDA to release updates to its actions on pulse oximetry one year after the AC meeting.
More broadly, the FDA can learn from other agencies with explicit policies guiding their public engagement, such as the Meaningful Involvement Policy at the Environmental Protection Agency. These FDA-specific recommendations build upon long-standing calls to reform FACA to reduce the administrative barriers that make it challenging to solicit expert advice when needed or lead some agencies to forgo processes that could invoke FACA altogether.
To improve patient care, it is essential to create a nimble, participatory, and transparent process that ensures regulated products will benefit the health of all Americans. AC reform will be essential to building the FDA’s capacity to address increasingly complex regulatory science challenges, from artificial intelligence, to real-world data, to emerging platform technologies, to health inequity, while also improving the federal government’s ability to more rapidly generate consensus-based science advice. FAS is excited to play our part in strengthening evidence-based policy by engaging in policy entrepreneurship to engage stakeholders, develop roadmaps, and advocate for change.
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