The recent and drastic Reduction In Force (RIF) at the U. S. Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. While much of the focus has been on how these cuts may impact application review timelines and industry engagement, see earlier post about the effect on generic drugs, another quieter consequence is emerging – a significant slowdown in the availability of information that FDA is required to produce under the Freedom of Information Act (FOIA).
FOIA is a U.S. federal law enacted in 1967 to promote transparency and accountability in the federal government by granting the public the right to request access to government records, subject to certain exemptions. As it relates to the FDA, FOIA serves as a vital tool for stakeholders – including patients, researchers, and regulated industry – to better understand the Agency’s scientific, policy and regulatory decision-making.
Documents that FDA discloses in response to FOIA requests can vary widely, from inspectional documents, like Form 483s and Establishment Inspection Reports, to correspondence between FDA and sponsors, and can be voluminous, such as 510(k) documents and other review memos. However, not all information contained in FDA records is disclosable. Under the law, FDA can redact or withhold information that falls under one of nine exemptions; the most commonly used exemptions are: information that describes FDA’s internal deliberative processes (Exemption 2), information that is prohibited from disclosure by other laws (Exemption 3), confidential commercial or financial information or trade secrets (Exemption 4), inter-agency and intra-agency communications (Exemption 5), information that could lead to an invasion of personal privacy of individuals (Exemption 6), and records or information compiled for law enforcement purposes (Exemption 7).
As a result of the RIF, stakeholders are now seeing longer wait times for both requested documents via FOIA and proactive disclosures, like approval packages routinely posted on Drugs@FDA which are required under the Food and Drug Administration Amendments Act (FDAAA) to be posted within 30 calendar days of approval for new products or within 30 calendar days of the third FOIA request for the action package. In some cases, previously routine postings are delayed or going unpublished altogether. We also have heard from the remaining FDA FOIA staff that it could be at least a month before they can even provide a new estimate for when to expect responses under pending FOIA requests. For those requestors who already have been waiting months (or even years) for FDA to provide the documents that FDA put on a “complex” track, the staffing cuts are hugely disappointing. Although there are avenues for escalating or litigating unreasonable delays for responding to FOIA requests, it is difficult to see how these approaches will be effective as no one may even be available to respond to an appeal until the dust settles.
Transparency has long been a cornerstone of FDA’s public health mission, and one that the new HHS Secretary and FDA Commissioner have reinforced as their priorities. But in these unprecedented times, as the Agency navigates the strain of recent workforce reductions, the ripple effects are increasingly hard to ignore. What began as a staffing challenge is quickly becoming an information bottleneck—one that threatens to erode the transparency that stakeholders rely on. If access to critical regulatory documents continues to slow or stall, the consequences could extend beyond inconvenience, ultimately impacting the ability of patients, providers, and developers to make informed decisions that affect public health.
