The FDA’s new year gift to the industry is a record-breaking reading assignment; it released 31 Guidance documents on the first Monday and Tuesday of the year. In an unprecedented data dump of sorts, the guidance documents span all centers at the Agency. This is not normal by any standards but how does it impact the industry?
The sheer number of guidance documents is extraordinary. FDA released 12 final versions and 19 draft guidance documents spanning diverse topics such as Artificial intelligence (for there are 2 new guidance documents), human cell and tissue-based products (for which there are 6 new guidance documents), clinical trials, accelerated approvals, food-related topics (5 guidance documents), and veterinary products (6 guidance documents). Before we read too much into the number of guidance documents, it is important to note that many of these guidance documents have been in the works for a long time and discuss topics under discussion in various ways. For example, the guidance document discussing accelerated approvals is a minor extension of the guidance document released last month on the same topic.
It is no secret that the incoming administration plans to make major changes at the FDA. So, is the release of these guidance documents intended to protect the current unwritten policies at the FDA from the upcoming changes? Although guidance documents are not legally binding, the FDA reviewers treat them as binding “recommendations” in their interactions with the sponsors, even when they are “draft” versions, citing “current policy”. The FDA has been accused of using the guidance documents to create policies without going through the rule-making process. Guidance documents frequently interpret regulations more conservatively than would appear from reading the relevant regulations. So, one could argue that foreseeing upcoming policy changes, the FDA staff wanted to get as many guidance documents as possible out to the public. The perception is not without merit. The number of guidance documents released this time is almost three times the number of guidance documents released in any one-week period in FDA’s history. For context, in the entire month of January 2024, the FDA released 12 guidance documents, 14 were released in January 2023, 6 in January 2022, 5 in January 2021, and 8 in January 2020.
Look as it may, this could just be a coincidence. The FDA is one of the few government agencies that is mostly not impacted by political changes. Yes, there is a change in the Secretary of HHS and the FDA Commissioner, but almost everyone else at the FDA stays in their positions, and hence almost all decisions and actions are unchanged. We should probably not read too much in this seemingly excessive number of new guidance documents released in a short time span.
