In the Trump Administration’s final days, the Department of Health and Human Services (HHS) has changed the US Food and Drug Administration’s (FDA) regulatory oversight policies. The Securing Updated and Necessary Statutory Evaluations Timely (SUNSET) rule would force expire most HHS regulations after ten years of issuance unless they are actively reviewed and re-established based on the Regulatory Flexibility Act. This takes effect in March 2021.
This is important because the HHS (which includes the FDA) has over 67 years’ worth of regulations that must be reviewed within ten years—for example, 17,200 regulations will automatically expire in 2026. Eighty-five percent of all HHS regulations created before 1990 have not been edited and subject to automatic expiration. This was only open to the public for comment for a reduced time period, although many people at the public hearing in November identified numerous legal and practical issues with the proposal. They noted that HHS has existing rules to review and expire regulations without needing this harsh rule. The rule was still enacted.
The change is critical because commonly special controls for newly established product codes are set as regulations—like when a deNovo product is approved or a product is reclassified—and must now be reviewed periodically or the special controls may be rescinded. Safety reporting, product approvals, clinical trials, and submission content would be impacted because the Federal Food, Drug, and Cosmetic Act is implemented through FDA regulations.
In addition to effectiveness, the review must determine regulations that have a significant economic impact upon a substantial number of small entities in which remedial action would be required.
This ruling comes right after the Good Guidance rule issued two weeks ago, which creates new procedural requirements surrounding the issuance and maintenance of sub-regulatory guidance documents. These requirements include that guidance documents do not impose any obligations on companies that are not already reflected or referenced in statutes or regulations, and they cannot exceed these requirements either. Many of the statutes were passed many years ago and are not reflective of current technology. This is important because FDA commonly provides their current opinion of the law in their guidance documents, expanding it beyond the actual statute text.
For example, although the Act would survive because it is a law, all the Affordable Care Act regulations would all be required to be reviewed within five years of the proposal being adopted. Had President Trump been reelected, his promise to eliminate that Act, stopped by Congress and the Supreme Court, would have occurred simply by HHS not reviewing those regulations.
However, it is important to note that the rule is not scheduled to take effect until well after Inauguration Day, and the incoming Biden Administration could delay the rule’s effective date as part of the “regulatory freeze” order that typically accompanies a White House transition. This would buy HHS time to undertake the rescindment or modification of the SUNSET rule if desired.
For example, although the Act would survive because it is a law, all the Affordable Care Act regulations would all be required to be reviewed within five years of the proposal being adopted. Had President Trump been reelected, his promise to eliminate that Act, stopped by Congress and the Supreme Court, would have occurred simply by HHS not reviewing those regulations.
However, it is important to note that the rule is not scheduled to take effect until well after Inauguration Day, and the incoming Biden Administration could delay the rule’s effective date as part of the “regulatory freeze” order that typically accompanies a White House transition. This would buy HHS time to undertake the rescindment or modification of the SUNSET rule if desired.
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