Azar’s ‘Sunset Rule’ will bring a dangerous new dawn for health regulation

Alex Azar, secretary of the federal Department of Health and Human Services, spent his final days in office under fire for misleading states about the number of coronavirus vaccine doses they would receive this month. Unfortunately, the criticism didn’t deter Azar from closing out his tenure by making yet another promise his department can’t keep, one that puts thousands of existing health and safety protections at risk of automatic repeal.

Azar’s insidious new policy, known as the Sunset Rule, commits HHS to reassessing the economic impacts of almost every one of the department’s existing regulations and establishes an extreme penalty for noncompliance: If a regulation is not reviewed by its 10th anniversary, it simply blinks out of existence.

Completing these analyses on schedule would be a herculean and likely impossible task. The bulk of HHS’s regulations — an estimated 17,200 provisions spread across 3,400 separate rule-making packages — have either already passed the 10-year mark for review or soon will, and the Sunset Rule provides only a five-year grace period in which to review all of them.

To meet the Sunset Rule’s targets, HHS would need to conduct 680 reviews per year. Compare that with the pace of Azar’s own Regulatory Reform Task Force, which managed to review a grand total of 111 rules for repeal in 2018, an achievement that looks downright impressive compared to 2019’s tally of 15.

Even former FDA Commissioner Scott Gottlieb, who was appointed to the post by President Trump, has criticized the Sunset Rule as burdensome and unnecessary. Gottlieb points out that many rules at the FDA, a sub-agency of HHS, “establish long term scientific and regulatory principles that don’t need constant updating” and that forcing the agency’s staff to retrospectively review them will, at best, distract from more important work.

At worst, HHS staff simply won’t have time to complete all of the required reviews, in which case the unreviewed rules — whether they govern the safety of food and pharmaceutical products, the accuracy of medical tests, or the operations of hospitals and nursing homes — would expire, leaving regulated businesses free to ignore them with impunity.

HHS insists that the Sunset Rule’s retrospective reviews “should be a priority” and that “it is willing to commit the necessary resources” to performing the thousands of analyses required by the new policy.

One might reasonably wonder why, if Azar believes that a sweeping retrospective review of all HHS regulations is so essential, did he wait until the final day of his three-year tenure to initiate the process? Imagine how many regulations his staff could have already reviewed by now had he not instructed them to instead spend their time reducing access to contraception, enabling discrimination against gay and transgender patients, and helping states add work requirements to their Medicaid programs despite repeated court rulings deeming such requirements illegal.

The truth is that Azar was unwilling to commit his own resources to a comprehensive review effort but is happy to volunteer the Biden administration for the task because doing so will impede the efforts of the incoming HHS secretary, Xavier Becerra, to reverse three years’ worth of harmful Azar policies.

Azar’s HHS likewise dismisses concerns that the Sunset Rule will lead to the automatic repeal of important health and safety protections, arguing that if the department neglects to review a regulation with an approaching expiration date, the public will notice and urge the department to complete the task. But while HHS provides spreadsheets listing its regulations and the dates on which they were initially issued, the department does not guarantee the accuracy of the lists — which were compiled with artificial intelligence — or specify which of the listed provisions qualifies for one of the Sunset Rule’s comically vague exemptions, such as that for regulations “whose expiration … would violate any other Federal law.” So it is far from clear to the public which policies are truly vulnerable to rescission.

Furthermore, the Sunset Rule does not provide that a regulation’s expiration will be suspended simply because of public objections to HHS’s failure to review it. If members of the public sound the alarm and HHS ignores them, the unreviewed provision will still expire.

All of this is illegal. The federal Administrative Procedure Act requires that agencies provide a “reasoned explanation” for repealing a policy, based on a consideration of “relevant factors” such as the rule’s costs and benefits and the extent to which members of the public rely on it. Failure to provide such an explanation has foiled several high-profile Trump policies, such as its attempt to end the Deferred Action for Childhood Arrivals immigration program.

Yet in the Sunset Rule, HHS claims the power to repeal thousands of rules at once without so much as explaining what they do, much less justifying the harm that could arise in their absence. It’s an outrageous overreach, even by the standards of an administration with an 80% loss rate in the federal courts.

In the end, the Sunset Rule won’t result in a large number of automatic rescissions — not because HHS will actually complete all of the required reviews but because the rule itself will be scrapped, either by Congress (using a joint resolution of disapproval under the Congressional Review Act) or through a new rule-making under Becerra’s leadership.

The likelihood that the Sunset Rule will be reversed, however, does not excuse Azar’s recklessness in issuing it. The fact remains that if the policy is implemented, it could do great damage to our system of health regulation and, in turn, to public health itself.

In response to states’ anger over the flubbed vaccine rollout, Azar offered a glib defense of regulatory ambition: “You fail to achieve 100% of the goals you do not set.” But it is hardly admirable for a public official to make unrealistic and unjustified commitments, secure in the knowledge that the costs of his failure will be borne by others.

Jack Lienke is the regulatory policy director of the Institute for Policy Integrity and adjunct professor of law, both at New York University School of Law.