The 21st Century Cures Act: One of Many Reasons Why Today’s Executive Order Is Misguided

By Rachel Sachs

Today, President Trump signed an executive order (EO) whose purpose is ostensibly to reduce the regulatory burden imposed by the government on many different types of industries.  The EO envisions achieving this goal through an incredibly sophisticated strategy: “for every one new regulation issued, at least two prior regulations be identified for elimination.”  Not how burdensome any particular regulation is, or how old it is, or how broad it is – just how many regulations there are.

The next question, of course, is what the EO means by “regulation.”  It clearly includes traditional APA notice-and-comment rulemaking (the EO specifically calls out situations when an agency “publicly proposes for notice and comment” a regulation).  More generally, the EO does provide a definition: “For purposes of this order the term “regulation” or “rule” means an agency statement of general or particular applicability and future effect designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

This sounds to me as if it includes guidance documents, which are used extensively by many agencies to set and implement policy. To be sure, it is not always clear what counts as a guidance document, and it is not always clear whether agencies are attempting to use guidance to circumvent the notice-and-comment rulemaking process.  But by many common definitions of guidance documents (including those put forth in executive orders by the Bush Administration, for instance), the term “regulation” as defined in this EO would seem to include guidance documents.  As with other EOs issued in the past week, this one could have benefited from more clarity, but I think the better reading of the EO is that it does cover guidance.

There are many reasons why this strategy in general is a bad one, but I’ll focus on just one: the need to develop policy as a result of particular statutes.  Take the 21st Century Cures Act.  Whatever your view of its merits, it passed with overwhelming bipartisan support in the last weeks of President Obama’s administration.  It also imposes enormous new obligations on HHS and the FDA to make all kinds of policy judgments going forward.  It rarely requires the creation of a traditional notice-and-comment rulemaking (see sections 4002 and 4003 for examples), but often speaks in terms of “establish[ing] a program” or “establish[ing] a draft framework,” much of which could be done through guidance.

The “regulations” the FDA would issue under the Act – whether through notice-and-comment rulemaking or guidance – are not ones the agency in its own judgment has decided are necessary.  They are ones that Congress and the President have deemed are necessary.  Yet for every one of these new “regulations,” this EO will require the agency to remove two prior regulations?  This is a terrible idea.

An agency which sought to resist this EO might fail to issue new regulations as required by Congress.  When called before Congress to explain the delay, the agency can quite reasonably say that it cannot identify past regulations which it ought to eliminate.  To the extent that particular Congressmen undoubtedly would like to see the agency adhere to its statutory obligations, we may see pushback from Congress on this EO or the inclusion of clauses in statutes going forward that would exempt their regulations from this EO.

[Note: I put aside here that the EO does not actually say that the prior regulations must be eliminated, just that they be “identified for elimination.” I do not know what that means and welcome any thoughts on the matter.]

This entry was posted in FDA, Health Law Policy, Rachel Sachs by rachelsachs. Bookmark the permalink.

About rachelsachs

Rachel Sachs is an Associate Professor at the Washington University in St. Louis School of Law. Previously, she was an Academic Fellow at the Petrie-Flom Center. Rachel earned her J.D. in 2013 magna cum laude from Harvard Law School, where she was the Articles Chair of the Harvard Law Review and a student fellow with both the Petrie-Flom Center and the John M. Olin Center for Law, Economics, and Business. Rachel has also earned a Master of Public Health from the Harvard School of Public Health, during which she interned at the United States Department of Health and Human Services. Rachel's primary research interests lie at the intersection of patent law and health law, with a particular focus on problems of innovation and access and the ways in which law helps or hinders these problems.

2 thoughts on “The 21st Century Cures Act: One of Many Reasons Why Today’s Executive Order Is Misguided

  1. Executive Order on Title 3 U.S.C is unconstitutional, the 21st Century Cures Act, is passed with overwhelming Bipartisan support in the last weeks of President Obama’s administration; President Donald Trump on Title 3 U.S.C applies Executive Order 12866; which means, it’s totally indicating he lacks experience and knowledge of the US Congress, US Constitution who have power to promote the Progress of Science and Useful Arts; the 21st Century Cures Act is breached by President Donald Trump who is also aiming to repeal the Affordable Care Act which was enacted by Act of Congress. 21st Century Cures Act is enacted in accordance with Title 42 U.S.C, The Public Health and Welfare. Therefore, this is a concern of the US Congress and something must be done.

  2. Your last aside is the key. This seems to be more performative in nature than anything, because “identifying” a regulation does nothing. And demanding that agencies rescind two rules when implementing has the opposite effect – the agencies would be required to publish the rescinded rules through notice and comment rulemaking (i.e., you have to make a rule to rescind a rule).

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