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FDA Takes First Steps to Cut Regulations, Solicits Public Feedback

Since our  March 17th post about President Trump’s executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called “2-for-1” Executive Order (E.O. 13,771) have occurred at the Executive Branch management level.  In addition, of great interest to us is the fact that the Food and Drug Administration (FDA) took its first major public step toward implementing the goals laid out in the President's directive. On September 8th, the FDA issued seven Requests for Information that solicit "broad public comment on ways [FDA] can change [its] regulations to achieve meaningful burden reduction while continuing to achieve [its] public health mission and fulfill statutory obligations." As detailed below, FDA issued one notice for each major product-focused Center, and one specific to cross-cutting agency regulations.

This post outlines the backdrop for--followed by the details of--FDA's public request for input about which regulations should be cut or modified.

Since early Spring 2017, recent Executive Branch developments include:
  1. The White House Office of Management and Budget (OMB) expanded its February interim guidance to agencies on how to implement the 2-for-1 order. The expanded OMB memorandum is intended to supplement the interim guidance and is set forth in the same question-and-answer format. It clarifies some open questions and also explains how agencies will be held accountable for not meeting OMB's deregulatory goals. The expanded guidance is dated April 5, 2017 and is available here.
  2. The Trump Administration's first Unified Regulatory Plan and Agenda for Spring 2017 was released in mid-July and was certainly a slimmed-down version of what stakeholders had seen from the Executive Branch in 2016. For the first time, this release included a separate online list of "Inactive Actions."
  3. Progress has been made in response to the President's directive in E.O. 13,777 that agencies must establish Regulatory Reform Task Forces, each headed by a Regulatory Reform Officer. Journalists and public interest groups have been working to obtain information about the selection process and the composition of those Task Forces, using both informal inquiries and the Freedom of Information Act. As one example of the investigative reporting on this issue, the latest installment of a ProPublica/New York Times investigation is available here.
  4. Congressional Democrats have also initiated requests for detailed information about the activities of the Regulatory Reform Task Forces (RRTFs), primarily via a letter to OMB. The recent letter asked for responses to be sent to the Oversight Democrats by August 25, 2017.

FDA's September 2017 Notices & New Dockets

The recent notices and Requests for Information issued by the Agency specifically respond to the White House call for deregulatory actions, noting further that the information collected from stakeholders will “support the work of the RRTF of the Department of Health and Human Services.” The FDA Deputy Commissioner for Policy, Planning, Legislation, and Analysis published a post on the "FDA Voice" blog in conjunction with the Agency's publication of these seven notices in the Federal Register on September 8, 2017.

Deputy Commissioner Anna Abram explained that the Agency was undertaking a "comprehensive review of our regulations" in order to "ensure that our policies and regulations keep pace with the challenges we face in protecting consumers, and the opportunities we have to improve their lives." She provided the context for the comprehensive regulatory review--an increasingly globalized, technology-driven world, in which risk-based regulation must be done thoughtfully and with all innovations and challenges being considered. "Our goal is to have regulations that reflect modern risks and opportunities, and use the full scope of our authorities to achieve our consumer protection mission," she wrote.

Ms. Abrams also reassured stakeholders that, "As in all our actions, science will remain FDA’s North Star when it comes to our role in devising regulatory policy." She pointed out that since Dr. Gottlieb was confirmed as Commissioner, "FDA has announced a number of broad policy efforts to address public health opportunities in areas such as regenerative medicine, tobacco products, and access to affordable medicines." (Mintz Levin lawyers have been closely following those agency activities as well, and in some cases blogging about them, as in here and here.)

Some of the issues FDA is asking interested parties to submit comment on include:

  • Is the regulation still current?
  • Has regulated industry had trouble complying?
  • "Does the regulation impose requirements that are also provided for in voluntary or consensus standards or guidance by third party organizations?”
  • Does the regulation cause unnecessary record collection?
  • “Could the goal of the regulation be achieved by less costly means that would provide the same level of public health protection?”
  • “What factors should FDA consider in selecting and prioritizing regulations and reporting requirements for reform?”

As noted above, the Agency issued seven concurrent notices.  The first one pertains to general, crosscutting regulations, and then the remaining six pertain to each of the six FDA Centers, which also correlate with a major category of regulated products. That is, Drugs, Devices, Biologics (including cells/tissues), Tobacco, Food/Cosmetics, and Animal/Veterinary.

Accordingly, there are multiple docket numbers that interested parties should be aware of. Ms. Abram's FDA Voice post includes links to each of the 7 notices in the electronic Federal Register, where individual docket numbers may be found. We encourage all individuals, collectives, and companies who would like to participate in this very interesting and unique regulatory process to do so. Comments should be submitted by December 7, 2017.

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Joanne counsels global clients on the regulatory and distribution-related implications when bringing a new FDA-regulated product to market and how to ensure continued compliance after a product is commercialized.