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Posted 27 February 2017 | By Zachary Brennan
President Donald Trump on Friday took another swipe at federal regulations, signing an executive order that requires all federal agencies to create task forces to help “alleviate unnecessary regulatory burdens placed on the American people.”
The added layer of bureaucracy created by the executive order is called upon to, within two months, designate an agency official as its Regulatory Reform Officer (RRO). Each RRO shall oversee the implementation of regulatory reform initiatives and policies to ensure that agencies effectively carry out such regulatory reforms.
A White House spokesperson told Focus that the EO "requires HHS name a Regulatory Reform
Officer and establish a Regulatory Reform Task Force. FDA’s role in that HHS
Task Force would be up to the Secretary of HHS and, of course, nothing would
prevent the Secretary from setting up a separate FDA Task Force if they wanted,
but that would be entirely up to them."
The executive order follows Trump’s call to cut 75% to 80% of US Food and Drug Administration (FDA) regulations, though a previous executive order calling to eliminate two old regulations for every new regulation implemented does not seem to include FDA guidance for industry.
Experts Focus spoke to earlier this month pointed to a couple of outdated regulations FDA could focus on initially, though if this “two out, one in” policy is enforced strictly over a long period of time for FDA, the cuts will inevitably lead to questions over diminished protections for Americans.
And back in 2011, in accordance with President Barack Obama’s Executive Order 13563, known as “Improving Regulation and Regulatory Review,” FDA offered a preliminary list of regulations to review. The Department of Health and Human Services (HHS) also identified regulations already being modified or streamlined and identifies additional candidates for further review.
Since the 1980s, FDA has reviewed its regulations with the goal of streamlining and improving its processes.
In the 1990s, FDA participated in the ‘‘Reinventing Government’’ initiative and met 95% of its goal for eliminating outdated or unnecessary regulations, and 89% of its goal for revising regulations, according to a Federal Register notice from 2011.
Following that initiative, FDA has undertaken other reviews of its regulations and regulatory processes including implementing new efficiencies such as withdrawing outdated proposed rules that were never finalized.
FDA currently has three main mechanisms that trigger a retrospective review of an existing regulation: First, a retrospective review may occur when there is a significant change in circumstances, such as technology advances, new data or a legislative change; Second, whenever FDA is revising an existing regulation, it reviews that regulation to determine if the underlying science and policy are still valid and whether the regulations should be updated based on current science, policy, data or technology; and the third mechanism is FDA’s Citizen Petition process, which allows the public to request the commissioner to issue, amend or revoke a regulation.
Other ongoing mechanisms that FDA uses to target regulations and specific audiences are biannual letters to state and local government officials and small businesses to highlight upcoming regulations that FDA believes may have an impact.
In addition, FDA uses the Federal Government’s biannual Unified Agenda of Federal Regulations to announce reviews conducted under the Regulatory Flexibility Act.
As part of that act, federal agencies are required within 10 years of the effective date of regulations that have a significant economic impact on a substantial number of small entities to review the regulation and seek public input on the continued need for the regulation or on possible changes.
According to the order signed on Friday, each federal agency’s Regulatory Reform Task Force shall evaluate existing regulations and make recommendations to the agency head regarding their repeal, replacement or modification, consistent with applicable law.
At a minimum, according to the order, each Regulatory Reform Task Force shall attempt to identify regulations that:
(i) eliminate jobs, or inhibit job creation;
(ii) are outdated, unnecessary, or ineffective;
(iii) impose costs that exceed benefits;
(iv) create a serious inconsistency or otherwise interfere with regulatory reform initiatives and policies;
(v) are inconsistent with the requirements of section 515 of the Treasury and General Government Appropriations Act, 2001 (44 U.S.C. 3516 note), or the guidance issued pursuant to that provision, in particular those regulations that rely in whole or in part on data, information, or methods that are not publicly available or that are insufficiently transparent to meet the standard for reproducibility; or
(vi) derive from or implement Executive Orders or other Presidential directives that have been subsequently rescinded or substantially modified.
Presidential Executive Order on Enforcing the Regulatory Reform Agenda
President Trump Remarks
Updated on 2/27/17 with comment from the White House.
Tags: regulations, Trump, FDA regulations, regulatory task force
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