Regulation ‘Trade-in’ Order Could Impact Cures Act: Attorneys
Three Arent Fox attorneys say that a Trump administration executive order requiring agencies to identify two existing regulations to be repealed for every new regulation they propose could cause delays in FDA efforts to implement provisions of the 21st Century Cures Act. Writing in an online blog post, the attorneys say that given FDA’s mission to protect the public health, the order may force it to propose repeal of regulations that it believes protect the public health to be able to institute other new regulations to protect the public health. And, they say, because the order provides that any cost associated with a new regulation should, to the extent permitted by law, be offset by elimination of costs associated with at least two prior regulations, FDA will have to consider not only the public health impact of the current regulations but also their economic impact.
“In addition to the potential for repealing rules with significant public health benefit, this new paradigm is also expected to cause delay in the issuance of new regulations due to the requirement to identify and presumably propose the repeal of two current regulations,” the post says. “Moreover, if after public comment the agency decides it is not in the interest of the public health to finalize the repeal of one or both of the current regulations, this could delay the finalization of the proposed new regulation even further. This may be particularly relevant when it comes to FDA’s statutory obligations, like those imposed by the recently enacted 21st Century Cures Act. In an effort to accelerate the drug and device approval process, the Cures Act, among other things, directs FDA to develop new pathways to approve medical devices and to evaluate biomarkers and other drug development tools. Requiring FDA to ‘trade in’ existing regulations and guidance documents to implement the Cures Act is likely to cause delay in the agency’s implementation.”
The attorneys also note that FDA is frequently criticized for issuing rulemaking through guidance documents and the Trump executive order’s definition appears to include guidance documents. “Many stakeholders have taken the public position that the agency tends to go beyond communicating recommendations in guidance documents and in fact asserts additional authority and expectations that are enforced,” they write. “Against this backdrop, FDA will not be able to retreat to issuing guidance documents in lieu of regulations when instituting policy.”
Given the expected delays in federal rulemaking, the post concludes, state governments may fill the void by issuing their own conditions for marketing FDA-regulated products that will not necessarily coincide with other states and can therefore create varying requirements across jurisdictions.