Earlier this year, in an effort to alleviate unnecessary regulatory burdens, President Trump issued two executive orders, Executive Order 13771, Reducing Regulatory and Controlling Regulatory Costs and Executive Order 13777, Enforcing the Regulatory Reform Agenda. On September 8, 2017, FDA published several notices in the Federal Register, to implement these orders, soliciting comments from the public on ways to modify the agency’s current regulations, while still meeting both the Agency’s public health mission and statutory obligations. Questions FDA hopes the public will consider include:
- Have advancements and innovations in science or changes in the law resulted in outdated or unnecessary regulations?
- Are regulations duplicative of FDA or other agency requirements or voluntary or consensus standards from third party organizations?
- Do regulated entities find compliance with any regulations particularly difficult, and if so, how?
- Do any regulations require an unnecessary amount of recordkeeping and reporting?
- Can goals be achieved through less costly means, while still protecting public health?
- How should FDA prioritize regulations for reform?
FDA has indicated that comments may address considerations beyond the list of questions provided, but that all comments should be as specific as possible, include supporting data or information, and be submitted in the format provided for in the notice.
Yesterday, Deputy Commissioner Anna Abram posted a statement explaining the purpose of the exercise. She stated that “science will remain FDA’s North Star when it comes to our role in devising regulatory policy.” She identified several possible areas of focus, including regulations that “may not adequately reflect advances in science, technology or changes in industry practice.” She also highlighted, as an example, “places where FDA’s rules concerning new drugs are being used in ways that may create obstacles to the timely entry of generic competition.”
Comments are due by December 7, 2017. The agency published seven virtually identical notices—one for each Center and one general notice. The Federal Register Notice for the Center for Drug Evaluation and Research can be accessed here, and the one for the Center for Biologics Evaluation and Research is here.
If you have any questions about these notices or are considering submitting comments, please contact one of the authors of this alert or the Hogan Lovells attorney with whom you regularly work.