Issues Seen in Regulatory Accountability Act
Healthcare and legal researchers at Harvard Medical School and the Georgia State University College of Law say the proposed Regulatory Accountability Act of 2017 “could have potentially disastrous consequences for FDA and other agencies that protect public health.” Writing in the New England Journal of Medicine, the authors say (subscription required) the legislation, which is touted as a way to reverse the increasing volume of regulations that are said to stifle economic growth, cost jobs, and put the U.S. at an economic disadvantage, would substantially revise the 1946 Administrative Procedures Act, a foundational law that set ground rules for federal agency regulation.
The bill, the authors say, would increase procedural requirements for rulemaking, impose a “gag rule” prohibiting agencies from explaining how new regulations are beneficial, and greatly expand the extent to which regulated businesses or other interested parties could intervene in the rulemaking process, increasing the potential for substantial delay and dissuading agency action.
The bill, they say, would “breathe new life into ‘formal rulemaking,’ an expensive and cumbersome trial-like procedure” that has rarely been used since the 1970s when the Administrative Conference of the United States found that FDA use of formal rulemaking “has worked poorly” and “emphatically” recommended that trial-type procedures never be used to develop rules of general applicability.
“The key components of the Regulatory Accountability Act are based on the premise that agency rules impose unjustifiable costs on industries and the economy,” the article concludes. “But industries benefit when regulations are clear, current, and certain…. Although proponents argue that the Regulatory Accountability Act will minimize unnecessary regulatory burdens that harm the economy, we fear it could have the opposite effect. The act would hamper efforts to deregulate as well as regulate, thereby ossifying existing rules. Furthermore, many regulations are not unnecessarily burdensome, and the proposed law would increase uncertainty for the healthcare industry and diminish agencies’ ability to protect public health. If the proposed law slows or prevents the enactment of important public health and safety precautions, the costs may be high, difficult to measure, and borne by the country’s most vulnerable populations.”