In May of 2017, the Regulatory Accountability Act passed through the committee phase in the United States Senate. The aim of this act is to minimize federal regulations in health and medicine, among other areas, thereby reducing regulatory requirements.
A report published in the New England Journal of Medicine notes that the bill “would pursue its deregulatory aims by imposing onerous requirements on rulemaking, which we believe could have potentially disastrous consequences for the Food and Drug Administration (FDA) and other agencies that protect public health and safety.”
The new bill increases the number of requirements for rulemaking and allows the application of a “gag rule” that prevents health and medical agencies from describing how new regulations could be beneficial. In addition, the bill would also enable other regulated businesses and organizations to intervene with new rulemaking, which could delay implementation of agency regulations.
Individuals and organizations are allowed to petition an agency to perform a hearing for either “major” or “high-impact” rules. Each respective rule category is defined as any changes that translate into economic effects of ≥$100 million or $1 billion per year. Considering that many health regulations would fall under either of these 2 categories, the medical industry is at a substantial risk for delayed regulation changes.
Those opposed to the bill claim that this new legislation will make regulation changes a time-consuming and economically inefficient process for agencies needing to modify existing rules or make new ones. In turn, this may translate into delayed responses to emerging health threats and prohibit the ability of many health agencies to respond to new scientific research.
“If the proposed law slows or prevents the enactment of important public health and safety protections, its costs may be high, difficult to measure, and borne by the country’s most vulnerable populations,” the authors concluded.
Darrow JJ, Fuse Brown EC, Kesselheim AS. The Regulatory Accountability Act of 2017 – implications for FDA regulation and public health. N Engl J Med. 2018;378(5):412-414.