Earlier this year, President Trump signed two executive orders aimed at slashing the number of federal regulations businesses in the US have to adhere to. Trump has claimed that such an effort is necessary as US businesses, across all industries, are currently unnecessarily burdened by regulations that are often outdated or redundant.
In line with this, the FDA is now seeking comments on which existing regulations the agency can modify, repeal, or replace. The FDA has said it is willing to work towards regulatory reform in order to reduce the burden on industry, as long as such efforts do not limit the agency’s ability to protect public health.
The FDA is interested in receiving comments on any and all regulations concerning researchers, drug manufacturers, health care institutions, patients and caregivers, public interest organizations, trade associations, academia, and local and state governments.
The comments will be used to guide the FDA’s initial review and help answer the following questions about current regulations:
- Is the regulation outdated or unnecessary in some way?
- Is there evidence to suggest regulated entities have had difficulties complying with the regulation
- Are the regulation requirements already covered in voluntary or consensus standards or guidance from third party organizations such as the International Council for Harmonisation, International Organization for Standardization, Codex Alimentarius?
- Does the regulation include redundant or unnecessary record retention requirements e.g. reporting, recordkeeping, or labeling requirements?
- Can the intended outcome of the regulation be achieved through less costly means without compromising the current level of public health protection?
The FDA also is open to receiving general input on other factors that should be considered when selecting regulations to do away with or reform.
However, although the FDA is now starting the review process, the agency’s deputy commissioner for policy, planning, legislation and analysis, Anna Abram, has claimed in an FDA blog post that there is “a lot of ground to cover”. The agency’s regulations currently comprise more than 4,000 pages in the Code of Federal Regulations. As such, it will most likely be some time before we see any concrete changes being made.