FDA: All Regs Half Off!


 

The FDA asked for help last week on some housecleaning it must do under President Donald Trump’s regulatory agenda.

The agency issued notices in the Federal Register seeking suggestions on what regulations it could cut or replace to comply with Trump’s January executive order on reducing regulations and controlling regulatory costs.

Trump’s plan is a two-for-one special: Every time an agency proposes or issues a new regulation, it must identify at least two existing ones to be repealed. And the costs new regulations will impose must be fully offset by the costs of the regulations being cut.

The FDA’s notices asked the public for advice on identifying drug, medical device, and biologics regulations it could target, as well as regulations in all other areas. The agency says it wants comments on which ones are outdated, unnecessary, or overly burdensome.

The administration’s mandate isn’t a burden on the agency, according to Anna Abram, the FDA’s deputy commissioner for policy, planning, legislation, and analysis. She painted the effort in a positive light, noting in a blog post the agency is over 100 years old, and its regulations need updating.

“Some have been in place for decades, and may not reflect the most up-to-date approach to achieving our public health mission,” she wrote. She said existing rules may hinder generic drug competition, for example.

Public interest groups like Public Citizen are skeptical. A similar review took place under the Obama administration, Public Citizen regulatory policy advocate Amit Narang said, leaving effective regulations on the chopping block.

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