Perspective: Regulatory Bill Could be Dangerous for FDA, Public Health

Regulatory NewsRegulatory News | 21 December 2017 |  By 

A bill making its way through Congress could end up having "potentially disastrous consequences" for the US Food and Drug Administration (FDA) and public health, professors from the Program on Regulation, Therapeutics, and Law at Harvard Medical School and the Georgia State University College of Law, wrote in the New England Journal of Medicine this week.

The bill, known as the Regulatory Accountability Act, has been promoted as a way to decrease burdensome regulatory requirements that have hamstrung a number of industries.

But if enacted, the bill could end up increasing procedural requirements for rulemakings, prohibit agencies from explaining how new regulations are beneficial and expand the extent to which businesses could intervene in rulemakings, "thereby creating the potential for substantial delay and dissuading agency action," the authors of the NEJM perspective write.

The bill also would make new rulemakings or modifications to existing rulemakings "time-consuming, difficult, and costly for agencies," raising the risk for outdated regulations to be locked in, they write.

"We noticed this bill earlier this year and it had been gaining some steam, which is why we thought to focus on it," Aaron Kesselheim, one of the authors of the NEJM perspective, told Focus. "As opposed to specific regulations, this bill is more about changing the way all regulations get made, so we thought that this was a particularly dangerous proposal."

And the bill may also push FDA to regulate more with guidance documents, which has already been a concern raised by congressional committees in hearings with FDA officials.

"If this law, or some close facsimile of it, passes, then I think it would lead to more informal guidance," Kesselheim added.

The bill’s movement and the NEJM perspective also follow pledges made by President Donald Trump to gut FDA regulations, though the agency has yet to take a saw to its regulations, and FDA Commissioner Scott Gottlieb seemed to walk back Trump's pledge with recent comments at the National Press Club on how many of FDA’s regulations are public health-related and generally deregulatory in nature.

NEJM Perspective


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