Kerry Dooley Young, Medscape: January 15, 2021
The Trump administration is making attempts in its final days to weaken regulation of medical products, say watchdog groups.
The Department of Health and Human Services (HHS) on January 11 unveiled two proposals meant to change the policies of the US Food and Drug Administration (FDA).
One seeks to build on emergency exemptions FDA allowed last year as part of its initial response to the COVID-19 pandemic. Released as a formal notice, this policy intends to immediately exempt seven devices — all medical gloves — from the FDA’s premarket notification requirement. It also proposes to exempt an additional 84 devices, including home-use ventilators and electrocardiograph software for over-the-counter use.
The second Trump administration proposal would add another mandate for the FDA to report on timelines for drug approvals. The agency already posts annual reports, for example, on its website detailing median times for approvals. The new HHS policy tells the FDA to post on its website more information on approved applications for new and generic drugs.
Both new policies were put forward by HHS Secretary Alex Azar, and not by FDA Commissioner Stephen M. Hahn, MD. HHS told Medscape Medical News that the FDA was notified before the announcement.
But policy experts who have long studied the workings of the FDA see this as a deliberate slight to the regulatory agency, which the Trump administration has tussled with over clearances for COVID-19 treatments and vaccines.
Diana Zuckerman, PhD, president of the nonprofit National Center for Health Research, described the medical device proposal as “obviously a last-ditch effort by the Trump administration to ignore the scientific expertise of FDA staff and decision-makers in ways that some companies will appreciate but will put millions of patients and consumers at risk.”
“It is particularly disturbing that the administration is taking advantage of the COVID-19 pandemic to expand emergency measures and make those measures permanent, despite the risks to public health,” Zuckerman said in an email exchange with Medscape Medical News.
Zuckerman said her group would be working with the Biden administration to reverse this policy. The nonprofit groups Public Citizen and the Center for Science in the Public Interest are also objecting to the policy.
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