Improving FDA's COVID-19 vaccine authorization and approval process:
Lessons from hydroxychloroquine

Date:
August 31, 2020
Source:
Dartmouth College
Summary:
In a new article, researchers propose reforms that the U.S. Food and
Drug Administration (FDA) could implement to improve the emergency
use authorization process and drug approvals during public health
crises, which could increase the FDA's credibility and the public's
trust in it.



FULL STORY ==========================================================================
On March 28, the Food and Drug Administration (FDA) exercised its
Emergency Use Authorization (EUA) authority to allow the use of hydroxychloroquine for the treatment of COVID-19. On June 15, after a
number of studies failed to find positive effects, the agency revoked this authorization. This chain of events raises questions about the speed,
rigor and potential politicization of the authorization process. These
actions also may have hurt the FDA's credibility and the public's trust in
the agency, which could decrease the public's confidence in and adoption
of eventual COVID-19 vaccines.


==========================================================================
In a Viewpoint piece published in JAMA: The Journal of the American
Medical Association, a research team proposes reforms that the FDA could implement to improve the emergency use authorization process and drug
approvals during public health crises, which could increase the FDA's credibility and the public's trust in it.

The recommendations are especially timely given that FDA Commissioner
Stephen Hahn has stated that the agency will consider using the EUA
process to authorize a COVID-19 vaccine, as well as the potential for
full approval of COVID-19 vaccines in late 2020.

The FDA is "responsible for protecting public health," which includes
ensuring that drugs are safe and effective. "The FDA entered highly
unchartered territory when it came to the approval and revocation of hydroxychloroquine for COVID-19, as emergency use authorizations have
typically been used for diagnostics and only rarely for therapeutics," explained co-author Herschel Nachlis, a research assistant professor
of government and policy fellow in the Nelson A. Rockefeller Center
for Public Policy and the Social Sciences at Dartmouth. "Through this
piece in JAMA, we provide recommendations to help the agency make the authorization process more robust, rigorous and transparent in this
pandemic environment," he added.

To improve the accountability and transparency of drug authorizations
and approvals, the researchers propose four reforms:
* The FDA could clarify evidentiary standards for EUAs and could
create
higher standards for widely used products like vaccines.

* The FDA could consult with the external experts on its Advisory
Committees before issuing EUAs. The committee meetings could
be live- streamed and more opportunities for public input could
be established.

* Once COVID-19 vaccines are granted marketing authorization, the
FDA could
establish extensive adverse event reporting systems, facilitate
phase 4 trials to monitor post-approval safety and efficacy,
and engage the National Vaccine Injury Compensation Program.

* As part of the FDA's ongoing efforts to enhance public communication
about COVID-19 diagnostics, therapeutics and vaccines, the FDA
could launch public education campaigns and utilize communication
tools like drug facts boxes to help explain regulatory decisions.

"The FDA's regulatory processes are often considered the gold standard
for the approval of drugs, and are fundamental to American and global
public health," said Nachlis. "Our entire pharmaceutical and healthcare
system depends on this standard. Maintaining credibility and public
trust is integral to the FDA's ability to fulfill its mission. Now is
the time for the FDA to consider ways to enhance its public support,
as our nation and the world waits for effective vaccines to be quickly
and safely developed, approved and deployed," he added.


========================================================================== Story Source: Materials provided by Dartmouth_College. Note: Content
may be edited for style and length.


========================================================================== Journal Reference:
1. Kyle Thomson, Herschel Nachlis. Emergency Use Authorizations
During the
COVID-19 Pandemic. JAMA, 2020; DOI: 10.1001/jama.2020.16253 ==========================================================================

Link to news story: https://www.sciencedaily.com/releases/2020/08/200831160804.htm

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