FDA biologics center director Peter Marks thanked seven former FDA chiefs for their recent op-ed in which they voice concern about the negative effects that political interference from the White House could have on the public confidence in a COVID-19 vaccine, and in the FDA itself.
Marks said that the public conversation surrounding COVID-19 vaccines is vital.
“Our ability to have this public process is very important because at the end of the day we need people to have trust in us and that’s why I’m very thankful to [Mark McClellan], and the other six commissioners who have put together at this editorial support,” Marks said during the Friends of Cancer Research’s 24th Annual Cancer Leadership Virtual Reception on Tuesday evening (Sept. 29).
Marks added that the most important thing he can do is to help generate and regain trust in vaccines.
“Vaccines have saved public health previously; they will save it again,” Marks said.
In their Tuesday Washington Post op-ed, former FDA chiefs Robert Califf, Scott Gottlieb, Margaret Hamburg, Jane Henney, David Kessler, Mark McClellan and Andy von Eschenbach say the Trump administration’s recent actions to control or undermine FDA’s decisions have negatively affected the way the public perceives the agency.
They point to Trump’s attempts to delay release of FDA’s guidance laying out stricter vaccine EUA criteria, as well as HHS’ move to deregulate laboratory-developed tests, saying such actions erode public confidence in FDA and risk the agency’s ability to make independent decisions based on science.
The lack of public trust in FDA could have dire consequences, the former FDA chiefs write, as recent surveys have found fewer people would be willing to take a COVID-19 vaccine due to safety concerns.
“Political intrusion only prolongs the pandemic and erodes our public health institutions,”
the op-ed says.
Despite concerns about political interference, the former FDA heads say they’re confident about the agency’s ability to independently authorize a vaccine based on clinical results. They add that FDA has already relayed its strict EUA-plus standards to industry, despite Trump’s comments.
FDA chief Stephen Hahn also reassured those tuning into the Friends of Cancer Research event that the FDA is committed to basing decisions on science and data, and not on politics.
“We continue to work with many different drug manufacturers and to provide guidance and technical assistance to help expedite the very necessary clinical trials for the development of a vaccine, and we continue our commitment to speeding the development of a vaccine,” Hahn said. “I want to assure you that we will not cut corners and any decisions that we make regarding the quality, safety, or efficacy of a vaccine.” — Kelly Lienhard (klienhard@iwpnews.com)
https://insidehealthpolicy.com/daily-news/marks-thanks-former-fda-chief…
