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With politics swirling around a vaccine approval, the FDA and drugmakers have been putting in (some) safeguards to make sure a potential vaccine gets reviewed based on solid safety and efficacy data: https://www.bloomberg.com/news/articles/2020-09-08/will-a-vaccine-be-politicized-fda-sets-up-safeguards?sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
What FDA is doing behind the scenes, @annaedney @langreth + I report:
-Sticking to June guidelines on what it will take for a vaccine to get through, whether under a BLA or EUA
-Making clear to the White House and HHS the public health value of process perceived as non-political
-Sticking to June guidelines on what it will take for a vaccine to get through, whether under a BLA or EUA
-Making clear to the White House and HHS the public health value of process perceived as non-political
Telling FDA staff + department heds to ignore the noise from outside the agency and focus on the science: https://www.bloomberg.com/news/articles/2020-09-08/will-a-vaccine-be-politicized-fda-sets-up-safeguards?sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
A mini-scooplet buried in the story -- the FDA plans to soon set up up more or less weekly placeholder sessions, starting in October and going through December, in case data comes in (in addition to the 10/22 adcomm): https://www.bloomberg.com/news/articles/2020-09-08/will-a-vaccine-be-politicized-fda-sets-up-safeguards?sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
All of this is happening at the same time the pharma industry is trying to do the same thing -- with their Bland But Kind of Unprecedented joint pledge: https://www.bloomberg.com/news/articles/2020-09-08/drugmakers-join-to-pledge-no-safety-shortcuts-for-covid-vaccine?srnd=premium&sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
The language here is pretty eh -- BUT the motive behind it is not. The drug industry in the U.S. benefits from a MASSIVE reputational halo because of a strong FDA. It is more important than drug pricing, 340B, duals, etc etc etc. https://www.bloomberg.com/news/articles/2020-09-08/drugmakers-join-to-pledge-no-safety-shortcuts-for-covid-vaccine?srnd=premium&sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
I can& #39;t emphasize that enough. *The* most important thing drug and biotech companies have is patient trust that their products are as safe/effective as they say they are. That is because of the FDA. Without it, the industry is in a very, very different place.
The damage done to the industry -- well beyond this vaccine -- of an FDA that half the country thinks can& #39;t be trusted is enormous, and worth defending quite ferociously. https://www.bloomberg.com/news/articles/2020-09-08/will-a-vaccine-be-politicized-fda-sets-up-safeguards?sref=leQ3i2ya">https://www.bloomberg.com/news/arti...
Want a counter-example? Look at China& #39;s domestic drug industry a decade ago. Anyone who could afford to buy products from the Western multinationals did. China started a campaign to build its own industry and shove out the legacy actors that has been years in the making.
