U.S. Representative Bill Foster (Illinois 11th) is working on the issue of speeding up vaccine approval. Along with former HHS secretary and current member of Congress Rep. Donna Shalala (Florida 27th), Foster is spearheading a letter signed by dozens of members of Congress to HHS Secretary Azar and FDA Commissioner Hahn asking them to consider using human challenge trials to speed up a vaccine. The letter, which is worth reading in its entirety, is here: https://foster.house.gov/hhs-fda.
I believe it is too late to add signatures at this point, but consider calling your representatives to alert this to this effort and to ask them to support it.
Dr. Theodore Bailey of Greater Baltimore Medical Center and I argue in a Washington Post opinion piece published today that one way the law can help end the pandemic is by speeding up the vaccine approval process at the FDA.
I co-authored a short paper about the law and the coronavirus pandemic with Dr. Theodore C. Bailey, who is chief of infectious disease at Greater Baltimore Medical Center. It is forthcoming in the Stanford Law Review Online. The pre-print is available now on SSRN.
Here is the abstract:
“The course of a pandemic is dictated not just by biology, but also by law. And crucially, unlike biology, law can be readily adapted in response to a pandemic. Unfortunately, the current law does not take account of the compressed timeframe and rapidly changing social needs that distinguish pandemic times from normal times. We thus suggest three urgent, early lessons for law in the pandemic context: First, free information flows save lives, an observation which has ramifications for freedom of speech and press, copyright law, and patent law. Identifying particular hazards that patent law poses to the free flow of scientific research findings, we suggest a government-funded reward system as an adjunct to the patent system to incentivize pandemic-relevant research and its rapid publication. Second, politically accountable decisionmakers may not act optimally to save lives. We suggest a refashioned, politically insulated U.S. Public Health Service imbued with administrative independence in the vein of the Federal Reserve Board. Third, pre-crisis regulatory structures are not proving nimble enough in the midst of the pandemic. We suggest legislation that directs the FDA to be creative in designing case-by-case approval procedures for vaccines and other treatments to allow them to get to market much faster. To accelerate approvals while retaining scientific rigor, we suggest allowing well-informed, consenting human testing subjects to take on more uncertain risk than the FDA currently tolerates. In sum, we argue for a more general, systematic, and critical perspective on law in the special context of a pandemic.”
by Eric E. Johnson