COVID Law Briefing: Drug Development, the Role of the FDA, and Emergency Use- Summary

Earlier this year, Public Health Law Watch, in collaboration with members of the George Consortium and other partner organizations, hosted a series of legal briefings related to COVID-19 and legal and policy issues associated with the global pandemic. Experts and scholars joined us for bi-weekly livestreamed discussions on these issues. We invite you to read the summaries of selected episodes below! And, enjoy relistening to the series (linked below and archived on our #COVIDLawBriefing webpage).

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4/15/20: Drug Development, the Role of the FDA, and Emergency Use

Mod: Nicolas Terry 

Speaker: Patricia Zettler, Michael Sinha 

In this #COVIDLawBrief, Dr. Sinha and Professor Zettler are guest speakers on a panel discussing the development of new drugs during this crisis. With the Trump administration providing so much uncertainty about the viability of different “cures” it can be unclear how drug development is coming along. The short of it is that no drugs have gone through the vigorous clinical trials needed to be approved. Furthermore, Dr Sinha speculated that we are likely still a year or two away from developing a vaccine which is a crucial goal of these studies. As of the time this podcast was published, (April 15th, 2020) 3 experimental drugs had moved to the human testing phase. While there has been sentiment that we should be trying every drug and vaccine as fast as possible to find a cure, the experts were against this philosophy. Due to the massive amount of people who will take an eventual vaccine, Dr Sinha stressed the importance of “getting it right” as the risk of giving out a vaccine that had not been properly tested is simply too high. The FDA has been in the forefront of testing drugs. Their diligent testing process was lauded by the professors as once again, it is important to get the vaccine right. Beyond making the drugs, prescriptions are also a key issue. With data changing by the day it is important to not prescribe remedies that have not been tested yet in the hope that they could work. This extends up to Washington, where the President has talked about cures to COVID-19, which instead have been lethal. In fact, the best action policy makers can take is not to push forward a “quick fix,” but rather to continue to hold pharmaceutical companies accountable to high standards. 

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Public Health Law Watch’s COVID Law Briefings are co-sponsored by the Center for Health Policy and Law at Northeastern University School of Law, the Center for Public Health Law Research at Temple University Beasley School of Law, the Network for Public Health Law, and the APHA Law Section.