Blackletter

Blackletter

Blackletter laws are the well-established legal rules that are no longer subject to reasonable dispute. Originally, "blackletter" was the Gothic type-style which was used to set forth the law in England until the mid 18th century. It was originally used so commoners couldn't understand the laws. Every business is subject to so-called blackletter laws. This podcast brings famously experienced business people, lawyers, accountants, and anyone else in the realm of business to the table to share personal experiences that have shaped their business and to talk about how to handle black letter issues in creative ways.... Show More
June 22, 2020 3 min

Today, we're going to talk about legal issues in the COVID-19 vaccine development arena. A big challenge from a legal perspective is how can these companies get the vaccine to us?

Typically when you're developing a new vaccine or anything for use inside of a human being, the FDA under the FD and C Act, the Federal Food, Drug and Cosmetics act, and the Public Health Service Act regulates the development of vaccines and anything that gets injected into your body. And there's a good reason for that and typically it takes a long time. These companies have to go through a series of clinical trials and they have to produce results to the FDA and the FDA has to come back, but there is a provision of the FD and C Act called an EUA, Emergency Use Authorization, and let's see if this happens.

For the FDA to issue this EUA, which basically allows temporarily the use of an unapproved product, or an approved product for unapproved uses, the FDA has to go through the secretary of Health and Human Services. And the secretary of Health and Human Services have to first determine that there's a qualifying emergency caused by biological, chemical, radiological or nuclear. And here we've got, I think number one, biological emergency, COVID clearly. Two, the secretary of Health and Human Services has to find out that this agent can cause serious life threatening disease and the secretary then has to determine that for each product it's reasonable to believe that based on the totality of all the evidence available, that the product can treat or prevent the disease caused by this agent, in this case COVID, and that the known potential benefits outweigh the risk.

Finally, that there are no other adequate and approved alternatives. So, in short, if COVID-19 is a biological qualifying emergency and the secretary of Health and Human Services finds that a company has produced something that it reasonably believes can help people, then it can issue this Emergency Use Authorization and we will get our vaccine.

Let's wait and see what companies come up with, and the FDA comes up with. Hopefully they come up with it quickly.

For more information check out this blog: https://www.dbllawyers.com/covid-19-progress-pfizer-inc-s-u-s-trials-for-coronavirus-vaccine/

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