The United States Food and Drug Administration has taken a beating in recent months over its role in the country’s efforts to combat the COVID-19 virus. The concerns have been focused on two basic areas:
- Delays in approving tests for use in diagnosing the virus and for determining whether individuals have produced antibodies to the virus; and,
- Confusion about the safety and efficacy of drugs like chloroquine and hydroxychloroquine touted as potential treatments for the virus.
Full disclosure time: I am ex-FDA. I spent nearly a decade with the agency, working in the Center for Drug Evaluation and Research (CDER) as a chemistry reviewer and team leader. At the same time, I recognize from my own experience, that FDA is not designed to be nimble or to make fast decisions. The whole history of FDA is a long series of reactions to public health disasters, after the fact.
The modern era of the FDA was created in 1906 through the passing of the Federal Food and Drugs Act. This was largely a reaction to the public outcry following publication of Upton Sinclair’s book, The Jungle—an exposé revealing the abominable conditions in the American meatpacking industry. The 1906 act was strengthened by further Congressional action in 1938 as a result of disasters such as Elixir Sulfanilamide (the poorly soluble drug was formulated in ethylene glycol, which is poisonous, and resulted in a number of deaths). Modern FDA regulations followed the thalidomide problem in which a drug given to pregnant women resulted in serious birth defects. Simply put, FDA has a history and a basis in law that causes it to be reactive rather than proactive.
And yet, if you follow the FDA as I do, you will have seen almost daily bulletins showing the agency’s flexibility in everything from how clinical trials are conducted and records kept in an era of social distancing, to temporary use of portable cryogenic containers not in regulatory compliance.1 FDA has even created a Coronavirus Treatment Acceleration Program (CTAP), which is intended to use “every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful or harmful.”2
The same thing is true for medical devices. “On February 4, 2020, the Secretary of Health and Human Services (HHS) determined that there is a public health emergency and that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of the novel coronavirus.”3
So, what does this mean for you? How do these changes, special programs, and new flexibility at FDA have an impact on your development program? Do you have a product, whether device or drug, that needs to get to patients as fast as possible to help in this crisis? We keep track of the changes at FDA, which are coming daily. And we have years of practice in finding ways to make things work with them.
In an effort to advance the life science community’s response to the pandemic, Pearl Pathways is offering two free consulting hours to companies developing diagnostics, drugs, or devices intended to diagnose or treat patients with COVID-19. These free consulting hours also apply to researchers who are conducting studies to better understand the virus. Contact Pearl Pathways today to schedule your free consultation.
1 FDA Code of Federal Regulations’ 21 CFR 211.94(e)(1) for oxygen and nitrogen during the COVID-19 Public Health Emergency – https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-temporary-use-portable-cryogenic-containers-not-compliance-21-cfr-21194e1-oxygen-and-nitrogen
2 Coronavirus Treatment Acceleration Program (CTAP) – https://www.fda.gov/drugs/coronavirus-covid-19-drugs/coronavirus-treatment-acceleration-program-ctap
3 Medical Devices and the COVID-19 (Coronavirus) Pandemic – https://www.fda.gov/medical-devices/emergency-situations-medical-devices/medical-devices-and-covid-19-coronavirus-pandemic