• Melita Ball

July 16, 2020 Blog Post

FDA Warning Letters

A Change is in the Air


If you haven’t looked at the FDA Warning Letter list lately, you may not know that there are some significant changes in what the FDA is focused on.  Since the beginning of March 2020,

the FDA has posted 95 Warning Letters and sent countless Untitled Letters to companies for violations relating to the severe acute respiratory syndrome Coronavirus 2 or SARS-CoV-2.


Now that we have a sizable number of them to analyze, I’m going to break down the changes I see and how those changes may be impactful to Life Sciences even after the pandemic is over. 


First, it is clear that a collaborative Task Force has been formed with a number of divisions within the FDA but also with a number of external entities that usually stay in their individual lanes.  The COVID-19 Warning Letters are littered with citations from the following divisions within the agency:

  • Center for Devices & Radiological Health (CDRH),

  • Center for Drug Evaluation and Research (CDER),

  • Center for Biologics Evaluation and Research (CBER),

  • Center for Food Safety and Applied Nutrition (CFSAN), and

  • Office of Biological Products Operations


Additionally, these Warning Letters either contain citations from external entities or point to additional citations from those external entities.  As if the FDA doesn’t carry a big enough stick, the Federal Trade Commission (FTC) and the United States Postal Inspection Service (USPIS) are also part of the massive effort to aggressively thwart companies trying to profit from the pandemic by making claims that their products can mitigate, prevent, treat, diagnose, or cure COVID-19.


Second, these Warning Letters have an extremely narrow window to respond.  Most Warning Letters have a standard 15-day window for the recipient to respond in writing to the FDA.  In contrast, the COVID-19 Warning Letters require a 48-hour rapid response to the FDA via a special task force email address.  This is likely because the mandates are fairly straight forward and simple to implement quickly but also due to the severity of these violations …

“take immediate action to correct the violations”

AND

“review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved (or cleared) by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act.”


Third, the speed with which the FDA is turning these Warning Letters around is pretty remarkable given their typical track record of 3-6 months from “Letter Issue Date” to “Posted Date” on the Website.  The COVID-19 Warning Letter posting dates can be measured in days rather than months.  Efficiency has not traditionally been a strong point for the FDA.  Could this be a new trend?


Last but certainly not least is the predominance of small companies in the list that appear to have been flying under the FDA’s radar for years.  Most of the companies are not brand new.  They’ve been marketing and selling products for years making some pretty outrageous claims of health benefits.  The mistake of slapping a COVID-19 claim in their sales literature or on their website has brought them into clear focus of the FDA.  From my analysis, a number of these companies have been in violation of the FD&C Act for a long time before they made a COVID-19 claim. 


It’s not a giant leap to expect the FDA to circle back to these companies in the future even if they comply and remove all claims related to COVID-19 now.  Those that have a mandate to recall all the products that they’ve sold will most likely go out of business when they realize the enormous costs associated with large recall efforts and refunding money consumers spent on products. 


I’m sure I’m not the only one asking how these companies managed to sell massive numbers of products for years without getting caught.  It’s not unreasonable if you know how the FDA typically provides oversight.  The FDA expects companies to largely self-regulate and do what the law mandates.  They traditionally deploy their limited resources to inspect facilities that are Registered and Listed with the FDA.  The problem is that most (if not all) of these companies have never been Registered or Listed with the FDA. 


The grounding of FDA inspectors during this pandemic has created a massive group of highly skilled and trained FDA inspectors that have now been deployed to virtually inspect

publicly-available information for violations.  In the process, they have shed a spotlight on a previous blind spot and uncovered a huge problem that has gone unchecked for far too long.  I expect that the FDA will not simply go back to business as usual once the pandemic is behind us.  I think Life Sciences companies can generally expect heightened scrutiny of any publicly-available information, advertising, and marketing efforts in the future. As always, thanks for reading!  Stay safe and be well!

Thoughts? Please comment below …

Cheers!


Melita Ball

CEO and Principal Consultant



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