Last week the FDA posted new guidance called “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act During the COVID-19 Public Health Emergency” that directly addresses everything I talked about in my last essay, “DSCSA Exemption For Public Health Emergencies” and more. This new guidance was “fast-tracked” and went direct to “final” status, skipping the “draft” stage used for most guidances. The FDA determined that the “…prior public participation for this guidance is not feasible or appropriate.” Things are moving fast at the FDA regarding Covid-19 so if you’re reading this essay more than a week or two after it is published, I suggest you search the FDA website to confirm that its contents are still fully valid. Make sure you check the links below for more info.
The new guidance covers some of the same territory that I covered in my earlier essay, showing how the Public Health Emergency (PHE) exemption built into the Drug Supply Chain Security Act (DSCSA) has been triggered by the Covid-19 declared PHE and what the implications are. As far as I can tell, there is only one difference between my interpretation of the situation, and the FDA’s. Of course, whenever your interpretation of the Food Drug and Cosmetics Act (FD&C) differs from that of the FDA, you lose. The FDA wins the disagreement, unless you want to try your luck in court, in which case, you’re probably going to lose, after you spend a fortune. I don’t need to do that and neither should you. But let me point out where we diverge.
It all comes down to the interpretation of the very first substantive clause in the very large Section 582, which is where the bulk of the DSCSA requirements are defined. The pertinent part of that clause reads:
“SEC. 582. REQUIREMENTS.
“(a) In General.–
“(1) Other activities.–Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in this section with respect to the role of such manufacturer, repackager, wholesale distributor, or dispenser in a transaction involving product. […]”
Let’s extract the following phrases:
“Each manufacturer, repackager, wholesale distributor, and dispenser shall comply with the requirements set forth in this section with respect to […] a transaction involving product.”
I take this to mean, the entire Section 582 applies to trading partners engaging in transactions involving product. Section 581 of the DSCSA defines many of the words used in that sentence and you should look them up. My previous essay covered the DSCSA definition of the word “transaction”, which includes an explicit exemption for products covered under a PHE declaration. The sale and distribution of those products are not considered to be “transactions”. That’s how I determine that the entire Section 582—including all of the parts that the FDA says in their new guidance are still in effect during a PHE—is exempted for the distribution of products that are covered by a PHE like this one. And that’s why I didn’t bother to talk about PHE exception in the definition of “wholesale distribution” in Section 503(e)(4)(C)—it’s not necessary for my argument to hold.
But I am just reading and interpreting the English used in the DSCSA. This is a good time to remind you that I’m not a lawyer and this is not legal advice. FDA is rightfully interpreting the intent and the practicality of operations under a PHE in the interest of public safety.
Here’s an example of how quickly things are happening. Since I posted my essay on April 20, not only has the FDA posted their guidance on the same topic, but they have also issued an Emergency Use Authorization (EUA) for Remdesivir “…to be distributed and used by licensed health care providers to treat adults and children hospitalized with severe COVID-19”. The earlier EUA was for hydroxychloroquine sulfate and chloroquine phosphate products donated to the Strategic National Stockpile (SNS) “…to be distributed and used for certain hospitalized patients with COVID-19.” For information about these and any future EUAs for Covid-19, see this page on the FDA website. That page also contains information about the EUA’s issued for many medical devices, including personal protective equipment (PPE), ventilators and the three types of tests related to Covid-19.
I hope you and your family are weathering the public health and economic emergencies in good shape. So far, we are here. I just bought a book about the great 1918 Flu Pandemic and the little I’ve read so far convinces me—as many scientist are predicting—that we will see a much bigger second wave of Covid-19 starting in September and continue through Election day, after which it will recede. Isn’t that timing prophetic? It will all be on its way out, right on Election Day 2020. That was the timing of the 1918 pandemic which peaked in late October and was pretty much gone in early December. The timing of the first wave this year was strikingly similar to the first wave that started in March of 1918. The sequence of events between the two episodes so far look too similar to think it will turn out differently (but I still have to finish the book).
Stay safe, and create a plan for September and November (mine starts around August 20). I think I’ll plan on getting my hair cut, my nails done, get a massage and a new tattoo…just before Christmas.