FDA Provides Guidance on DSCSA Exemptions for Covid-19 PHE

FDA explains EUAs under a PHE

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.

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DSCSA Exemption For Public Health Emergencies

On March 10, 2020, Alex M. Azar II, Secretary of Health and Human Services of the US government, declared a public health emergency (PHE) under Section 319F of the Public Health Service Act “…to provide liability immunity for activities related to medical countermeasures against COVID-19.”  This action immediately opened an exemption embedded in the Drug Supply Chain Security Act (DSCSA) for the “covered persons” performing the “covered countermeasures” aimed at the specific “threat” in the covered “geographic area”, for the identified “population” for the “effective time period” specifically identified in the declaration. 

This is only the second public health emergency with nationwide scale announced in at least the last 20 years.  The first was for the opioid crisis.  The intent of these declarations is to lower the liability exposure to companies helping to create, distribute and administer countermeasures aimed at ending the emergency.  Let’s take a closer look at the effect of the Covid-19 PHE on the DSCSA and companies in the US pharma supply chain.

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Sponsored: 2021 UDI Conference Has Been Rescheduled

This event has been rescheduled to April 12-13, 2021.

Calling all medical device manufacturers, distributors, GPO’s, Providers, and healthcare industry stakeholders to make plans now to be in Baltimore in ???! The 12th annual UDI Conference continues to be the platform for you to stay informed about the latest developments in UDI implementation, enabling technology, regulatory updates, Provider momentum, and Global expansion.

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ACTION REQUIRED: RxTrace Subscriber Update

To tell which type of notification email you are receiving, check the bottom line for the text “Email subscriptions powered by FeedBlitz. If you don’t see it, you are probably receiving the new WordPress notification emails. If you are confused, contact me.

Changes are coming to the way you connect with RxTrace.  Next month RxTrace will return to being free to everyone and open to all.  For the last year, all paid subscriptions have been pro-rated to end in March 2020.  As part of that approaching transition I will switch back to an email notification system that I used between 2010 and 2012.  It’s less configurable and less controllable…but it’s a free service!  What that means is, if you are currently receiving “Feedblitz” email notifications whenever new RxTrace essays are posted—whether on a paid or FREE subscriptionyou will need to “re-subscribe” to the “Wordpress” email notifications to continue receiving notices. Here’s how.

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WHO Publishes Draft Policy Brief for Medicines Traceability Regulations

Late last month the World Health Organization (WHO) published a draft “policy brief” for comments by February 28, 2020.  The draft is aimed at regulators of medicines around the world who might be considering the development of new medicines traceability mandates.  That pool of countries shrinks each year as more and more new mandates are announced, but considering the wide variations in the quality of the existing regulations, guidance aimed at those who would create new mandates is welcome.  Let’s take a look at the draft.

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What Happens To The FMD In the UK After Brexit Day? Seriously, Does Anyone Know?

Friday was “Brexit Day” in the United Kingdom—the last day the UK was a full member of the European Union.  At 11pm London time, the UK entered an 11 month “transition period” that will lead to the full exit on December 31, 2020.  On Wednesday the European Parliament voted overwhelmingly to accept the UK withdrawal agreement, but a lot more negotiations are necessary before a true “deal” is made.

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How The DSCSA Is Designed To Work

There are quite a few people people in the industry who misunderstand how the Drug Supply Chain Security Act (DSCSA) was designed to protect the supply chain. The most common misunderstanding is that it is a full “track and trace” system where drugs are verified at each step. In fact, the DSCSA is mainly just a breadcrumb system that forces companies in the supply chain to retain standardized documentation of supply chain events, “just in case”. Very few drug packages will ever get “verified” at any point in their existence in the supply chain. And that’s by design.

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The HHS Importation Proposed Rule

Last month the US Department of Health and Human Services (HHS) published a new notice of proposed rulemaking (NPRM) related to the importation of finished drugs from foreign supply chains–initially, only Canada but expandable in the future to other countries. The proposal is the result of President Trump’s initiative to lower the price of some medicines and it would invoke Section 804 of the Food, Drug and Cosmetics Act (FD&C)–inserted in the early 2000s–that envisions importation programs, under certain strict conditions. Programs under Section 804 can only be implemented if the Secretary of HHS certifies that the they will pose no additional risk to the public’s health and safety, and will result in a significant reduction in the cost of covered products to the American consumer (see “Can Trump/Azar/Sharpless Eliminate Parts of the DSCSA to Enable Importation?” and “Here We Go Again. Florida Flirts With Opening Door To Counterfeits“). Those are high bars. So high, that no Secretary of HHS has been willing to pursue Section 804 Importation Programs (SIPs) until the current one. Will the HHS proposed rule result in programs that pose no increased risk to American consumers? Let’s take a look and see if we can find the answer.

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…a comprehensive exploration of the intersection between healthcare supply chains, track and trace technology, standards and global regulatory compliance

DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer.
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