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 (CIPs) 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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The Partnership for DSCSA Governance Is Up and Running

Early rejected Logo for the PDG

The most exciting thing happening lately with the Drug Supply Chain Security Act (DSCSA) is the setting up of a new non-profit organization aimed at coordinating the development of “…a comprehensive shared vision for interoperable drug tracing...” so all companies can comply in 2023 and beyond (See “PDSA’s Proposal for Governance of DSCSA Phase II Interoperability” and “PDSA Brainstorms Vision For DSCSA Governance Organization With Stakeholders“).  The Pharmaceutical Distribution Security Alliance (PDSA) initiated the development of that new organization last year and we now have its name:  The Partnership for DSCSA Governance, Inc., or PDG.  I am told their website will be set up in the next few weeks, so until then, I have posted several of their public documents for RxTrace readers.  Let’s take a look at them.

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China Sets Aggressive Date for Vaccine Traceability

For a few years now, China has been building a library of documents that define standards for traceability, but no dates have appeared in any of them (see “China Adds Traceability Requirement To CFDA Drug Quality Management Specification”, “China Posts New Draft Pharma Serialization Guidelines”, “China: NMPA Drug Traceability Guidance”, “China Commits To The Digital Future In Healthcare, Including Pharma Traceability” and “China Inches Closer To Another Pharma Serialization Mandate”).  In a new posting on their website yesterday, the China National Medical Products Administration (NMPA) provided a notice of aggressive deadlines for vaccine traceability.  Let’s take a look at it because a vaccine traceability mandate is probably a herald of a near-term future pharmaceutical traceability mandate.

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Japan Moves To Mandate Barcodes For Drug Traceability

Last week, the Japan Diet, the bicameral legislature, enacted a bill that amends the Pharmaceuticals and Medical Devices (PMD) Law there. From the limited information I have seen from GS1 Healthcare and from online articles I found through Google, it appears that one of the many things the new bill does is add a new barcoding mandate.  Previously, barcoding of medicines and medical devices in Japan was only recommended.

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DSCSA: Industry Moves Forward

Some members of the US pharmaceutical supply chain are not waiting for the FDA to make the next move (see “DSCSA: Will 2020 Be FDA’s Year To Leap Forward?”).  Instead, they are proactively organizing and setting the standards that will most likely be used to meet the requirements of the Enhanced Drug Distribution Security (EDDS) phase of the Drug Supply Chain Security Act (DSCSA), which goes into effect on November 27, 2023.  Forward motion has been made over the last month on two fronts:  The DSCSA governance organization and the Verification Router Service (VRS).

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Brazil Moves to Formalize A Phased Rollout, Starting Next October

If you do business in Brazil then you know that everything is published there in Portuguese, including ANVISA’s documents.  It is necessary to translate everything unless you can read Portuguese.  I can’t, so whenever something comes out I have to do a quick translation to get an idea of how significant it is.  Last week, ANVISA published two new documents related to their future pharma serialization and traceability mandate.  They are important, because they relate directly to the schedule and some of the requirements of Brazil’s pharma serialization and traceability mandate.

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DSCSA: Will 2020 Be FDA’s Year To Leap Forward?

When it comes to the Drug Supply Chain Security Act (DSCSA), the FDA seems to alternate between hibernating, and leaping forward.  2017 through mid-2018 was a leap forward period with the publication of 8 draft or final guidance documents and 3 public meetings.  Then in 2019, hibernation.  Yes, FDA’s list of DSCSA guidance and policy documents has two entries for 2019 so far, but one is simply a notice reopening the comment period on the DSCSA Pilots request for information that was originally opened in 2016 and 2017.  The other is the compliance policy that provides one year of enforcement discretion for the 2019 wholesaler saleable returns requirement (see “No Surprise: DSCSA Verification Delay”).  Neither were very taxing on the FDA to prepare.  What should the FDA do next?  What should they be doing right now?

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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.
The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel
and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating
the positions of any company, organization or individual other than Dirk Rodgers.

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