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FDA postpones compliance deadlines to 2023 while issuing new guidance on drug importation
The US pharmaceutical supply chain progressed by fits and starts during 2020 in its quest to enable end-to-end traceability along with compliance with the Drug Supply Chain Security Act (DSCSA). Clearly, the ongoing global pandemic has had a retarding effect—supply chain managers’ top priority these days is preparing for the coming wave of Covid-19 vaccine shipments. But other factors—technical, organizational and political—are having an effect as well.
Data from the 2020 Serialization Readiness Survey, released by the Healthcare Distribution Alliance Research Foundation, revealed that only 21% of manufacturers polled plan to send serialized data with 100% of products in 2020, a decrease from last year’s survey. Adoption of aggregation—the technical need to link serial data on individual packages with the cases or pallets in which they are shipped—is at something of a standstill: in last year’s survey, more than half of manufacturers (56%) noted that they planned to aggregate by 2019. “The same number responded that they plan to aggregate by the end of 2020, indicating there has not been much additional progress over the past year,” notes the report. “The number of manufacturers who plan to aggregate by 2023 is down to a quarter from a third, indicating other companies have shifted their timelines up and will aggregate between now and then.”
The survey was conducted over the summer (even as the industry was scrambling to address the pandemic), and was part of the reason that FDA recently announced an enforcement delay in meeting the DSCSA requirement of verifying the integrity of returned products returned to wholesalers by Nov. 27. That deadline has now been pushed to November 2023, which is when the entire “enhanced drug distribution security” framework of DSCSA is to be in place. A limitation of the survey data is that it is based only 57 manufacturers, and it’s not clear that the same respondents in 2019 participated in 2020.
“While DSCSA implementation is still a high priority for the pharmaceutical supply chain, we can see an industry adapting and adjusting to support patients and frontline healthcare providers during the COVID-19 response,” said Perry Fri, EVP, industry relations at HDA.
VRS and EPCIS
A key enabler of verifying returned product at the wholesaler has been the Verification Router Service (VRS), a system voluntarily set up among wholesalers and many of the leading IT providers of DSCSA-compliant software. From late 2019 to mid-2020, providers and wholesalers were testing the ability to link the VRS of one provider to others, so that product verification queries could be directed to the correct manufacturer.
According to the HDA survey, 49% of manufacturers “had concerns” about their own ability to support verification requests. Among wholesalers, only 4.8% of respondents felt that dispensers (i.e., retail pharmacies) understood the latters’ DSCSA responsibilities; 47.6% of wholesalers had concerns about their own capabilities. These findings were among the reasons that HDA, together with the American Pharmacists Assn. and others, successfully petitioned FDA to postpone the November 2020 deadlines.
A similar insufficiency exists with EPCIS, an acronym representing the protocol for communicating product data among trading partners. Although most manufacturers use some version of this protocol, and most distributors are equipped to receive EPCIS data, only a fraction of both are doing so currently. (EPCIS is not a requirement of DSCSA, now or in 2023; however, nearly everyone in the supply chain believes that some agreed-on standard is essential to making the entire program work.)
While attendees of this year’s HDA Traceability Seminar (online, Nov. 2-4) were mulling over these technical issues, some part of their attention was focused on the Trump administration plan to allow imports of pharmaceuticals from abroad, which sidestep the structure of the domestic supply chain and flies in the face of the security concerns that led to the DSCSA’s passage. This “reimportation” has been touted as a cost savings to the US healthcare purchaser (whether a patient or a state health fund), although the savings are in doubt.
A final rule was issued in late September, and on Oct. 1, FDA provided a guidance document for its implementation. Florida was a leading state seeking to set up an importation program, but according to Kaiser Health News, no vendor had answered the state’s RFP as yet. Vermont, Colorado, Maine, New Hampshire and New Mexico are other states that have signaled intentions to set up programs as well.