Pharmaceutical companies: FDA should authorize portals and emails for tracing products under DSCSA

Regulatory news

| September 08, 2022 | By Joanne S. Eglovitch

Two major pharmaceutical companies and a national organization representing distributors are asking the US Food and Drug Administration (FDA) to allow trading partners to track pharmaceutical products through the supply chain using portals and e-mail exchanges.

Use of these portals will meet the needs of smaller pharmacies who may not have encrypted internet connections to exchange GSI’s Electronic Product Code Information Services (EPCIS) messages throughout the chain. supply.

The comments were made in response to FDA’s draft guidance on using standards for interoperable information exchange for drug tracking. (RELATED: FDA releases two critical DSCSA draft guidelinesRegulatory guidance July 5, 2022)

The Drug Supply Chain Security Act (DSCSA) is calling on trading partners to use an interoperable data exchange to track products through the supply chain once the law takes effect in November 2023.

FDA’s draft guidance recommends that trading partners use GSI’s EPCIS standard to transmit information through the supply chain.

Respondents said the FDA’s first draft guidance released in 2014 allowed the use of web portals and email and questioned why the latest draft omitted language granting permission to use these methods. alternative tracking.

Clarification needed on web portals

Three major groups, including Pharmaceutical Research and Manufacturers of America (PhRMA), the Association for Accessible Medicines (AAM), and the Healthcare Distribution Alliance (HDA) have urged the FDA to retain language from the 2014 guidelines allowing manufacturers to follow products via these alternatives. methods.

“We recommend that the FDA include in the final guidelines an explicit acknowledgment that web portals are an acceptable method for exchanging information. A variety of trading partners currently use web portals, and their use is a generally accepted methodology for exchanging data,” PhRMA wrote.

The group also asked the FDA to discourage trading partners from using phone or fax to track products in a final directive. “This confirmation would help reduce the burden on trading partners and encourage entities currently using these methods to adopt new methods that meet interoperability requirements.”

AAM said small distributors need portals

The Association for Accessible Medicines (AAM) said data portals and email were “ingredients” used in its members’ 2023 plans to establish interoperable data exchange with business partners, including small distributors. .

“These methods are an integral part of our AAM members’ compliance strategy for exchanging data with certain smaller trading partners after November 27, 2023. Specifically, due to the 2014 draft guidance, a common way to exchanging transaction information (TI) and a transaction record (TS) has been to make this data available by sending trading partner data hyperlinks to a secure data portal operated by the manufacturer or service provider under contract with manufacturers. »

AAM said some business partners are community pharmacies and other smaller distributors and practitioners who may not have the systems and processes in place to accept EPCIS events. Or they may not have encrypted internet connections as large manufacturers, repackagers, wholesalers, 3PLs and large drugstore chains to allow the exchange of EPCIS information.

“Methods such as emails with PDF attachments and forwarding links to access data portals are the means by which these companies told AAM members they could receive TI/TS, and this would likely not change in 2023. Therefore, we urge the FDA to continue its existing policy to allow the use of data portals, as well as email as interoperable, non-paper data exchange methods after the 27 November 2023.”

HDA also weighed in, writing that “lots of [its] member customers do not have the resources, ability, or need to set up B2B connections to receive and store an EPCIS event file containing transaction data. The Portal is how we and our customers meet our §582 obligations. We urge the FDA to include in the final guidance language similar to that of the 2014 draft guidance that authorized and approved portals.


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