Pharma groups: FDA should allow portals, emails for tracing products under DSCSA

Regulatory NewsRegulatory News | 08 September 2022 | By

Two major pharmaceutical groups and a national organization representing distributors are calling for the US Food and Drug Administration (FDA) to permit trading partners to track drug products through the supply chain using portals and email exchanges.
 
Use of these portals will accommodate the needs of smaller pharmacies who may not have the encrypted Internet connections to exchange GSI’s Electronic Product Code Information Services (EPCIS) messages through the supply chain.
 
The comments were made in response to FDA’s draft guidance on the use of standards for the interoperable exchange of information for tracking drugs. (RELATED: FDA publishes two critical DSCSA draft guidance’s, Regulatory focus 5 July 2022)
 
The Drug Supply Chain Security Act (DSCSA) calls for trading partners to use an interoperable data exchange to track products through the supply chain once the law takes effect next November 2023.
 
FDA’s draft guidance recommends that trading partners use GSI’s EPCIS standard to transmit information through the supply chain.
 
Respondents said that FDA’s earlier draft guidance published in 2014 allowed the use of web portals and email and questioned why the latest draft omits language granting permission to use these alternative tracking methods.
 
Clarification needed on web portals
 
Three major groups, including the Pharmaceutical Research and Manufacturers of America (PhRMA), the Association for Accessible Medicines (AAM) and the Healthcare Distribution Alliance (HDA) urged FDA to retain the language in the 2014 guidance allowing manufacturers to track products through these alternative methods.
 
“We recommend that FDA include in the final guidance explicit acknowledgment that web portals are an acceptable method to exchange information. A variety of trading partners currently use web portals, and their use is a generally accepted methodology to exchange data,” PhRMA wrote.
 
The group also asked FDA to discourage trading partners from using the phone or the fax for tracking products in a final guidance. “This confirmation would help reduce burden on trading partners and encourage those entities that currently use these methods to adopt new methods that meet the requirements for interoperability.”
 
AAM said small dispensers need portals
 
The Association for Accessible Medicines (AAM) said data portals and emails were “ingredients” used in its members’ 2023 plans to establish interoperable data exchange with trading partners, notably small dispensers.
 
“These methods are an integral part of our AAM members’ compliance strategy for exchanging data with certain smaller trade partners after November 27, 2023. Specifically, because of the 2014 Draft Guidance, a common way of exchanging Transaction Information (TI) and Transaction Statement (TS) has been to make this data available through sending trade partners’ data hyperlinks links to a secure data portal managed by the manufacturer or manufacturers contracted service provider.”
 
AAM said that some trading partners are community pharmacies and other smaller dispensers and practitioners that may not have the necessary systems and processes to acept EPCIS events. Or they may not have encrypted Internet connections as larger manufacturers, repackagers, wholesalers, 3PLs and large pharmacy chains to allow the exchange of EPCIS information.
 
“Methods such as emails with PDF attachments and transmitting links to access data portals are the ways that these companies have told AAM members that they can receive TI/TS, and that would likely not change in 2023. Therefore, we urge FDA to continue its existing policy to allow the use of data portals, as well as emails as interoperable, non-paper methods of data exchange after November 27, 2023.”
 
HDA also weighed in, writing that “many of [its] members’ customers do not have the resources, capability, or need, to set up the business-to-business connections to receive and store an EPCIS event file containing transaction data. The portal is how we, and our customers, both satisfy our §582 obligations. We ask that FDA include in the final guidance language similar to that in the 2014 Draft Guidance that permitted and endorsed portals.”
 
Comments

 

© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

20;25;33;