Lawmakers ask FDA for caution on DSCSA implementation

Members of Congress in the US have written to FDA Commissioner Robert Califf, urging "additional action" to safeguard the US medicines supply as the deadline approaches for the Drug Supply Chain Security Act (DSCSA).

The letter (PDF), signed by 21 lawmakers from both sides of the political divide, claims there are still challenges for the various actors in the US medicines supply chain to meet the requirements of the DSCSA, which is due to come into full effect on November 27.

The deadline has already been set back by a year via a stabilisation period – designed to allow them to "implement, troubleshoot and mature" the IT systems that will need to be in place.

The DSCSA – now approaching a decade in the implementation phase since it was enacted in 2013 – requires trading partners in the pharma supply chain from manufacturers to pharmacies to install traceability systems that allow prescription medicines to be tracked at the pack level, using serialised codes.

The objective is that manufacturers can respond in real-time to queries about the legitimacy of a product, to improve the security of the supply chain and prevent counterfeit and otherwise illicit medicines reaching patients.

"The stabilisation period has enabled trading partners to establish necessary technical connections for serialised data exchange, increase the volume of data being exchanged, improve the quality of data exchanged, and refine processes for managing data exceptions," according to the lawmakers.

However, they go on to assert: "It is our understanding that there are remaining challenges for some pharmaceutical supply chain participants to meet DSCSA's full implementation requirements," including gaps in data quality and accuracy.

"Absent government intervention, there will likely be disruptions that could lead to drug shortages and patients being unable to access critical medications."

The FDA has already announced exemptions from some of DSCSA requirements for small dispensers, but the Members of Congress – including Representatives Troy Balderson (R-OH) and Lori Trahan (D-MA) – want the regulator to consider additional exemptions to keep supplies of medicines flowing smoothly.

The FDA has introduced a waivers, exceptions, and exemptions (WEE) process for trading partners that are concerned about being ready in time, and according to the lawmakers the agency has received a "large volume" of these requests.

"We ask that the FDA work expeditiously to evaluate and respond to waiver or exemption requests on a case-by-case basis to ensure continuity across the supply chain," they write.

"We also ask that FDA evaluate whether the volume and nature of WEE requests justifies that FDA on its own establish exemption(s) for specific products or transactions from certain requirements to provide trading partners more time to stabilise data exchange."

The regulator should also consider a phased implementation with manufacturers in compliance by 27 November this year, wholesalers following six to eight months later, and pharmacies complying by February 27, 2026, something that has been pushed for by various trade organisations.