Congress Seeking To Prevent Drug Shortage With Pending DSCSA Serialization Requirements
Members of Congress are calling for action to prevent drug shortages in light of upcoming issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with requirements under the Drug Supply Chain Security Act (DSCSA). Beginning November 27, 2023, all drugs in the US must be able to be tracked electronically on the unit level, and drugs not complying cannot be distributed or dispensed.
Implementation of DSCSA’s serialization requirements
The Drug Quality and Security Act (DQSA), was enacted by Congress on November 27, 2013. Title II of DQSA, the Drug Supply Chain Security Act (DSCSA), outlines steps to achieve interoperable, electronic tracing of products at the package level to identify and trace certain prescription drugs as they are distributed in the US. Implementation of the DSCSA has occurred over a 10-year period, with additional requirements coming into play this year (2023), effective November 27, 2023. With the deadline approaching, certain members of Congress are urging the US Food and Drug Administration (FDA), which is largely responsible for implementing the DSCSA, to delay or phase in the last set of implementation requirements, a view also shared by industry. The traceability requirements in effect under DSCSA from 2015 to 2023 generally require products to be traceable at the lot level. A second phase of requirements, to go into effect November 27, 2023, require the interoperable, electronic tracing of products at the package level.
The purpose of the DSCSA is to enhance FDA’s ability to help protect consumers from exposure to drugs that may be counterfeit, stolen, contaminated, or otherwise harmful. These requirements also improve detection and removal of potentially dangerous drugs from the drug supply chain. Additionally, the DSCSA directs FDA to establish national licensure standards for wholesale distributors and third-party logistics providers and requires these entities to report licensure and other information to FDA annually.
In a bipartisan letter to FDA Commissioner Robert Califf, 28 members of Congress, led by Representatives Troy Balderson (R-OH) and Ann Kuster (D-NH), both members of the House Energy and Commerce Committee, outlines issues facing pharmaceutical manufacturers, distributors, and dispensers as they work to bring the drug supply chain into compliance with DSCSA requirements. At issue is the implementation timeline for requiring drugs to be tracked at the unit/package level (currently it is at the lot level), beginning November 27, 2023. Any drugs that do not comply with the new requirements cannot be distributed or dispensed to patients, and as such, Congress is concerned that the new requirements may potentially lead to drug shortages. While supporting DSCSA implementation, Congress is seeking that FDA extend the timeline for implementing the new requirements or take further action as a means to prevent possible drug shortages.
“The FDA’s efforts to protect patients have been enhanced by the systems and processes implemented across the supply chain over the past decade,” said Representatives Balderson in an August 1, 2023, press statement. “Further efforts required by the DSCSA will ultimately improve the ability to trace pharmaceutical products and remove potentially dangerous products from the pharmaceutical supply chain,” he said.
“However, it is our understanding that some supply-chain participants are facing difficulties meeting DSCSA’s full implementation requirements. Based on what we are hearing from healthcare supply-chain stakeholders about readiness for the November 27th deadline, absent government intervention, there will likely be disruptions that could lead to patient access problems and further drug shortages.”
The letter is supported by the Healthcare Distribution Alliance, the American Pharmacists Association, the National Association of Boards of Pharmacy, the National Community Pharmacists Association, and the National Association of Chain Drug Stores.
Congress seeks response by FDA
Effective November 27, 2023, products that are not DSCSA-compliant cannot be sold, distributed, nor dispensed to patients. Those non-compliant products will include legitimate prescription drugs whose products do not have corresponding serialized electronic data records. Congress is requesting that FDA respond to a set of questions (see below) by September 15, 2023, and inform Congress of the steps FDA is taking to address the issue of potential disruptions to patients as a result of DSCSA noncompliance. These questions are outlined below.
Assessment of DSCSA readiness. How is FDA assessing the readiness of trading partners to meet the enhanced distribution requirements under the DSCSA by November 27, 2023? How is FDA currently utilizing its internal data provided under the Food, Drug and Cosmetics Act to assess this readiness?
Impact on the drug supply chain. DSCSA noncompliance could cause more drug shortages and interruptions to patient care. If trading partners are not ready to comply, how will that affect the pharmaceutical supply chain? What actions is the FDA taking to prevent these concerns? What support does the FDA need to address these concerns?
Consideration of a phased-in approach to implementation. There are reports that some trading partners are not connected yet with other trading partners to enable electronic, interoperable data exchange. Congress says it is its understanding that testing technology and interoperability can take months. If some trading partners are not compliant with the November 27, 2023, deadline, will FDA consider a phased-in approach to implementation to provide flexibility while allowing product to still move through the supply chain, as has been done previously with DSCSA implementation?
Impact on US military. The letter specifies that the Department of Defense (DoD) also gets tits medications from pharmaceutical manufacturers and distributors. If DSCSA is not implemented properly, it could cause a shortage of battlefield medications, putting our national security at risk. What is the FDA doing to ensure that the DoD gets its medication in a timely manner if there are implementation challenges with DSCSA?
FDA guidance. The letter says that although Congress intended for this law to be fully implemented this year (2023), if the supply chain is unable to fully implement the DSCSA by November 27, 2023, will FDA issue guidance within the next 30 days [as reported on August 1, 2023] on enforcement policies for certain DSCSA requirements?