In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.
The comment period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed
via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others. SDOs, in general, showed support for CDER’s efforts to establish its own program for recognition of VCS, yet most had some caveats to their support.
By leveraging the use of VCSs, CDER aims to promote innovation in pharmaceutical development and manufacturing while also streamlining the process for compiling and assessing marketing applications.
Comments—most of which were posted earlier this week—from ASTM International and the Standards Coordinating Body (SCB) were more critical of CDER’s proposed approach compared to those from the United States Pharmacopeia (USP), which wants to meet with the agency to discuss an element of CDER’s proposal regarding informal recognition of alternative standards compared to that of USP’s.
The American National Standards Institute (ANSI) touts the draft guidance’s proposal as “a positive step” in the direction toward greater innovation and reduced burden on sponsors and CDER reviewers. Other commenters also welcome CDER’s proposal. “The recognition of voluntary consensus standards allows industry to avoid duplicating efforts unnecessarily and optimizes the use of scarce resources,” writes SCB senior technical program manager Dawn Henke. “By referring to standards that have been harmonized internationally, CDER and industry can facilitate the elimination of barriers to trade.”
But from a lack of encouragement for FDA to participate during a standard development process to potential impediments in the review process’ timeliness, the concerns voiced by other commenters are wide-ranging. The concern shared across at least four commenters calls for alignment in FDA’s drugs, biologics and medical devices centers, underscoring growing interest in cross-center collaboration.
As the draft guidance notes, CDER’s proposed program would differ from the decades-old program in FDA’s Center for Devices and Radiological Health (CDRH) in that a VCS would only be informally FDA-recognized. The routinely updated formal recognition standards program is for both CDRH-regulated medical devices and those regulated by FDA’s Center for Biologics Evaluation and Research (CBER).
AST International, SCB, PhRMA and the Combination Products Coalition (CPC) question the proposed approach as it relates to how it will fit into the larger picture. To this end, they seek clarity around whether cross-center recognition of standards would exist and greater consistency in expectations across centers.
The program’s establishment is an opportunity “to coordinate with CBER and CDRH to assess recognition of standards and expectations across FDA centers in an effort to achieve greater alignment among CDER, CBER and CDRH,” says PhRMA senior director of science and regulatory advocacy Olivia Shopshear. “Greater consistency in expectations across centers has the potential to reduce regulatory uncertainty for manufacturers and therefore facilitate more efficient adoption of advances in biopharmaceutical manufacturing as well as further encourage innovation in how drugs are manufactured.”
CPC says it welcomes a program in CDER like CDRH’s, citing the usefulness of a well-structured program.
CDRH’s program “affords industry the opportunity to participate along with regulatory authorities, such as FDA, in the bodies that create and maintain such consensus standards,” says Bradley Merrill Thompson, an attorney at Washington-based law firm Epstein Becker Green, on behalf of CPC.
CPC asks for clarifications on how the proposed program will align with the CDRH Standards and Conformity and Assessment Program for the device constituents of combination products that fall under CDER’s jurisdiction. “The applicability of the CDRH program to such products is not explicitly clear; although such device constituents are not directly within the scope of CDRH’s program, recognized device consensus standards are generally applied to device constituents as taken from similar non-combination device product codes,” Thompson notes. He argues the current description of CDER’s program is “fundamentally…. very similar” to CDRH’s program “without the commitment to honor the recognized portions of the standard,” despite draft guidance stating the two programs are different.
CDRH’s program “does afford flexibility to the review staff to request additional information not covered by the recognized portions of the standard, but the expectation is that this additional information would only be requested regarding information not covered by the standard. This is a key commitment for success of the program,” Thompson further argues. “Therefore, CPC requests that CDER also offer the same good faith commitment to honor the requirements of the recognized portions of a standard.”
CDRH and CBER issued
a final joint guidance document last September on the appropriate use of a VCS along with a new draft guidance on the VCS recognition and withdrawal process. Last month, CBER finalized
guidance to clarify its own approach to VCS development and use. The rise of biologics has led to the supply of many third-party biologics standards, though CBER does not have its own listing like CDRH. CDER intends to maintain a listing of informally recognized VCS on a publicly searchable database.