Bradley Merrill Thompson Quoted in “Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH”

RAPS Regulatory Focus

Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in RAPS Regulatory Focus, in “Experts Seek Alignment of Standards Recognition Across FDA’s CDER, CBER, CDRH,” by Ana Mulero.

Following is an excerpt:

In comments to US Food and Drug Administration (FDA) February draft guidance, industry experts called on the agency for alignment of the approaches to voluntary consensus standards (VCS) recognition.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period for feedback on the VCS program FDA’s Center for Drug Evaluation and Research (CDER) proposed via its February draft guidance closed earlier this week, with submissions from several standards development organizations (SDOs) and others.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. …

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.”