Devices

FDA Real-World Evidence Guide Stirs Critics

David McFarland

— 1 min read
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The Medical Device Manufacturers Association (MDMA) says it is concerned that some aspects of an FDA draft guidance on using real-world evidence (RWE) to support regulatory decision-making for medical devices “place overly restrictive burdens on the use of RWE and real-world data (RWD) are not consistent with the agency’s longstanding commitment to least burdensome principles and MDUFA commitments. “Indeed,” the comment letter says, “MDMA is concerned with the draft guidance’s frequent comparison to approaches and standards applicable to traditional clinical trials. In order to realize the promise of RWE and RWD, the agency should continue to embrace flexible, least burdensome approaches that help to support our shared goal of facilitating prompt patient access to safe and effective treatments.”

MDMA raises these points for FDA to consider:

  • the draft guidance fails to adhere to the commitments in the MDUFA 5 commitment letter;
  • the draft guidance is likely to confuse stakeholders;
  • the draft guidance is not consistent with the least burdensome principles;
  • the draft guidance proposes new requirements that could hinder the promise of RWE and RWD; and
  • the final guidance should provide sufficient time for implementation.

The Real-World Evidence Alliance says it advocates for policies that will:

  • advance FDA’s RWE framework;
  • encourage the use of RWE to better understand treatment effects in underrepresented populations;
  • enhance opportunities for RWE organizations to consult with FDA;
  • increase communication on the generation and use of RWE; and
  • recognize the unique aspects of and opportunities for RWD/RWE.

The alliance letter lists several items it appreciates in the agency’s draft.

The Friends of Cancer Research comment calls on FDA to clarify the requirements for capturing relevant covariates and outcomes and provide strategies for addressing inherent limitations of RWD, such as non-random missing data, mismeasurement, and selection bias. “Strategies could include analytical techniques for bias, mitigation, and the explicit inclusion of methods for assessing and reporting data quality within regulatory submissions,” the letter says. It also provides suggestions for changes in other elements of the draft.

The Duke-Margolis Institute describes its programs on RWE and RWD and says that despite the differences between medical device and drug regulation at FDA, consistency across the agency on RWD/RWE guidance will better enable sponsors and other medical product development stakeholders to leverage relevant and reliable RWD to generate evidence for decision making.

Finally, AdvaMed lists agency positions it supports and areas where it believes additional clarity is needed.

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