NHC RWE, EHR and Medical Claims Comments


Dockets Management Staff
Food and Drug Administration Department of Health and Human Services
5630 Fishers Lane, Rm.1061
Rockville, MD 20852

RE: FDA Guidance, “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products”

Dear Acting Commissioner Woodcock:

The National Health Council (NHC) applauds the Food and Drug Administration (FDA) for continuing to advance the Agency’s approach to Real-World Data (RWD) and Real-World Evidence (RWE) and encourages the Agency to continue its efforts of clearly detailing their approach in guidance to ensure transparency for all stakeholders. The NHC appreciates the opportunity to provide comments on the FDA draft guidance “Real-World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision Making for Drug and Biological Products” and is looking forward to continued collaboration with the Agency.

Created by and for patient organizations over 100 years ago, the NHC brings diverse organizations together to forge consensus and drive patient-centered health policy. We promote increased access to affordable, high-value, sustainable health care. Made up of more than 140 national health-related organizations and businesses, the NHC’s core membership includes the nation’s leading patient organizations. Other members include health-related associations and nonprofit organizations including the provider, research, and family caregiver communities; and businesses representing biopharmaceutical, device, diagnostic, generic, and payer organizations.

Patients must continue to be a primary focus in RWE generation to support the drug development process
As the FDA, health researchers, policymakers, and patient advocates establish standards and structure for using RWD as evidence in regulatory and clinical decision making, patients must continue to be the primary focus.

The Agency has made great strides to ensure the patient voice is considered within the framework for RWE and RWD as it is being developed. We appreciate the continued focus to enhance patients’ voices and ensure decisions throughout the product-development and regulatory-approval processes capture and use patient perspectives. Specifically, NHC is pleased to see the FDA incorporating the following items related to RWD and RWE:

  • Engagement opportunities throughout the process of developing guidances and processes on appropriate uses for RWE;
  • Guidance on specific RWD sources, in this case electronic health records (EHRs) and medical claims data;
  • Impact of health disparities on sourcing accurate and representative data from the real world; and
  • Identifying the overall limitations and benefits of specific RWD sources.

As the FDA continues to focus on these important pillars and revises existing guidance documents to advance the RWE Program, the NHC urges the Agency to consider the following to help ensure the patient community can contribute to RWE generation and utilization which, ultimately, is used to develop and optimize treatments for the patients.

Read our full comments here: NHC RWE – EHR – Medical Claims Comments