February 8, 2023

Volume XIII, Number 39

Advertisement

February 08, 2023

Subscribe to Latest Legal News and Analysis

February 07, 2023

Subscribe to Latest Legal News and Analysis

February 06, 2023

Subscribe to Latest Legal News and Analysis
Advertisement

FDA Issues Latest Draft Guidance on the Use of Real-World Data and Evidence to Support Regulatory Decision-Making for Drug and Biological Products

On December 8, 2021 and in response to the mandate under the 21st Century Cures Act to issue guidance on the use of real-world evidence (RWE) in regulatory decision-making, the U.S. Food and Drug Administration (FDA) released a draft guidance document: Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products(Draft Guidance). As part of the RWE program, FDA previously issued the following draft guidance documents:

In the Draft Guidance, FDA discusses the applicability of 21 C.F.R. Part 312 (Investigational New Drug Application) to studies that use RWD, and addresses FDA’s expectations related to studies using RWD in support of a regulatory decision for the safety and effectiveness of a drug. In the Draft Guidance, FDA defines RWE as “the clinical evidence about the usage and potential benefits or risks of a medical product derived from analysis of RWD” and RWD as “data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources.” Additionally, the focus of this guidance is primarily on non-interventional studies (i.e., observational studies). FDA defines an observational study as a “type of study in which patients received the marketed drug of interest during routine medical practice and are not assigned to an intervention according to a protocol.”

In the Draft Guidance, FDA discusses regulatory considerations for observational studies involving the use of RWD, including RWD access, study monitoring, safety reporting, and other sponsor responsibilities. With respect to RWD access, FDA advises that sponsors should confirm that they are able to submit patient-level data for any RWD used in studies in support of a marketing application required under a New Drug Application and Biologics License Application. Furthermore, FDA advises that sponsors should ensure that RWD, in addition to associated programming codes and algorithms, are documented and complete to allow FDA to replicate the study analysis.

With respect to safety reporting, FDA recommends that sponsors submit relevant adverse events to FDA in accordance with regulations pertaining to post-marketing safety reporting. For other sponsor responsibilities, FDA advises that sponsors should take responsibility for all activities related to the design, conduct, and oversight of the observational studies. This includes selecting researchers qualified by training and experience, maintaining and retaining study records, and ensuring that FDA can access and verify relevant records.

FDA recommends that stakeholders submit any comments on the Draft Guidance by March 8, 2022 through this docket.

© 2023 Foley & Lardner LLPNational Law Review, Volume XI, Number 362
Advertisement
Advertisement
Advertisement

About this Author

Devaki Patel Healthcare Lawyer Foley and Lardner
Associate

Devaki (Devki) Patel is an associate with Foley & Lardner LLP, based in the firm’s Washington D.C. office, where she is a member of the firm’s Government Solutions and FDA Regulatory Practices. She is also a member of the Life Sciences, Food and Beverage and Cannabis Industry Teams. In addition to being an attorney, she is a licensed pharmacist. Devaki is admitted to practice only in Maryland. She is practicing under the supervision of a member of the District of Columbia Bar.

Prior to joining Foley, Devaki worked for the Food and Drug Administration as a legal intern,...

202-295-4174
Kyle Faget, Foley Lardner, Government policy lawyer
Partner

Kyle Faget is a Partner and business lawyer with Foley & Lardner LLP. She is a member of the firm’s Government & Public Policy Practice and the Health Care and Life Sciences Industry Teams. Her practice focuses on advising clients on regulatory and compliance matters involving the Food, Drug & Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code, and the PhRMA Code. She also regularly drafts and negotiates agreements required for the development and commercialization of pharmaceutical and medical device products. Prior to joining...

617.502.3292
Advertisement
Advertisement
Advertisement