Former FDA Top Lawyer Hails RWE Advances
The Covid-19 emergency has been the single greatest catalyst for advancing the use of real-world evidence (RWE) at FDA, according to former FDA chief counsel and now Morrison & Foerster partner Stacy Cline Amin. Writing in a 11/19 Clinical Leader guest column, Amin noted that in the early pandemic days there was no time for the gold standard blinded, controlled clinical trials, and “FDA had to pivot to finding and using data sources that it never previously would have relied on for regulatory decisions. Some of those decisions have been criticized in hindsight, but what everyone seems to agree on is that FDA desperately needed more access to more data.”
Amin resigned her FDA post in January (see story) after almost two and a half years at the helm of the agency’s legal shop, and joined Morrison & Foerster as a partner in its life sciences/healthcare practice in June. Prior to FDA, she served in the White House as senior associate counsel to president Trump. Prior to her administration post, Amin served as chief counsel to the U.S. Senate Committee on Health, Education, Labor and Pensions, and before that as counsel to the U.S. House of Representatives Energy and Commerce Committee.
Amin’s column said that from her experience during the pandemic, FDA experienced a “cultural shift in its willingness to consider and even rely on RWE to inform policy and regulatory decision-making. The agency also undertook huge efforts during that time to improve its access to such data.” She also positively acknowledged the agency’s publication of two related draft guidances.
A September draft guidance entitled Real World Data: Assessing Electronic Health Records and Medical Claims Data to Support Regulatory Decision-Making for Drug and Biological Products provides recommendations when sponsors are intending to use electronic health records (EHRs) or medical claims data in clinical studies to support a regulatory decision on effectiveness or safety. Amin said the document discusses three key factors in relying on these kinds of data: “1) that the data sources appropriately address the study question and population, 2) that the study develops and validates definitions for study design elements, and 3) the importance of data provenance and quality.”
An October guidance, Data Standards for Drug and Biological Product Submissions Containing Real-World Data, “addresses real-world data (RWD) from EHRs, medical claims data, data from product and disease registries, patient generated data, and data from alternative sources that can provide information on health status, such as mobile devices,” according to Amin. “FDA advises that for now, sponsors should submit data using the formats described in the Study Data Catalog, but FDA intends to issue further guidance on this or update the catalog in the future,” she wrote.
Going forward, Amin said she expects continued interest from Congress and the healthcare industry in developing RWE policies, and it should continue to be a top priority for senior FDA leaders.