Bradley Merrill Thompson, Member of the Firm in the Health Care & Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Inside Health Policy, in “FDA Extends Postmarket Reporting Deadline for Combo Products,” by Beth Wang. (Read the full version – subscription required.)
Following is an excerpt:
FDA again is extending the period of time during which it will not enforce certain combination product postmarketing safety reporting requirements, the agency announced via an updated guidance on Tuesday (April 23). The extension marks the second time in the past year FDA has pushed out the compliance deadlines for its 2016 postmarket safety reporting final rule, which applies to combination products that are subject to premarket review by FDA.
In its Federal Register announcement, FDA says it is implementing the update without prior public comment, as it does not believe prior public participation is feasible or appropriate. …
The agency’s latest update to that guidance released Tuesday sets in motion the second round of extensions for those postmarket safety reporting requirements.
The new dates are: July 31, 2020, for applicants use FAERS and eMDR; and Jan. 31, 2021, for applicants using VAERS to report ICSRs.
In 2018, Brad Thompson, a member of the law firm Epstein Becker & Green and general counsel for the Combination Products Coalition, told Inside Health Policy the extension was a “big deal for combination product manufacturers,” as the coalition had repeatedly told FDA that certain timelines in the final rule were not feasible.