Bradley Merrill Thompson Quoted in “Combination Products: US FDA Extends Safety-Reporting Deadline”Pharma & MedTech Business Intelligence's The Pink Sheet Daily March 22, 2018
Bradley Merrill Thompson, Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in Pharma & MedTech Business Intelligence’s The Pink Sheet Daily, in “Combination Products: US FDA Extends Safety-Reporting Deadline,” by Ferdous Al-Faruque. (Read the full version – subscription required.)
Following is an excerpt:
Two new draft guidances on combination products released Tuesday (March 20), one of which extends compliance deadlines and the other which reduces the number of safety reports sponsors have to submit, left one attorney satisfied, but he maintained that companies are still unclear on how to deal with safety reports that come from outside the United States. FDA Commissioner Scott Gottlieb argued the guidances should lead to clear and useful safety reporting from manufacturers. …
FDA is extending compliance dates for constituent part-based PMSR requirements, submission process for constituent part-based Individual Case Safety Reports (ICSRs) and recordkeeping requirements until July 31, 2019, for Combination Product Applicants using the FDA Adverse Event Reporting System (FAERS) and Electronic Medical Device Reporting System (eMDR) to report ICSRs, and Jan. 31, 2020, for Combination Product Applicants using the Vaccine Adverse Event Reporting System (VAERS) to report ICSRs.
Prior to the guidance, the compliance date for these provisions was July 19, 2018.
“This is a big deal for combination product manufacturers,” said Brad Thompson, a member of the law firm Epstein Becker & Green and general counsel of the Combination Products Coalition.
Thompson said his group has continually told FDA that certain timelines in the final rule were not feasible. “There were serious challenges that were not considered in the Final Rule. Overall, this extension makes good sense as industry stakeholders now have the time to methodically and appropriately implement the IT infrastructure that the Rule requires.”