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.
“We want to make sure that the process for submitting safety information to the FDA is clear, efficient and promotes timely evaluation of potential safety issues,” Gottlieb said in a statement. “Today’s action will help sponsors comply with important FDA regulations on postmarketing safety reporting for these products.”
Both guidances speak to elements of the 2016 final rule on postmarket safety reporting (PMSR) for combination products. …
“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.” …
Thompson said the guidance provides helpful details and examples “which we needed because there was a huge gap in clarity before the language in the final rule,” he said.
Still, he said, the guidance does not fully answer many questions on how manufacturers are supposed to go about notifying FDA of reportable events outside the United States.
“The guidance brings this up but it just says the requirements essentially align with the underlying requirements for drugs, devices and biologicals,” he said. “It’s still a bit confusing how and when these events are supposed to be reported. The section ends by saying applicants who have questions about the requirements for foreign events should contact [Office of Combination Products]-which they might need to do for more clarity.”
Despite the confusion, Thompson welcomed the draft guidance, which he described as especially long overdue. “The [Combination Products Coalition] has been asking for clarity on the reporting requirements ever since the Final Rule on PMSR for combo products came out. Overall, it’s a good day,” Thompson said.