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 “Lawyer Applauds Combo Products Guide but Says Some Details Missing,” by David Roza. (Read the full version – subscription required.)
Following is an excerpt:
A recently issued final FDA guidance clarifies key industry questions about how combination product makers should comply with postmarket safety reporting requirements (PMSR), but an industry lawyer said some of the finer points, such as details to be included in foreign event reports and the number of constituent parts in a safety report, will have to be hashed out in practice.
The guidance, released July 22, aims to flesh out the requirements laid out in a 2016 final rule, which goes into effect for some products in July 2020.
Brad Thompson, a member of the law firm Epstein Becker & Green and general counsel of the Combination Products Coalition, told Inside Health Policy that the guidance addresses industry confusion on how to conduct follow-up reports; how and when to implement PMSR; what details to include in periodic safety reports; and when to file reports for events that occur outside the United States. …
“Once again kudos to FDA for addressing industry’s concern regarding clarity of definition between combination product applicant and constituent part applicant,” Thompson wrote to IHP. “At least based on a quick review it appears that FDA has addressed comments provided by industry on topics like follow-up reports, details to be included in the periodic safety reports, foreign events, same / similar devices and information sharing responsibilities.”
When FDA released the PMSR draft guidance in 2018, Thompson was confused about how manufacturers were supposed to notify FDA of reportable events outside the United States.
While the final guidance clarifies several of the lawyer’s questions, some of the finer details are still unresolved.
For example, on page 17 of the guidance, FDA says companies, when reporting an event for a product marketed only outside the United States, should include the foreign trade name or brand name in a manner consistent with the process for the lead FDA center in charge of that product. But that process is operationally unfeasible if an organization does not have a same or similar product in the United States, Thompson said.
Similarly, FDA also recommends companies include information about every constituent part of a combination product, regardless of which constituent parts may have been implicated in a safety event. This, the lawyer argued, is not necessarily the least-burdensome approach FDA could have recommended.
“Those [unresolved details] are potentially problematic, but we’re going to need to spend more time with the document to understand what FDA is truly saying,” Thompson said.
He added: “The operational challenges related to complex scenarios will be uncovered as we implement.”
Despite the uncertainties, Thompson said FDA’s guidance is a boon for industry, and a well-timed one at that.
Following an extension in April, FDA pushed back the final rule’s deadline to July 31, 2020, for companies using FDA’s Adverse Event Reporting System and Electronic Medical Device Reporting System, and to January 31, 2021, for companies using the Vaccine Adverse Event Reporting System.
“Perfect timing!!!” Thompson wrote. “A year from the final guidance to the implementation date! This will be very helpful.”