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 the Bloomberg BNA Medical Devices & Industry Report, in “FDA Streamlines Safety Reporting for Drug-Device Combos,” by Bronwyn Mixter. (Read the full version – subscription required.)

Following is an excerpt:

Drug-device combination makers are getting long-awaited guidance from the FDA on how to meet new standards for post-market reporting of patient deaths and injuries.

Food and Drug Administration guidance documents released March 20 address key elements of a 2016 final rule on postmarket product safety reporting (PMSR) for combination products. The new reporting requirements are intended to reduce duplicative reporting. Combination products, such as Mylan Inc.’s Epipen, are composed of two or more different types of medical products (device, drug, and/or biological product).

“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,” FDA Commissioner Scott Gottlieb said in a March 20 statement. “Combination products, like continuous glucose monitors combined with insulin pumps to act as an artificial pancreas for patients, present significant opportunities for innovation and improvement in patient care.”

A combination product industry group welcomed the new draft guidance and final compliance guidance, saying they finally deliver clarity on questions the group has had about the final rule. But the guidance documents still don’t explain when manufacturers should report adverse events that happen outside of the U.S., the group said. …

“The guidance is really detailed and provides helpful examples which we needed because there was a huge gap in clarity before with the language in the final rule,” Bradley Merrill Thompson, general counsel for the Combination Products Coalition, told Bloomberg Law in a March 20 email.

Thompson said the guidance provides two separate scenarios, one for a drug-application combination product and one for a device-application combination product. Combination products can be approved by the FDA through either drug, device, or biologics applications.

While the draft guidance doesn’t go into detail on combination products approved under a biologics license application, it does include BLAs as a category in the appendix that overviews all the requirements by application and product type, Thompson said.

But Thompson said the draft guidance still doesn’t clarify how manufacturers are supposed to notify the FDA of reportable events outside the U.S. The guidance just says that the reporting for foreign events must “essentially align with the underlying regulatory requirements for drugs, devices, and biological products,” he said.

“It’s still a bit confusing how and when these events are supposed to be reported,” Thompson said.

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