OCP director: Office continues to operate normally despite staff losses

PROVIDENCE, RI – Despite significant changes at the US Food and Drug Administration (FDA) over the past year, the agency’s top combination products regulator says that work at his office has mostly continued business as usual.

James Bertram, director of the Office of Combination Products (OCP), who presented virtually at the AFDO/RAPS Healthcare Products Collaborative Combination Products Summit on Thursday, noted that despite staff changes at OCP, the office has generally been able to meet its obligations.

“Obviously, a lot in the news, a lot of changes over the year, but for OCP, it's been relatively stable,” said Bertram. “It's been very sort of nose to the grindstone and continuing to check boxes and do what we do.”

“A number of staff have left over the past year,” he added. “That being said, there are still a good number of staff with extensive years of support that are not new to combo products.”

Bertram provided a preview of the report OCP plans to submit to Congress on its fiscal year 2024 performance. He noted that the office received 645 original combination product premarket submissions last fiscal year of which 433 (67%) were led by the Center for Drug Evaluation and Research (CDER), 138 (21%) were led by the Center for Biologics Evaluation and Research (CBER), and 74 were led by the Center for Devices and Radiological Health (CDRH).

Bertram also noted that the top three submission types were investigational new drugs (IND), which accounted for 55% of submissions, followed by abbreviated new drug applications (ANDA) at 21%, and third were 510(k) combination product submissions at 6%.

"There was a new frontrunner in the most common product type this year, which was pre-filled biologic delivery device systems with 26%," he added. "Close second were pre-filled drug delivery systems. Last year, if I remember correctly, it was the pre-filled drug, so a slight shift, though, the numbers are still fairly close and consistent.”

While the number of combination product submissions decreased from the previous two fiscal cycles, from 735 submissions in FY 2023 and 674 in FY 2022, they were still higher than in FY 2020, with 559 submissions, and FY 2021, with 596 submissions.

“When I was preparing these slides, it was reassuring that there obviously are still a significant number of combination product applications, and we're sort of ‘Steady as she goes,’” said Bertram.

Intercenter consult requests (ICCR) were also consistent with past trends, according to Bertram, who noted that the total ICCRs for FY 2024 were 1,162. He noted that CDER led with the number of ICCRs, at 707, with 50% for INDs and pre-INDs; CDRH had 360 ICCRs, with 65% for investigational device exemptions (IDE) and pre-submissions; and CBER had 95 ICCRs, with 84% for INDs and pre-INDs.

The numbers are consistent with those of the past few years, when OCP received 1,199 ICCRs in FY 2023, 1,149 in FY 2022, 1,202 in FY 2021, and 1,146 in FY 2020.

Bertram said that OCP received 48 requests for designation (RFD) in FY 2024, for which it issued 11 decisions, and 82 pre-RFDs, for which it conducted 39 assessments. He also noted that 29 (74%) of those assessments were issued within 60 days, with an average review time of 61 days.

“One noteworthy comment, the average review time for the pre-RFDs had a significant decrease from prior years to 61 days, very close to the 60-day [internally established] goal,” said Bertram. “Pre-RFDs, unlike RFDs, don't have a statutory mandate on the time that a review must be completed.

“It's 60 days for an RFD, but we do look to provide timely feedback in the context of the pre-RFDs,” he added.

RFD decisions are up, while pre-RFD assessments are down compared to recent years. In FY 2023, OCP issued eight decisions and 60 assessments. Looking back to FY 2020, it issued nine decisions and 79 assessments.

Bertram also gave the attendees an update on the Office of the Chief Medical Officer's (OCMO) FY 2025 guidance agenda. He noted that two of the four combination product guidances listed on the agenda are complete, including a draft guidance on unique device identifier (UDI) requirements for combination products and a final guidance on how to prepare a pre-RFD. He added that he hopes to get the remaining two guidances on the agenda, a draft guidance on choosing the right center for a master file submission, and one on labeling of infusion pumps used for subcutaneous insulin delivery, out by the end of the year, if not early next year.

Bertam noted that OCP is working to update documents to meet the requirements of a quality system management regulation (QMSR) final rule and a medical gas final rule that go into effect in February 2026. He also noted the office was working to revise the bridging guidance for combination products.

Combination Products Summit

OCP director: Office continues to operate normally despite staff losses

Related topics

Recommended content

Welcome to the new RAPS Digital Experience