FDA could have a new combination products approval pathway ready for congressional consideration within a year, commissioner nominee Robert Califf said.

During his Nov. 17 confirmation hearing at the Senate Health, Education, Labor and Pensions Committee, Califf, who is currently deputy commissioner for Medical Products and Tobacco at FDA, agreed that FDA’s existing structure for reviewing combination products is not suitable.

“It’s a strong view at the FDA that we need another pathway that will give the FDA the flexibility to require the data that’s needed to ensure the public that the proposed treatment is safe and effective,” Califf said. “I feel like within the next year that the FDA’s opinion can be adjudicated back and forth with you and we’re really happy to work with you.”

FDA commissioner nominee Robert Califf, center, introduces his parents to Senate HELP Committee Chairman Lamar Alexander, left, before the start of his confirmation hearing.

Photo by Derrick Gingery

Sen. Sheldon Whitehouse, D-R.I., raised the issue during the roughly two-hour hearing. He said drug and device leaders at FDA have said their individual pathways are not workable for combination products.

Califf also agreed that Congress would have to create any new combination products pathway because it could not be done under existing FDA authority.

“I think we need some help to get the right balance here,” he said.

Legislation introduced in the Senate in July seeks to streamline the combination products process with multiple reforms including provisions that would nudge more products into the device rather than drug primary review pathway. (See Also see "Senate Bill Aimed At Streamlining Combo Product Regulation" - Medtech Insight, 20 July, 2015..) FDA officials have generally been positive about the proposal, although the agency has not weighed in on the Senate plan in detail.

The one-year timeframe described by Califf suggests that the FDA proposal would be ready by the end of 2016, positioning it well for inclusion into the user fee reauthorization legislation that Congress must pass in 2017.

FDA’s problems reviewing combination products are well-known. Among the most common are a lack of user fee goals and deadline coordination between review centers. There are also inefficiencies with intercenter consultations, a practice that has ballooned in recent years, in part due to a growing number of inquiries about human-factors issues surrounding drug-delivery devices. (See Also see "Human Factors Questions Drive Rise In FDA Inter-Center Consults" - Medtech Insight, 7 May, 2015..)

Further, many in industry say FDA leans too heavily toward designating a drug rather than device primary mode of action for combination products, a practice that is being challenged in federal court. (See Also see "Ball In Judge’s Court In Combination Product Classification Suit" - Medtech Insight, 24 February, 2014..)

Califf's comments at the confirmation hearing favoring combination products reform echo statements he has made previously at public forums and in an interview earlier this year with "The Gray Sheet." (See Also see "Podcast: FDA's Califf Talks About Combo Product Reform, Commish Prospects" - Medtech Insight, 17 June, 2015..) Center for Devices and Radiological Health Director Jeffrey Shuren has also stated his support for reforms, potentially including the need for a distinct review pathway and distinct user fees for combination products. (See Also see "Combo Product Reforms Are A Priority For Next User Fee Round, FDA Officials Say" - Medtech Insight, 24 June, 2015..) And FDA issued an internal assessment last month laying out recommendations to streamline interactions between review centers for combination products. (See [A#01151019020].)

Hearing Mostly Civil

The confirmation hearing appeared to go largely as expected with most senators on the committee expressing support for Califf's nomination.

HELP Committee Chairman Lamar Alexander, R-Tenn., said in his opening statement that committee staff found nothing that would appear to prevent him from serving as a fair and impartial commissioner during their examination of his financial disclosure statements and other records.

Califf, a longtime clinical trial leader and cardiologist at Duke University, faced several questions about his relationship to industry and how it may affect his leadership of the agency.

But Califf, a longtime clinical trial leader and cardiologist at Duke University, faced several questions about his relationship to industry and how it may affect his leadership of the agency. Some consumer groups oppose Califf's nomination due to his history of financial relationships with drug and device firms. (See Also see "Consumer Groups Oppose Califf To Head FDA, Citing Industry Ties" - Medtech Insight, 18 September, 2015..)

Sen. Elizabeth Warren, D-Mass., pressed him on his ties to industry and whether he would lower standards for drugs and devices. Califf insisted that he would not. And Sen. Bernie Sanders, I-Vt., who is a Democratic presidential candidate, was the only one on the panel that outright says he will oppose Califf's confirmation, arguing that the cardiologist will not stand up to industry to protect consumers.

Stronger Postmarket Surveillance Urged

Several device-specific issues were raised during the hearing. HELP Committee Ranking Member Patty Murray, D-Wash., and Sen. Al Franken, D-Minn., both asked Califf how he would strengthen postmarket safety surveillance of devices.

Califf emphasized the need to expand the current Sentinel surveillance system, which leverages insurance claims data to track drug safety, to medical devices. (See Also see "Postmarket Device Surveillance Reforms Raised At Califf Confirmation Hearing" - Medtech Insight, 19 November, 2015..)

Califf defended FDA's plans to regulate laboratory-developed test services. (See Also see "On Eve Of House Hearing, FDA Makes Its Case For LDT Framework" - Medtech Insight, 16 November, 2015..) He also fielded questions about the agency's practice of issuing guidance documents in instances when stakeholders feel rulemaking is more appropriate.

Califf is vying to replace Margaret Hamburg, who left the agency in April. Stephen Ostroff is serving as acting commissioner in the interim. (See Also see "FDA Staying The Course Under Ostroff; Hamburg’s Concerns Will Remain Focus" - Pink Sheet, 21 April, 2015..)

Sue Darcey contributed to this report. A version of this story also appears at "The Pink Sheet" Daily.

Califf Supports Combo Products Pathway At Confirmation Hearing

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