Skip to content

Inside Health Policy – Attorney: Combo Review Issues Signal Hurdles For FDA Intercenter Institutes

Inside Health Policy – Attorney: Combo Review Issues Signal Hurdles For FDA Intercenter Institutes

An industry attorney says FDA’s challenges with combination products suggest the creation of new disease-specific intercenter institutes, as called for by the 21st Century Cures law, could slow down reviews. FDA Commissioner Robert Califf recently indicated the agency is mulling how to reorganize around diseases.

Language in the recently signed Cures bill requires FDA to establish one disease-specific intercenter institute within a year of Cures enactment.

“The Secretary shall establish one or more Intercenter Institutes within the Food and Drug Administration (referred to in this section as an ‘Institute’) for a major disease area or areas. With respect to the major disease area of focus of an Institute, such Institute shall develop and implement processes for coordination of activities, as applicable to such major disease area or areas, among the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Center for Devices and Radiological Health (for the purposes of this section, referred to as the ‘Centers’),” the bill states.

The Cures language mandating the center is nearly identical to bills introduced in the House by Energy & Commerce Chairman Fred Upton (R-MI) and ranking Democrat Frank Pallone (NJ), and in the Senate by health committee Chairman Lamar Alexander (R-TN) and ranking Democrat Patty Murray (WA).

However, Bethany Hills, chair of Mintz Levin’s FDA practice, argues that the Cures language, and FDA’s push toward intercenter institutes, is another challenge that sponsors must now weigh when submitting products for FDA review.

“I think its just another challenge for our clients to think about,” Hills said. “It just creates another administrative step for us to get to and we need to figure out how to navigate that new structure. It seems ironic because we are streamlining review but you are actually adding more people to discuss the issue.”

Hills points to FDA’s review of combination products as evidence of the difficulty FDA has had in streamlining intercenter reviews.

“[W]e are doing [intercenter review] in the combination products office and we are doing it really badly,” Hills said.

Combination products have been frequently held up as an example of FDA’s failures to coordinate reviews between centers. A former FDA official turned private practice attorney recently told Inside Health Policy that combination reviews are often hampered by the different mindsets and review standards of FDA’s centers. [93328]

However, the agency says it is making significant progress in streamlining combination products reviews.

“The team has made tremendous progress toward the goal of modernizing the combination products review program by improving coordination, ensuring consistency, enhancing clarity, and providing transparency within the Agency as well as with all stakeholders,” Califf and Nina Hunter, associate director for science policy in the Office of Medical Products and Tobacco, wrote in a Dec. 2 FDA Voice blog.

The call for intercenter institutes follows the establishment of FDA’s first of such institutes, the Oncology Center of Excellence, which was pushed for by patient advocates. Twenty-eight advocacy groups sent a letter to the agency in June pushing for the creation of the oncology center. [90255]

There have been continuing calls for FDA to further organize around diseases, and FDA appears to be listening.

Friends of Cancer Research, a signer of the June letter supporting the oncology center, has argued that FDA should be reorganized from product-specific to disease-specific centers.

Califf at the Nov. 4 Prevision Policy and Friends of Cancer Research Biopharma Congress indicated that reorganization conversations are happening now at FDA. However, Califf tempered hopes that the agency would become entirely organized around diseases.

“[W]hat you hear loud and clear from patients is they’d like to have a way to be in contact with the FDA, to interact with the FDA — and you also hear this from clinicians and practitioners — in a way that’s not by product type but more by whats relevant for their disease…that’s the first effort in the Oncology Center of Excellence. But I also think that exactly, you know, how far the matrix goes is a matter of discussion and it may be quite different in different fields. We have something like 6,000 diseases so we cant have 6,000 Centers of Excellence and we have to think about how to group things,” Califf said.

However, Hills cautions that the streamlining sought from the establishment of the Oncology Center of Excellence may not translate into efficiencies for other centers, because such centers may not be dealing with comparably complex drugs often paired with companion diagnostics, as is the case with oncology treatments.

“What I would note as a concern around multiple different disease specific institutes, and one where sponsors of new technology and patient advocates interests align, is that the streamline effect that may be seen in the Oncology Center of Excellence due to those specific therapies for cancer and the unique issues companion diagnostics create, are not necessarily challenges in other disease areas and thus the desired efficiency might actually become inefficiency due to the restructured institutes,” Hills wrote.…