Executive Summary

Agency is still working to get oncology center of excellence off the ground and has other large pending reorganizations that could take precedence.

FDA may wind up only meeting the minimum requirements for establishing intercenter institutes within the agency that are included in the new version of the 21st Century Cures bill.

The latest draft of the legislation, which is expected to receive a vote in the House of Representatives on Wednesday, includes a provision requiring the agency to create cross-center groupings to better coordinate its handling of major diseases. The “intercenter institutes” are intended to streamline activities among the centers for drug evaluation and research, biologics evaluation and research and devices and radiological health.

The provision appears similar to a Senate bill introduced earlier this year. (Also see “FDA ‘Intercenter Institutes’ Legislation Headed For Senate Mark-Up” – Pink Sheet, 28 Mar, 2016.) And the model already has been made famous by the federal Cancer Moonshot initiative, which mandated creation of an Oncology Center of Excellence at FDA. (Also see “FDA’s Pazdur Jumps Over To New ‘Moonshot’ Role” – Pink Sheet, 29 Jun, 2016.)

But the Cures language is interesting because it states that FDA “shall establish one or more” intercenter institutes for a major disease area or areas. Whether FDA will be able to or want to create multiple institutes remains to be seen, which may be why the legislation does not mandate a more widespread implementation of the idea.

A number of stakeholders have embraced the opportunity to potentially use the legislation to reorganize FDA around diseases instead of product areas. But there have been questions about whether such a radical change would actually be more efficient.

Former FDA Commissioner Mark McClellan, who favors passage of the bill, has said FDA resources remain limited and that some of its areas of expertise are limited in size compared to the rest of the agency and may not lend themselves to such a reorganization. (Also see “Look Before Leaping To Reorganize FDA – Former Commissioner McClellan” – Pink Sheet, 14 Mar, 2016.)

FDA would receive $500m in additional funds through the Cures bill, spread between fiscal years 2018 and 2026. Among the uses for the FDA Innovation Account are creation of intercenter institutes.

Patients Can Be A Focus

Intercenter institutes may be created for a number of activities, according to the bill.

They include:

• Coordination of staff expertise in a major disease area;
• Streamlining when appropriate “the review of medical products to diagnose, cure, mitigate, treat, or prevent the specific diseases” in a specific area;
• Promotion of scientific programs within centers related to a major disease area;
• Development of programs to recruit, train and provide continuing education for expert personnel;
• Enhancement of patient interactions; and
• Facilitation of collaborative relationships with other agencies within HHS

The agency also must allow a public comment period while an institute is being created as well as give notice at least 60 days before one is terminated, according to the bill.

Improving patient interaction could provide an interesting impetus for creating a cross-center group. FDA has been working on a number of avenues for increasing patient input in drug development for the past several years, such as conducting public meetings to gather patient views on specific diseases.

Rare disease advocates have been looking for more consistent access to FDA staff at conferences and other forums (Also see “PDUFA VI: NORD Wants Reviewers To Be More Accessible” – Pink Sheet, 18 Aug, 2016.) and the idea of a patient-facing institute would be in keeping with other themes in the legislation, which also requires FDA to release a summary of the patient experience data that was considered for product approval. (Also see “21st Century Cures Revisions Tell FDA To Highlight ‘Patient Experience Data’” – Pink Sheet, 27 Nov, 2016.)

Will Oncology Be The Only One?

It seems possible that only one intercenter institute may be created in the near future.

Indeed, only one must be completed within a year of the bill’s enactment. That likely will be the Oncology Center of Excellence, which is now being established.

Richard Pazdur, director of the Office of Hematology and Oncology Products, has been named the center of excellence’s acting director. He also will maintain his drug review and approval duties. (Also see “FDA’s Pazdur To Retain Drug Approval Duties In Oncology Center Of Excellence” – Pink Sheet, 7 Nov, 2016.)

Jeff Allen, president and CEO of the Friends of Cancer Research, told the Pink Sheet that FDA could use the oncology center of excellence as a pilot project before considering using the concept for other disease areas.

Many other diseases areas have been suggested for intercenter institute treatment, such as infectious diseases, neuroscience and cardiovascular disease.

Another candidate could be rare diseases. Some stakeholders have suggested the agency create rare disease-focused staff to make orphan product reviews more consistent.

However, a center of excellence for orphan products may already have been created indirectly as part of the prescription drug user fee renewal. FDA agreed to place rare disease staff within review divisions where necessary to enhance application review. (Also see “Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI” – Pink Sheet, 18 Jul, 2016.)

Reorganizations also can take years to implement. FDA’s Program Alignment Group process, which will include the integration of Office of Regulatory Affairs field staff into the product centers, began in 2013 and is not yet completed. (Also see “ORA Device Director: Inspection ‘Program Alignment’ Scheme Not Ready Anytime Soon; Investigator Training, Retention Pose Challenge For FDA” – Medtech Insight, 17 May, 2016.)

FDA also could have a new commissioner arriving in the coming months once the Trump Administration begins. The new agency head may not be willing or able to change the complexion of the agency right away.

FDA Commissioner Robert Califf is pushing establishment of the Oncology Center of Excellence, but otherwise has not made significant organizational changes. When he hired Rachel Sherman to become deputy commissioner for medical products and tobacco, he continued the practice of having the center directors report directly to him, rather than have them report to Sherman. (Also see “Finally … Rachel Sherman Takes Califf’s Old FDA Job” – Pink Sheet, 22 Sep, 2016.)

https://pink.pharmamedtechbi.com/PS119587/Cures-Bill-Authorizes-Interce…