Drugs

Health Groups Push Oncology Center of Excellence Proposal

A letter from 28 organizations, including Friends of Cancer Research, to FDA commissioner Robert Califf urges the agency to create an FDA Oncology Center of Excellence, providing detailed recommendations as to how this program could be implemented. The proposal asks the agency to “refocus resources” based on specific diseases to better reflect 21st century science and modern medical care. The proposal has been added to the vice president Joe Biden’s s Cancer Moonshot initiative, and a Senate bill on 21st Century Cures.

The letter say that such a center “could assemble a highly expert workforce in cancer biology, clinical and psycho-oncology, and foster increased intellectual collaboration and a consistent FDA approach by forming teams of FDA staff with expertise in the prevention, detection, treatment and management of cancer and its impact on patients and families. Ensuring that there is a forum for coordinating cross cutting disease-oriented activities at FDA will help consolidate core competencies to focus on scientific advancement within the agency and streamline processes for the review of oncology products.”

The proposed center should also develop a “regulatory incubator,” the letter says. There is a need for novel approaches to address areas of high unmet medical need and the incubator would create an environment to develop and test new regulatory techniques, it says. Novel approaches that could be investigated and developed include:

1) New Techniques in Reviews: streamlined “one review” processes to alleviate current redundancies for interventions that involve different medical product centers, use of summary reviews for supplemental applications, and use of FDA/sponsor pre-application meetings prior to application review.

2) Advanced Regulatory Tools: new clinical trial designs, novel endpoints, and advanced statistical approaches.

3) Elevate the Patient Perspective in Drug Development: comprehensive patient-centered clinical measures including the identification, development and integration of psychosocial measures, and patient treatment preferences as clinical measures could be included in core data sets

4) Global Collaborations: harmonization of similar international programs such as the Breakthrough Therapy Designation and European’s PRIME.

5) Optimal Oncology Workforce: improve coordination between HHS agencies, establish pre- approval meetings between FDA/NCI/CMS, and develop educational fellowships.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome