FDA BRIEF: Week of September 12, 2016
FDA Oncology Center of Excellence (OCE) announced 2 months ago
OCE and Cancer Moonshot focus
- leverage combined expertise in drugs, biologics, and device
- most innovative approaches for new oncology prod
Commitment to optimally designed clinical trials
- Emphasis on design for increased efficiency
- Stakeholder engagement across government and industry to revisit eligibility criteria and enhance generalizability
- Transition from Phase 1/2/3 paradign to a more seamless approach – expedire regulatory pathway
- Use of ‘common control trials- with a common control arm and multiple different drugs with same indication and different companies
- Use of ‘large simple trials’ with easily-measured endpoints safety or secondary efficacy endpoints
- Public meetings to interact with patients and stakeholders.
FDA and Access to Medications
Recent news about the price spike of EpiPen has caused concern about medications become prohibitively expensive and some people losing access to a potentially life-saving treatment.
FDA’s Role
- doesn’t regulate drug prices – prices are set by the drug makers or distributors.
- does approve new drugs, including generic versions of a drug, to improve competition in the marketplace.
- Office of Generic Drugs prioritizes and expedites our review of applications for first generics
- roadmap developed for expedited access
FDA Facilitates Research on Earlier Stages of Alzheimer’s Disease
Alzheimer’s disease is a nightmare
- > 5 million diagnosed, 6th leading cause of death, most common cause of dementia
- limited treatment options
New Paths for New Alzheimer’s Drugs
2013 DRAFT GUIDANCE
- focus clinical trials on stages before the onset of overt dementia
- earlier and more precise identification of patients with early brain changes
- earlier interventions, before further extensive brain damage, more successful
PUBLIC-PRIVATE PARTNERSHIP
- Anti-Amyloid Treatment in Asymptomatic Alzheimer’s study, funded in part by the National Institute on Aging.