FDA BRIEF: Week of February 26, 2018
Brain Implant for Some Blind People Shows Benefits of FDA’s Breakthrough Device Program
FDA’s Breakthrough Devices Program is beginning to show important results
- Second Sight Medical Products Inc.’s Orion Cortical Visual Prosthesis System
- Early FDA interactions for flexible study design, review team support, and senior management engagement
- Involved specialists across disciplines such as ophthalmology and neurology
- Solved any potential stumbling blocks – e.g. measuring benefits/risks
Novel technology with novel way to evaluate benefits/risks of device
- Mimics perception of light through miniature video camera worn by patient
- Transmits signals to implant in their visual cortex
- CDRH approved clinical trial involves five patients at two sites; first patient received the implant on Jan. 30, 2018
Taking new steps to meet the challenges of rare diseases – FDA markets 11th Rare Disease Day
One out of every 10 Americans lives with at least one of more than 7,000 rare diseases
- U.S. observes last day of February as Rare Disease Day
- Raise awareness about rare diseases and their impact on patient’s lives
- What more FDA can do to advance needs of patients and families
FDA incentives, approvals, trends
- Orphan Drug Act financial and other incentives (1983)
- Humanitarian Device Exemption regulatory path for devices (1990)
- >650 therapies, 72 devices approved
- Increasing emphasis on personalized medicine, including genetically targeted drug development
Modernization and new initiatives
- Orphan Drug Designation Modernization Plan for more efficient process
- Orphan Products Council to further address scientific and regulatory challenges
- New Memorandum of Understanding with National Organization for Rare Disorders (NORD) to conduct outreach
- Public meeting om changing landscape of orphan drug development
FDA’s ongoing efforts to help improve effectiveness of influenza vaccines
Working to determine the root causes
- Collaborating with CMS to use large database with details of flu vaccine administered to four million individuals
- Better understand less than optimal effectiveness with both cell-based and egg-based vaccines
- Potential differences in outcomes between high-dose vs. normal dose
Looking ahead to 2018-2019 flu season
- FDA advisory committee meeting March 1, 2018. to select strains, WHO recommendations
- Apply learnings from this flu season
Duodenoscope surveillance sampling and culturing
Duodenoscopes used to treat patients undergoing endoscopic retrograde cholangiopancreatography (ECRP)
- Life-saving, least invasive way treating cancerous tumors, gallstones
- > 500,000 ERCPs performed each year in US
- Scopes are reused; if not thoroughly cleaned and disinfected, high risk of patient-to-patient infection.
FDA, CDC and ASM announced availability of voluntary, standardized duodenoscope surveillance sampling, culturing protocols
- For hospitals and health care facilities
- To further reduce risk of infection and increase safety of these medical devices
Image credit: FDA, CDC