Future of FDA under New Administration?
In a carefully researched article entitled “Whither FDA? by Steve Usdin, Washington Editor, BioCentury, the author considers decisions by the new leadership and their possible impact on the FDA. The agency has been on a 15-year bi-partisan path of regulatory reform. His vision does not include a substantial lowering of the threshold for product approvals. The agency is bound by laws and regulations which regardless of next commissioner’s philosophy are unlikely to be changed by the Congress. The industry professionals at the FDA can hopefully lead the agency in an agenda that is “firmly grounded in science, not politics.”
The Congress needs to quickly reauthorize user fees for reviews of new drugs, generic drugs, devices and biosimilars so as not to force need to terminate large numbers of professional review staff. There are 15,000 staff members who, hopefully, can control political appointees by the weight of their influence.
The naming of competent head respected by the public and stakeholders as commissioner will be important to avoid chaos. Some names floated have frightened industry but we hope Congress helps shift replacement decision to one that makes sense for a science-based agency.
Overview of Upcoming Life Science Events the Week of Jan. 22, 2017
- PMWC 2017 Silicon Valley, Jan. 23-25, 2017, Date and Time: Monday – Wednesday, Jan. 22-25, 2017, 8:00am – 5:00pm
- UCSC Extension Course, Mondays, Jan. 23-April 10, 2017; Event: “ Validating Software for Medical Devices and Emerging Technologies”
- Bio2Device Group, Tuesday Morning, Jan. 24, 2017, Topic: “Q4 numbers, views from JP Morgan and an open discussion of what the Trump Administration’s Impact may be on Healthcare,” Speaker/Moderator: Harry Wachob and Attendees
- JLABS, Thursday Morning, Jan. 26, 2017; Topic: “Who’s Who in 2017: A Rocky Road for Healthcare Investments?” Speaker: Jonathan Norris | Managing Director, Silicon Valley Bank
- California Life Sciences Association, Thursday Afternoon, Jan. 26, 2017, Topic: “Federal Grants Management – Accounting and Compliance”
- PBSS, Friday MidDay, Jan. 27, 2017, Topic: “Stem cell gene therapy to cure diseases: overview, a success story and current advances,” Speaker: Maria Grazia Roncarolo, MD
You can download the details for the upcoming events this week and those through April 2017 with audreys-picks-jan-22-2017.