In some recent postings, it has been noted that the FDA Commissioner has made liberal use of the vehicle of “Commissioner Statements”. Last month, there were 9 – on average 2 a week. Then suddenly this month, the entire first half of the month went by with no word. Finally this week, there was a statement. But it’s about more than numbers, it is about the substance and this week there was a good deal of activity, a few things of which are noted below.
- Gottlieb on FY 19 FDA Budget – Scott Gottlieb delivered remarks regarding the increases for FDA’s budget for the upcoming fiscal year where he outlined his pathway to developing an approval process that relies on cross-disciplinary experience to build a “knowledge management platform” to build a more empirical approach to review and approval, one that would ostensibly re-tool the process to be more effective in a modern world and to enhance the speed and efficiency of review. He also was able to relate that FDA had just come off an extremely productive year in terms of approvals for new molecular entities, devices and generic drugs and that two public health initiatives – on smoking and nutrition and food labeling – were moving forward. He got a lot into a short set of remarks.
- Advisory Committee Unanimous Go on Cannabidiol – The Peripheral and Central Nervous System Drugs Advisory Committee this week gave a unanimous approval vote respecting a candidate cannabidiol compound seeking approval for the treatment of two serious, rare forms of epilepsy. If approved, it would be the first drug approval involving a compound derived from marijuana. The PDUFA date set for a decision from FDA is June 27. The company release can be found here.
- FDA Issues Guidance on Caffeine Supplements – Following two deaths after consumption of highly concentrated caffeine supplements, FDA issued a new guidance with immediate effect to outline the circumstances by which supplements may pose a serious risk. The release regarding the guidance notes that a single teaspoon of highly concentrated powdered caffeine can contain the equivalent of 20-28 cups of coffee. The guidance addresses both powdered and liquid formulations sold in bulk.
Things to Keep an Eye on This Week
- April 23 – Science Board Meeting respecting FDA Patient Affairs Initiative
- April 23 – Arthritis Drugs Advisory Committee – considering NDA for RA Treatment
Regulatory Developments in Pharma/Biotech/Devices
- Breakthrough Therapy granted to Drug for Hemophilia A without inhibitors
- Drug Approval for Chronic ITP
Photograph by Lynne Bertram