Spring is definitely springing early. Buds are popping everywhere here in the mid-Atlantic region. Heck in some places, they are more than buds, they are blossoms. Still, the flu season drags on and this week Commissioner Gottlieb mentioned that it may be with us through April. And a Nor’easter looms ahead with lots of wind. In fact, the federal government closed today due to wind. Have fun with that one – you’re welcome.
But on to better things – a bit of what happened this week.
- Food and Nutrition – There have been a lot of starts and stops connected with food and nutrition following the 2016 election, resulting in an overall lack of clarity and obscurity with respect to intent. This week FDA moved to paint a clearer picture which begins with a newly modified label for food that delineates what sugar has been added from that which occurs naturally and will engage in a consumer education campaign to acclimate people to the new label. In addition, the agency moved on the guidance front. This includes a final guidance on what can constitute dietary fiber for purposes of being included in labels – specifically to include those synthetic fibers that may have a benefit over those which do not; and a draft guidance applying to added sugars on the label of honey, maple syrup and some cranberry products; final guidance on how to determine appropriate reference amounts for what is an actual serving when used on the label. FDA states that it intends to issue a final rule this Spring on the timing for compliance by manufacturers.
- Flu Blues – In a flu season that has been particularly active, much has been said about the efficacy of this year’s vaccine and this week FDA added to it. The predominant strain – H3N2 – is being studied by the agency to understand why effectiveness tends to be lower when facing this strain, per the statement from FDA Commissioner Gottlieb this week. He stated that they did not believe that the lack of effectiveness was due to a difference in the strains used to manufacture the vaccine from those in actual circulation and that effectiveness with both cell-based and egg-based vaccines was less than optimal. One theory is that this particular strain requires a higher antigen to evoke the appropriate immune response. On a related note, NIAID announced this week a strategic plan for the development of a universal flu vaccine.
Upcoming Events to Keep an Eye on This Week
- March 5 and 6 – Risk Communications Advisory Committee Meeting – impacts of Pregnancy Lactation Rule
- March 7 – Oncologic Drugs Advisory Committee Meeting – consideration of sBLA for blinatumomab
- March 8 – Gastrointestinal Drugs Advisory Committee Meeting – consideration of sNDA for tofacitinib)
Regulatory Developments in Pharma/Biotech/Devices
- Expanded label for breast cancer drug abemaciclib
- MS NDA turned down by FDA
- Non-opioid pain patch gets clearance
That’s it for me this week folks! Next week will be Daylight Savings!