Weekly Roundup 3.30.18

It is hard to believe, but we have completed the first quarter of 2018. Time is flying. Spring is springing. And we are the cusp of the commencement of another election cycle.  It has been another busy week without a posting between Weekly Roundups, but I am aiming to have at least one for next week. The days just whizz by…

In the meantime, here is a bit of what happened this week which might interest you:

  • Pass  (on) the Salt – Gottlieb Talks Food – In a speech given at the National Food Policy Conference held March 29 here in Washington, Dr. Gottlieb gave an outline of how he sees FDA’s role in promoting good health respecting American dietary habits. While there has been progress in both heart disease and cancer in the US, obesity has continued to plague American consumers and he very much linked the public health interest with a governmental role citing a statistic from the American College of Cardiology that over 20 percent of deaths in the U.S. in 2015 were directly attributable to poor dietary factors – some of which he said are by choice and some are due to the conditions in which many must make their food choices. However, he also stressed that consumers want information by which they can make decisions and therefore (as the regulatory of 80 percent of the food supply) FDA was embarking on a comprehensive, multi-year Nutrition Innovation Strategy that builds upon the  Strategic Policy Roadmap laid out by FDA earlier this year. To that end, FDA will be working on labeling issues in particular to (1) modernize claims and help define “healthy” and “natural”; (2) modernizing ingredient labels that are clean, readable and understandable; (3) implementing nutrition facts and menu labeling; (4) modernizing standards of identity, i.e., what it means when a particular term is used to describe a food so that there is a reliable and common frame of reference; (5) reducing sodium content.  In short, it is a comprehensive and far-reaching effort and embodies many aspects which have long been goals, but where execution has been challenged. FDA has opened up a Webpage on the Food Innovation Strategy to follow the progress and developments. 
  • Congressional Research Service Report on REMS and Generics – Under certain conditions, FDA may have drugs to have risk evaluation and mitigation strategies (REMS) which may involve a range of tactics such as the development of a medication guide to patient registries to restrictions on prescribers.  Some stakeholders have expressed concerns that REMS programs have been used by brand name manufacturers to delay the entry of generic competition into the market place and legislation has been introduced in Congress to address that concern. The Congressional Research Service has issued a report – FDA Risk Evaluation and Mitigation Strategies (REMS): Description and Effect on Generic Drug Development that provides a detailed history of REMS with a focus on the development of same on generic drugs. 
  • First Fully Interoperable Continuous Glucose Monitoring System – It is a mouthful, but it meant something for diabetics this week when FDA authorized marketing for a device that would be the first type of continuous glucose monitoring system that can be utilized as part of an integrated system with other medical devices that may be used in the management of diabetes such as dosing systems, insulin pumps and other electronic devices. In addition, unlike other glucose monitoring systems that were reviewed as class III medical devices, this approval was a class II device approval offering a more streamlined pathway for future devices, which is a big deal according to diabetes friends of mine and will serve to speed innovation and progress significantly – (more “open development of the closed loop” – a funny turn of phrase). And finally, according to the company press release, new device this eliminates the need for fingersticks for calibration or treatment decisions. 

Upcoming Events to Keep an Eye on This Week

  • Congress is not in session, so no hearings
  • No FDA AdComms scheduled for this week
  • No Public Workshops or FDA related meetings

Regulatory Developments in Pharma/Biotech/Devices


Photo by Stephanie Braconnier on Unsplash


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