Weekly Roundup 11.13.15

The leaves are falling in earnest and faster than they can be raked and packaged for pickup. The stomach craves comfort food. Thanksgiving goodies are just around the corner. This week FDA had a federal holiday (Veteran’s Day) while many of us did not.

In fact, it was another busy week for me, sadly resulting in no intervening postings here. I will endeavor to post at least one additional next week.

In the meantime, here are a few of the things that did manage to happen:

  • FDA Commish Hearing Scheduled – The Senate HELP Committee has scheduled a hearing regarding President Obama’s nominee for the new Commissioner of FDA, Dr. Robert Califf, currently Deputy Commissioner for Medical Products and Tobacco. Prior to joining FDA in February of this year, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. The hearing is scheduled for Tuesday, November 17, 2015 at 10 AM. The Committee has set up a page for a live video feed for the hearing here.
  • What Does Natural Mean? FDA is seeking your opinion – at least when it comes to food labels. The agency opened a docket this week to collect information on the use of the term “natural” when used on the labels of food, including food that has either itself been genetically engineered or contains components that have. FDA said that it was doing so in response to 3 citizen petitions asking that the term be defined, one of which sought the prohibition of use of the term on labels. In addition, the agency has been asked by some courts in relation to litigation for information related to the standards for the use of the term. The docket is opened here at Regulations.gov.
  • FDA Letters Regarding DTC Genetic Test Marketing – As our age transitions to one where more consumers are more actively involved in their own healthcare, FDA has once again acted on the matter of genetic tests that are marketed directly to consumers. This week the agency sent three untitled letters – as opposed to warning letters (and note, these are not letters from the Office of Prescription Drug Promotion – OPDP) to manufacturers and marketers of genetic tests meant to inform the consumer whether they have a genetic predisposition to various conditions. This follows other actions the agency has taken with respect to this topic, some going back to 2010. The letters, including a warning letter sent in 2013 to another manufacturer, can be found here.

That’s all for me this week folks. Have a wonderful weekend. Get those leaves cleaned up and start making the menu for Thanksgiving Dinner.

Photo Credit:  Cows in Italy – Anne Becker (with thanks!)

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