Last weekend was so warm I got to take my first bike ride and went around the Mall. It was delightful with temps in the 60′s. Early in the week, I was excited to find a blooming crocus where just a few days before, there had been a huge drift of snow. There it was on my dog walk, blooming purple against dark earth.
Later in the week I took the same picture. Here it is.
This weekend is slated to be in the teens. Definitely no bike ride.
But on the chance that you are more interested in FDA-related stuff, here is some of what happened this week that was notable:
- Proposal for New Food Labels – FDA announced that it was proposing changes to food labeling that would reflect current nutritional science to help consumers make more informed choices. The proposed changes to the label include formatting changes that emphasize some aspects of the same information that was included on the earlier version such as number of calories and the serving size. The proposed new version also seeks to add new information not present before, such as including the amount of “added sugars” . The release has links to a wealth of information about the new proposed label.
- New Hispanic Health Data – Ok, it is not FDA, but it is significant – NIH released comprehensive data on Hispanic/Latino health and habits derived from a study that enrolled over 16,000 adults in geographically diverse cities around the U.S. and who had origins that included Central America, Cuba, Dominican Republic, Mexico, Puerto Rico and South America. The study contains a good deal of information and some of it that was highlighted in the press release included the percentage of people who reported having asthma ranged from 7.4 among those of Mexican ancestry to 35.8 among those of Puerto Rican ancestry. You can see the full data book here.
- Another Approval for a Rare Condition - FDA seems to be on a roll when it comes to approving drugs intended to treat conditions that are rare. This week it was a drug called Myalept marketed by Amylin Pharmaceuticals intended to treat the complications of leptin deficiency, in addition to diet, in patients with congenital generalized, or acquired generalized lipodystrophy – a condition associated with a deficit of fat tissue. According to the press release from FDA, the product has a REMS program that will require prescribers to enroll and certified after completing training. By my count, that appears to be the fifth approval for a rare condition this year.
- First Stop Sale Order for Tobacco Products – While tobacco products used to come on and off the market without oversight, under the authority of the Tobacco Control Act, FDA now as the authority to review products and determine which may be sold on the market by determining if market entries are substantially equivalent to a valid predicate product. According to the press release, FDA identified four products for removal from the market.
That’s it for me this week. A little more than one more week until Daylight Savings!