In late August while on my morning dog walk, I saw a neighboring Dad in his front yard with his five year old daughter getting ready for her first day at school. She was wearing pink and had a pink back pack. As he began to walk her out of the yard to the school bus stop, she began to cry. By time they got down the street, she was screaming mournfully. Eventually he picked her up and carried her the rest of the way as her wails raised to a new pitch at the bus stop. Today I saw them again walking to the bus stop. Again clad in pink and with the same back pack, she held her Daddy’s hand and then took off running ahead of him for the bus stop and she was laughing. It is good to be reminded now and then that time and experience can really change one’s perspective.
And here is a little bit of what changed this week:
- Warning Letter for Aeroshot! – In late February Eye on FDA reported that the agency was looking closely at the product Aeroshot – an “inhalable” caffeine. Now in early March, that effort took the form of a warning letter issued by the agency to the manufacturer. In addition to the letter, to drive the point home with the consuming public, FDA also undertook the somewhat unusual step of issuing a press release about the letter. Among other things, one of the concerns the agency stated was the fact that the label refers to “breathable energy” which may actually lead consumers to try to inhale the product when it is meant for ingestion by swallowing.
- More on the Evolving OTC Switch Environment – Also here on Eye, I recently wrote about the potential for change in the OTC switch environment. On the heels of that posting, a few days later reports surfaced stating that FDA was actively considering new proposals that could liberalize access to many medications for chronic conditions such as diabetes, high blood pressure and high cholesterol.
- Euro Docs on Twitter – My friend Bertalan Mesko a/k/a Berci this week reported in his blog Science Roll about a list compiled by Andrew Spong that listed European physicians on Twitter, along with other social media assets such as blogs that Berci then turned into an nifty interactive map. Check it out as well as the overall Twitter list of Docs listed at TwitterDocs.net.
- FDA Approves Surfaxin for Premature Infants -Discovery Laboratories won approval from FDA for its treatment Surfaxin (lucinactant) to be used for the prevention of respiratory distress syndrome in premature infants. It is the fifth drug approved in the U.S. to treat RDS, one of which is no longer marketed.
- Happy Birthday to Me – Eye on FDA Turns 6 – Eye on FDA officially enters its 7th year of chatting to you about FDA stuff. Hard to believe but six years ago, Facebook was just getting started and Twitter was not even aflutter. It has been great fun to watch communications change so dramatically and see how we have adapted to the change (and in the case of some – have not). I am grateful to all the thousands of subscribers and followers on Twitter, and look forward to keeping my Eye on FDA in the future. Thanks everyone!
That’s it for me. Have a great weekend everyone!
Happy 6th Birthday!