It was another long, hot week. The high pressure system over Washington abated somewhat when the Congress actually accomplished something, even though it was something almost no one liked, which apparently saved us from economical disaster, but the market tanked anyway. Confused yet?
Sticking to our more predictable and saner world, here is a bit of what happened in FDA-related-land this week:
- FDA Approves First Treatment for Scorpion Stings – Yes, for the many who have been waiting, the FDA approved the very first treatment for scorpion stings. The drug is called Anascorp and is produced by a Mexican company called Instituto Bioclon and licensed to Rare Disease Therapeutics. According to the release “[v]enomous scorpions in the U.S. are mostly found in Arizona. Severe stings occur most frequently in infants and children, and can cause shortness of breath, fluid in the lungs, breathing problems, excess saliva, blurred vision, slurred speech, trouble swallowing, abnormal eye movements, muscle twitching, trouble walking, and other uncoordinated muscle movements. Untreated cases can be fatal.” I did not know they were so serious and I did not know there was no treatment. Interesting.
- Lots of Talk of Statin RX to OTC Switching – News reports abounded this week about the potential for an RX to OTC statin switch. It would not be the first attempt. Several years ago, many companies tried to switch statins from RX to OTC – some companies trying several times. It didn’t happen. Could it happen now? Having attended or watched the meetings of all of those attempts to switch, little has changed that would seem to encourage the notion of a switch. The bottom line – OTC patients do not presently have a mechanism for (1) monitoring their liver enzymes and (2) monitoring their own cholesterol levels. Unless someone develops an iPad app that would do both, any switch attempt might lend a profound sense of déjà vu.
- FDA Reopens Comment Period on Gluten Labeling – And speaking of déjà vu, this week reopened the comment period for its 2007 proposal on labeling foods as “gluten-free” providing fresh evidence to those waiting for a guidance on social media that the agency does not move quickly. The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.
That’s it for me this week. Have a good weekend everyone.