Another week has zoomed by and we have already entered the second month of 2012 and yet in my head, it is still really the 1990s. Really.
But for those of you who are in real time, it was an interesting week and here is a bit of what happened:
- FDA Approves Treatment for Cystic Fibrosis (CF) – One doesn’t often see the word “breakthrough” used in serious circles, but the FDA used it this week in the subtitle of the agency’s press release announcing the approval of Vertex Pharmaceutical’s Kalydeco. CF affects about 30,000 people in the U.S. and about 4 percent of them are people with a particular mutation known as G551D for which this treatment is effective. FDA reviewed and approved the application in just 3 months under priority review, and was approved ahead of the PDUFA date.
- Komen Withdraws Planned Parenthood Support – Two women’s health giants were in the news this week as on withdrew support from another. Susan G. Komen announced this week that it was an interesting case study on the role of social media in crisis communications demonstrating how quickly the flames of action and reaction can ignite on a grand scale. Today, the Komen blog stated “We will continue to fund existing grants, including those of Planned Parenthood, and preserve their eligibility to apply for future grants…”
- FDA Sued for Allegedly Reading Employee Emails – And speaking of crisis, employees who are said to have been involved in questioning the agency’s approval of some devices and notifying Congress and the Administration of same, have brought a lawsuit against the agency alleging that their personal email accounts were viewed by the agency. This, in turn, has prompted Senator Charles Grassley to send of another letter for the FDA to read expressing strong concern, posing several questions, and providing a detailed account of the situation. This will likely be an interesting one to watch for some time to come.
That’s it for me this week. Enjoy the Super Bowl – if you are a fan and going to watch it or if you are like me and headed to the malls to shop because it won’t be crowded….