Here in the mid-Atlantic, we are experiencing daily rains. Not just rains. Biblical deluges. The gardens are happy. The dogs are not.
Meanwhile, while FDA seems rather slow, there is news – breaking news even – and here is a bit of that and other stuff that has transpired:
- House Passes 21st Century Cures Act – Today the House of Representatives overwhelmingly passed H.R.6 – popularly known as the 21st Century Cures Act. (Vote= 344-77) It is perhaps surprising in that there was bipartisan support and the bill actually aims to accomplish a lot – touching virtually every healthcare stakeholder imaginable from researcher right to the patient. To that end, I wrote a posting for another blog regarding the communications challenges related thereto – and you can catch that here. And in yesterday’s posting on EyeonFDA, I talked about the social media aspects. Passing the House is certainly one hurdle and this bill developed a great deal of momentum, but how will it fare in the Senate?
- FDA Approves New Drug for Heart Failure – Entresto(TM), a tablet to treat heart failure, was approved this week by the agency which said in its release that it had demonstrated ability to reduce the rate of cardiovascular death and hospitalization. The drug joins many others this year reviewed under priority review and given fast track designation. In the release from the manufacturer – Novartis – it was noted that this was the first and only treatment to show a significant mortality benefit in head-to-head testing against an ACE-inhibitor. You can also check out the digital multimedia press release here.
- Calorie Count on Menus Delayed – While many menus already provide caloric information, the agency announced this week that it would be extending the date for compliance with the Final Rule which was published on December 1, 2014. In response to many requests for an extension and even legislation to do so, the agency announced that there would be a one-year delay.
- FDA Ups the Warning on NSAID Labels – FDA issued a Consumer Update related to the label for both prescription and OTC NSAID products, not including aspirin. The agency is taking action to strengthen the warning related to heart attack and stroke risk. While the labels already contain information related to the risk, FDA is going to require manufacturers to update with more specific information.
That’s it for me this week. I am hoping for a nice, rain-free weekend and hoping the same for you.