I awoke to the sound of the creek rushing by this morning. It would have been pleasant but for the fact that I don’t have a creek. However after heaven knows how many inches of rainfall over the past several days, my property has given birth to one. Its ok. I always wanted a creek and I think it looks better than my neighbor’s new duck pond.
Congress is back. There will be a lot of pressure on them to do something about the economy. The Senate was first back to work and reportedly has slightly increased the amount of money for FDA for the upcoming fiscal year. No telling yet if that will stick. Meanwhile, here is a little bit of what went on this week:
- Lilly Launches YouTube Channel - Lilly jumped into social media existence not that long ago with the launch of a blog called LillyPad, and accompanying Twitter feed and has now added a new YouTube channel to its portfolio this week when it launched the Lilly Health Channel. YouTube has not been such a hot medium for most pharma companies for the most part. Channels are largely not well thought out, organized or maintained. It looks like Lilly has robust plans however including a range of topics from diabetes related issues to coverage of their socially responsible and philanthropic efforts. In the blog post about the launch, the company says it will feature “videos on health and wellness, employee and community outreach efforts, health innovation, Lilly programs and other non-product-branded initiatives.” We look forward to seeing how the channel fares.
- AdComm Votes in Favor of Approval for New Anti-Coagulant - An unusual situation emerged as the Cardiovascular and Renal Drugs Advisory Committee voted 9-2, witgh 1 abstention, to recommend approval of rivaroxaban, a novel, once-daily, oral anticoagulant, for the prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (AF). The drug, Xarelto was put forth by Johnson & Johnson and Bayer for consideration, is unusual because, as reported by Ed Silverman on Pharmalot, FDA review staff offered a quite blunt assessment that posed serious question about approval. That said, the panel voted in favor though, as the Forbes live blog from the meeting pointed out, despite the vote, it was not a ringing endorsement. It will be interesting to see how the agency approaches the approval decision given this circumstance.
- FDA Announces Changes to Medical Device Reviewer Training – In the wake of an Institute of Medicine report issued this past summer that looked at the medical device review system a very critical eye and didn’t like what it saw – the FDA has announced a new training program for medical device reviewers. However, the launch is not in response to the IOM report, but rather the agency is launching a pilot program begun in April 2010. According to the agency release, the new program includes up to 18 months of training, aimed at complementing the skills and knowledge that new reviewers bring to CDRH from fields such as biomedical engineering and health care and the agency is also developing a pilot review program for pre-market reviewers. No word as to whether this would change the IOM’s assessment of the current system which posed serious questions to current protocols but it would serve the agency well to be reporting their efforts at reforming the system of review against the backdrop of that highly critical report. Otherwise they appear to be changes happening in a vacuum.
That’s it for me this week. I’m going to go down and check out the creek. Hope everyone has a good and safe weekend. Be well.