Washington is swept up in the startling pace of change. Things are on their way up, things are on their way down, things are on their way out, things (and many people) are on their way in. You practically need a scorecard to keep track. Here is a bit of what happened in our field of vision:
- Waxman Introduces Biosimilar Legislation – While Europe has had a regulatory pathway for the approval of biosimilars, or sometimes called Follow-on-Biologics (FOBs), the U.S. does not. This week, Congressman Henry Waxman, who was one of the sponsors of the Hatch-Waxman Act that set up a regulatory pathway for the approval of generic drugs from brand names, has picked up the mantle once again by introducing HR 1427 – the Promoting Innovation and Access to Life Saving Medicines Act. While not a very catchy title, it proposes a framework for the approval of biosimilars in the U.S. Whether or not the Act looks like this bill for now is not certain, but this is probably a "must do" for Congress in the coming year, and President Obama is likely to sign whatever he is sent.
- Merger Mania – Like the peanut recall, mergers are on a roll. Genentech and Roche seem to have solved their issues with a "friendly agreement", Pfizer and Wyeth are a done deal and this week CV Therapeutics, after rejecting the hand of Astellas for $16/share, is marrying Gilead for $20. And of course, Merck and Schering Plough are to merge. All this leaves me feeling rather lonely….
- New IT Chief Appointed - President Obama appointed the first ever IT Chief who will oversee a large IT budget for the whole government. Presumably that includes health IT in federally funded health facilities. Someone should take her to lunch.
- And Speaking of Health IT – Walmart? - Walmart announces plans to get into the Health IT business by teaming up with Dell to develop software to bring Health IT into physician offices. Interesting….
There was a lot of other good stuff, but that's it for me this week. Have a good weekend everyone. Next week, I have a special podcast to bring you.