A collective sigh of relief comes to us all this week as the cycle of candidate commercials comes to an end. I just want to say – we did not approve this message. One thing is for sure, candidates and their ancillary supporters sure showed us how profoundly irritating they can be.
As noted in an earlier post this week, the election may have some profound affect on FDA and is still playing out. One House race in Arizona, for example, features one "Tea Party" backed candidate as saying in a video apparently filmed at a campaign event that he does not support the intrusion of government regulation in general, and specifically in response to a question about the government's role in enforcing safer food standards in the wake of the recent salmonella egg outbreak. That race, between the Republican candidate Jesse Kelly and the Democratic incumbent Gabriele Giffords has not yet been called, though with 100% of the precincts reporting as of this writing, she is leading.
Something tells me that the election will give us lots to write about in the coming months respecting the FDA.
And here is a bit of what else happened this week:
- FDA Approves Cymbalta for Pain Indication – On Thursday the FDA announced approval of a new indication for Cymbalta, first approved for a major depressive disorder indication, for the treatment of musculoskeletal pain, including osteoarthritis and lower back pain. If one is wondering how a medicine for depressive disorder has an impact on pain, you will have to keep on wondering. The release from Lilly states that the exact way it works is not known, but theorizes that the drug enhances the body's system for the suppression of pain by increasing the activity of serotonin and norepineprhine in the brain and spinal cord.
- FDA Held Public Meeting on Biosimilar Pathway – While one may assume establishing a regulatory pathway for biosimilars is very similar to the one put into place for generic drugs, it is in fact very different and there are a host of unique issues that distinguish both the regulation and the market impact of biosimilars from that of generic drugs. This week the FDA held a two day public meeting to gain input in helping establish that pathway – a process that could presumably take a great deal of time.
- FDA, CDC and Costco Warn Customers to Avoid Bravo Farms Dutch Style Gouda Cheese – Of course it isn't as big as the egg recall, but it is another log to throw on the fire for those who support legislation that would give the FDA broader authority to regulate food safety. The cause of this public health warning is concern over the possibility of an association with e-coli.
- FDA Issues Guidance on Cellular Therapy for Cardiac Disease – 'The agency released a guidance this week to provide sponsors of therapies for cardiac disease with recommendations regarding the design of preclinical and clinical studies as well as other information that should be submitted with an IND.
That's it for me this week folks. I hope you all have a wonderful and cozy autumn weekend.