Autumn clicked into place on the calendar early in the week and we were tempted to breathe a sigh of relief, though that would have been silly. Today the temperature is supposed to top 95 degrees. We shall wait until next week and then, autumn simply must begin. I put all my summer clothes away already….
There has been quite a bit going on this week as we have probably all seen and far too much to capture in the span of this small effort, but here are a few:
- FDA Approves First Oral Drug to Reduce MS Relapses – Gilenya, manufactured by Novartis, was approved this week by FDA as the first oral drug to reduce relapses and delay disability progression in patients with a relapsing form of multiple sclerosis. According to the FDA, it is the first in a new class of drugs that affects the central nervous system.
- Genetically Modified Salmon Swimming Upstream? An FDA panel met this week to consider the ramifications of allowing a salmon genetically modified to grow bigger, faster into the food supply. Members of this panel were not voting on approval, but discussing the data and offering opinion, which reportedly covered a wide range. This issue has echoes of past food modifications (growth hormones, irradiation) where safety is assured by many, but where others fiercely resist such developments, demonstrating how truly emotive the issue of food really is.
- FDA Publishes Article in NEJM on the Regulatory Action on Avandia – Drs. Hamburg, Sharfstein and Woodcock jointly penned an article in the New England Journal of Medicine that outlines the decision and reasoning behind the action taken this week respecting diabetes drug Avandia. It has been reported that the drug will be pulled from the market in Europe, while remaining in the U.S. but under the restriction that a physician will have to justify its use by ensuring all other options have been tried first.
- FDLI Presentation on Social Media and the First Amendment - As mentioned in a few posts from this week, I was able to present at this year's Food and Drug Law Institute Advertising and Promotion Conference held here in Washington, D.C. I had two posts this week that toplined some of the main points from that presentation that set out to answer three questions: (i) have the Internet and Social Media outmoded the current regulatory approach; (ii) has regulation of social media respected the First Amendment; and (iii) is there a better way? I have put the presentation up on SlideShare.
I also had the opportunity this week to spend some time with Dr. David Kessler, former FDA Commissioner from 1990 through 1997 and he and I recorded a few interviews on topics related to the regulatory environment today and I'll be running some of them in the coming days.
That's it for me! Have a good weekend everyone.