The elections are over. Campaign commercials are now replaced by Christmas shopping commercials as we enter the home stretch for the year’s end. Thanksgiving is next week when we will be giving thanks, if you can believe it, followed by frenzied shopping, when we will be giving gifts and then the welcome of 2007. Meanwhile, I’m still trying to cope with the fact that it is no longer the 1990s. But I digress. What happened this week?
- Scott Gottlieb Gives Long Speech – It has been a while since anyone at FDA gave a speech that had anything substantive. That changed this week when Dr. Gottlieb went to great lengths at the Manhattan Institute to lay FDA’s positioning on matters related to drug safety, such as greater PDUFA fees to support greater safety efforts. Dr. Gottlieb is a qualified, credible, well-heeled spokesperson for the FDA. Unfortunately, the agency has done little over the months to bolster its sagging credibility, so the ultimate effect of such efforts may be in question. Also he chose a venue where he was probably singing to the choir.
- Kennedy/Enzi Hearing – At a different venue – the lame-duck Senate, for its sake, did some of its own dive into the matter of FDA and drug safety in the 21st Century. Dr. Steven Nissen, noted cardiologist and FDA advisory committee member, was a scheduled panelist. I was not able to attend, but a reliable source told me it was a snoozer.
- Herceptin Use Expanded – The FDA issued a release outlining a basis to expand the use of Herceptin in the treatment of early stage breast cancer. According to the release, "The new indication is for Herceptin, in combination with other cancer drugs, for the treatment of HER2 positive breast cancer after surgery (lumpectomy or mastectomy). FDA granted priority review to the supplemental application for Herceptin."
- HHS and FDA Announce Effort to Aid Consumers Use Food Labels – In a release issued this week, the agency announced assistance for consumers to read food labels in what appears to lately be a greater interest in food-related matters. Two new tools were developed – Make Your Calories Count, a Web-based learning program, and a new Nutrition Facts Label brochure. I didn’t have a chance to test-run the learning program, but will do so and let you know what I think, or you can click the link above and see for yourself.
Get to the recipe books and plan your menus. For those of you traveling this week – safe travels.
As usual, a great overview. One FDA issue that you forgot was the updated PDMA info, which Dr. von Eschenbach rolled out last Monday.
See “The FDA on PDMA”
Have a great holiday!