Forgive me, it has been a while since we've gone out and had a round up of the week's news. What can I say? This is the Spring that totally got away from me. Last week alone I sat in traffic jams in several different states in just a few days. One friend on Facebook even asked if I were running for office or something because I was always checking in from somewhere different. Today though, I am home and it is a beautiful day, and one ripe for a round up.
- FDA AdComm Endorses New Morning After Pill – This week, the Reproductive Drugs Advisory Committee held a meeting to consider their recommendation of elleOne, a one-dose emergency contraceptive pill that can be taken within five days of intercourse. The committee unanimously voted in favor on the questions of safety and efficacy. The drug works differently from Plan B, which was made approved as an over-the-counter product in 2006, after a lengthy ordeal where the FDA initially failed to act on the approval recommendation of two advisory committees.
- FDA Announces a Public Meeting on REMS Programs – Suffice it to say, since REMS supposedly came into existence (I say supposedly because for all the talk, I think it is very difficult to discern any real (as opposed to bureaucratic) difference in REMS from the way risk was managed pre-REMS), there has been confusion on the part of many in terms of implementation and understanding the scope and execution of same. So the FDA has scheduled a public meeting for July 27 and 28 at the new FDA White Oak Office (wear comfortable shoes – that walk from the parking structure is longer than it looks). If you are interested in speaking, you have to reserve space by emailing REMSpublicmeeting@fda.hhs.gov and that has to include the speaker name, title affiliation, address, email and phone number.
- FDA Approves New Prostate Cancer Treatment – In lightning time too. Under priority review and getting a look-see by the FDA that lasted only 11 weeks, the agency announced approval of Jevtana (cabazitaxil) made by Sanofi-Aventis, in combination with prednisone, for the first-line treatment of advanced, hormone refractory prostate cancer. It is the second prostate cancer treatment approved this year, though with a far different experience in timing and review.
That's it for me this week. Have a wonderful weekend everyone.