We are staggering through the lame duck and Congress is providing us with lots of reminders as to the unpopularity of the institution. A cold wave has continued to wash over a good part of the nation. Fewer Americans are using credit cards for their Christmas shopping. And there is a great temptation to simply stop watching the news until after the New Year….
And here is a bit of what happened in our world this week:
- FDA Issues Guidance on Public Comment Procedures at AdComms – The use of the public comment period will be the topic of a post next week here at Eye on FDA, but here is a bit from FDA about actual procedures. Highlights from the guidance issued this week include: (i) Before an advisory committee meeting, people may ask, either orally or in writing, to speak at the meeting; they should include contact information, topic to discuss, time requested; FDA usually allots 5-10 minutes per person. (ii) FDA staff responds to requests and, if the topic is unrelated to the committee’s work, may decline the request. (iii) At the meeting, speakers should identify themselves to FDA staff and provide any handouts or other materials, which staff then provides to committee members. These materials then become part of the meeting’s permanent record. (iv) Committee members are encouraged to ask questions of the speakers, to discover more information that might be useful to the committee’s deliberations. Committee members and the public should be reminded of the importance of the open public hearing session and that all speakers should be treated with courtesy and respect. (v) Public speakers are encouraged to disclose any financial relationships they may have with the topic of the meeting or with sponsors of competitors of the products under discussion. (vi) FDA will provide a designated seating area for speakers.
- Takeda Diet Pill Gets Thumbs Up from AdComm – Like a salmon going to spawn, Orexigen and Takeda’s diet pill Contrave swam against the current environment this week to gain a vote of approval from the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC). It was not a slam dunk – the Committee voted 13-7 in favor of recommending approval, and further voted 11-8 for a specific post-marketing study on potential cardiac adverse events. The PDUFA date for this action is January 31, 2011, according to the press release. A nearly completely un-related note – a friend who was at the meeting, which was held at the FDA’s new facility – the White Oak Campus in Silver Spring – said that the new meeting space was nice. But a note of caution – he said the food service support was just “silly”. Note to FDA, get some better grub services….
- Pfizer Pulls Thelin – Pfizer announced on December 10, 2011 that the company would be stopping all clinical trials involving Thelin (sitaxentan) – a treatment for pulmonary arterial hypertension – and pullling the compound from countries where it is already on the market (the EU, Canada and Australia) because of what the company characterized as “a new potentially life-threatening idiosyncratic risk of liver injury”.
- House Calendar for 2011 is Out – In case you are interested in charting out the timing for the continued failures of the House of Representatives, the approaching leadership published the House calendar for 2011. It is one of the resources you want to consult when planning an event, or for many other reasons…
That’s it for me this week. Have a wonderful weekend everyone. Not many shopping or shipping days are left!