As we enter the home stretch of the election cycle, I find myself wanting very badly for it to be November 5. For me, this was once again another very busy week that included preparation for another speaking gig that is next week (see below). Still, the weather has been beautiful and I took some time out for a special drive in the mountains to see the leaves. Even nature is into Change We Can Believe In!
Here is a bit of what happened this week:
- Several Upcoming FDA Advisory Committee Meetings Announced Today – Today’s Federal Register announced several upcoming Advisory Committee meetings. First, there is to be a joint meeting of the Pulmonary-Allergy Drugs Advisory Committee, Drug Safety and Risk Management Advisory Committee, and the Pediatric Advisory Committee for December 10 and 11 to discuss the benefit risk assessment of long acting beta-2 adrenergic agonists for the treatment of asthma in adults and children. Second, the Dermatologic and Ophthalmic Drugs Advisory Committee published notice of a meeting for December 5 to discuss NDA) 22-308, besifloxacin ophthalmic solution, Bausch & Lomb, Inc., proposed for the treatment of bacterial conjunctivitis and NDA 22-369, bimatoprost ophthalmic solution, 0.03%, Allergan, Inc., proposed for the treatment of hypotrichosis of the eyelids. Lastly, the Peripheral and Central Nervous System Drugs Advisory Committee announced a meeting to be held January 7 and 8, 2009 to discuss two new drug applications for Ovation Pharmaceuticals, Inc – (NDA) 20-427, vigabatrin, for the proposed indication of adjunctive therapy for the treatment of refractory complex partial seizures in adults. January 8, 2009, the committee will discuss NDA 22-006, vigabatrin, for the proposed indication of treatment of infantile spasms. I’ve never seen a company do 2 NDAs at the same time!
- Covalence Published Quarterly Ethical Reputation Ranking – Geneva-based Covalence issued their ethical ranking for the third quarter of 2008. Looking at the Best Ethical Quote Score, no pharma companies made it into the top 10 and Toyota and Unilever made it into spots 1 and 2. Best Ethical Quote Score was derived by confronting positive and negative news. You can also see divisions by Best Ethical Quote Progress and Best Reported Performance. When segmented to pharma, however, the rankings for Best Ethical Quote Score were:
- Boehringer Ingelheim
- Astra Zeneca
- DTC in the Era of Consumer Choice – I will be speaking at a conference next week put on by DTC Perspectives – the title of the conference being "DTC in the Era of Consumer Choice" to be held at the Westminster Hotel in Livingston, New Jersey on October 29-30. My talk will be on preparing for coming pharmaceutical marketing and FDA reforms.
That’s it for me this week. And I absolutely promise that Monday will have the 3rd quarter review of Warning Letters!
Have a good weekend everyone.