I have been super-busy, as you may have discerned from my recent lack of correspondence here. But I am not alone! Things have been hopping from the FDA perspective, and here are a few things that occurred this week that I thought I would pass along:
- FDA Advisory Committee Overwhelmingly Recommends Approval of New Weight Loss Medication – To the surprise of many, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) at a meeting this week voted 20-2 in favor of recommending approval of Qnexa sponsored by Vivus. There had not been a weight loss medication approved since 1999 in a category that has proven to be a tough one along many fronts. In a previous go at approval, the sponsor received a Complete Response Letter in 2010, which was the fate of two other candidates in the category that year. This is evidence of just how dicey predicting advisory committee outcomes can really be.
- FDA Takes Action on Drug Shortage Issue – FDA announced this week steps that it was taking to address the on-going and well-publicized drug shortage issue as it respected two medications. The first was Doxil, used in multiple treatment regiments, including the treatment of ovarian cancer after failure of platinum-based chemotherapy, Kaposi’s sarcoma and multiple myeloma. FDA will be allowing the temporary importation of a replacement drug called Lipodox. In addition, FDA approved a new manufacturer of preservative-free formulation of methotrexate to help supply. In addition to a release on the action, FDA Commissioner Margaret Hamburg wrote a blog post on the new FDA blog FDA Voice. In addition, FDA published a draft guidance on drug shortages.
- Draft Guidance on AE Reporting – Less in the news, but interesting nonetheless, was a draft guidance issued today by FDA that is entitled “”Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic“. Not as catch of a title as “Love in the Time of Cholera” it is nevertheless interesting precisely because it is so peculiar. Six years ago, there as a lot of discussion and preparation around the potential for a serious flu pandemic and while it has receded from headlines for the most part, it is still poses a serious threat. According to FDA, the guidance outlines the agency’s enforcement of AE reporting during an epidemic when there may be a high level of disruption to systems and high employee absenteeism.
That’s it for me this week. Have a wonderful weekend everyone. We are edging ever close to Daylight Savings Time on March 11!
