Well, we had a winter of no snow. Then on Wednesday they said it would start at 4 o’clock. At precisely 4 PM I looked out my office window and darn if it didn’t begin to snow – the heavy white pillow fight wet snow type. I left at 4:30 for my five mile commute home. I was one of the lucky ones. I got home two and a half hours later. We all need a good snow story at least once a year….
In the meantime, here were a few other things of interest from the week:
- FDA Issues Release Warning of Possible Link Between Implants and Rare Anaplastic Large Cell Lymphoma (ALCL) - This week, the FDA said that data reviewed by the agency suggest that patients with breast implants may have a very small but significant risk of ALCL in the scar capsule adjacent to the implant. The agency apparently issued the notice in an effort to get additional data on the matter and is requesting that health care professionals report any confirmed cases of ALCL in women with breast implants.
- FDA Posts First Annual Report on Agency Efforts for Early Warning on Food Problems – Remember the Reportable Food Registry? It was launched back in 2009 and is an electronic portal through which food manufacturers or processors must report a problem or potential problem with a food, either human or animal. This was established under the 2007 Food and Drug Administration Amendments Act. During a food contamination event, discovery of the existence of a problem can often take many days, incurring greater public health risk. The report, entitled “The Reportable Food Registry: A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration,” includes information about the number and types of reports submitted to the Registry, as well as FDA initiatives launched in response to information from the Registry. The report contains Key Findings as to the quantitative aspects of the effort. As funding for the Food Safety Modernization Act is debated, some qualitative conclusions might be helpful as well.
- GSK’s Advodart Gets Complete Response Letter for sNDA – GSK had sought a new indication for its drug Advodart for use in reducing the risk of prostate cancer in men at increased risk for the disease, defined as those who have had a prior negative biopsy due to clinical concern and have an elevated serum prostate-specific antigen (PSA). In its press release on the matter, the company was mum about the basis for the CRL.
- DDMAC Issues Two Letters So Far in January - Though there is often a lag time between the time a Warning Letter or Notice of Violation (NOV) letter, meaning there could be more January letters to come, so far only two letters have been posted by the agency in 2011. Of note, in prior years DDMAC used to post the date of the letter and the date of the posting, so that one could, in fact, see the lag time. Not this year. There is no column for the date of the posting. And speaking of NOV and Warning Letters and DDMAC, on February 7 at the ePharma Summit in New York, I will be conducting a 3-1/2 hour Workshop on regulatory action letters called “What Can You Say? How Can You Say It? Examining FDA/DDMAC Enforcement Trends“. Drop by!
As I wrote this, a gentle snow has begun! I love symmetry. Have a good weekend everyone.