I can scarcely believe that the first two months of the year are over. Time is rushing by. Layer on top of that how quickly the world has changed in just the last 8 weeks. What will the next 8 weeks bring? What did this week bring? Here are a few recaps:
- U.S. Marshals Seize Food Products at Tennessee Company – FDA announced seizure of cheese and related food products from a facility in Tennessee where FDA inspection found rodent feces, rodent hair, rodent nesting material, to name a few. This is noteworthy given two considerations that affect food safety. First, the move to cut over $220 million from FDA’s budget for this fiscal year and second, the point of view held by some on the Republican side of the aisle that the Food Safety Modernization Act is not in need of funding. I don’t know about you, but I prefer my rats not to be in my cheese.
- FDA Commissioner Calls for Generic User Fees – In a speech at the GPhA Annual Meeting in Orlando actually delivered last week, but I believe only posted to FDA’s site this week, Dr. Margaret Hamburg outlined the need for user fees related to the generics industry which, as she pointed out, is the “only major medical product industry in which FDA provides marketing review that doesn’t have a program.” She outlined her reasoning stating that user fees would provide funding that would allow the agency to move more quickly to address the rapidly increasing number of generic applications that are coming in. That may be true, but it is also true that the House of Representatives is aiming to decrease FDA funding and without the user fees that were supposed to support the Food Safety Modernization Act, money is going to stretch very thin without user fees to support the regulatory process for generics.
- Statement by Pharma Company that it Expects CRL – I’m sure it may have happened before, but I do not know when a company with a New Drug Application before the FDA took the unusual step of announcing that they expected to receive a Complete Response Letter from the FDA before they got the letter. But that is what happened yesterday when Salix Pharmaceuticals issued a press release saying it “anticipated” a Complete Response Letter for the supplemental New Drug Application (sNDA) for XIFAXAN® (rifaximin) 550 mg tablets for the proposed indication of treatment of non–constipation irritable bowel syndrome. The company conveyed the news following a telephone call with the FDA.
That’s it for me this week. I hope everyone has a wonderful weekend. Look for your daffodils coming up! Only two more weeks till Daylight Savings!
