It was a funny week here in America. We had the 4th of July – Independence Day – stuck right in the middle of the week, leaving many of us to believe that yesterday was the second Monday of the week. That being said, today would be Tuesday and Friday at the same time…. But at least the traffic was light as nearly everyone seemed to take at least part of the week off. Meanwhile, for those of us who were around all week, here were the going’s on….
- Draft Guidance to Be Published Next Week on Scientific Evaluation of Health Claims – Next week the FDA will post a draft guidance – "Guidance for Industry: Evidence-Based Review System for the Scientific Evaluation of Health Claims". A health claim can apply both to foods as well as dietary supplements. The agency will lay out its current thinking on this topic and they will be accepting comments for a period of time not discussed in the notice.
- EFSA and FDA Strengthen Cooperation in Food Safety Science – In the wake of several high profile food-related issues, many involving Chinese exports, the European Food Safety Authority (EFSA) and the U.S. Food and Drug Administration (FDA) entered an international agreement to assess food safety risk, representing the first such formal agreement EFSA has signed. Unfortunately, the release from the FDA was short on details as to what the priorities will be for the agencies, or how exactly this agreement will work to protect consumers. On a related note, more recalls have been announced respecting Chinese products.
- Also Regarding Food – Meet the Food Czar David Acheson – On July 4th the Washington Post ran a very nice profile of David Acheson, recently appointed Assistant Commissioner for Food Safety. Seems like a very nice and smart fellow.
- Washington Post Runs Good PDUFA Overview – For those interested in learning more about the current round of PDUFA legislation, the Washington Post on July 5 ran a very good overview of the situation. Unfortunately, the article limited itself to a focus on the effect of user fees solely on the FDA. The article, while a good overview of PDUFA, asks us to consider aspects of user fee impact without really talking about the effect of user fees in the EMEA or in the U.K., where user fees provide 100% of regulatory funding. That would have made the article much more useful in assessing the U.S. situation.
- Chinese Ex-Drug Registration Chief Sentenced – According to a Xinhua press release "[f]ormer drug registration official Cao Wenzhuang was given a suspended death sentence by a Beijing court on Friday, following the death sentence given to his former boss, Zheng Xiaoyu." If he were in the U.S., perhaps he could get it commuted entirely.
That’s the roundup for this week folks. Hope you had a good week, and a pleasant holiday – our last until Labor Day!