Last week you may have noted I was highly deficient in postings. My apologies, but some personal circumstances made it very difficult for me to post each day. Hopefully this week, things will have settled down for me a bit to resume my routine. In the meantime, while not a weekly roundup, here are some of the things that caught my attention while I was otherwise engaged.
- FDA Statement on "Erythropoiesis-Stimulating Agents (ESA)" - On June 26th, John Jenkins, M.D. Director, Office of New Drugs, Center for Drug Evaluation and Research, Food and Drug Administration delivered testimony before the Committee on Ways and Means, Subcommittee on Health, United States House of Representatives. He provided an extremely thorough job of outlining the regulatory history of this class of drugs, reviewing label changes and providing an overview of studies that were both successful and not. It is good reading for anyone interested in the class or the current swirl of attention around it.
- More Bad News About Chinese Imports – FDA Detains Imports of Farm-Raised Chinese Seafood – I don’t know about you, but I’m going through my pantry to toss anything that came from China. I’m not even sure I’m going back to my favorite Chinese restaurant that makes the most excellent Peking Duck. The agency announced last Thursday a broader import control of all farm-raised catfish, basa, shrimp, dace (related to carp), and eel from China. "We’re taking this strong step because of current and continuing evidence that certain Chinese aquaculture products imported into the United States contain illegal substances that are not permitted in seafood sold in the United States," said Dr. David Acheson, FDA’s assistant commissioner for food protection. "We will accept entries of these products from Chinese firms that demonstrate compliance with our requirements and safety standards." Is the spate of bad news about China a coincidence or an indication of a market that grew faster than the government’s ability to appropriately regulate it?
- New Malaria Quick Test Approved - The Binax NOW Malaria Test, manufactured by Binax Inc., a subsidiary of Inverness Medical Innovations Inc. of Scarborough, Maine, has been cleared for marketing by the FDA. This may be an important development for the millions of people world-wide, particularly women and children, who are at risk for malaria.
I do hope to be better this week and plan a piece this week that looks at Consent Decrees – what causes them and what should companies do?