What a week. I’m super busy. Hence I’m’ not publishing the Weekly Roundup until Sunday. Sorry about that Weekly Roundup gauchos. And while lots and lots and lots happened this week, I was left with little or no time to give you my thoughts on it, so today’s Weekly Roundup may be lengthier than usual.
- FDA Provides Update on Melamine Issue – The FDA issued a Health Information Advisory last week regarding Chinese infant formula and the potential for melamine contamination. The agency provided an update to let the public know that there is no known threat of contamination in infant formula manufactured by companies that have met the requirements to sell such products in the United States. That advisory also warned members of Chinese communities in the United States that infant formula manufactured in China, possibly available for purchase at Asian markets, could pose a risk to infants. It states that the FDA had contacted the companies who manufacture infant formula for distribution in the United States and received information from the companies that they are not importing formula or source materials from China. At the same time, the FDA—in conjunction with state and local officials—began a nation-wide investigation to check Asian markets for Chinese manufactured infant formula that may have been brought into the United States. In particular, this effort focused on areas of the country with large Chinese communities, such as Los Angeles, San Francisco, Seattle and New York. To date, investigators have visited more than 1,000 retail markets and have not found Chinese infant formula present on shelves in these markets.
- Waxman Sends Letter to FDA Questioning Priorities – Congressman Waxman has sent Commissioner von Eschenbach a letter that was written because of a particular set of emails within the FDA that to the Congressman’s point of view has indicated that individuals with ties to the pharmaceutical industry have been involved in setting some policy priorities for the agency. To my way of thinking, these "connections" are a bit loose… "Mr. Bradshaw, Mr. Danzis, and the Deputy Secretary of Health and Human Services, Tevi Troy, all have ties to the pharmaceutical industry. Before joining FDA, Mr. Danzis worked for Covington & Burling, LLP where he represented drug companies. A few months after this email exchange, Mr. Bradshaw left FDA to join Hunton & Williams, where he also represents the pharmaceutical industry. Prior to his time in the Bush Administration, Mr. Troy worked for the Hudson Institute and the American Enterprise Institute, two think tanks with ties to the pharmaceutical industry? Mr. Troy is also the brother of former FDA counsel Daniel Troy, now general counsel for GlaxoSmithKline." Frankly, this seems a bit of a stretch – like one of these people was known to take a product made by a pharmaceutical company during the period of their lives…. Congressman, I think you are great, but give me a break.
- FDA Issues Draft Guidance on Genetically Modified Animals – The FDA announced the issuance of a Draft Guidance on Genetically Modified Animals. The comment period for the draft guidance, titled "The Regulation of Genetically Engineered Animals Containing Heritable rDNA Constructs," runs for 60 days and closes Nov. 18, 2008. The 25-page document is available online at http://www.fda.gov/cvm/Guidance/guide187.pdf. "Genetically engineered animals hold great promise for improving human medicine, agriculture, the environment, and the production of new materials, and the FDA has long been involved in their scientific evaluation," said Randall Lutter, Ph.D., deputy commissioner for policy. "Our guidance provides a framework for both GE animals and products made from them to reach the market." You may leave comment on the draft guidance on Genetically Modified Animals.
- EyeonFDA YouTube Channel Adds New Playlist – I have added a new playlist that features Kaiser Family Foundation videos of Barack Obama and John McCain talking about various aspects of healthcare and reforms they would bring if elected. Check it out.
- RNCentral.com Ranks Healthcare Policy Blogs – RNCentral.com created a list of the top 100 healthcare policy blogs. I’m happy to say that Eye on FDA made the list!
That’s it for this week. Again sorry for the paucity of postings. I’ll make up for it next week!