2016 is speeding by. We are over two-thirds of the way through the first quarter. Mother Nature continues to taunt us. Daffodils were blooming this week, only to have snow accumulating around the blossoms today. Election fever runs rampant as does a never-ending flow of commentary. At FDA, the enforcement page once again displays very little going on – with only a single OPDP letter issued so far this year.
There was actually a lot going on at the agency this week, but in the interest of brevity, here are a few things that caught my eye. There is a lot about Zika this week and given the outbreak and the approaching summer, that is a trend likely to continue.
- FDA Testifies on Zika Before House – FDA Chief Scientist Luciana Borio, M.D. appeared before the Subcommittee on Oversight and Investigations, House Energy and Commerce Committee this week to talk Zika, covering key areas of concern and FDA activities related thereto. A full text of her remarks can be found here. Summarily she covered:
- Blood and Tissue Safety – She stated that in absence of a blood screening assay, risk of transmission by blood transfusion is considered likely. To that end, FDA has issued new blood donor guidance and this week (see below) issued guidance for human cells and tissue based products. She said FDA is facilitating the development of tests for screening blood;
- Diagnostic Testing – While there are no commercially available tests now, she stated that the agency has been reaching out to potential manufacturers to encourage and accelerate development and she said that under Emergency Use Authority that FDA had authorized the use of a test for detection of antibodies;
- Vaccines and Therapies – She stated that there were not any treatments or vaccines in advanced development at this time;
- Vector Control – She did state that FDA is reviewing information regarding the potential of a genetically engineered mosquito that might help suppress mosquito populations – however if approved an environmental assessment would have to be conducted and released;
- Fraud – She stated that the agency would be actively monitoring for product claims related to Zika and will implement enforcement actions if necessary.
- FDA Recos on Zika and Human Tissue/Cells – A few weeks ago FDA issued recommendations related to Zika and the blood supply and this week the agency followed up with Human Tissue and Cell products. In some respects, the recommendations are similar to those for blood – donors should be considered ineligible if they were diagnosed with infection or were in an area with active transmission or had sex with a male with either of those risk factors in the past six months. However, since tissue donation includes that from non-living donors the agency stated that donations should not be considered if the donor had been diagnosed within the past six months – a period chosen with limited data in mind.
- FDA to Study Cartoon Use in RX DTC Ads – The agency published intent this week in the Federal Register to conduct a study examining the effects of using cartoons in direct-to-consumer advertising of pharmaceutical products to determine if it is a distraction for viewers when it comes to risk information. The agency is seeking public comment on this. As of this writing, no comments had been submitted, but if you are so inclined…. here is a link.
That’s it for me this week folks. Have a good and safe weekend.