At least here in the mid-Atlantic region, the ground hog appears to have got it wrong, with a week that had quite moderate temperatures. In the herb garden, the chives have popped up, always a harbinger of Spring. I tried to get in a posting this week, but being a short one the week got away from me. It was a short week in a short month and things have moved a bit slower. Even the FDA blog – FDA Voices – has not been updated since February 7.
Still, all that said, things still occur here is a bit of what happened this week that caught my eye, but like the week and month, will be short:
- OPDP Issues First Letter of 2018 – The Office of Prescription Drug Promotion, which last year issued only a total of 5 regulatory action letters, eeked out their first for 2018. Given the enormous focus on opioids by FDA in the past year, it comes as perhaps little surprise that the product involved was an opioid. The communications vehicle was an Exhibit Panel and the violation – only one cited – had to do with supplying incomplete risk information as well as there being issues of placement. Apart from being the first, the letter is significant because it (1) demonstrates that despite the massive slowdown last year in enforcement there nevertheless continues to be activity vis a vis promotion of products and (2) that being the subject of so much scrutiny in this environment, the makers of pain killers and in particular opioid products should take extra care in the presentation of promotional language, especially regarding risk.
- The Destruction of Kratom – Sounds like a SciFi novel doesn’t it? This week FDA announced the voluntary recall and destruction of supplies of the herbal supplement known as Kratom. Earlier in the month, FDA Commissioner Gottlieb released a statement regarding a scientific examination of Kratom asserting that there were opioid compounds present in Kratom. The effort included product under three brand names distributed by one company, but did not say whether there are other brands from other companies still that might be on the market. And in a related development, the Centers for Disease Control also announced an multi-state outbreak of salmonella possibly associated with Kratom. The outbreak to date is reported to have caused 28 cases in 20 states and resulted in 11 hospitalizations.
- The Flu Season and FDA– By all reports, it has been a particularly difficult flu season with the vaccine that had been available this year apparently dipping in terms of its efficacy. Commissioner Gottlieb issued a long statement that details FDA’s involvement in the development of a vaccine each year and notes that the advisory committee meeting that will consider what strains go into the mix for the next season will be occurring shortly – in fact on March 1. He also states that while the development a universal vaccine would be ideal, that it is also something that is likely many years away from reality.
Upcoming Events to Keep an Eye on This Week
- March 1 – Meeting of the Neurological Devices Panel of the Medical Devices Advisory Committee – to discuss evaluation of clinical study data around aneurysm treatment devices
- March 1 – Meeting of the Vaccines and Related Biological Products Advisory Committee – to discuss strains of flu for inclusion in the next 2018-2019 flu vaccine
Regulatory Developments in Pharma/Biotech/Devices
- FDA Denies Formal Dispute Resolution Appeal of CRL
- NDA for Topical ED Treatment Gets CRL
- FDA Sets AdComm Date for Cannabadiol NDA
That’s it for me this week folks. Have a good weekend!