Well, the “poor man’s polar vortex blew through and frankly, while it did make life overall more bearable. But the dogs, the lawn and the flowers all seem happier so that makes it ok by me. I also had my Webinar this week and will be posting a link to a live replay for those who may have been interested and could not make it. Hopefully I will have that by Monday.
In the meantime, here is a bit of what happened this week that was newsworthy:
- Non-OPDP Warning Letter Issued Involving Social Media – Warning letters come from more places than the Office of Prescription Drug Promotion (OPDP) – an office which this year has issued only 5, the lowest rate in two decades – and many more are issued by FDA itself. One such letter involved social media – as happens from time to time. There are two primary sources for understanding FDA’s evolving point of view regarding practices related to social media – one is guidances which despite the recent flurry – have been not very forthcoming over the years – and the other is through warning letters, both from OPDP and from FDA. This particular warning letter came out in June. It is notable to the issue of firm responsibility for content – one of the 5 areas explored during the November 2009 FDA hearing on the Internet, Social Media and promotion. Here this non-OPDP letter cited a number of issues associated with therapeutic claims the company made on its website, Facebook page and Twitter page. But the thing to draw your attention to is the fact that the company “liked” testimonial comments for uses for their products which were not FDA-sanctioned, demonstrating an example of when a company can be held responsible for third party generated content.
- FDA’s “OpenFDA” Provides Access to Recall Data – FDA’s blog FDAVoice carried a posting this week that announced that the agency is opening up access to information regarding recalls and enforcement reports. Apparently at present the agency provided different ways to access information on recalls, including the RSS feed, but is now providing a new Application Programming Interface (API) that provides comprehensive access to the agency’s entire enforcement archive. There is a learning curve associated with its use, but it is interesting and covers prescription drugs, OTC products and more.
- A Followup to the Smallpox Vials Issue – Earlier in the month it was reported that some leftover smallpox vials had been discovered dating apparently from the 1950’s in FDA facilities that had been transferred to the agency from NIH in 1972. This week FDA provided an update on the situation, including the numbers of vials discovered and the fact that agents other than smallpox were included in the discovery as well as a statement on steps moving forward.
- Dr. Woodcock Testifies on Modernizing Clinical Trials – This actually happened last week but the posting was not immediate – last week Dr. Janet Woodcock, the director of CDER, provided testimony before the House Energy and Commerce Committee’s Subcommittee on Health entitled “21st Century Cures: Modernizing Clinical Trials and Incorporating the Patient Perspective” and it is worth the read on many fronts, including giving you a good idea of the rate of approvals in different markets around the world and the current state of approvals, among other things.
That’s it for me this week folks. Have a wonderful summer weekend.