As we head into the weekend after a busy week, with at least part of the country being informed about significantly cooler temperatures for next week being termed the “poor man’s polar vortex” of the summer – news, if not the name, that is most welcome – here are a few of the things that happened or will happen that are worth noting:
- FDA Holds Webinar on Recent Social Media Guidances -FDA scheduled a Webinar that was held on July 10 for interested parties regarding the publication of the two most recent draft guidances related to industry use of social media. There was keen interest in the Webinar. Here is a link to the slides that were presented. In addition, FDA has created a Web page for industry using social media. Finally, if you would like to hear more on this topic – and hear about it from a communications perspective – I will be holding a Webinar on July 17 at noon. It is my intent to review where we are with social media regulation overall – including the two most recent guidances. I will also raise some implications that became apparent during the agency’s presentation. You can register for it here.
- Consent Decree with Dietary Supplement Manufacturer - Shedding light on the enforcement process here, FDA this week announced that it had entered into a consent decree with a dietary manufacturer in New York. The agency issued a Warning Letter regarding violations of current Good Manufacturing Practices (cGMP) in November 2012 that FDA said went unaddressed. The consent decree terms include the recall and destruction of all dietary supplements manufactured by the company since February 6, 2012 under FDA’s supervision and, of course, to bring manufacturing practices into compliance with cGMP.
- Cellular, Tissues and Gene Therapies Advisory Committee Vacancy – The agency published notice this week that it was seeking nominations for a non-voting industry representative for this important advisory committee. The agency is also soliciting industry organizations interested in participating in the selection. This committee reviews information around human cells, tissues, gene transfer therapies and xenotransplantation products, among other things. The notice has instructions for anyone wishing to nominate or self-nominate.
Optimistically off to find my summer sweaters. Have a good weekend everyone.
I crammed a lot into that title. But here is the skinny. A few weeks ago, FDA issued some new guidances around social media. This week, (yesterday) an untitled letter was posted about a sponsored link - the subject matter of one of the guidances. More on that later.
Next week I am providing a free Webinar on social media and FDA which includes, among other things, my take on the most recent guidance documents. But overall, we will look at the fact that it has been a five year wait to get an answer to five questions. Has it been worth the wait?
A few years back, FDA issued a guidance that merely mentioned social media that ended up creating headiness that the agency had issued social media guidelines, when in fact, that was not the case. Subsequently, there have been other guidances. There have also been a few warning letters. And recently there were two more substantive guidances issued by the agency.
- What, in its totality, does it all mean?
- Which of the five questions now has answers and what are we still waiting for?
- What do we know now that we didn’t know before?
- Will it change anything?
- What difference does it make for those in the pharma industry responsible for communications?
I provided some insight in a prior blog post about the two most recent guidances and I also gave some thoughts in an interview for Pharmalot. On July 17 at 12 noon EST, I am going to provide a comprehensive Webinar on the regulation of social media by FDA – where we’ve been and where we are. I hope you will join me! You can register by clicking here.
From time to time, I field questions centered around FDA press releases and what they say. Every time I would have to go hunt and peck through years of releases to get an answer. Eventually I just put them into a data base so that I could track them categorically and end the scavenger hunt. In February of this year after completing it, I posted a review of the previous year’s releases and what they said and there was a good deal of interest in it – so here is an update looking at the first six months of 2014 – which I can scarcely believe are already over.
What does the agency that oversees the regulation of one-quarter of the U.S. economy have to say for itself? Here is an overview by subject matter:
To put that in context, the chart below compares the first six months of 2013 with the first six months of 2014. A few bullet points of observations:
- There were slightly fewer releases in the first half of 2014 compared to last year;
- There was a significant drop in the numbers of releases related to drugs and an increase in those referring to devices;
- There were slightly fewer announcements regarding approvals – 44 in 2013 compared to 40 in 2014, but perhaps more interesting was the fact that last year nearly 80% of approval announcement involved drugs while this year that dropped to 63%. Correspondingly, last year by this time there were 8 device approvals announced – a number which has nearly doubled to 15 for this year.
- There have been slightly fewer public health alerts and far fewer recalls, but there has been a slight increase in the numbers of new rules and guidances that were announced.
Here it is strictly by the numbers:
Happy Independence Day for America. This week also so Canada Day. So while a week where work productivity may have dipped, enjoyment factors probably drove up – at least in North America. The season is marked by hot, humid days and stormy nights, especially now as Hurricane Arthur takes an excursion along the Southeast coast in the Atlantic. So many things going on.
And here are few from this week that caught my eye related to FDA, pharma and communications:
- Accelerated Approval for a New Drug – Always noteworthy, FDA announced this week the accelerated approval of Beleodaq – a new treatment with orphan status for a type of Non-Hodgkin Lymphoma called peripheral T-Cell lymphoma (PTCL) – one of the ways in which lymph nodes can become cancerous – from Spectrum Pharmaceuticals. The drug works by stopping an enzyme that contributes to T-Cells becoming cancerous and is the third drug approved since 2009 for PTCL, according to FDA and FDA took the unusual step of listing those in this press release. Accelerated approval, it should be noted, allows approval based upon surrogate endpoints which would be reasonably likely to produce a clinical benefit. Accelerated approval is one of four designations that can alter the approval pathway timing and course and differs from Fast Track. Here is an FDA Web page that provides an overview of them. And here is the Guidance on Expedited Programs for Serious Conditions.
- More Information on Regulation of Compounders – In 2012 and throughout 2013, in response to highly publicized adverse events associated with compounded products, policy actions were taken to increase FDA’s authority over that sector resulting in a series of new steps to help define the environment regarding compounding. Eye on FDA has a tab for compiling a historical timeline of many of these actions. This week, FDA announced a series of steps to move the process along, including (1) a draft interim guidance on maintaining current Good Manufacturing Practices (cGMP); (2) a new proposed rule that would revise the list of drugs that may not be compounded; (3) a Final Guidance on the practice of compounding and regulatory actions related thereto; two Federal Register notices – one a list of bulk drugs that may be used in compounding according to one section of the regulations and another for a second section.
- Legal Actions – FDA announced two legal actions that provide insight into different regulatory oversight – the first was against a California company in which the agency was seeking a permanent injunction because FDA said was selling products that were actually over-the-counter (OTC) drug products without approval. The second action related to a dietary supplement manufacturer where the agency obtained a consent decree due after the agency issued warnings about a product being sold that contained ingredients in the form of controlled substances that were not included in the ingredient label.
Time to fire up the grill! Happy Independence Day to U.S. readers; Happy Canada Day to Canadian readers and the rest of you – have a wonderful weekend.