We are at the end of summer. Though not young, my mental calendar is still locked into the mentality regarding the beginning of school. This is the last week to relax before the onslaught of back to school, days full of classes, new people to meet, new subjects to explore. And of course, the coming of Autumn. But first, the last, lazy days to spend at the beach, at cookouts and driving in days that are low in rush-hour traffic.
On that note, I will be taking next week as a end of summer holiday week – so unless something extraordinary happens, there won’t be any postings. However, I will be working on a few things that I hope will interest you when we are “back to school” and in the swing of things.
FDA it seems has already been on vacation – it has been a slow August, but a few items of note:
- Approval for HSDD Drug for Women – Here it is. There has been a long quest to bring to market a drug for women affected by hypoactive sexual desire disorder (HSDD). Back in June, we reported on the Advisory Committee being held to consider approval, having voted 18-6 in favor of a recommendation. Now, the first successful candidate to treat HSDD, Addyi (flibanserin) (and pronounced add-ee) was approved this week by the agency for us in premenopausal women. Much of the media coverage of the approval employed an unfortunate shortcut to describe it – using terms to equate it with male treatments for erectile dysfunction – when it is in fact, quite different. In its press release, FDA stressed that the drug was coming with a Boxed Warning due to its potential effects when used with alcohol (fainting and low blood pressure) and that it would be available as a result only through certified prescribers. The REMS program also extends to pharmacies as well. The treatment, which is not hormonal, was also described by the agency has having a mechanism of action that is not known. The manufacturer – Sprout Pharmaceuticals – said in its press release that it was aiming to have the drug available in mid-October. It was a big news week here as it was also announced that the company was being acquired.
- Consent Decree Related to Supplement Manufacturer – Many times people are under the impression that FDA does not really regulate supplements so it is therefore worth noting when action is taken that sheds a spotlight on the role that FDA has in that regard. In April 2014, FDA issued a Warning Letter to Iowa Select Herbs regarding the misbranding of supplements due to the claims being made in relation to their marketing which would cause them to be drugs rather than supplements. Specifically the claims that FDA centered on related to stated that a range of specific products could treat and prevent very specific conditions. The letter provides a strong example of how FDA can act when certain conditions are present. This week the agency announced that a consent decree which will address the labeling issue.
That’s it for the week, and the summer. Enjoy the last lazy days before the return to school!
The summer is flying by. The lightning bugs have lit up and lit out. The grass has had it. Vacations are nearing an end. The last of the picnics are being planned. Somewhere someone is busy tuning up the yellow school buses so that in a few weeks time, they will be hauling the kids – some eager, some not – back to their school days. Heck, it won’t even be that long before we are looking at a snow day.
It was kind of a slow week (other than the OPDP Warning Letter re the Kim Kardashian social media promotion), here is a bit of what happened in the past few days:
- Big Court Decision on Off Label Speech – It was big news – bigger even than the Warning Letter from OPDP that was issued this week. Everyone by now will have heard the news by now that there was a court decision in New York this week that may put FDA on a bit of a leash when it comes to having its way on off-label promotion by a pharmaceutical company. Specifically Amarin Pharmaceuticals brought suit against the agency asserting that if information about a product were truthful and not misleading, then speech about an off label use should be considered a legal exercise of speech. How this will play out is still a bit up in the air and FDA could appeal, though the company said in a press release that it would begin promotional efforts consistent with the court opinion. I almost wrote a posting on this, but there were greater minds doing a better job of it and you can read some of them here on the FDA Law Blog and here on In the Pipeline.
- Sculpture Protesting FDA Policy on Gay Blood Donation – For many years FDA had a policy that virtually banned blood donations from men who have had sex with men. In 2015, the agency put out a new proposed guideline for blood donation from gay men proposing that blood be accepted from any gay man who has been celibate for a period of one year. While many feel the step is in the right direction, it nevertheless holds gay individuals to a different standard in spite of the fact that donated blood is screened. This week, media reports carried news regarding a new exhibit being put on at the American University Museum in Washington, D.C. featuring a sculpture that contains blood donations from various gay, bisexual and transgendered individuals encased in resin.
- FDA Responds to Energy and Commerce Letter Re Warning Letters - Back in a June posting in the Weekly Roundup, it was noted that FDA had received a letter from the House Energy and Commerce Committee seeking information on how the agency posts Warning Letters as well as how it decides whether to send a Warning or Untitled Letter. In late July, FDA responded to the letter and it has posted to the House E&C site. The deets are more than we can go into here in the Roundup, but I thought they were interesting. See what you think as well.
That’s it for me this week. As we wind down the summer, enjoy!
Can’t say that I ever thought I would be writing about Kim Kardashian here on Eye on FDA, but that just goes to show you, life always entertains surprises.
This week FDA posted a Warning Letter issued to a company for a posting on Instagram and on Facebook by none other than the public figure, Kim Kardashian, promoting the use of a prescription product for morning sickness during pregnancy. In the posting, Kardashian writes about her use of the product – using the product name and providing a link to the website – but without the inclusion of any risk information. There was a link to fuller risk information. The material was submitted to FDA under Form 2253, but was also turned in under the Bad Ads Program.
The omission or provision of incomplete risk information is the most common of violations, but the letter is noteworthy for the fact that it not only employs a high profile celebrity, but that it was put out on multiple social media channels. The existence of the letter may spook those who may view social media with greater trepidation, but had this language been contained in a brochure and not a posting on Instagram, it would have been the same story. In the end, the lesson here is FDA’s old adage – it’s not the medium, it’s the message.
One other thing, as written in this space before, one must take particular care with patient testimonials, not only to include risk information, but to ensure they are well scripted to be compliant.
The dog days of Summer are upon us. No matter what one does, it seems, lawns turn a faded color. Bright daisies and black-eyed Susan flowers dance lazily in gentle breezes. Gazpacho can be a complete meal. The porch swing, while inviting, is only a place to sit for a short while as the ceiling fan does its best to keep us cool. We take solace in the fact that many are on vacation and commutes are nice and easy with both the Congress out and school out.
In the meantime, a bit of what happened this week:
- Approval of 3-D Printable Pill - Aprecia Pharmaceuticals announced this week that it had received FDA approval of the first 3-D printed drug product. The drug is called SPRITAM (levetiracetam) indicated as an adjunct therapy for adults and chlidren with epilepsy and utilizes a technology platform to print a porous formulation of the drug that rapidly dissolves when taken with liquid. The system can deliver high doses of drugs and may be useful for patients who have trouble swallowing pills. And it provides us with one more way 3-D printers can be used.
- Guidance for Finding Guidance – This week the FDA blog – FDA Voice carried a posting regarding a new tool for use in finding guidance documents when you need to. According to the posting, there are over 3100 guidance documents which represent the agency’s thinking on a wide range of issues under FDA’s jurisdiction. The tool is referred to as a dynamic search list – and will afford you access to the guidance no matter where it resides on the FDA site. I tested it out doing a search for “social media” and two guidance documents – one related to character space limitation and one related to correcting third party misinformation came up. But there are other guidances that discuss some aspects of social media – such as the 2011 guidance on Responding to Unsolicited Requests About Off-label Information and the one on Fulfilling Regulatory Requirements for Post-Marketing Submission of Interactive Promotional Media so don’t assume a search term that you enter that is broad will necessarily capture all subject matter. That said, the tool seems to make finding specific guidances much easier.
- OPDP Issues First Warning Letter of 2015 – While there have been 7 Untitled Letters issued by the FDA office that oversees drug promotion regulation, in July the first Warning Letter was issued. One of the violations cited in this letter concerned a professional sales aid that did not contain any risk information but did contain a statement that the sales aid was to remain in the possession of the professional sales representative. The agency did not find the fact that the sales aid was not to be distributed to be a mitigating factor. While this violation was of particular interest, other violations can be seen in the letter.
That’s it for me this week folks. Have a wonderful summer weekend.