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.
Sometimes events present us with a seismic shift in the environment. And often when that happens, we have to have new language to describe the altered terrain. Inevitably there are gaps in our understanding. Familiar frames of reference become obsolete. We keep trying to look at the world through an old lens that no longer is correctly focused.
The health care sector is full of examples of this. For example, when there is an emerging pathogen in play – like the early days of AIDS, or MERS, or SARS or even Ebola moving from a foreign shore to our own – rumor often runs ahead of fact. New terms are introduced but understanding is scant. It is practically a law of nature – where there is a vacuum in information, it is soon filled by the projection of others.
But rapid change is not limited to emerging pathogens. It can be when technology moves ahead at a rapid clip – like social media – leaving many behind (like FDA) and where myths can easily arise (it is only for kids). And it can be about policy change as well. We have only to look at the unfolding of the debate around the Affordable Care Act where “end of life care” and benefits got translated into “death panels”.
There are two areas where some of these seismic type of shifts could occur in healthcare. We would do well now to prepare for the communications challenges later.
The first is with the passage of the 21st Century Cures Act in the House of Representatives this summer – also known as H.R.6. The vote was 344-77, which in and of itself is something of a wow factor. If the Senate moves and this piece of legislation becomes law, it will institute a huge change in healthcare today – from the way that clinical trials are conducted to the way we access care. There is virtually no stakeholder in healthcare who would not be affected by this Act. The fact that there is a gap in time between the overwhelming passage in the House and its resolution in the Senate means two things. First there is going to be some on-going debate and second, the time is now to get caught up on what the bill does and does not do and how it will change not only our care, but our vernacular when it comes to talking about our health care.
The other area chomping at the bit to burst into a wider reality comes with Telemedicine. There have been a number of surveys about acceptance of the notion of Telemedicine and a recent survey publicized in mobilhealthnews found that 41 percent of American consumer had never heard of telemedicine. As public understanding of Telemedicine may be scant, the fact is that the policy and regulatory aspects of it are going to be debated at the federal and state levels. This is a time for many key stakeholders – from providers to medical societies to payers – to get a firm grasp of the implications and develop their communications to help shape consumer understanding as well as policy.
Because communications is the lynch pin to public understanding, or lack thereof, when the environment quickly undergoes change, looking around the corner and preparing early can save a good deal of headache later. Good communications early can save on the effort to undo bad communications later.
It is the end of July! Even though childhood is far away in my rear view mirror, my year is still defined by the school calendar and I find myself lamenting a bit that the summer is already two-thirds over. And the summer has been anything but relaxing – a heavy travel week meant no postings in-between the Weekly Roundup. Hopefully this coming week will provide more opportunity.
While last week was busy at FDA, this week the summer has dialed down the clock.
In the meantime, here is a bit of what happened:
- Non-surgical Device for Obesity – FDA announced approval of a new device to treat adult obesity. It is aptly called the ReShape Dual Balloon System and it works by taking up space in the stomach to lead one to the sensation of being full. The device is inserted through an endoscopic procedure with the patient under mild sedation and the balloon is inflated after insertion with a sterile solution and patients are advised to pursue a diet plan to supplement. The device is indicated for adults with a BMI between 30 and 40 who have an accompanying obesity-related condition such as high blood pressure, high cholesterol or diabetes. The device is manufactured by a company specializing in non-surgical weight loss also called ReShape.
- AdComm Schedule Dries Up – It has been my observation that there are normally a lot of advisory committees on deck that are slated to happen at almost any given time. By my count there have been 19 advisory committee meetings so far this year. But if you look on the current FDA Advisory Committee calendar you will see that there are NO meetings schedule for August and only two in September. Right now, that’s it. It is just THAT slow of a summer.
- Cilantro Import Ban - And speaking of summer – a slightly uncharacteristic note for Eye on FDA – but since we use it a lot in summer (and it is one of my favorites) – it seemed worth noting that the agency this week issued an import alert regarding some cilantro from Mexico. News coverage provides further detail.
- SocialMedia.org Meeting – And in case you are going to be at the member meeting next week of SocialMedia.org being held in Washington on August 4-5, I hope you will come to my presentation. The meeting topic is “How Government Affect Social Media at Big Brands” and I will be joined by the Federal Trade Commission, the National Labor Relations Board, the Securities Exchange Commission, the White House and more. Three guesses what I’m talking about! #fdasm
That’s it for me this week. Have a good weekend everyone.