For the past few years here in Washington, the summer ended in August seemingly with the flip of a switch following Labor Day Weekend. The daily threat of storms abated, the high humidity retreated, air conditioners were switched off in favor of open windows and there was a hint of chill in the air each morning. The brown grass starts growing green again. We are still two weeks away, but I, for one, am counting the moments.
And here are a few other things that some may have been counting on that happened this week:
- FDA Approves Drug for Gaucher Disease – Genzyme won FDA approval for Cerdelga (eliglustat) for the long-term treatment of adult patients with Type 1 form of Gaucher disease. Gaucher disease is a rare genetic disorder that results in a person producing an insufficient amount of the glucocerebrosidase enzyme which causes fatty materials to collect in the spleen, liver and bone marrow. Cerdelga inhibits the metabolic process that produces the fatty materials. Cerdelga received orphan drug designation from FDA.
- FDA Allows Marketing of New Type 1 Diabetes Diagnostic – The agency announced this week that it would be allowing the marketing of the first zinc transporter 8 autoantibody (ZnT8Ab) test to help diagnose Type 1 diabetes, the most common form of diabetes diagnosed in children and adolescents. ZnT8Ab is produced by the immune system of many people with type 1 diabetes and the test detects the presence of the antibody in a patient’s blood. The device was reviewed by the agency through the de novo premarket review pathway which is intended for low-to-moderate-risk devices that are not substantially equivalent to an already legally marketed device.
- Plan Related to Diversity and Clinical Trial Data Released – The agency released a plan and had an accompanying blog post from Commissioner Hamburg related to diversity in clinical trials. It is called the “FDA Action Plan to Enhance the Collection and Availability of Demographic Subgroup Data“. The Action Plan follows a report issued last year on the topic and includes 27 different action items that the agency is putting on its “to-do” list that the commissioner states is designed to meet three primary goals – (1) improving quality of data collection regarding sub-groups (the term used by the agency related to diversity); (2) to identify barriers to greater participation among diverse populations; and (3) to make the data collection more transparent. The plan is to be executed by a steering committee and the blog posting states that a website has been set up to track progress, but there was not a link to the website provided.
That’s it for me this week. Enjoy the waning August days.
FDA’s OPDP views nearly all industry communication – whatever the venue and intent – through a lens of advertising. Certainly a big focus of regulatory enforcement has been direct-to-consumer advertising and for a long time, there has been guidance available for both print and broadcast.
From time to time, I have used this space to look at different communications platforms to look at OPDP enforcement patterns consulting the Warning/Untitled Letter database that I have put together. As a reminder the database spans the years 2004-2014, inclusive. There are 294 letters covering over 1000 violations over that period and among other items tracked are the company involved, the product name, the treatment area, the type of communications vehicle and of course the violations, among others. I have pulled together an overview of those letters involving direct-to-consumer advertising. Here are a few of the factoids:
- Of the 294 letters in the database issued since 2004, 58 (19.7 percent) of them involved DTC communications vehicles making it the largest category of communications vehicles involving a letter, followed by Webpages/sites – 56 (19.1 percent) and then Sales Aids – 30 (10.2 percent);
- Of the 58 letters regarding DTC advertising, 22 were Warning Letters (38 percent) which is slightly higher than the ratio of Warning versus Untitled Letters for all letters issued in this time frame (33 percent);
- There were 18 letters involving Broadcast (either radio or TV) while there were 40 letters involving print ads (including Journal Ads);
- The 18 letters for Broadcast DTC had a total of 46 violations (2.5 violations on average) while the 40 letters involving print ads had a total of 107 violations (2.7 violations on average).
The most common violation cited in Warning or Untitled letters is Risk Omission or Minimization. Here is a profile comparison of proportions for each:
One can see that Risk Minimization or Omission was the primary violation for DTC as well as all letters, but that the second highest number of violations in DTC were superiority claims while the second highest for all letters was Overstatement of Efficacy, which may lead one to consider that DTC ads as a communications vehicle may be particularly susceptible to a presentation that implies superiority more readily than most other promotional communications vehicles.
Next time I do a comparison, I’ll look at Websites, the second most common communications vehicle involved in a violation that triggers a Warning or Untitled letter.
In June I put on a Webinar about the communications impact and considerations respecting the upcoming release of data from CMS under the terms of the Sunshine Act. That followed a blog posting from April. The point in both of these was to state that the release of data from earlier this past spring regarding Medicare payments to physicians might serve as a harbinger of what was to come in terms of media coverage with the release of financial data regarding payments from the medical products industry to physicians, teaching hospitals and others.
Specifically, the release of the Medicare payments resulted in headlines that focused on money paid to specific physicians as well to specific categories of medical practice with stories taking a national and regional focus. One could expect much of the same from coverage of the Sunshine Act data, set to be published at the end of September.
However, on August 15 ProPublica reported that the government may actually be withholding one-third of the records from the data base that was to be published, though a press release by CMS on the data base makes no such mention of a delay. A delay would have many likely side-effects, one of which is to impact the nature of the media coverage of the Sunshine Act data. That could occur in at least two major ways.
First, it becomes somewhat challenging to report on the data if the data is incomplete – particularly to the tune of one-third of the data being withheld. What is not known by such a disclosure is just as important as what is known. The stories that would have been written had there been a complete set of data about which physicians – and which types of physicians – have received the most – and which therapeutic areas have had the greatest investment by companies – and which companies have paid the most – all will have to be qualified if data is withheld. In other words, every story would include the caveat – “based on what we know now…” Certainly a release of partial data if that happens would have a diluting effect on the nature of the coverage.
Secondly, if there is a partial release the focus of the story migrates from the amounts of money tracked by the government to the way the amounts of money were tracked and reported. Criticisms about the collection and publication of data will pull attention from the data itself and the stakeholders – to the government agency responsible for collecting it.
Originally the roll out of the Sunshine Act data would have likely had a focus on the actual amounts of money followed by a secondary wave of coverage that might have focused on the process for collecting and reporting the information. A reporting of partial data may result in switching the waves of coverage – with the first focusing on the delay and the second wave on the financial aspects when the data is finally fully reported.
It is hard to believe that I see on Facebook many of my friends who are parents talking about their kids headed back to school this week. Back to school? Back to school? Why when I was a lad, which was really not that long ago, school never began until the day after Labor Day. I know because my birthday is the week before and it left me bitter that I never got to partake in the cupcakes in honor of my birthday that everyone else got during the school year. As you can tell, I have never gotten over that.
What I have gotten over is this past week. Here is a little bit of what happened:
- Fraudulent Ebola Products Alert - FDA issued a statement alerting consumers that they should be aware that there are products being sold online that are claiming to prevent or treat the Ebola virus. The agency reminds consumers that, while there are experimental treatments under investigation, there are no products approved for use either as a treatment or vaccine. The release refers to sources promoting the unapproved and fraudulent products but does not name them.
- New Sleep Drug Approved – The agency announced approval of a new, first-in-class drug to treat insomnia called Balsomra (suvorexant). Balsomra is an orexin receptor antagonist. The agency states that the drug alters the signaling action of orexin in the brain – with orexin being a chemical that is involfved in regulating the sleep-wake cycle. The most common side effect reported was drowsiness and the agency has asked the manufacturer to study next-day driving performance in people who take the drug. The product will be accompanied by a Medication Guide.
- FDA Approves First Non-Invasive DNA Colorectal Cancer Screening Test – Cologard was approved by FDA this week and it is the first stool-based colorectal screening test that would detect the presence of red blood cells along with DNA mutations that could be indicative of the presence of either cancers or precursors to cancers. The test requires a stool sample and will detect the presence of hemoglobin and if a positive test is received, the patient will be recommended for a diagnostic colonoscopy, offering patients a new option in their approach to screening but does not change the current practice guidelines for colorectal cancer screening.
That’s it for me this week folks. Have a good, safe and pleasant weekend. Next week we will take a look at FDA enforcement around DTC advertising. Watch for it!
August is supposed to be slow. And lazy. Laying around doing nothing. That is what Marky the Cow is doing in this picture. (For those of you who are new to Eye on FDA, Marky is a dairy cow in the state of Washington who was named for your’s truly.) Marky the Guy though has not been laying around. You may think I have disappeared, but I have just been very, very busy which means that there have been far fewer postings than usual. And in fact, last week there wasn’t even a Weekly Roundup.
But there is one this week and here it is:
- FDA Publishes Fact Sheet on Ebola – Authorizes Test Use – The watchword of the week has been Ebola with the serious outbreak in Western Africa and the return home for treatment of two American medical personnel working there. This week, on August 5, FDA published “Fact Sheet for Patients: Understanding Results from the Ebola Zaire (Target 1) Real-Time PCR (TaqMan) (EZ!rRT-PCR Test“. The Fact Sheet is actually more of a Q&A and while interesting, it was also noteworthy that in answer to the first question – what is the Ebola Zaire Test – FDA stated that it the “test has not been cleared or approved by the U.S. Food and Drug Administration..” but “FDA has authorized the emergency use of this test under an Emergency Use Authorization (EUA)”.
- CDC Puts Up Comprehensive Ebola Page – In addition, the Centers for Disease Control has put up a very comprehensive page on Ebola hemorrhagic fever on its web site covering topics such as transmission, diagnosis, signs and symptoms and treatment among other things. The page appears to be updated daily with new information. It includes fact sheets and chronologies and would appear to be an excellent resource for multiple stakeholders, including journalists.
- FDA Modifies Hold on Investigative Ebola Treatment – A company that has been researching a possible treatment for Ebola announced this week that while a full clinical hold had been placed on the clinical trial of the investigative compound TKM-Ebola, FDA had conveyed to the them that the hold would be modified to a partial hold. The Phase 1 clinical trial is looking at safety, tolerability and pharmacokinetics of administering the drug to healthy adult volunteers in single ascending doses and multiple ascending doses, though the company – Tekmira Pharmaceuticals – indicated in their release that the multi-ascending dose portion of the trial remains on hold. The story was reported in media on August 7.
That’s it for me this week. Have a good August weekend everyone.
Photo courtesy of Anne Becker.