Patient Engagement Mainstreams

One Tuesday morning early in October in 1988, a large group of protestors appeared in front of the building that housed the Food and Drug Administration and effectively shut the agency down. There were hundreds of protesters present, organized by ACT-UP (the AIDS Coalition to Unleash Power) and scores were arrested by glove wearing policemen who told many FDA staffers coming to work to turn around and go home. Said one protester, “[w]e are here for all the people with AIDS but we are also here for all the other people with life-threatening illnesses who need drugs now.” The demands of the protesters were numerous, but chief among them was a greater say in the way clinical trials were conducted and the speed with which drugs were approved.

As a result, the approach to drug approvals changed and mechanisms formally introduced into the process that significantly cut down on the time that it took to get candidate therapies reviewed by the agency. AIDS activism – demanding a greater say – changed the system. The mold of patient advocacy changed shape.

Over the years, those pathways have been refined – Fast Track, Accelerated Approval and the like. But the bottom line is that the involvement of patients into the process changed the status quo and most would argue, for the better.

Patient engagement can mean many things. It can mean that when in a doctor’s office, a patient is engaged with his or her physician to ask important questions. Or it can mean that patients are in a position to have some input into the development of treatments for their conditions. This is about the latter.

In the fall of 2015, FDA formally embarked on the development of a new advisory committee – the Patient Engagement Advisory Committee - by announcing its formation in September and soliciting nominations for membership. According to the Federal Register notice, the agency said that the committee would provide input for FDA related to the development of guidance and policy documents, clinical trial registries, patient preference study design and other aspects related to medical devices. Last week FDA published notice that the committee would be formally added to the roster of Advisory Committees.

That is what is happening with devices. With respect to the development of medicines, FDA has been involved in a five year initiative to get patient input related to drug development though a series of public meetings and a list of the topics and meetings can be found here.

Times have changed from 1988. But a generation following the protest of that Tuesday in October, it would appear that there are more ways and more opportunities for patients to have direct input into the development of treatments. And though the list of demands from that day have yet to be fully addressed, formalizing pathways for greater patient involvement is a start. And it’s not just for patients with life-threatening illnesses, it is for all of us.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in FDA Policy | Comments Off

Weekly Roundup 3.18.16

St. Patrick’s Day is behind us, Easter is before us. And yet, there is a forecast of snow for our area here in the mid-Atlantic looming before us for the weekend. Yes, it is that delightful time of the year when on a recent warm day edging into the mid-seventies you might be inspired to plant your herbs even though something tells you it is too early, and then Mother Nature reminds you that in fact, it was.

Still, we persevere and here are a few things that happened this week I wanted to convey:

  • FDA Starts New Twitter Feed – This week the agency added yet another twitter feed to its assembly of twittering pronouncements called FDA Patient Network – a/k/a @FDA_Patient_Network – making of a total of 18 FDA Twitter feeds. As of this writing, the feed had only two tweets, but the description on the home page for the feed states that they will cover a “range of FDA-specific topics and conducts numerous activities that are of interest to patients” – which seems pretty broad, but hey the more, the merrier. And if you are interested, the @eyeonfda twitter feed has a list to which you can subscribe where you can see all FDA tweets (and feeds) and what FDA is saying.
  • FDA Provides Alteration to Approving Generics -¬†Recently you may have noticed many headlines reporting where the price of a single available generic product were raised astronomically to much public criticism. This week, FDA responded by issuing a new policy that will speed up approvals for generic drugs and prioritize approvals where there is only one product available. This could dramatically speed up the number of competitive generics available thereby making such pricing actions less practical.
  • Expanded Use of Biologic for Use in Lung Cancer - FDA announced expanded approval of Xalkori (crizotinib) for use non-small cell lung cancer for treating tumors that have an ROS-1 gene alteration. As noted in the agency’s press release one of the things that makes lung cancer so difficult to treat is the existence of different mutations. This is the first treatment approved by the agency for treating this particular mutation. The expanded use application had FDA breakthrough status, priority review as well as being designated orphan status. You can review the meaning of these status designations here. You can see the company press release here.

That’s it for me this week folks. Have a great weekend.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

Testimonials – The Pitfalls

People like to get information from people they trust. Moreover, a hallmark of digital communications has been a turning away from large, institutionalized sources for information and turning instead to hear from individuals.

Pew Research has shown that especially for people with chronic conditions, there is a reliance on getting information and support from friends and family and one quarter say that they seek information from people who have the same health condition that they do. In other words, there appears to be good reason for the use of testimonials by patients when seeking to promote a medical product. A patient like me who has faced what I faced and now has been through the experience tells me what it is like, and I may take great stock in what they say.

But while it may make sense, there may be inherent regulatory risks in going down that path – risks that are peculiar to use of testimonials. Why?

Part of the appeal in having a patient describe their experience using a medical product is that they provide a real, first-person description of how the product worked for them and the difference it made for them with respect to their condition. That is also the drawback.

Communications about the use of a medicine are supposed to reflect the label that FDA approved for the product. Going outside of that parameter risks an FDA regulatory action like a warning or untitled letter from the Office of Prescription Drug Promotion (OPDP).

I went through my database of OPDP Warning and Untitled Letters which includes letters from 2004 through today and tracks multiple characteristics of the letters, including descriptions of the communications vehicle (brochure, video, e.g.) and of course, the violations cited. The data base profiles more than 300 letters and over 1000 violations. While not a separate field, when a testimonial has been involved it is noted in the file.

I was able to identify 12 instances in which FDA sent a letter regarding a communication that involved a patient testimonial – in 3 of those instances the patient was also a celebrity spokesperson.

It is noteworthy that the most common violation cited in OPDP letters generally is the minimization or omission of risk information – by far. However, when it comes specifically to patient testimonials, the most common violation was the overstatement of efficacy, involving 11 of the 12 letters.

The basis for that is likely that when a person describes in subjective terms their experience with a medication, it usually includes a reference to the impact the use had on their lives. Phrases such as it “literally changed my life” and “restored my confidence” or describing in personal terms the use of the medication for which evidence does not exist to demonstrate that everyone would have such an experience.

Almost all of the communications vehicles involved video, but it also involved some print.

It also bears reminding that OPDP usually looks not only to an individual statement or action (though that can suffice) but also the entirety of the presentation.

This is not to say that testimonials are bad or should not be attempted, but it does say that one should take care to examine the presentation carefully, with particular sensitivity to the issue of overstatement of efficacy and to take note of historical examples where FDA has acted.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in FDA Policy, Warning Letters | Comments Off

Weekly Roundup 3.11.16

The chives have poked their way up through the winter refuse of leaves and dried stems letting me know it is time to get the garden beds all ready again for Spring and to even be so optimistic as to begin some cautious planting. I fully believe that one day I will have my little farm that I want, but in the meantime, a small back yard that despite its size still overwhelms me, will have to do. In any case, welcome Spring!

And as we prepare ourselves for outdoor labors, here is some of what happened indoors that was interesting this week:

  • FDA Settles “Off-Label” Lawsuit – A long-standing lawsuit regarding corporate speech and off-label discussion of products made the news this week when FDA and the company involved arrived at a settlement. The lawsuit involved a company aiming to use truthful and accurate communication to discuss its product even where the discussion involved an off-label use. A lower court had ruled that FDA could not prohibit such communication. In the settlement it was reported that FDA agreed to circumstances whereby the company could promote an off-label use where the promotion was truthful and not misleading. Despite the fact that the settlement only applies to the company in the lawsuit, it does necessarily beg the questions whether the agency will eventually reconsider its approach to this issue. You can read media coverage of this here.
  • Another DTC StudyLast week it was noted in The Weekly Roundup that FDA was seeking input on a study that the agency would undertake regarding the impact of the use of animation in DTC ads. This week there is another chapter, indicating a broader assessment of DTC advertising, as FDA announced that it was also seeking input into the use of superimposed text and its impact on consumer comprehension. On a related note, all the study would be for naught if Senator Al Franken gets his way – having introduced legislation this week to deny the tax deduction available to companies engaged in RX DTC advertising.

Off to the garden beds!  Have a great weekend everyone.

Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Weekly Roundup | Comments Off

Socializing Medicine – FDA Enforcement Involving Social Media

Have you ever had a conversation with someone who said pharma needs to stay away from social media because it is too risky? Even today, some hold that opinion. When social media, used primarily by individuals in its nascent stage, began to migrate into use by institutions, highly regulated industries were necessarily wary. In particular, the pharmaceutical and biotech industry had reason to be concerned given all of the oversight over promotional speech in print and broadcast. Add to that the slow and often confusing efforts by FDA’s Office of Prescription Drug Promotion (OPDP) to enunciate regulatory positions and what resulted for many was a genuine reluctance to engage.

Today, however, most companies are involved in social media platforms, some more than others, and do so across a spectrum – from career recruitment on Twitter to corporate communications and even a small amount of product-specific efforts. There are hundreds of industry sponsored Twitter feeds, Facebook pages, YouTube channels, Pintrest pages and on Periscope. However, there are still some who believe that digital communications in general, and social media in particular, is a riskier communications adventure than traditional communications vehicles.

In 2013, I tried to address that somewhat by issuing a white paper that compared OPDP enforcement actions as represented by the issuance of Warning or Untitled Letters. Measuring the period when institutional adoption of social media was in its ascendancy – 2008-2012 – the results demonstrated that not only did traditional communications vehicles such as print ads, brochures and sales aids garner the bulk of violations, there was no increase occurring among digital media when you looked at it on a year by by year basis. That analysis was recently updated in a blog posting that again showed no increase in regulatory actions aimed at digital properties.

But that is digital broadly, where have the pitfalls been when it comes to social media?Looking through my warning letter data base which tracks enforcement through a range of characteristics, I came across only six OPDP letters involving a social media communications vehicle. Here is a brief overview:

  • 3 involved YouTube
  • 2 involved Facebook
  • 1 involved Instagram (with subsequent Facebook posting, also deemed violative)
  • It is perhaps notable that no violations occurred involving Twitter, despite the fact that Twitter is likely more heavily utilized by industry in number of outlets, number of updates and number of followers than any other social media platform
  • All in all, with the Instagram posting to Facebook, there were a total of seven social media encounters in the six letters occurring between the years 2008 and 2016 (this year’s only letter so far did involve a YouTube video)
  • Two of the letters involved situations involving the use of patient testimonials
  • Two of the letters were Warning Letters, the rest were Untitled
  • Of these seven, six of the violations had nothing to do whatever with the fact that the communication occurred via social media. In other words, had the same communication been carried in a written brochure, the material still would have been in violation
  • The single violation that did relate to the social media platform was the situation involving a Facebook Share widget whereby the risk information did not convey when shared;
  • In fact, the common thread through all of the social media-related violations was the minimization or omission of risk information

So while not to suggest that social media is risk-free (any communication carries risk), 6 letters involving social media over 6 years is not bad considering the migration of communication by both industry and patients into social media and health.By contrast, looking at the same time period, there were 22 letters citing brochures for violations. While not definitive, it certainly gives you something to respond with next time someone says that social media is too risky for industry.


Share this:
Share this page via Email Share this page via Stumble Upon Share this page via Digg this Share this page via Facebook Share this page via Twitter
Posted in Social Media, Warning Letters | Comments Off