FDA Enforcement of Digital Communications – An Update

In 2013, I published a white paper called “FDA Communications Oversight in a Digital Era” that drew upon the data base I had put together of OPDP Warning and Untitled Letters (referred to collectively as “regulatory action letters”). The object of the exercise was to (1) examine whether or not there had been an increase in regulatory action letters aimed at digital communications platforms given the enormous increase in the use of the Internet for health seeking behaviors by consumers/patients and the use of digital and social media platforms by pharmaceutical and biotech companies, and (2) to assess if there was a different in the patterns of enforcement versus more traditional means of communications.

The analysis of letters that (1) the letters aimed at digital/social platforms were lower in proportion to traditional communications (56 percent of the letters aimed at traditional, 44 percent at digital). And (2) when you looked at the more serious type of letter – Warning Letters – nearly 3 out of 4 (73 percent) involved traditional communications vehicles and only one-fourth were among social/digital. Finally (3), the rate per year did not show an increase year over year in the proportion of letters aimed at digital/social.

The analysis looked at letters from the years 2008-2012 to capture the ascendency of social media. I thought enough time had passed to do a little update to see if there had been any change in the patters since 2012.

Since then there have only been a total of 38 letters issued 2013-today, inclusive. Those letters represented 40 different communications vehicles. Of the 38 letters, only 14 involved a digital/social communications vehicle.

So, even though the output from OPDP has been extremely low, from what little experience there is with the issuance of regulatory action letters by the agency there has been no increase in attention to digital media over traditional media since 2012. In fact, if anything, enforcement vis a vis digital media is a diminished focus.

What does it mean? That the EyeonFDA Warning Letter database cannot tell us. Does it mean that digital media is safer than traditional? Probably not. Does it mean that more communications occurs in traditional than in digital? We don’t know, but what I do know from a separate data base that tracks social media activity among pharmaceutical companies, as well as the information supplied on patient use of the Internet in seeking health information and huge number of Websites that exist – it is hard to imagine that digital media around healthcare is dwarfed by traditional. Does it mean that FDA doesn’t care as much about digital and social media as traditional? Again, probably not though some might reasonably think, given the track record on guidance in this area, that it might not be a priority.

Finally, does it mean that industry does not need to exercise as much caution when communicating through digital and social means? Definitely not. In the end, what it may mean is that even as new means of communications come (and go) in digital media (See “Live Streaming – Game Changer at Medical Meetings and Beyond“) FDA is still coming to grips with how to regulate the 21st Century from the 20th.

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Weekly Roundup 6.19.15

No postings this week – sorry about that – travel and business, but will shoot for some good ones next week.

This was another week of tropical rain – the kind that comes and dumps steady water as if a large sponge were being wrung out overhead. The garden is having a mixed experience – the lettuce has had it and so has the dill. The basil, rosemary and thyme on the other hand, appear thrilled. I am less so. In a few days, we will have the longest day of the year. In the meantime, it was an interesting week where the  agency really made some headlines with some news that was both wide and deep and some interesting developments transpired.

  • FDA Moves to Remove Trans Fats – By now, nearly everyone has heard the news that the agency announced this week related to Trans Fats. FDA is giving food manufacturers three years to remove all partially hydrogenated oils (PHOs) – the source of trans fats – from food. This action finalizes a 2013 preliminary determination that PHOs would no longer hold the Generally Regarded as Safe (GRAS) status. You can learn more about GRAS status here. While providing a three year window, FDA is encouraging consumers to check labels to reduce dietary exposure to PHOs. The agency noted in its press release that “currently” food that is labeled as zero transfat may in fact have up to .5 grams per serving. One wonders if the use of the word “currently” signals a change in the future.
  • FDA Partners with PatientsLikeMe – PatientsLikeMe announced this week that the company had entered into a collaborative research agreement with FDA to assess how patient-reported data can have a role in risk assessment and risk management. This new effort appears to open up a new avenue for the reporting of adverse event experiences and pave a new way for the inclusion of patient generated data. In the larger context, patient generated data is occupying a bigger role in medical research – particularly with the addition of wearable devices. There was no word in the release from PatientsLikeMe on the details of the effort.
  • FDA Takes Action on Illegal Website Sales – This week the agency announced that it was participating in the eighth sweep of action against websites globally that are selling unapproved or counterfeit drugs and devices to consumers. According to the release, action was taken against a total of 1050 websites. Called “Operation Pangea VIII”, FDA said it sent Warning Letters to operators of nearly 400 websites and in collaboration with other federal agencies did screenings and seizures of material through International Mail Facilities in various cities in the U.S. FDA also provides in the release resources to help consumers identify whether or not a source is possibly an illegal pharmacy.

That’s it for me this week folks. Have a good weekend and enjoy the longest day of the year. Happy Summer!

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Weekly Roundup 6.12.15

It is as if the calendar just knows when to turn up the heat. We have crossed over into the second week of June and already we face days that head into the 90s and late afternoon thunderstorms that characterize this time of year. It seems like only yesterday the daffodils were waving in a nippy Spring breeze. Soon, the newly arrived grass will look thirsty and sad. But let’s not get ahead of ourselves.

Some things did move ahead this week though – certainly there was a lot of advisory committee action, so let’s take a look at it.

  • Cholesterol Considerations – The Endocrinologic and Metabolic Drugs Advisory Committee met on June 9 and 10 this week and both days reviewed data for two investigative compounds seeking a cholesterol lowering indication. On June 9, the committee reviewed Praluent (alirocumab) Injection – a monoclonal antibody. The sponsors, Regeneron and Sanofi announced that the committee voted 13-3 that the cholesterol lowering benefit of the compound exceeded risks to the degree that supported approval. The safety and efficacy data included more than 5,000 patients from 10 pivotal phase 3 double blind trials. On the 10th, Amgen got its turn to discuss data on another biologic for the proposed indication of cholesterol treatment called Repatha (evolocumab). According to media coverage, the committee indicated approval with an 11-4 vote, but also got a recommendation for approval in treating a rare subset of familial hypercholesterolemia caused by genetic disease in a unanimous vote.
  • Asthma Treatment Recommendation – The Pulmonary-Allergy Drugs Advisory Committee also met this week on June 11 to consider another biologic, mepolizumab – an IL-5 monoclonal antibody, this time proposed to treat asthma as an add-on maintenance treatment in patients 12 and older, submitted by GlaxoSmithKline. The company announced a unanimous vote in favor of recommending approval (14-0) for use in adults, but ultimately did not recommend approval for adolescents aged 12-17 with severe asthma, seeking further data. The company mentioned that the PDUFA date for the compound is November 4. While regulatory filings have been made outside the U.S., it is not yet approved in any country.
  • FDA Issues Guidance on Drug Development for Duchenne – The agency is also announcing the availability of a draft guidance for drug development to treat Duchenne Muscular Dystrophy (DMD) – a form of muscular dystrophy that is caused by a genetic mutation that leads to muscle degeneration and resulting decreased life expectancy and a condition where treatments are needed. A docket has been opened for the submission of comments.

That’s all for me this week. Stay cool everyone!

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Live Streaming – Game Changer for AdComms and Beyond?

This week there was a lot of talk about last week and the meeting of the American Society of Clinical Oncology annual meeting ASCO 15, which was the 51st annual meeting of the society held May 29 – June 2 in Chicago. Naturally most of the talk was reserved for the clinical developments that were presented at the meeting that could have an important impact on a range of cancers faced by so many. But some of the talk was focused not on the news, but the way the news from the meeting could be reported. We are talking live streaming.

Live streaming is not new. My ability to use it is.

This year, platforms have emerged that allow a person to live-stream with the use of their phone – noteworthy examples being Meerkat (love the name) and Periscope (also a good name), the latter being an effort owned by the good people at Twitter. This is not meant to be a comparison of the two apps, you can get that in many places.  Google it. And here is one. Learn about live streaming.

But the point is that I, or any one of you, can now pick up our phone (that handy little item with which we used to make phone calls) and live stream from where we are to all of our friends wherever they are. Who would be watching it? Well, you can have followers like any other media platform who will watch you, but with the advent of these apps, you can bring in everyone who follows you on Twitter.  As you begin to stream, your Twitter account can send out a tweet with a link letting your followers know that you have content that is being produced. And if they miss it, with Periscope, they can catch a replay – or they can watch what you’ve live streamed a second time, if it is just that good.

The ability of anyone, anywhere, having the ability to live stream events or proceedings brings into play some new policy questions. At ASCO, a few reporters used live streaming to report on events, but the technology in effect makes us all reporters. And it raises interesting policy questions. For venues that are non-public in nature – i.e., sponsored – there could be a policy decision laid down that live streaming is not permitted – but how would it be enforced? Would some venues – such as a live performance play or concert – be regarded as off limits while others – such as a meeting (any meeting) – be considered fair play?

And certainly public meetings – hearings before Congress, for example, would be open to live streaming. Every Congressman has a twitter feed, maybe at some point they will be live streaming to us. And of course, there are advisory committees. Right now, many tweet various snippets of meetings, but conceivably one could live stream to one’s own followers. Or just sections of a meeting, like the voting which is the only thing many would care about – such as the vote.

And then there are even one on one meetings with public officials. Live streaming brings transparency to the front burner most certainly. Can a public official forbid you to live stream a meeting?

Social media and the Internet have long represented a democratization of communications. Live streaming from your phone to Twitter – well it maybe takes things up a notch. Whoever you are – FDA official, drug company, medical society – it is probably a good idea to consider the strategic and policy implications and plan accordingly.

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Weekly Roundup 6.5.15

It has been a week of rain and gloom in our nation’s seat of government. It has been cold, gray and unpleasant. Commutes are nasty. The lack of sunshine is getting serious. But on the bright side, pollen has been washed away, the garden appears happy and baby birds have hatched in one of the hanging baskets of flowers I keep on the front porch. So the glass remains more than half full.

Here is a bit of what happened in FDA-world and a little beyond this week that I thought noteworthy and hope you do too:

  • NIH Suspends Operations of its Clinical Center Pharmaceutical Development Section Following FDA Inspection – Big oops. On Thursday this week NIH announced that it had suspended operations of its own Pharmaceutical Development Section (PDS) following an FDA inspection. According to the release, FDA responded to the receipt of a complaint and conducted an inspection in late may and discovered what NIH termed as “serious manufacturing problems and a lack of compliance with standard operating procedures.” NIH Director Francis S. Collins, M.D., Ph.D was quoted as saying that he would be personally overseeing the steps to address the situation.  The inspection report is located here and media coverage here.
  • Congressman Concerned Over FDA Inspection Letters - And speaking of FDA inspections, Ed Silverman this week reported on the Wall Street Journal Pharmalot site an interesting development. Congressman Tim Murphy has sent a letter to FDA seeking details related to the agency’s policies in posting untitled letters regarding manufacturing problems discovered in the facilities of companies making pharmaceuticals. Specifically, he is looking for insights on the timing of posting such letters along with what does into the decision into how detailed the letters are when posted. The concerns seem to be related not to warning and untitled letters from the Office of Prescription Drug Promotion, but rather those that are results of inspections of facilities. The letter was sent ont he 27th of May – no word as to when FDA will respond or if the response will be posted.
  • AdComm Approval for HSDD Drug – There have been past attempts to provide a treatment for women experiencing Hypoactive Sexual Desire Disorder but this week we saw the first to get a recommendation for approval by an FDA Advisory Committee. Sprout Pharmaceuticals announced that the company’s investigational product ADDYI (flibanserin) was recommended for approval in an 18-6 vote on the condition that certain risk management options beyond labeling are put into place. While men have had many pharmaceutical options for the treatment of erectile dysfunction, relief for women has not been as forthcoming. All eyes now go to FDA to see what it will do in response to the recommendation.

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

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