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Last month, the FDA held open hearings to debate the topic of social media guidelines for the pharma and biotech industry.  I was following from afar on my iPhone at the NY Chemotherapy meeting, as this was the first such hearing since 1996 and many in the industry were excited that the FDA at ,east appeared to be listening and finally getting social media. 

Several things struck me at once while following the Twitter stream on Fabio Gratton's excellent custom site for the purpose,

  1. There were a lot of agency people presenting (some argued they had a vested self interest)
  2. Not many pharma people were actually presenting (despite griping about the lack of guidelines in this space)
  3. Not many patients or patient advocacy groups were involved either.

What was also interesting was that there was plenty of justification for the use of social media, but very little in the way of practical solutions and suggestions that the FDA could consider, thus speeding up the process.

In the past, the FDA have claimed that it is all about the message not the medium, witness sending 14 pharma and biotech companies letters back in April this year for their Google ads with 1 or 2 clicks from the full safety information.  However well intentioned the wrist slap was, it ws later shown to negatively affect public health, as some of the presenters at the meeting clearly showed. 

Rather than look at this incident negatively, I wondered if the respectful and interesting interactions between the FDA DDMAC and industry seen at the hearings could not continue in the same vein on a more frequent basis.  Dialogue and discussion make for much more constructive rather than destructive relationships.

There are several things I'd like to point out about safety and adverse events (AE's):

  • They happen, no drug is immune from them, so best not to avoid them
  • Have policies and procedures for easily recording and submitting AE's
  • The currernt MedWatch reporting system is awful and cumbersome to use
  • If there was a better system, more doctors and patients would be more likely to report them
  • Social media could be a great tool for improving the MedWatch system, reaching more people, more easily and collating the relevant information

What was particularly poignant about these hearings is that, for me at least, a great chance was missed to put patients front and centre, whether this was in the form of better public health information and education or looking at ways to improve clinical outcomes.

Are patients really out of sight and out of mind?

The FDA will still be collecting comments and suggestions until February 2010, so if you missed the hearings this month, please do take the time and contribute offline.  The link to the FDA is here type in FDA-2009-N-0441 in the search box and it will bring up the dockets for comments.

In the meantime, John Mack of Pharma Marketing News is also running an anonymised survey to gather feedback and further suggestions post meeting and will send the aggregated results to the FDA.  Click here to make your views known!

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11 Responses to “FDA, social media and patients”

  1. Chris Iafolla

    Excellent post. In my opinion, the most important piece of this is your question on whether or not patients are really out of sight, out of mind. Part of the problem with the social media divide between pharma companies and the FDA is that they have historically come at it from different angles. The FDA is only concerned with patient safety while pharma was interested in social media first as a way to enhance its brand. The FDA and pharma need to discuss this issue from the same side of the fence. The conversation has to center around the patient. In fact, the patient should be at the center of every social media interaction that a pharma company engages in. This will help to ensure authenticity and transparency. I recently wrote a post on this very topic if you are interested:

  2. John Mack

    I don’t agree that presenters proved public health was harmed because FDA’s warning letters prevented drug companies from running branded sponsored ads on search engines. Yes, their CTRs dropped but no-one has proven any harm to the public as a result. If you have data otherwise, I’d like to see it.

  3. MaverickNY

    John, perhaps my wording could have been been better expressed as I wasn’t present at the hearing, but I was referring to Mark Senak’s synopsis in Eye on the FDA:
    To quote from Mark’s post:
    “Google then made the case that since the FDA issued the April 2 Notice of Violation letters that cited 14 companies for paid search ads covering 45 brands, there has been a sea change in the relevance of ads and their transparency, which in my mind, reinforces the unintended negative public health impact of the FDA’s lack of understanding of the Internet and patient use of the Internet and of the disastrous 14 letters.”
    If the relevancy dropped and more dubious, less transparent ads were displayed as a result, that can hardly be a good thing. Certainly no adverse event or accurate PI information would have been available from those sites, even at 1 or 2 clicks away.

  4. MaverickNY

    Chris, good points.
    However, sometimes in the charge for patient safety, we forget to ask the patients themselves how they search for medical information, what is relevant or useful and what other education could be provided that would enhance safety and public health.
    Totally agree that patients and consumers should be at the centre of the conversation, but it also has to be a two-way street of interaction.
    I wonder if Gilles Frydman or any other patient advocates will join the conversation?

  5. blogaceutics

    Great post, Sally! In my opinion AEs is doctors’ responsability and therefore they should be mainly responsible for reporting them to the FDA, through MedWatch or an improved version of it. On the other hand access to AEs data should be restricted until they have been confirmed by the authorities, otherwise it might cause a lost of confidence and a poor compliance of treatments by patients.

  6. Gilles Frydman

    Great post, Sally!
    I listened to the video feed of the FDA meeting for much of the time. And was shocked at the almost complete lack of the patient voice. How can the FDA conduct a 2-day meeting about social media and not hear the many voices of patients that are using the Internet not for commercial purposes but to advance the care they receive?
    As I said to Aliya Sternstein (see “FDA mulls regulating online claims, discussions about pharmaceuticals” ) the FDA should remember that not everything that is happening via the Internet is searchable. The deep web, the non searchable part of the Internet is considered to be 50 times bigger than the googable part. Millions of people are using a variety of social media technologies to communicate with peers with the same medical issue(s). Not putting these front and center in the conversation with the FDA is, I believe, a fatal mistake and shows that after almost a generation of Internet use, many still do not understand that the age of broadcasting is dead. I’ll certainly say more about this in an upcoming podcast with John Mack.
    IMO, it is fundamental to change the way the FDA interacts with the public. It is another element that will help us foster the principles of participatory medicine where the (e-)patients are engaged and take charge of their health. It is unthinkable that a society fostering constant transparency of businesses and government would not help bring much needed transparency and accountability at the FDA. This could happen if the FDA social media initiative is brought within the confine of the larger OpenGov initiative.

  7. MaverickNY

    Hi Miguel,
    Yes, adverse events are and should be the responsibility of the doctors, but in my experience from clinical trials, they sometimes get snowed under and forget to post the yellow forms and inform the trial sponsors. That’s probably an indicator of what happens with AE’s with marketed products too.

  8. MaverickNY

    ‘The deep web’ is a great observation, Gilles, and warrants a whole blog post on it’s own.
    It’s amazing what kind of useful and supportive debates go on in patient forums, although I have to say some advice I’ve witnessed perhaps one might not be inclined to follow from non-medically qualified personnel. That said, I’ve also seen much better advice and help from sensible patients than I have from community oncologists who are sadly not always as up to speed as one would like.
    The OpenGov initiative is an excellent idea. Personally, I would also like to see the FDA set up working groups with all interested parties, including Pharma and patients to develop a more active and participatory style on an ongoing basis. The challenges we all face with social media are not going to be solved overnight and the web is a fast moving technology, so perhaps an all inclusive longer term project would be to the benefit of all?
    I sincerely look forward to your observations on John’s blog talk radio, so do come back and post the link so that anyone following this debate can be sure not to miss it!

  9. blogaceutics

    Agree! Then the focus must be put on improving the protocols and tools to inform, not to move responsability elsewhere. FDA has to take and address this challenge. Regards.

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