FDA Issues a Guidance and the Social Media World is Disappointed…hmmmm
01/11/12 22:35 Filed in: Social Media Regulation | Off-label promotion
FDA issued a guidance document in late December on responding to unsolicited requests for medical information. Lots and lots and lots and lots and lots of people have anticipated this and have described this as a "social media guidance." It isn't. Never was and never could have been. Of course, it's not entirely unreasonable for people to have this impression since FDA touted this particular guidance document (prior to its issuance) as a social media guidance (of sorts). On multiple occasions, FDA personnel announced at public meetings that this guidance was a part of its efforts to provide guidance on social and electronic media. But its not very instructive when it comes to the multitude of platforms and possibilities that drug, biologic, and medical device manufacturers have to communicate in new media spaces. That's bad news for all the media agencies and pundits and consultants who are living and dying in the new and social media space. But there's good news!
The good news for drug, biologic and medical device manufacturers is that the guidance is good, and useful, and clarifies an issue even more desperate in need of clarification than social media. The entire concept of the unsolicited request is an industry convention that lacks any formal acknowledgment in the law and regulations, and is practiced widely every day by companies and even enforced by FDA and the Department of Justice. In a way, FDA is providing guidance on something that isn't even really the law (at least explicitly). Overall, I don't find anything entirely surprising about the guidance document. It aligns squarely with my thinking on how FDA thinks (not necessarily how I think, but I get paid to think about how FDA thinks about things).
So anyway, I was on twitter and I saw that someone had catalogued a bunch of articles on FDA's social media guidance and was disappointed to see so many articles waxing poetically about what the guidance means or doesn't mean for social media and FDA guidance on social media and I just have to step back and acknowledge that the guidance wasn't a social media guidance. If you thought it was, perhaps you were mislead. I don't think FDA meant to mislead you, but they all along told the public that this guidance was about responding to unsolicited requests and said they would include some content on what this meant in social media. I think FDA misjudged how many people were going to misunderstand what this meant. This is not FDA's reaction to the 2009 public hearing, it is a sign of how FDA is reacting to the public hearing. Slow and deliberate slow deliberation.
Anyway, sorry for a lack of true analysis of the guidance. In a way I feel like this blog post is a total cop out. But the fact is, as a regulatory professional (who also engages in social media), I am too busy dealing with other regulatory issues (like making sure companies response appropriately to unsolicited requests), than to pundit today about FDA's social media guidance approach. I don't mean at all to sound smug either, but this is an indication of FDA's approach to its regulatory priorities. FDA has lots of other issues to tackle along with social media. Moreover, I do believe that FDA has social and electronic media as an important guidance and enforcement priority. However, they have too much to lose by getting a guidance wrong, so they're gonna work sloooooooowly. Expect maybe, maybe, one or two guidances over the next 5 years. Maybe even one that focuses solely on social media.When that one comes out, expect FDA to articulate how the regulations apply to the media, but don't expect FDA to articulate how you can use new media and comply with regulations (that's not really FDA's job). It is possible that many platforms cannot comply with regulations, or that once you apply FDA's guidance you will come to that conclusion. I guarantee one thing. Whatever guidance they issue that everyone is longing for…this guidance… will be sure to disappoint anyone who is expecting the guidance to open up the floodgates of business opportunity.
The good news for drug, biologic and medical device manufacturers is that the guidance is good, and useful, and clarifies an issue even more desperate in need of clarification than social media. The entire concept of the unsolicited request is an industry convention that lacks any formal acknowledgment in the law and regulations, and is practiced widely every day by companies and even enforced by FDA and the Department of Justice. In a way, FDA is providing guidance on something that isn't even really the law (at least explicitly). Overall, I don't find anything entirely surprising about the guidance document. It aligns squarely with my thinking on how FDA thinks (not necessarily how I think, but I get paid to think about how FDA thinks about things).
So anyway, I was on twitter and I saw that someone had catalogued a bunch of articles on FDA's social media guidance and was disappointed to see so many articles waxing poetically about what the guidance means or doesn't mean for social media and FDA guidance on social media and I just have to step back and acknowledge that the guidance wasn't a social media guidance. If you thought it was, perhaps you were mislead. I don't think FDA meant to mislead you, but they all along told the public that this guidance was about responding to unsolicited requests and said they would include some content on what this meant in social media. I think FDA misjudged how many people were going to misunderstand what this meant. This is not FDA's reaction to the 2009 public hearing, it is a sign of how FDA is reacting to the public hearing. Slow and deliberate slow deliberation.
Anyway, sorry for a lack of true analysis of the guidance. In a way I feel like this blog post is a total cop out. But the fact is, as a regulatory professional (who also engages in social media), I am too busy dealing with other regulatory issues (like making sure companies response appropriately to unsolicited requests), than to pundit today about FDA's social media guidance approach. I don't mean at all to sound smug either, but this is an indication of FDA's approach to its regulatory priorities. FDA has lots of other issues to tackle along with social media. Moreover, I do believe that FDA has social and electronic media as an important guidance and enforcement priority. However, they have too much to lose by getting a guidance wrong, so they're gonna work sloooooooowly. Expect maybe, maybe, one or two guidances over the next 5 years. Maybe even one that focuses solely on social media.When that one comes out, expect FDA to articulate how the regulations apply to the media, but don't expect FDA to articulate how you can use new media and comply with regulations (that's not really FDA's job). It is possible that many platforms cannot comply with regulations, or that once you apply FDA's guidance you will come to that conclusion. I guarantee one thing. Whatever guidance they issue that everyone is longing for…this guidance… will be sure to disappoint anyone who is expecting the guidance to open up the floodgates of business opportunity.
0 Comments
Where Is the Rain?
03/31/11 20:00 Filed in: FDA Enforcement
So here we are at the brink of the second quarter of 2011 and we've seen a substantial slowing of FDA enforcement coming from DDMAC. In the past few years, it has looked as if FDA was entering into a sustained period of steady enforcement actions. Yet as we complete the first three months of 2011, DDMAC has issued only 4 total letters pacing for 16 letters total for the year. In 2010, DDMAC alone issued 52 enforcement actions (warning and untitled letters).
Top 5 Health Care or Regulatory Songs of All Time
02/17/11 22:42 Filed in: Fun Stuff
You know honestly, I do find it hard to focus sometimes. So sometimes I need to just treat myself to something funner than analyzing regulatory issues. Nonetheless, to do that and do it here still requires that the topic is relevant to regulation and healthcare. So I decided to put together my list of the 5 greatest (and I mean indisputably greatest) healthcare and regulation songs ever.
The criteria is that
1) The song has to do with patient care, medicine, or regulations
AND
2) It has to be an awesome song. So even though there may be more obviously relevant songs to medicine (e.g., "Doctor My Eyes" by Jackson Brown, "Bad Medicine" by Bon Jovi, or "Doctor Love" by KISS) they don't make the list because I don't think they're good songs. They either bore me to tears or the "cheese factor" is off the charts. Don't bother arguing with me about this either, because I'm the emperor of truth and taste on this particular blog post.
So here goes. I'll start with number one to avoid the whole "countdown and suspense" cliche.
1. Smokers Outside Hospital Doors by Editors This song has one of the more poignant lines in music I've ever heard "The saddest thing that I'd ever seen were smokers outside the hospital doors." For a bunch of young artists to point out one of the most commonly seen tragic ironies of healthcare with such a simple vivid image earns this song the number one spot. It also is just a really beautiful song full of spiraling ear-piercing guitars (I'm a softie for those). Listen to and view the song below. Sony wouldn't let me embed the official video, but there are two excellent performances below from the band. The first one is a toned down version that captures the song nicely. The second one is a live version more true to the original recording that requires listening at full volume!
2. Someone Saved My Life Tonight by Elton John. Ok this song is really about Elton John being convinced by a friend not to get married, hence his friend "saved" his life. Nonetheless, if you misunderstand the lyrics properly, then you can enjoy the distorted reality that this is really about medically saving peoples lives. Not a stretch at all. It's one of my favorite all time songs, and, through the magic of youtube, I discovered a solo performance of this song from the mid seventies that blows my mind. Listen to and view the song below.
3. Sister Morphine by the Rolling Stones. It would be hard not to put a Stones song on this list since they're probably one of the most hospitalized bands of all time. Also, it begins with the line "Here I lie in my hospital bed, tell me Sister Morphine, when are you coming 'round again?" So, its definitely about institutional care and addiction and an important FDA regulated drug (morphine). It's also from perhaps the most consistently excellent Stones album ever--Sticky Fingers. "The scream of the ambulance is sounding in my ear. Tell me Sister Morphine, how long have I been lying here?" Listen to and view the song below.
4. What Sarah Said by Death Cab for Cutie. This is a really sad song about someone dying in a hospital. It's really just a beautiful song and if you're not paying attention to the lyrics, its easy to just think to yourself "this is a really great song." But if you listen closely to the lyrics you understand that narrator is depicting the experience of being in a hospital visiting someone dying in an ICU and expressing very painful and beautiful insights. If you're uninitiated to Death Cab for Cutie, don't let the name of the band fool you. It's not some heavy death metal band or missanthopic punk band, they're a smart melodic band with excellent songwriting. The song What Sarah Said, to me, is perhaps the most meaningful song about health care I've ever heard. Seriously. If you sell, make, administer, or take healthcare products, its a beautiful reminder of death, dying, and caring. In reality, this is the #1 song on this list, but I put it at number 4 to stun you with truth. Listen to the song below. Youtube doesn't really have a good performance of the song, and the official video is somewhat hard to watch but here's a good selection that gives you a sense of the song. Ethics in medicine and in medical marketing requires a conscience and a conscience requires compassion. This song drips of the concept of compassion.
5. The Catastrophe and the Cure by Explosions in the Sky--I might have mentioned that I love soaring electric guitars. This band makes songs with no singing. But the song is called catastrophe and "cure" so it must be about medicine. And it's good and I can sit back and listen to it on my earphones on my iphone while I type my regulationships blog. Therefore, Good Song+Reference to "cure" in the song title=#5 song on my list. Check out this performance from Austin City Limits on PBS. The drummer is insanely excellent.
6. Light and Day the Polyphonic Spree--This song makes the list because a) the Polyphonic Spree is maybe my favorite band over the last 5 or 6 years, but also b) because this excellent song was in a mind blowing surreal scene in an episode of Scrubs! See the video below. I give you the scrubs version and also the official version too just in case you want to listen to it all the way through. You might have noticed that this Top 5 list has 6 songs. So it does. Sorry, medicine is unpredictable and full of on-the-fly decisions--and so is my top 5 list of the 6 greatest health care songs. Universal Music Group may throw a bullet into the ability to embed the videos on my site, but I just couldn't leave this song off the list because of that. You can click the link below to see the video on youtube if clicking the link on the video player doesn't work. I think the it should work though.
The "Scrubs" version
http://www.youtube.com/watch?v=mUHgKBw994A
The Official version
http://www.youtube.com/watch?v=rHJo_klmPcA
So that's my list. If you have suggestions for something I left off, please let me know. Remember though, it has to be a good song and a song I like and you must relate it to healthcare or medicine.
JM
The criteria is that
1) The song has to do with patient care, medicine, or regulations
AND
2) It has to be an awesome song. So even though there may be more obviously relevant songs to medicine (e.g., "Doctor My Eyes" by Jackson Brown, "Bad Medicine" by Bon Jovi, or "Doctor Love" by KISS) they don't make the list because I don't think they're good songs. They either bore me to tears or the "cheese factor" is off the charts. Don't bother arguing with me about this either, because I'm the emperor of truth and taste on this particular blog post.
So here goes. I'll start with number one to avoid the whole "countdown and suspense" cliche.
1. Smokers Outside Hospital Doors by Editors This song has one of the more poignant lines in music I've ever heard "The saddest thing that I'd ever seen were smokers outside the hospital doors." For a bunch of young artists to point out one of the most commonly seen tragic ironies of healthcare with such a simple vivid image earns this song the number one spot. It also is just a really beautiful song full of spiraling ear-piercing guitars (I'm a softie for those). Listen to and view the song below. Sony wouldn't let me embed the official video, but there are two excellent performances below from the band. The first one is a toned down version that captures the song nicely. The second one is a live version more true to the original recording that requires listening at full volume!
2. Someone Saved My Life Tonight by Elton John. Ok this song is really about Elton John being convinced by a friend not to get married, hence his friend "saved" his life. Nonetheless, if you misunderstand the lyrics properly, then you can enjoy the distorted reality that this is really about medically saving peoples lives. Not a stretch at all. It's one of my favorite all time songs, and, through the magic of youtube, I discovered a solo performance of this song from the mid seventies that blows my mind. Listen to and view the song below.
3. Sister Morphine by the Rolling Stones. It would be hard not to put a Stones song on this list since they're probably one of the most hospitalized bands of all time. Also, it begins with the line "Here I lie in my hospital bed, tell me Sister Morphine, when are you coming 'round again?" So, its definitely about institutional care and addiction and an important FDA regulated drug (morphine). It's also from perhaps the most consistently excellent Stones album ever--Sticky Fingers. "The scream of the ambulance is sounding in my ear. Tell me Sister Morphine, how long have I been lying here?" Listen to and view the song below.
4. What Sarah Said by Death Cab for Cutie. This is a really sad song about someone dying in a hospital. It's really just a beautiful song and if you're not paying attention to the lyrics, its easy to just think to yourself "this is a really great song." But if you listen closely to the lyrics you understand that narrator is depicting the experience of being in a hospital visiting someone dying in an ICU and expressing very painful and beautiful insights. If you're uninitiated to Death Cab for Cutie, don't let the name of the band fool you. It's not some heavy death metal band or missanthopic punk band, they're a smart melodic band with excellent songwriting. The song What Sarah Said, to me, is perhaps the most meaningful song about health care I've ever heard. Seriously. If you sell, make, administer, or take healthcare products, its a beautiful reminder of death, dying, and caring. In reality, this is the #1 song on this list, but I put it at number 4 to stun you with truth. Listen to the song below. Youtube doesn't really have a good performance of the song, and the official video is somewhat hard to watch but here's a good selection that gives you a sense of the song. Ethics in medicine and in medical marketing requires a conscience and a conscience requires compassion. This song drips of the concept of compassion.
5. The Catastrophe and the Cure by Explosions in the Sky--I might have mentioned that I love soaring electric guitars. This band makes songs with no singing. But the song is called catastrophe and "cure" so it must be about medicine. And it's good and I can sit back and listen to it on my earphones on my iphone while I type my regulationships blog. Therefore, Good Song+Reference to "cure" in the song title=#5 song on my list. Check out this performance from Austin City Limits on PBS. The drummer is insanely excellent.
6. Light and Day the Polyphonic Spree--This song makes the list because a) the Polyphonic Spree is maybe my favorite band over the last 5 or 6 years, but also b) because this excellent song was in a mind blowing surreal scene in an episode of Scrubs! See the video below. I give you the scrubs version and also the official version too just in case you want to listen to it all the way through. You might have noticed that this Top 5 list has 6 songs. So it does. Sorry, medicine is unpredictable and full of on-the-fly decisions--and so is my top 5 list of the 6 greatest health care songs. Universal Music Group may throw a bullet into the ability to embed the videos on my site, but I just couldn't leave this song off the list because of that. You can click the link below to see the video on youtube if clicking the link on the video player doesn't work. I think the it should work though.
The "Scrubs" version
http://www.youtube.com/watch?v=mUHgKBw994A
The Official version
http://www.youtube.com/watch?v=rHJo_klmPcA
So that's my list. If you have suggestions for something I left off, please let me know. Remember though, it has to be a good song and a song I like and you must relate it to healthcare or medicine.
JM
I'm Back and Speaking at DIA on February 22
02/09/11 22:26 Filed in: Announcements
Oh boy, well, I haven't done a blog post since last November (last November 2010!), and it was all about Social Media regulation in the wake of FDA's public meeting on electronic and social media. And Oh boy, well, where's that guidance document everyone is clamoring for? That's the speed of FDA. If you're new to paying attention to FDA's guidance or rule making productivity, this is about the pace you get. I'm not saying FDA is being lazy or slow either, but the process is slow, is fraught with competing priorities and other administrative gauntlets. Moreover, industry lack of prolific use of new social media technologies really isn't harming anyone, so I'd say I'm certain FDA has bigger priorities on any given day.
Enough about FDA, sometimes this site is just about me. And me explaining myself. I've been terribly busy. It was a crazy year being a regulatory person. And yes, I did work on some social media stuff, but most of my work was dealing with lots of other issues largely unrelated to social media. So be it. I didn't blog. I didn't tweet (much) and didn't really pay attention to any tweets or blogs. And, you know what? I don't feel any less informed or less connected to my world and my clients. Wait...I do confess...I pay attention to the Pharmalot blog, a lot. Thanks Ed for getting back on track.
I do want to tell you though that I'll be making a rare public appearance at the DIA meeting in Washington in two weeks hosting a panel of esteemed colleagues to discuss FDA regulation of health economic information and the rise of comparative effectiveness research. This is a super great topic. In fact, I think it may be the single most important regulatory topic over the next decade. A case of regulatory policy, public and private interest, and Federal Legislation all at war with one another. I'll share my thoughts soon on this blog, but in the meantime if you're at the DIA meeting, come to our panel discussion on the 22nd of February.
So anyway, I'm back, somewhat embarrassed by my lack of blogging, and remain fully committed to being more prolific on this site if time permits and if I have the energy and initiative. How's that for commitment?
JM
Enough about FDA, sometimes this site is just about me. And me explaining myself. I've been terribly busy. It was a crazy year being a regulatory person. And yes, I did work on some social media stuff, but most of my work was dealing with lots of other issues largely unrelated to social media. So be it. I didn't blog. I didn't tweet (much) and didn't really pay attention to any tweets or blogs. And, you know what? I don't feel any less informed or less connected to my world and my clients. Wait...I do confess...I pay attention to the Pharmalot blog, a lot. Thanks Ed for getting back on track.
I do want to tell you though that I'll be making a rare public appearance at the DIA meeting in Washington in two weeks hosting a panel of esteemed colleagues to discuss FDA regulation of health economic information and the rise of comparative effectiveness research. This is a super great topic. In fact, I think it may be the single most important regulatory topic over the next decade. A case of regulatory policy, public and private interest, and Federal Legislation all at war with one another. I'll share my thoughts soon on this blog, but in the meantime if you're at the DIA meeting, come to our panel discussion on the 22nd of February.
So anyway, I'm back, somewhat embarrassed by my lack of blogging, and remain fully committed to being more prolific on this site if time permits and if I have the energy and initiative. How's that for commitment?
JM
Complete abridged guide to FDA social media Guidance and regulation
11/18/09 07:32 Filed in: Social Media Regulation
While you are trying to steer around the multiple points of view about last week's FDA hearing and FDA's approach to regulating drug, biologic, and medical device promotion on the internet and in social media, below are some (mostly) indisputable facts you need to know. If you grasp the points below, you can save yourself a lot of wheel spinning.
Start here:
1. FDA will likely issue a draft guidance document following the comment period for the public hearing.
2. The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period.
3. Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance.
4. The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft. Industry will have to follow the final guidance once finalized.
5. Any guidance document will CLARIFY how FDA believes FDA laws and regulations apply to the internet and social media. It will not CHANGE regulatory requirements. The latter would require either Congress to enact a new law or amend the Food, Drug and Cosmetic Act or would require FDA to issue a new regulation through its rulemaking procedures. The rulemaking procedures are much more burdensome and would take a much longer time than issuing a guidance. Comments and proposals should keep in mind whether or not a proposal would require a CHANGE of regulation or a CLARIFICATION of how existing regulations apply to internet and social media. All good ideas should be communicated, but should first be communicated with a goal of clarifying how they're allowable under current regulations. Only laws and regulations are legally enforceable. Guidance documents clarify how legally enforceable laws and regulations will be enforced.
6. FDA did state in its Strategic Plan on Risk Communication that certain aspects of its promotional regulations needed modernization, so there is in fact a potential for an update to regulations that would impact internet and social media promotion. (See Policy Strategy 4). Both a Guidance and new Regulations are conceivable in the coming years.
7. FDA's risk communication initiatives, steered mostly by the Commissioners office and not DDMAC, will also have a major impact on FDA's guidance, particularly around how the internet handles risk communications as well has how risk communications are perceived by the public. Integrating these two initiatives adds another wrinkle in the ability for FDA to finalize policy. Ultimately, expect some double standards in terms of what FDA can do and what industry can do.
9. Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet.
10. At all times, any internet or social media strategy must be strategizing for outcomes that are legal, scientifically substantiated, and medically responsible, regardless of the current state of any FDA guidance. FDA, the Department of Justice, Plaintiffs lawyers and perhaps company employees/potential whistleblowers will look far deeper than what you tweeted or put on your Facebook page to see if you had any intentions to do something that was illegal. This will focus on the outcome you were trying to achieve far more so than what media you used to achieve it. So, if you are documenting social media or internet communication strategies, make sure the claims and perceptions you are trying to communicate are actually legal in addition to the methods used to get them out.
Bonus Point: The biggest and most difficult issue facing FDA and any regulatory, medical, and legal review committee at any company is the substantiation of claims. It is not the internet or social media. Whether or not a claim is presented in a way that is not misleading and is supported by FDA's substantial evidence standard is the most difficult and time-consuming issue. Claims in any media, including social media or the internet, must be truthful and substantiated on their face and be presented and stated in a way that is not misleading. When FDA says that "Its the message, not the media" this is what they're talking about.
Good luck.
John Murray
Start here:
1. FDA will likely issue a draft guidance document following the comment period for the public hearing.
2. The ultimate draft guidance will have its own process and comment period, which will in all likelihood come well after the close of the public hearing comment period.
3. Once FDA collects comments after the comment period for any future draft guidance, it will then consider them and work on a final guidance.
4. The draft guidance will likely be able to be followed by industry even if it isn't final, because it represents FDA's current thinking, even in draft. Industry will have to follow the final guidance once finalized.
5. Any guidance document will CLARIFY how FDA believes FDA laws and regulations apply to the internet and social media. It will not CHANGE regulatory requirements. The latter would require either Congress to enact a new law or amend the Food, Drug and Cosmetic Act or would require FDA to issue a new regulation through its rulemaking procedures. The rulemaking procedures are much more burdensome and would take a much longer time than issuing a guidance. Comments and proposals should keep in mind whether or not a proposal would require a CHANGE of regulation or a CLARIFICATION of how existing regulations apply to internet and social media. All good ideas should be communicated, but should first be communicated with a goal of clarifying how they're allowable under current regulations. Only laws and regulations are legally enforceable. Guidance documents clarify how legally enforceable laws and regulations will be enforced.
6. FDA did state in its Strategic Plan on Risk Communication that certain aspects of its promotional regulations needed modernization, so there is in fact a potential for an update to regulations that would impact internet and social media promotion. (See Policy Strategy 4). Both a Guidance and new Regulations are conceivable in the coming years.
7. FDA's risk communication initiatives, steered mostly by the Commissioners office and not DDMAC, will also have a major impact on FDA's guidance, particularly around how the internet handles risk communications as well has how risk communications are perceived by the public. Integrating these two initiatives adds another wrinkle in the ability for FDA to finalize policy. Ultimately, expect some double standards in terms of what FDA can do and what industry can do.
9. Risk communication, minimization of risk, or omission of risk is FDA's most frequently cited violation for ALL media, print, broadcast, or internet.
10. At all times, any internet or social media strategy must be strategizing for outcomes that are legal, scientifically substantiated, and medically responsible, regardless of the current state of any FDA guidance. FDA, the Department of Justice, Plaintiffs lawyers and perhaps company employees/potential whistleblowers will look far deeper than what you tweeted or put on your Facebook page to see if you had any intentions to do something that was illegal. This will focus on the outcome you were trying to achieve far more so than what media you used to achieve it. So, if you are documenting social media or internet communication strategies, make sure the claims and perceptions you are trying to communicate are actually legal in addition to the methods used to get them out.
Bonus Point: The biggest and most difficult issue facing FDA and any regulatory, medical, and legal review committee at any company is the substantiation of claims. It is not the internet or social media. Whether or not a claim is presented in a way that is not misleading and is supported by FDA's substantial evidence standard is the most difficult and time-consuming issue. Claims in any media, including social media or the internet, must be truthful and substantiated on their face and be presented and stated in a way that is not misleading. When FDA says that "Its the message, not the media" this is what they're talking about.
Good luck.
John Murray