Happy Anniversary! First Ever Pharmaguy Social Media Procrastinator Award Goes to...

Today is the third anniversary of the first day of the 2-day November 2009, FDA public hearing on the Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see here, here, and here).

Shortly after that hearing, some FDA staffers lead us to believe that FDA would come out with social media regulatory guidance for the pharma industry by the end of 2010 (see here). That never happened.

Instead, FDA kept procrastinating and throwing roadblocks in the way such as proposing further studies (see, for example, "FDA's Proposed Web Study Will Further Delay Social Media Guidelines").

Meanwhile, to add insult to injury, Tom Abrams, head of FDA's DDMAC (now OPDP), keeps showing up at industry meetings where industry leaders were expecting him to announce progress towards issuing draft guidance. At one such meeting in February, 2011, Abrams spent a scant 4 minutes discussing social media guidance (read this). At that meeting, he said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Well, guess what? It's almost two years later and YouTube, Facebook, and Twitter are still BIG, if not BIGGER and nothing has come along that's bigger. [BTW, Abrams also pooh-poohed Groupon, which now seems prophetic! And Google eliminated sidewiki, which was a big concern at the 2009 public hearing (read this).]

In recognition of the role Abrams has played in all this procrastination regarding social media guidance from FDA, I hereby present to Abrams the first ever Pharmaguy Social Media Procrastination Award^TM.

This award, as you may notice, is the antithesis to the famous Pharmaguy Social Media Pioneer Award, which was recently given to the sanofi US diabetes team (see here).

The iconic Hawaiian shirt in the "Procrastinator Award" is dark, symbolizing the negative implications of procrastination versus the bright yellow, positive Hawaiian shirt image used in the "Pioneer Award."

Abrams continues to show up at industry meetings promising that social media guidance is a high priority at FDA and it will be coming soon -- perhaps as "soon" as July, 2014 (see here). Yet, we've heard it all before. That's why I think it is fitting that Abrams receive the the "Procrastinator Award."

If Abrams lives up to his latest promise -- which is doubtful, IMHO -- it would have taken the FDA only 4 years and 8 months to issue draft social media guidance. In terms of Internet/social media timeframes -- in which 2 years can bring BIG changes -- this is procrastination on an epic scale. But in terms of FDA guidance timeframes, 4 years and 8 months is par for the course (see, for example, "A Cautionary Tale for Anyone Expecting FDA Social Media Guidelines Any Time Soon").

Will FDASIA Get FDA Off Its Butt to Finally Issue Social Media Guidance?

I noted with interest the headline in today's FDA News email: "OPDP: Social Media Guidance Will Be High Priority in 2013"." Here's the teaser copy that explains what's going one:

"The Office of Prescription Drug Promotion (OPDP) has placed developing social media guidance at the top of its work plan for 2013, director Thomas Abrams says. Abrams outlined the offices priorities at the Pharmaceutical Regulatory and Compliance Congress in Washington, D.C. The social media guidance is of critical importance because the Food and Drug Administration Safety and Innovation Act (FDASIA) mandates the agency produce the guidance by July 9, 2014."

I have three comments regarding this:

1. I reported back in July 2012 (here), about a little-noticed "Miscellaneous Provision" of the "Food and Drug Administration Safety and Innovation Act", which was signed into law by president Obama on July 10, 2012. This provision simply states: "Not later than 2 years after the date of enactment of this Act, the Secretary of Health and Human Services shall issue guidance that describes Food and Drug Administration policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by such Administration."


2. This is NOT the FIRST time Abrams has promised that social media guidance was a "priority." At the November, 2009, FDA public hearings on social media, Abrams said he heard "loud and clear from folks in this room" (ie, pharma companies) that "we want guidance on social media... We heard that message. Let me tell you that we are devoting a lot of resources and effort to this" (read this: "Is It Time for Abrams to Leave?").


3. Although it's nice that Abrams says social media guidance will be "at the top" of FDA's work plan for 2013, I wonder why it was REMOVED from the published work calendar as far back as 2011 (read this: "FDA Drops Social Media from Its 2011 Guidance Agenda").

So, will Abrams keep his promise this time? Pardon me for being a doubting Thomas. You think a "do nothing" Congress that's facing a "fiscal cliff" will spend any energy to make sure the above "provision" is adhered to by the FDA? I said it before and I'll say it again now: If FDA misses the deadline set by FDASIA, what can Congress do? Write a letter? Not another letter from Charles Grassley! I'm sure FDA is shaking in its boots.

FDA Drops Social Media from Its 2011 Guidance Agenda

I just downloaded the "Guidance Agenda: New & Revised Draft Guidances CDER is Planning to Publish During Calendar Year 2011" from the FDA site (find it here).

Missing from this agenda is "Promotion of Prescription Drug Products Using Social Media Tools", which WAS on the 2010 Agenda (see here).

However, included in the 2011 agenda under the Advertising Category is "Responding to Unsolicited Requests for Prescription Drug and Medical Device Information, Including Those Encountered on the Internet." Is this supposed to be the promised guidance we've all been waiting for? "Responding to unsolicited requests" is NOT a social media issue nor was it one of the questions FDA asked at the November 2009, public hearing (see all the questions here).

I don't know who/what to believe. In February, 2011, Tom Abrams, Head of DDMAC, said "We want to have these [social media] guidances out as soon as possible" (see here). FDA set the end of the first quarter of 2011 as the deadline goal. It missed that goal and hasn't set a new one. Now I see that the 2011 Guidance Agenda doesn't even include social media guidance.

I don't think the FDA is being very transparent and is sending the industry conflicting signals. What do you think?

P.S. See "Breaking – Its Official – FDA Delaying Social Media Guidance Until at Least Q1 2011" which highlighted email from the FDA that had "Responding to unsolicited requests" at the top of the list of social media issues the FDA is researching for draft guidance.

Although social media and the Internet expose pharma companies to unsolicited requests (ie, when they allow comments on Facebook or follow people on Twitter) it is NOT an issue that was discussed at the November, 2009 Public Hearing nor in the comments submitted to the FDA regarding social media.

[I stand corrected. The issue of how to respond to "unsolicited statements" about off-label use of drugs on pharma-owned social media sites WAS discussed at the hearing. See  see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information"]

Writing guidance for handling unsolicited requests is a no-brainer compared to developing guidance on how pharma marketers can comply with FDA regulations when space is limited as in search engine ads and tweets. Why isn't the FDA tackling THAT all-important social media issue first? After all, those infamous 14 NOV letters were all about that and NOT about handling unsolicited requests. For my answer to that mystery, see "FDA, DOJ, & Google: Conspiracy Theory, Part 2."

P.P.S. I called and e-mailed Jean-Ah Kang, Special Assistant to Tom Abrams at DDMAC. Here's the response I received from her via e-mail:

Hi John,

Thanks for your voicemail and e-mail messages. You should have received an autoreply e-mail from this account with the current status of our policy and guidance development on Internet/social media promotion, which is an Agency-wide effort that involves an extensive work and review process. While "Responding to unsolicited requests..." is listed by name on the 2011 CDER Guidance Agenda, it is only one of multiple topics for which we plan to issue draft guidances. At this point I cannot provide any specific timeframes due to our GGPs as many parties are involved, not just DDMAC. Please know that we are committed to moving forward with policy development in this important area by issuing well-vetted and meaningful draft guidances!

Sincerely,

Jean-Ah

P.P.P.S. For a follow up, see "First FDA Social Media Guidance to Address Responding to "Unsolicited Requests" for Off-label Information".

Is It Time for Abrams to Leave?

There were rumors at the recent ePharma Summit that DDMAC would come out with social media guidelines sometime in the next few months -- maybe by April, 2011. The crowd who gathered the following day in the great hall was at first jubilant in anticipation of the speech by Thomas Abrams, Head of DDMAC since 2000.

The crowd's mood changed dramatically, however, when Abrams did NOT mention any specific date during his presentation. Instead, he stated his allegiance to FDA's "Good Guidance Practices," which govern the orderly process of issuing guidance.

It seems that Abrams will remain as head of the hated DDMAC regime for some time to come. But his promises may no longer be enough to stem the growing frustration of the crowd.

P.S. I urge all my readers to support the demands of the Egyptian people for democracy and the ouster of the dictator Mubarak! You can get the best coverage of events by watching the live streaming video with commentary via Aljazeera English here.

FDA's Abrams Spends 4 Minutes Discussing Social Media Guidance at ePharma Summit!

This just in: FDA Won't Issue Specific Guidance for Youtube, Facebook, or Twitter. Claims These Media Are Just Passing Fads! Now Back to Your Regularly-Scheduled TV Ad.

Tom Abrams, the Head of FDA's Division of Drug Marketing, Advertising, and Communications (DDMAC), apparently believes Twitter and YouTube are passing fads.

During his presentation at the just-concluded ePharma Summit in NYC, Abrams said FDA would NOT "do guidance on specific technology platforms such as YouTube, Facebook, or Twitter. Those things are really big now, but you know what, two years from now who knows what the next thing [will be]?" Abrams also pooh-poohed Groupon

Meanwhile, both Google and Facebook (valued at $50 billion) are courting Twitter, which so far has rebuffed their offers to purchase the company. According the the WSJ, people familiar with the matter say potential suitors put an estimated valuation of Twitter "in the neighborhood of $8 billion to $10 billion."

Abrams devoted exactly 4 MINUTES of his 45-minute presentation to "Social media in prescription drug promotion"!!! In contrast, Abrams spent about 7 minutes on TV drug promotion regulation.

Abrams then threw the ePharma Summit audience a bone by spending several minutes analyzing one specific internet-based drug promotion: the Derma-Smoothe website. Using several colorful screen shots, Abrams drove home the point that NONE of the violations -- Omission and minimization of risks, Overstatement of efficacy, Unsubstantiated superiority claims, Broadening of the indication -- had anything to do with the Internet. It was all about the message, not the medium.

Unfortunately, the Derma-Smoothe site that Abrams used as an example was nothing more than a printed brochure repurposed as a web site.

We are being conditioned by the FDA and other regulatory experts not to expect much guidance regarding specific Internet technologies such as Twitter. "It is unlikely," said Paul Savidge, General Counsel at BMS, "that the FDA will move away from the regulations that apply currently to print and broadcast media. If the expectation is that the FDA is going to somehow carve out electronic media or social media, that's probably unlikely." Instead, Savidge suggested the guidance will merely reiterate the basic rules that apply to other media.

I asked point-blank why the "media-agnostic" approach is expected for Internet guidance, when the FDA "carved out" TV -- actually "television, radio, or telephone communications" -- as a special case in 1999 when it released specific guidance on how to adequately inform consumers where to get complete prescribing information. The FDA recognized that it was impractical to include the complete prescribing information in a 60-second TV ad. The guidelines said providing a web site, 800 number, or magazine ad within the ad would be sufficient.

My question was why wouldn't the FDA also publish SPECIFIC guidelines for social media SUCH as Twitter where space is also limited?

What followed was a complicated discussion about why TV deserves special guidance whereas the Internet does not. One regulatory expert said that TV ads are "limited by time and space" (ie, the 60-second ad), whereas the Internet is NOT. "It seems," this person said, "that there is limitless amounts of information that you can put on the Web."

Nowhere in that discussion did the experts mention Twitter or Google Adwords, which cannot include "limitless amounts of information."

P.S. Meanwhile, in a white paper released today (find it here), AstraZeneca said: "The FDA should recognize that social media is a new communication channel that both distinguishes and can appear to intermix the dissemination of information and advertising in the digital space." That doesn't sound media-agnostic to me!

Questions I Intend to Ask DDMAC Director Thomas Abrams at the ePharma Summit

I've noticed that FDA's DDMAC Director Thomas Abrams has been making presentations at several recent drug industry conferences. At the 10th Annual ePharma Summit that begins today in New York City (see here), Abrams presentation is titled: "Regulation and Oversight of Prescription Drug Promotion: Update from DDMAC," which is similar to presentations he's made at other conferences.

Of course, as I mentioned in a previous post ("11.5 Things I'd Like to Learn at ePharma Summit"), most attendees of the ePharma Summit are looking for updates on FDA's guidelines for use of the Internet and social media by pharmaceutical companies; ie, Where are they? When are they? What are they?

From a preview of Abrams' Powerpoint presentation, it appears that he will have very little to say in answer to these questions. Only 3 out of 46 slides concern social media guidelines. Two slides merely summarize what we already know: how many people made presentations at the November 15, 2009 public hearing and how many comments FDA received to the public docket.

The third slide describes the FDA's guidance sausage-making process (shown below; click for enlarged view):

Again, nothing new: Abrams, for example, has said before that FDA will issue "multiple guidances." We are somewhere in the "Prepare a draft guidance document and vet through internal clearance process" stage; ie, the sausage is jammed in the machine.

Here's what I hope to ask Tom Abrams at the Summit (if he allows questions from the audience):

"Tom -- I hope I can call you 'Tom'; I've seen you at so many of these conferences that I feel we should be friends on Facebook or Twitter if not in real life, but I can't find you on these social networks, so maybe I should stick to Mr. Abrams: What's holding up the process of releasing SM guidance? For example:

• "Has President Obama's recent executive order for government agencies to review all regulations old and new to determine if they hinder economic growth thrown a monkey wrench into FDA's 'Social Media Guidance Process'? That is, is the FDA's guidance process slowed down because of this extra internal review that is required?

"Any comments at all about this issue that might be affecting the FDA's guidance process will be appreciated."

BTW, look for me wearing a special shirt, which may or may not be this one: