FDA Panelists at the Upcoming Social Media Public Hearing

Only the following 13 FDA panel members will be able to ask questions during this week's public hearing on the use of social media by the pharmaceutical industry:

• Thomas W. Abrams - Director, Division of Drug Marketing, Advertising, and Communications (DDMAC) - Center for Drug Evaluation, and Research (CDER)
• Kathryn J. Aikin - Social Science Analyst, DDMAC - CDER
• Rachel E. Behrman - Deputy Director, Office of Medical Policy (OMP) - CDER
• Gerald Dal Pan - Director, Office of Surveillance and Epidemiology - CDER
• Kristin Davis - Deputy Director, DDMAC - CDER
• David J. Horowitz - Assistant Commissioner for Policy, Office of Policy, Planning, and Budget - Office of the Commissioner
• Ele Ibarra-Pratt - Branch Chief, Advertising and Promotional Labeling Branch - Center for Biologics Evaluation Research
• Jean-Ah Kang - Special Assistant to the Director, DDMAC - CDER
• Sharon Kapsch - Chief, MDR Policy Branch - Center for Devices and Radiological Health (CDRH)
• Dorothy R. McAdams - Supervisory Veterinary Medical Officer, Division of Surveillance - Center for Veterinary Medicine
• Seth S. Ray - Associate Deputy Chief Counsel for Drugs and Biologics - Office of the Chief Counsel
• Robert Temple - Director, OMP - CDER
• Deborah Wolf - Regulatory Counsel, Office of Compliance - CDRH

This is a formidable list. Aside from Jean-Ah Kang, the only person on this list who has been featured on this blog is Robert Temple (see "Temple vs. Nissen: Blood Rematch"). As one commenter to a Pharmalot post put it: "Somehow I can't work up any empathy for Dr. Temple. His 25 years at the FDA have coincided with the deterioration of the agency.

The FDA has organized two staging areas for speakers in order to facilitate getting on and off stage:

(1) Reserved rows in the front left with assigned seats, and

(2) an "On-Deck" section on stage.

"On-deck" speakers will led to the podium like cattle to slaughter! Sorry, I am in a dark mood. But I am doubtful that such a well-oiled machine will be conducive to dialogue. Perhaps some of the FDA panelists will make it to one of the "Tweetups" planned on Thursday evening (see www.fdasm.com). That kind of interaction would be valuable.

PhRMA Proposes FDA-Approved Use of Universal Safety Symbol for Branded Tweets & SE Ads

In a telephone news briefing, PhRMA proposed an "FDA-Approved Use of Universal Safety Symbol" that could be used in branded/sponsored ad links (eg, Adwords) and Twitter posts (see image below).

PhRMA says in its slide presentation (see here):

• Universal safety symbol (FDA logo or other FDA-approved symbol) and universal statement would indicate that the linked page contains FDA-regulated risk information (e.g., official Prescribing Information, patient Medication Guide)
• Throughout the Web, a universal symbol would help healthcare professionals and consumers identify official, FDA-regulated medical product Web sites. Prominence of graphic could drive clicks to comprehensive information
• Include established name and true abbreviated indication, if Internet media do not allow for full information
• Include affirmative statement about risks, even if abbreviated
• Universal symbol could be used on search engines, blogs, microblogs, video
• FDA would set conditions on use of the safety symbol by manufacturers

“Leveraging the FDA’s logo – or a universal FDA-approved graphic symbol – in search results and throughout the Web would inform patients, at a glance, that they are visiting a legitimate site that contains comprehensive FDA-regulated benefit and risk information. Such a graphic symbol could be combined with a universal warning statement to provide an indication of risk when there is little space (e.g., a search result or tweet)," said PhRMA (see "PhRMA Statement About Accessing Online Health Information").

Reporters had several questions about the proposal, including what kind of resources FDA would need to review material before granting use of the symbol and monitoring thereafter. Jeff Francer, Assistant General Counsel at PhRMA, mentioned user fees that PhRMA proposed for FDA review of promotions. "Unfortunately," said Francer, "congress did not appropriate the money in order for that user fee to go into effect. PhRMA will continue to support a strongly-funded FDA even if it means that user fees from our companies will have to support some of these activities."

Francer realized that there would have to be some sort of governance structure associated with the use of this symbol, such as that provided by Trustee for privacy policies. "We haven't gotten into the operational details," said Francer. "We want to use this as a way to start the conversation and have other stakeholders respond to it."

I asked about voluntary guidelines for use of the Internet. The answer: PhRMA will wait for FDA guidance before it issues any further self-regulatory guidelines for the Internet as it did for print & TV DTC advertising. "Once the FDA acts," said Francer, "we can then move to put those standards into effect and then we can take a look at PhRMA's voluntary standards to make sure they are adequate."

With regard to adverse event reporting, PhRMA cited "International Conference on Harmonisation (ICH) Tripartite Guideline E2D:"

• Sponsors “are not expected to screen external Websites for ADR information.
• However, if [a Sponsor] becomes aware of an adverse reaction on a website that it does not manage, the [Sponsor] should review the adverse reaction and determine whether it should be reported.
• [Sponsors] should regularly screen their Websites for potential ADR case reports.”

Later this week PhRMA will put forward the idea that FDA and FTC should "redouble their enforcement efforts against fraudulent activities on the Internet."

FDA Public Hearing: Not Deja Vu All Over Again?

At eyeforpharma's eCommunication & Online Marketing Summit, the audience had a lot of questions about the upcoming FDA public hearing. At one point, the discussion turned to the nature of the speakers for this hearing versus the 1996 hearing. I prepared the following chart to illustrate the differences:

There are some interesting differences, including:

• No representatives from search engines spoke at the 1996 meeting. Search wasn't a factor yet.
• There was good representation from healthcare professional groups (18%) in 1996. I'm talking about organizations like the AMA. This time there are no physician groups presenting. There's Sermo, but I count that among the health Web sites.
• This year there are far fewer pharmaceutical/device companies presenting than in 1996 when 21% of the speakers were from pharma.
• This year, agencies and industry service providers dominate the speaker roster. Obviously, they have the most to gain (or lose).

Just FYI.

My FDA Social Media Hearing Presentations

As you no doubt know, FDA is hosting a public hearing on pharma's use of social media for Rx drug (and device) promotion next week (see here). I will be making two presentations at that meeting (see speaker schedule here):

• 9:30-9:45 AM on Thursday, Nov 12 (following PhRMA)
• 10:20-10:30 AM on Friday, Nov 13

You can find my presentations here (warning: BIG pdf files):

• Part 1, covering FDA issues 1 (Accountability) & 2 (Fulfilling Regulatory Requirements)
• Part 2, covering FDA issues 3 (Posting Corrective Information) & 5 (Adverse Event Reporting)

These presentations summarize most of the results to date of the ongoing survey I have been running since 20 September 2009 (find the survey here). The survey includes all 19 questions for which FDA seeks answers. There were 354 respondents as of 1 November 2009.

Some key points I will make include:

• Media agnostic regulations are not popular among industry experts.
• The “One-Click Rule” is desired by the industry. However, most often it takes two clicks to reach the approved labeling (PI). Since the PI is virtually unreadable, there needs to be a better way to provide the fair balance regardless of the number of clicks!
• There are some ideas for dealing with space limitations imposed by certain social media apps.
• DISCLOSURE of involvement with or influence over 3rd-party social media content should be prominently displayed alongside relevant content when possible.
• Each company should have a Public Social Media Policy (SMP) that includes a notice of its transparency/disclosure and other policies relating to social media. [Just like every pharma company has a public privacy policy that applies to all its product Web sites, each pharma company should have a public SMP that applies to all its social media activities, whether owned or sponsored by the company.]
• Companies should monitor social media sites for unauthorized use or modification of its approved content and make a best effort to remove or correct the content. But they should be REQUIRED to do so only for sites owned or directly sponsored by them.
• Vast majority of “Adverse Experiences” reported on social media sites do NOT meet the requirements for AE reporting.
• Although there are monitoring tools available, the resources required to monitor all social media sites for adverse events are not justifiable.
• Consequently, few companies have standard operating procedures for processing adverse event information from social media sites.
• However, pharma companies can help consumers report adverse events directly to the FDA using social media tools such as widgets placed on drug.com Web sites.
• Some innovative ideas for fulfilling regulatory requirements to submit social media promotional materials to FDA were suggested, including:
• Register sites with FDA for agency to monitor
• Submit “template” (design and/or sample content) of social media site to FDA for pre-approval/approval
• But there was no consensus opinion about satisfying regulations regarding submission of social media promotional materials.
• Too stringent regulations will prevent companies from carrying on two-way social media conversations with consumers and HCPs. Such conversations can have a beneficial impact on public health, especially when clarifying or correcting misinformation.

While I am in favor of some new and relaxed FDA regulations/guidelines regarding pharma's use of social media, I am also in favor of HIGHER standards, the development of which should be a collaborative effort among all stakeholders. That is, FDA regulations merely define the BASEMENT level best practices that pharma needs to adopt for effective use of social media. I believe there is a need to look beyond the FDA and start building the FIRST & UPPER FLOOR level best practices. More about that in later posts.

Right now, all eyes are focused on the FDA. No matter what guidelines the FDA comes up with, I will continue to "out" pharmaceutical marketing worst practices on this blog.

Industry Groups will Eat Consumer Advocates' Lunch at FDA Social Media Public Hearing

Speakers at FDA's upcoming November public hearing on social media have received the schedule of presentations, which you can find here.

Each speaker has 10 minutes, but some -- like myself -- were given two 10-minute slots. As you may know, I will present results from the survey I have been hosting (see here). Why some of us got two slots, I don't know. I plan to address several questions put forward by the FDA and requested 15-20 minutes (see my proposal (pdf) here). I thought they would say 10 minutes and that's all you get! Instead, FDA gave me two 10-minute time slots. Nice of them.

Fabio Gratton (@skypen) of Ignite Health, a marketing communications agency, sent me a spreadsheet that listed all the 55 unique presenters and characterized the services offered by each presenter's organization. I simplified Fabio's schema into the following 7 categories (the number in parentheses represents the number of speakers in each category):

1. Search Engine (2)
2. Trade Media (2)
3. Pharma Company (4)
4. Consumer Advocate (5)
5. Industry Advocate (6)
6. Health Website (8)
7. Industry Service Provider (28)

Obviously, there's quite a skew towards industry groups, which can best be seen in the following pie chart:



[NOTE: a few "Health Websites" may also represent the consumer and/or patient point of view. These include PatientsLikeMe and WEGO. Putting those two sites into the "Consumer Advocate" bin would increase the consumer slice of the pie to 13% vs. 9%.]

This distribution of speakers may be typical of FDA public hearings. After all, the FDA is not paying for speakers' expenses. Money talks because nobody walks to these things. Unfortunately, that means that consumers are under-represented.

Consumers, however, can submit written comments to the docket (see here). I have yet to see ANY submitted comments and I don't know if this is because there are none, or the FDA is keeping comments hidden from public view even though they promised otherwise. It would be a travesty if consumers do not have a voice in this process.

I think the preparations for this hearing have been pretty disorganized and hasty. It appears that not much planning has gone into it and I'm afraid that the whole experience will be anti-climatic. A series of 10-minute presentations one after another without dialogue seems quite numbing and UNEDUCATIONAL. FDA may be doing this more out of formality than necessity. Reading between those lines leads me to believe that FDA already has some draft guidelines on the drawing board and really doesn't need any public input.

Social Media Best Practices for Pharma Are Needed, Whatever Happens at FDA

Many pharma eMarketing pundits and FDA policy wonks out there are already predicting that nothing much will come out of the upcoming public hearing on Promotion of Food and Drug Administration-Regulated Medical Products Using the Internet and Social Media Tools (see "FDA Announces Public Hearing on Promotion of Drugs on Internet & via Social Media. This is NOT a Hoax!").

Rich Meyer, blogger over at World of DTC Marketing, says "So what do I expect from the FDA open hearings? A lot of self promotion ... the fact that they are having these hearings communicates a lack of understanding of how people are using the Internet for health information."

Meyer predicted several months ago that the FDA would never have such a hearing in the first place. Now that there is a public hearing scheduled and a public comment process underway, Meyer does not believe that DTC marketing as we know it will change. He may be right about that, but there will be some changes.

First of all, the mere fact that there will be a public hearing where approximately 62 people will be making presentations (see list-in-progress here), will lead to an increased awareness among the public of how the pharma industry may be tapping into social media to influence patients and physicians. Whenever the public becomes aware of potential problems, Congress is not far behind. And when Congress starts investigating, the pharma industry rolls out another set of voluntary guidelines for best practices.

Of course, the FDA could also issue regulatory guidelines for use of social media for Rx promotion. The jaded among us think that it may be years before that happens, if ever. I, however, believe the FDA already has some kind of draft guidelines in the works that it will publish before the end of 2010 (see "Expect FDA Social Media Draft Guidance Before End of 2010"). As I said before, this is NOT your father's FDA -- case in point: Jean-Ah Kang, special assistant to DDMAC director Thomas Abrams, picks up the phone when you call. She also sent out the e-mail invitation to speakers at 2:07 AM! That's dedication!

After the 1996 FDA public hearing on the Internet, a bunch of presenters -- including patient advocates -- got together to form the Internet Healthcare Coalition, a non-profit grassroots organization that created the eHealth Code of Ethics. Pharmaceutical companies were involved in that effort and it received much media attention.

So, a lot can happen as a result of FDA's public hearings: Increased public awareness, congressional investigations, new regulatory guidance, voluntary industry guidelines, codes of ethics, and perhaps even new regulations. These are significant changes that cannot be ignored.

Pharma marketers also cannot long ignore the lure of social media, whatever form it takes in the future.

Although, according to polls, a majority of consumers out there do not trust pharmaceutical companies, there are millions of patients who have been helped by the industry. Many of these are patient advocates involved in social media and they want conversations with pharma companies. They want to partner with pharma companies and vice versa. But there needs to be "rules" or "best practices" for carrying on these conversations.

I don't have the answers, but I am enjoying the questions and responses to the questions I am receiving from readers who have taken my survey (see here). I have reviewed one set of answers having to do with adverse event reporting and social media. I made this presentation (pdf) of the results at the recent ePatient Connections 2009 conference in Philadelphia this week. You can also read this article in the October, 2009, issue of Pharma Marketing News: "Social Media Adverse Event Reporting Safe Harbors." Use the discount code SM222 to get it FREE.

Expect FDA Social Media Draft Guidance Before End of 2010

Let me make a prediction: FDA's DDMAC will issue some version of draft guidance on the use of social medial for Rx drug/device promotion BEFORE the end of 2010. Just for the record, I tweeted about this last week (October 21, 2009; see here).

Yesterday, at the ePatient Connections 2009 conference, I was a member of the Regulatory Panel that also included my friend Preeti Pinto, MS, MT (ASCP), Head of Medical Education and Regulatory Compliance at AstraZeneca, and Paul Loebach, Project Manager, DDMAC. I never met Loebach before, but I liked him even though he never fully revealed what he has been doing at DDMAC for the past 18 years.

During that panel discussion, Loebach informed the audience that it was too late to request a seat at the upcoming November FDA public hearing on social media. Over 800 people applied for seats, but the meeting room can only accommodate 350. Pharmaceutical Executive Magazine, for example, won't have a seat (see "Fear and Loathing in Washington, DC").

Someone in the audience asked Loebach and other panel members what their thoughts were regarding some best practices for using social media to get information out to consumers/patients. I would have responded by pointing out that one best practice for using social media was not to push info out to an audience, but to engage members of that audience in dialogue. But I let Loebach answer the question -- I'll have more to say about social media best practices in a follow-up post.

Loebach, speaking for himself and not DDMAC, suggested it was "too early" to offer advice and that DDMAC was "still fishing for information." He also said something I thought was revealing: ie, "we have ideas." Of course, by law, DDMAC has to solicit opinions of the public before it issues guidance and that's what the November hearing is about. "We still need to hear from everybody, because we're on the other side of the fence and we can't think of all the issues that you all will come up with and all the ways to use social media that you will come up with in the future. I know a lot of you in the audience feel that this hearing coming up in November is long overdue, but we're still too early in the learning curve to start giving advice on what will work and what won't."

This prompted me to ask Loebach: "Do you personally think the FDA will come out with some kind of guidelines relating to social media by the end of 2010?"

After a brief dramatic pause, Loebach responded "Yeah, probably that's a good estimate -- by the end of 2010. But if it happens earlier, even better," said Loebach hopefully.

This is as close as you're going to get for an official estimate of when FDA may publish social media guidelines. I happen to believe it is accurate not just because of what Loebach said, but because the FDA needs to prove that it's not your father's FDA. The new FDA leaders are younger than the previous leaders. They are smart people who believe in and have grown up using new media tools like social media. Besides, the FDA will lose tremendous face and credibility if, for the second time, they fail to act after calling a public hearing on the use of the Internet. This time they mean business.