FDA's Actions Speak Louder than Its Words: On the Internet It's the Medium as Well as the Message!

It has been widely reported that as far as the FDA is concerned it's the message not the medium when it comes to regulating pharmaceutical use of the Internet (see, for example, "A Conversation with the FDA Associate Commissioner for Public Affairs"). This is turning out not to be entirely accurate.

In 14 recent warning letters, FDA challenged the conventional wisdom of consultants to the drug industry about application of the so-called "one-click rule" to Google Adwords. Clicking is unique to messages delivered via the Internet or other interactive media.

The "one-click rule" states it's OK on an Rx product Web site to merely provide a link to the package insert or brief summary. The "rule" was an interpretation of FDA thinking by consultants to the drug industry and was never something the FDA ever claimed as a rule it would use to regulate drug information on the Internet. When I challenged the existence of any such rule, these consultants backed off and called it "received precedence" rather than a rule (see "Death of the One-Click 'Rule' or 'Received Precedent' or Whatever!").

With these additional FDA letters there is much more "received precedence" to indicate that the rule or whatever does NOT apply to Google Adwords (see "The 'One-Click Rule': Rant or No Rant?" for more on that).

The Wall Street Journal reported that "The Food and Drug Administration warned 14 major pharmaceutical companies about brief Internet ads that accompany searches on Google and other search engines, saying the ads were misleading because they didn't include risk information." (See "FDA Warns Drug Firms Over Internet Ads").

The ads in question were similar to this Lunesta Google Adword that I first talked about in 2006 with my infamous "Girl from Google" post (see ad below). Google actually advised their pharma clients to create such ads.


In my 2006 blog post, I warned pharmaceutical marketers to be wary about using such tactics and called these ads "bAdwords."

My argument was simply that an AdWord could be said to comply with the one-click "rule" only if within the AdWord text there was a direct link to the package insert (PI) or brief summary. In most Adwords there is a link to the product Web site where the consumer would have to click on a second link to get to the PI. I didn't think two clicks would pass muster with the FDA. After 2 and half years I am proven correct.

One FDA letter went to Biogen Idec Inc. over its multiple sclerosis drug Tysabri (find letter here). "Biogen's ad includes a link to the Web site for the drug," said the WSJ article, "which does contain the relevant risk information. The FDA said the link 'does not mitigate the misleading omission of risk information from these promotional materials.'" See violative Tysabi Adwords below. On the left is the sample provided by FDA. On the right is the one I just found myself.

You can see how easy it is for pharmaceutical marketers to follow bad advice from consultants in the absence of CLEAR GUIDELINES from the FDA. Instead of regulating through "received precedence" the FDA should follow common regulatory practice and issue PUBLIC guidance on the use of the Internet for promoting drugs and devices.

BTW, I HAVE ONE BIG QUESTION. WHY DID IT TAKE THE FDA THIS LONG TO GO AFTER VIOLATIVE ADWORDS WHEN I WARNED THEM ABOUT THIS IN AS FAR BACK AS 2006? IMHO, with the new administration, all the FDA "chickens" who "left the coop" so to speak under Bush's lackeys are coming home to roost!

How the FDA develops this guidance is as important as the guidance itself!

To help determine what the best procedure is, I have developed a survey that presents several different procedures the FDA could use to develop guidance for the use of the Internet and specifically social media for the promotion of drugs and other medical products it regulates.

The options are:

1. Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
2. FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
3. FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
4. If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.

Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.


Continue the discussion via Twitter...

Detrol v. Toviaz: Marketing Replaces Innovation at Pfizer!

"You won't have bathroom lady to kick around anymore because, gentlemen, this is my last DTC appearance," said the iconic Detrol spokesperson.

Yes, Detrol is joining the growing legion of off-patent medications. Pfizer, however, is replacing $1.2 billion blockbuster drug Detrol, with Toviaz, a "new" treatment for "overactive bladder."

Not only is Pfizer jettisoning the blue DTC icon, but it also intends to use a new marketing approach where drug reps won't be focused so much on the features of the product in discussions with physicians.

"In the old world, [sales reps] might have come to talk with the doctors about the features of the product," he [Jim Maffezzoli, senior director-marketing in Pfizer's new primary-care unit, which is marketing the drug] said. "Now they'll be talking about the product and also the YourWay plan." He added that it is "emblematic of the primary-care business unit to try and bring solutions to the physicians vs. simply coming to physicians with a new product." (See "Pfizer's Prescription for Patent Loss: New Drug").

Toviaz, however, is perhaps just a repackaging of Detrol and not really a "new" drug as the Advertising Age article cited above claims in its headline.

"Toviaz is structurally related to Detrol but has two doses instead of one, Mr. Maffezzoli said, giving physicians and patients more flexibility in treatment for the drug's efficacy and tolerability," said the article.

Taking advantage of my graduate degree in biochemistry from Columbia University, I decided to take a look at the molecular structures of these two drugs and see how similar they actually were. The following were copied from the package inserts:


Hope this doesn't bore you, but these two compounds are pretty closely related and it looks like it was a "no-brainer" to convert the Detrol molecule to the Toviaz molecule: merely an "esterization" of an -OH group and an oxidation of a H3C group to an ethyl alcohol group. The whole thing was then combined into a different salt configuration using the fumarate salt instead of the tartrate salt.

Not so "innovative" in terms of R&D. A college chemistry major could easily do the conversion in a minimally-equipped lab.

Marketing, however, is a whole 'nother story!

"The somewhat snarky Toviaz ads, which will appear in TV and print and as online banners, target women with questions such as 'Does running to the bathroom count for a good portion of your cardio?' and 'Do you feel like kids and careers are far less demanding than your bladder?'," says Advertising Age. "All feature the prominent tagline, 'Time out. It could be overactive bladder.' Pfizer will experiment with out of home, too, placing ads on grocery carts and in women's bathrooms. There is a consumer-facing informational website as well, at overactivebladder.com. Toviaz.com, the official website for the drug, is set to launch in May. A brand campaign for Toviaz will unfurl later this year, but Mr. Maffezzoli declined to furnish details."

I am sure the brand campaign will make a big deal about how "new" and "improved" Toviaz is versus Detrol. And to think that the FDA's PRECIOUS time was wasted in approving this "new" drug! What a travesty!

Should FDA Convene a Public Hearing on Use of Social Media by Pharma?

Now that everybody has calmed down about my April Fools joke (ie, "FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media!"), we should make sure that when it comes time for the FDA to actually create a guidance document on social media that it does it with input from ALL stakeholders.

I suggested this in yesterday's post (see "FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!") because it seems that the FDA and some pharma companies are "mulling" this over behind closed doors and I want those doors opened.

What do you think?

I have a survey to get your opinion, but first let me explain FDA's procedures for developing and issuing guidance documents, using its own words (see here for the Full Monty):

What is a guidance document?
"Guidance documents are documents prepared for FDA staff, applicants/sponsors, and the public that describe the agency's interpretation of or policy on a regulatory issue."

"Before FDA prepares a draft of a Level 1 guidance document, FDA can seek or accept early input from individuals or groups outside the agency. For example, FDA can do this by participating in or holding public meetings and workshops."

I emphasized "can" because FDA doesn't always seek or accept input form the public, as in:

"FDA will not seek your comment before it implements a Level 1 guidance document if the agency determines that prior public participation is not feasible or appropriate."

My opinion is that we need to make sure that the FDA DOES determine that public participation is both "feasible" and "desirable." As I mentioned in yesterday's post, there is a precedent for holding a public hearing on Internet issues prior to issuing guidance (see here). However, the FDA chose NOT to issue any Internet guidance after that public hearing. Therefore, even if we win the battle to get a public hearing, we must make sure that the FDA follows up with guidance on social media that takes public comments into account.

When the FDA goes the non-public route in issuing guidance, here's the procedure:

"FDA publishes a notice in the Federal Register announcing that the guidance document is available; it posts the guidance document on the Internet and makes it available in hard copy; it immediately implements the guidance document; and it invites your comment when it issues or publishes the guidance document. ...If FDA receives comments on the guidance document, FDA will review those comments and revise the guidance document when appropriate."

Obviously, it's much more difficult to revise public documents after the fact. It's much better to get involved at the start when making gov't sausage!

The Survey
OK, that's the background. My survey presents you with several different procedures the FDA could use to develop guidance for the use of social media for the promotion of drugs and other medical products it regulates. These are:

1. Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
2. FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
3. FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
4. If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.

Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.

FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!

If you were taken in by my FDA-social media guidance April Fool's post (see here), you were not alone. Many other savvy people were also fooled.

Within minutes of posting a notice on Twitter, hundreds of visitors flocked to Pharma Marketing Blog to read the amazing news. Hundreds are still visiting while I write this.

The fake press release I posted was even copied and uploaded to other blogs, including the Medical Sales Recruiter blog: see "FDA sounds off about Pharma/Medical and their use of Social Media: Youtube, Twitter, etc." and Drug Wonks too!

Many people are also e-mailing me asking if it's true because they can't tell if it's an April Fool's joke or not!

Why do so many people want to believe?

It's about time is why!

And the time may be near! The FDA may actually issue such guidance in the near future -- no kidding this time!

Regulatory executives from several pharmaceutical companies have been meeting and discussing guidelines on how the drug industry can take advantage of social media for marketing and other healthcare communications purposes. The FDA has been involved as well! I was told this several weeks ago by a regulatory person in attendance at an industry conference.

But you don't have to take my word for it. You can read about it here: "Key Headline From Waggener Edstrom Webinar: Pharma Working With FDA On Social Media Marketing Guidance"

The same story was repeated in the April issue of MM&M.

What's the next step?

Call to Action: Bring More Stakeholders Into the Discussion!

I believe that more stakeholders need to be involved in the discussion of social media pharma marketing guidelines and best practices. I'm talking about ad agencies that work for pharmaceutical companies, patient advocates, healthcare professionals, social network site owners, etc.

The FDA did it right in 1996 when brought in all these stakeholders -- including me -- for a two-day public hearing on FDA AND INTERNET: ADVERTISING AND PROMOTION OF MEDICAL PRODUCTS (find the minutes here).

In his opening remarks to that hearing, Bill Schultz, who was Deputy Commissioner at the time, said "With the increased popularity of the Internet, it's not surprising that questions would begin to be raised about how the laws pertaining to drug and device advertising apply to the Internet. FDA has no question but that they do apply and, in fact, the Agency has issued a number of warning letters during the past six months. But we also recognize that the Internet raises some new and important and very different issues regarding the regulation of promotion."

Well, it's deja vu all over again! I bet the current people in charge of the FDA don't realize there was such a public meeting.

Next week I am hosting a invitation-only roundtable discussion entitled "Overcoming Barriers to Pharma's Engagement in Social Networks." It's a special event primarily for members of the ePharma Pioneer Club. At least a dozen people will be participating, including several pharma people. I am also inviting Jean-Ah Kang from the FDA and a representative from PhRMA to attend.

If you are interested in attending (openings are limited), fill out the ePharma Pioneer Club membership form and let me know.

Maybe we can get the ball rolling a little faster on this issue!

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Should FDA Convene a Public Hearing on Use of Social Media by Pharma?
[Click here for background.]

This survey presents you with several different procedures the FDA could use to develop guidance for the use of social media for the promotion of drugs and other medical products it regulates. These are:

1. Before issuing and draft guidance, FDA should convene a public hearing in which ALL the stakeholders can put on record their suggestions and concerns.
2. FDA should consult privately with drug companies and then issue draft guidance open for public comments according to normal rulemaking procedures.
3. FDA, without ANY prior consultation with drug companies, should issue draft guidance open for public (including industry) comments as per normal rulemaking procedure.
4. If FDA solicits public comments -- no matter in what fashion -- it should publish ALL the comments it receives.

Please take the survey and indicate your level of agreement or disagreement with the above options/statements. Be sure to add comments as well. Thank you.

FDA Issues First-ever Draft Guidance on Pharma’s Use of Social Media!

The US Food and Drug Administration (FDA) today issued a new guidance document that addresses the use of “social media” by pharmaceutical companies.

I'm very excited about this and look forward to seeing the details. I note, however, that acting FDA Commissioner, Dr. Joshua M. Sharfstein, implied a "carrot and stick" approach to regulating pharma social media marketing.

See the press release posted below for more information. [BE SURE TO READ TO THE VERY END.]

------------------------------------------
FOR IMMEDIATE RELEASE
P04-12
April 1, 2009

Media Inquiries: 301-827-6242
Consumer Inquiries: 888-INFO-FDA

New FDA Draft Guidance Aims to Improve Health Information Obtained via “Social Media” Websites

The Food and Drug Administration today issued a draft guidance document designed to improve communications to consumers and health care practitioners about health conditions and medical products that they obtain on “social media” Websites such as Facebook, YouTube, Twitter and online bulletin boards. The guidance is the result of FDA research and policy development, and was influenced by the success of the recent social media based peanut recall program (see http://tinyurl.com/d3lvag).

"We intend to do all we can under the law to make sure that the information conveyed by prescription drug promotion is as useful as possible," said acting FDA Commissioner, Dr. Joshua M. Sharfstein. "Our new regulatory guidance provides new direction to sponsors on how to provide higher-quality health information to the public via social media sites, based on recent evidence on what works and what doesn't. The evidence shows that social media promotions directed to consumers can play an especially important role in helping patients start a discussion about conditions that are often unrecognized and therefore undertreated, such as diabetes, high blood pressure, high cholesterol, depression, and obesity. And we think those discussions should reflect a better understanding of the key risks and benefits of a product. Without participation by pharmaceutical companies in those discussions, there is increased likelihood of false or dangerous information being promulgated throughout the Internet."

According to an FDA study, a majority of interactive agencies surveyed feel that social media product messages increase patient awareness and involvement, and improve compliance. That study also shows that social media-stimulated visits to a physician can help identify a previously undiagnosed condition. Importantly, of patients who visited their doctors because of an online discussion they participated in, 95% actually had the condition the drug treats. That percentage was even greater than that reported among patients who viewed DTC ads on TV.

The draft guidance provides (1) a simple method by which sponsors can insert a notice about reporting adverse events in their posts to social media sites, (2) “safe harbor” conditions that relieve manufacturers of responsibility for reporting adverse events they may hear about on social media sites, and (3) advice for manufacturers on the types of branded and unbranded communications that fall under the rules set forth in the guidance.

"Clear, evidence-based regulatory guidance will help FDA use its limited resources to police the marketplace as effectively as possible," said Sharfstein. "FDA will take action against sponsors whose ads violate the law by presenting false or misleading information to the public via social media sites. Our new draft guidance is intended to help responsible companies comply, for the benefit of the public health. If they don't, we now have an even stronger basis for pursuing enforcement actions."

"Improving our nation's health literacy a critical step in improving our nation's health," said Jean-Ah Kang, special assistant to director Tom Abrams. Kang was tasked with developing policy on pharma social media marketing and was responsible for the social media communications that was instrumental in the success of the recent peanut recall program. "More and more patients are seeking health information online and through social networks of their peers. The FDA's new guidance will help empower these patients with accurate information from manufacturers rather than relying upon unsubstantiated claims made by anonymous online sources. It's also way cool."

The draft guidance document is part of FDA's strategic social media plan, one goal of which is to help create better-informed consumers. To access FDA's strategic plan go to http://tinyurl.com/c5jyaf

The Social Media draft guidance document is available online (see links below). FDA encourages public comment on these documents.

####

FDA's Use of Social Media: http://tinyurl.com/d3lvag
Consumer-Directed Social Media Promotion of Prescription Drugs: http://bit.ly/eJlk

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THIS IS A FAKE PRESS RELEASE

I apologize that many people did not realize this was a prank designed to raise awareness of an important issue (see follow-up post: "FDA and Pharma - Bring More Stakeholders into Your Discussion of Social Media Guidelines! No More Joking!").

I had thought that the phrase "way cool" attributed to Jean-Ah Kang PLUS the links would have given it away.

Unfortunately, a few people did not catch those hints.