In comments to the FDA, Johnson & Johnson (JNJ) stated “Flexibility in regulatory approach is crucial in the evolving digital world.” The comment was part of an 8-page document submitted to Docket No. FDA‐2009‐N‐0441 regarding Promotion of FDA‐Regulated Medical Products Using the Internet and Social Media Tools (find it here).

JNJ especially would like FDA to be as flexible as the FTC in regards to disclosure of important drug safety information within the context of space-limited digital applications.

“Technology,” says JNJ, “can help companies provide information about products in convenient and easily accessible ways, particularly for applications with limited space options. In such cases, links, rollover and scrolling functions can enable direct connections to safety and efficacy information about regulated products.”

JNJ cites FTC’s “reasonable man” as a model (see “Dot Com Disclosures: Information About Online Advertising (2000)”). From that source, JNJ offered this quote:

“Website are interactive and have a certain depth–with multiple pages linked together and pop-up screens, for example–that may affect how proximity of required disclosures is evaluated.” Therefore, “advertisers have the flexibility to be creative in designing their ads, so long as necessary disclosures are communicated effectively and the overall message conveyed to consumers is not misleading” given that “in reviewing their online ads, advertisers should adopt the perspective of the reasonable man.”

Arnie Fried, former Pfizer Counsel, has already brought up the issue of “reasonable man” in context of FDA regulation of the Internet (see “Arnold Friede Blasts FDA’s Right to Define “Reasonable Man” Without External Input“).

What JNJ and Friede omitted to mention is this quote from the same FTC report: “On a Web page, the disclosure is more likely to be effective if consumers view the claim and disclosure together on the same screen. Even if a disclosure is not tied to a particular word or phrase, it is more likely that consumers will notice it if it is placed next to the information, product, or service to which it relates.”

And this:

“In reviewing their online ads, advertisers should adopt the perspective of a reasonable consumer. They also should assume that consumers don’t read an entire Web site, just as they don’t read every word on a printed page. In addition, it is important for advertisers to draw attention to the disclosure. Making the disclosure available somewhere in the ad so that consumers who are looking for the information might find it doesn’t meet the clear and conspicuous standard.

“Even though consumers have control over what and how much information they view on Web sites, they may not be looking for — or expecting to find — disclosures. Advertisers are responsible for ensuring that their messages are truthful and not deceptive. Accordingly, disclosures must be communicated effectively so that consumers are likely to notice and understand them.”

When it comes to this precedent, pharma can’t have its cake and eat it too. Somehow it doesn’t seem right to selectively quote the FTC only when the quote bolsters your case.

Admittedly, I have not studied the FTC document thoroughly, but I do note that it was written at least 10 years ago, long before space-limited social media emerged within the “evolving digital world.” It’s utility as a model in today’s world, therefore, is limited.

The FTC, however, did address one case where space is limited: banner ads.

“Disclose required information in the banner itself or clearly and conspicuously on the Web site it links to. In some cases, a required disclosure can be incorporated into a banner ad easily. Because of the space constraints of banner ads, other disclosures may be too detailed to be disclosed effectively in the banner. In some instances, these disclosures may be communicated effectively to consumers if they are made clearly and conspicuously on the Web site the banner links to and while consumers are deciding whether to buy a product or service. In determining whether the disclosure should be placed in the banner itself or on the Web site the banner links to, advertisers should consider how important the information is to prevent deception, how much information needs to be disclosed, the burden of disclosing it in the banner ad, how much information the consumer may absorb from the ad, and how effective the disclosure would be if it was made on the Web site.” My emphasis.

It seems to me that this would have been a better quote for JNJ to cite. Perhaps it’s because the drug industry has long ago figured out a way how to use rich media banner ads to supply all the necessary balance within the ad itself. That technology may not have been around in 2000.

Which leads me to think about how technology will evolve 10 years from now. Perhaps all this fretting about “space-limited” social media (eg, Twitter) will be as irrelevant as space-limited banner ads are today. Flexibility, therefore, is required from the FDA when it issues regulations regarding social media. However, that does not mean that it should not issue any guidelines at all. As the technology evolves FDA should also revise its guidelines to keep up (see “FDA Social Media Guidelines Best Done in Baby Steps“). Some day, even TV technology may evolve that would require new broadcast regulatory guidelines.

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Johnson & Johnson Urges FDA to Be As Flexible As FTC in Its Regulation of Social Media, But…

Health Care Professional Marketing

1. It might be a good idea to do some research with HCP’s to rate the credibility of both your marketing materials and your sales reps. Believe it or not physicians view different companies differently when it comes to trust and the credibility of the information they present.

2. Do NOT selectively use content from journal articles. You can highlight certain findings from the journal articles but it’s better to give the physician the whole article so she/he can determine the facts for themselves.

3. When a clinical study comes out questioning the efficacy of your product do NOT point fingers and question the methodology of that study. This week both Medtronic and Abbott both tried to question clinical studies that showed their products may not have been effective as previously thought. The objective here is to say “that data raises some questions but let me provide you with another point-of-view.

Consumer Marketing

1. Acknowledge to your team that consumers are skeptical of your marketing and understand that it comes from a lot of factors that are both internal and external to the drug industry.

2. License content from credible sources to use in your website and collateral material.

3. Include links to other credible sites and competitors on your website. Consumers are going to go there anyway so help them get all the information they need to make a decision.

4. Align yourself with credible organizations and have the content you develop reviewed by them.

5. Ask your thought leaders to write content for consumers and include the thought leaders credentials on when you use it. Also be transparent that the thought leader is a paid consultant.

Understand that in any relationship TRUST is something that has to be earned; if that trust is broken than it can take a long long time to earn back that trust.

When you come to Healthbase’s homepage just type in the keyword, in this case Diabetes and Healthbase returns search results like you have never seen them before. First they are categorized by Drugs & Medications, treatments and Food & Plants but over on the sidebar are the results for diabetes in Social Media along with content sources. Extend the search and you can read a summary of each site without having to click through to the site. My experience with the site has been great and as the word gets around I’m sure more and more people are going to be thinking that this site provides real value. The only issue still to be resolved is credibility of information but I guess for now it’s reader beware of the information available on the Internet.

When we conducted usability testing for a new website earlier this year we started by following people as they searched the Internet for health information. The older the user the more difficult it was for them to get to the information they really wanted (defined by credible information from credible sources). Sure there are some top tier sites such as Web MD that are reliable but all too often people go to a number of different websites to collect all the information they need.

We asked people to search for health information on breast cancer, high blood pressure and allergies. As we watched our panel search we noticed that a lot of people stared with search but then consistently came back to their search results as they went through various websites. After they had an hour to search this is what we learned:

-Search often proves to be time consuming with too many search results.

-The main factor to determine if someone stays on a health site is both credibility and navigational utility (can they get to the pages they want to in the order they want to without having to search deeper in the sites).

-Consumers seem to getting used to paid placement vs. organic placement. Even the older demographics seemed to understand that paid placement was not always their best choice and there was a direct correlation between people who use the Internet more vs. new bees.

-Social media maybe a stop in the search but when we asked people if they found the information credible there was some debate. Some said “it could be” but most said that they would seek out more information.

-For conditions like breast cancer the searches were more detailed vs. searches for allergies. The more serious the health condition the more likely the deeper the search.

I was surprised at how many pharma product websites in search results do not go directly to specific pages within the website but rather they go to the homepage. There is a definite opportunity here to optimize your search engine marketing.

Google has a real opportunity here for brand extension and that in my opinion would be a search page dedicated to health that also ties into Google’s plans for online health records. Google needs to help consumers sought through the information by separating credible sources from social media posts and promotional sources. Having search results clearly broken out by causes, symptoms and treatments would also be very helpful.

We are planning to conduct another round of search research later this year or early next year when we will again invite a bunch of people in and have them search the Internet for health information and record their results. The more information that is out there the harder it’s going to be to cut through the clutter.

Hospitals are fighting for business and have realized that patients/consumers have a choice when it comes to where, what, how and when. As the chart below illustrates more and more hospitals are using social media to reach out to consumers and answer any questions they may have as well as to assure them that they offer a great health experience. This is another possible opportunity for DTC marketers, not to intrude on the development of the relationship, but to give hospitals the information they need to communicate with patients.

When I had rotator cuff surgery on my shoulder 5 years ago I was amazed at how the hospital, St Vincent’s in Indianapolis, went out of their way to make me feel at ease. Two days before the procedure a coordinator called me to ask me some questions and gave me her cell phone and eMail in case I had any questions. When I checked in I was taken to a small private room with a bed and remote control TV as nurses prepared me for surgery by inserting IV’s. When I was rolled into the ER I remarked how cold the room was and a nurse immediately put a warm blanket over me while another explained the procedure and the sedatives that I would be given to knock me out.

Now hospitals are taking that a step further. They are using social media to communicate with consumers and why not? It’s a competitive market and more and more patients want a choice. Here in LA some hospitals even offer gourmet food for patients and wide screen flat panel TV’s.

After the procedure you could receive an eMail, as I did, asking you to rate the hospital staff and your stay. Hospitals are focusing more and more on patients because they get it. So why don’t DTC marketers and pharma learn from them??

When you come to Healthbase’s homepage just type in the keyword, in this case Diabetes and Healthbase returns search results like you have never seen them before. First they are categorized by Drugs & Medications, treatments and Food & Plants but over on the sidebar are the results for diabetes in Social Media along with content sources. Extend the search and you can read a summary of each site without having to click through to the site. My experience with the site has been great and as the word gets around I’m sure more and more people are going to be thinking that this site provides real value. The only issue still to be resolved is credibility of information but I guess for now it’s reader beware of the information available on the Internet.

1. More people are going online for health information than at any other time in our history.

2. Patients are taking the information and using it to take active participation in their healthcare decisions.

3. Congress believes that the public has to be protected from DTC advertising and wants to scale back DTC.

Per a quote from one of my favorite movies: “what we have here is failure to communicate”. A good marketing person should always try and put him/herself in the shoes of their customer and right now customers are going online to take an active participation in their healthcare. Why? Because they want a say in what goes on within their bodies, because they are more likely to be dealing with an aging parent who needs extended healthcare and saying “that’s not going to happen to me!” The point is that people are questioning their HCP’s from medical procedures to the type of medication they take.

I have recommended before that before Congress develop healthcare programs they listen to how consumers are obtaining and using healthcare information. They would see that consumers in fact don’t trust DTC ads even though the drug industry continues to spend millions to sponsor the network news. I again call on lawmakers to invite Manhattan Research and Prevention magazine to give a presentation on how consumers are using health information. Once they have the facts maybe then they’re realize that the ideas they are coming up with are not relevant to today’s empowered consumer.

The Vitamin D Council’s website recently had the following information posted:

-Epidemiological evidence shows an association between reduced sun exposure and mental illness.

-Mental illness is associated with low 25-hydroxyvitamin D [25(OH)D] levels.

-Mental illness shows a significant comorbidity with illnesses thought to be associated with vitamin D deficiency.

-Theoretical models (in vitro or animal evidence) exist to explain how vitamin D deficiency may play a causative role in mental illness.

Now if you are an average online health seeker and you read this information what are you supposed to think? You certainly are not going to make an appointment to talk to your doctor about your vitamin D levels and health food stores have all types of claims for OTC supplements.

When we talked to online consumers about credibility they thought that drug company website information was credible when it came to disease information but the information on products was too promotional for most of them. They often turn to online web portals and when the moderator asked them “would you find the information more of less credible if you knew that the health portal website runs paid promotional programs from drug companies” most said that it would change their opinion of the information they read. “If they’re taking money how can they be impartial and tell me the real truth about the drug” one person said.

The FDA is charged to protect us from medications that could be harmful but who is going to protect consumers from health information that could be harmful? With more people self diagnosing and less going to see their physician this could become a major problem for doctors in a very short time.

It didn’t take long for Aleve to start running commercials that target the latest news on Acetaminophen or Tylenol. TV spots are running showing that “two Aleve can last all day compared to a lot of Tylenol”. Not to be outdone the makers of Tylenol are running spots saying that Acetaminophen is the most recommended pain reliever by doctors with a lot of safety studies behind them. If you’re a consumer you just want a good pain reliever and you don’t want to have to spend time online determining what is best for your headache or aching legs. The FDA is confusing the hell out of consumers and is doing little to truly explain risks.

As a follow up to the research we conducted earlier with physicians on the use of the Web by patients we followed up with a quantitative survey and asked physicians to rate pharma product websites on a scale of 1 to 5 with one being poor and 5 being excellent (information on disease and medications). I expected that there would be some who felt that pharma product websites could be better but I was not prepared for the comments that indicated that pharma websites have a “long way to go”.

One would think that when a physician is paid $800,000 that the company would go out of their way to verify that the information was factual and accurate but it seems that in this case Medtronic continued to issue the checks for a physician who developed products for the company, trained doctors and spoke at company events. So the line between good medical information and being a paid cheerleader was crossed and as long as this physician spoke and promoted the product it seems that Medtronic was willing to write a check. What’s wrong with this picture and how could common sense go out the window?

Physicians do have a right to be compensated for their time in developing products and for speaking but before those checks are written the companies have an obligation to ensure that the products he/she is developing are done with independent oversight and that the data presented is accurate and reliable.

If you were a patient going to see your doctor about back pain and he recommended an implant wouldn’t you want to know whether he has a vested interest in the medical device or has take money from a medical device company? I sure would especially with all the latest information coming about the ineffectiveness of a host of expensive medical devices.

For medical device companies it comes down to common sense:

…When physicians are compensated for their time their work should be verified by an independent third party to ensure accuracy.

2. A published list should be available to the public to show all payments to physicians by state.

3. Physicians should not be compensated as a percentage of sales for medical devices. They should receive a one time payment based upon forecasted sales.

Money has to big an allure and is forcing too many people to cross the line.

There are a lot of health conditions to connect patients

Consumers are going to be the final judge however. The key for them is going to be credibility and the ability to get to the information they want in a clear and fast method. There is just way too much information out there and today people are looking for ways to filter all this information so they don’t have to spend hours and hours getting what they need.

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