Disease State Websites and Ads

NOTE: The opinions in this article are mine and are presented solely to cause thought on this subject and do not represent legal or regulatory advice.  Companies or individuals should seek appropriate legal or regulatory help to address these types of issues.

Information about a disease that is provided to consumers and/or healthcare providers has had many names over the years:  help-seeking ads, disease state ads, disease awareness ads, among others, have been used.  No matter what you call them, for a long time FDA has seen the advantages in drug companies providing useful, unbiased, non-promotional information to help educate patients and healthcare providers about diseases.   Likewise, pharmaceutical companies have long used these to raise awareness about a disease both with consumers and prescribers.   In most cases, and logically so, these companies have put their money into developing materials for diseases they have a treatment for. This has created the possibility for these disease awareness materials to be used as 'veiled' drug promotion. 

OPDP put out general  guidance in 2004 on this topic which was withdrawn by FDA in 2015.  To the best of my knowledge there has been no follow-up since that time.   Since the currently available, non-withdrawn documents from 1985 and 1988 are actually precursors to the 2004 guidance, there doesn't appear to be a lot of current, updated information.

From my experience and using the 2004 guidance as a source, I have constructed a series of dos and don'ts to keep your disease state materials pure and not product promotional.

DO

• Provide relevant, specific and useful information about the disease in question.  
• If directed at consumers, advise the consumer to go see an appropriate health care professional

DON'T

• Combine disease awarenss communications with mention or inference of a drug unless you also including fair balance and access to a product package insert (i.e., you are using disease awareness material within a product promotional setting)
• Make the design, images, color schemes, etc. between your disease awareness materials and product promotional materials be the same or similar
• Put disease awareness materials or ads near (or for multimedia, close in time) to product promotional materials
• Present information in such a way that it unduly scares consumers into going to their doctor or convincing them they have a disease because they have a particular symptom
• Present disease state information in an unbalanced way to imply that treatments can do more than they are approved to do (e.g., saying that treatment for diabetes will reduce the risk of heart attacks or strokes if the sponsoring company's diabetes treatment has not been shown to do that)
• Suggest self-diagnosis or suggest the use of unapproved testing as a definitive diagnostic test for the disease.
• In a situation where there are classes of drugs that treat the same disease, highlight the advantages or disadvantages of those classes, especially a class that a company's drug may fall under.
• If there is only one drug that treats a particular condition, discuss pharmaceutical treatment. (NOTE: A company MIGHT be able to include limited statements (e.g., 'this disease can be treated with exercise, pharmaceutical therapy or a combination of exercise and pharmaceutical therapy') about treatment of the disease.  It should be noted that this approach may entail some small risk based on the 2004 guidance and other things I have heard over the years.  Companies need to choose whether they are willing to accept this risk and, if they do, they must be careful on the wording they use when they mention that there is a treatment.  Any mention of treatment should also be in line with the approved indication.   For example, if a drug is approved to treat symptoms the language chosen should reflect that limitation).
• Provide disease state information on a disease that you do not have an approved indication for, especially if your drug is known to be used off-label to treat that condition and you do not have a drug approved to treat that disease.

Some things that I have learned over the years that might be helpful to people are as follows:

• OPDP Submission of Disease State Materials - Look, by definition you don't have to submit your disease state materials to OPDP.  However, I would consider submitting to OPDP your 'portable' (e.g., hard copy or flash drives) disease state materials.  In some cases these materials might up being used with promotional materials.  If submitted to OPDP with that intended use ('may be used in the future with promotional materials') it can help a company if the disease state materials are inadvertently used in the future along with promotional materials.  It also helps set up that these materials will be regulated internally.  
• Create an intended use for disease awareness materials - One thing that I have seen done over the years is that promotional materials can (and probably SHOULD) be approved with an intended use.  If they are used for something else this should involve a separate approval for the new use.   This same thought could be used for disease awareness materials.   If they are internally approved to be used alone, any use of them with promotional materials would have to be separately approved.  This would help to avoid situations where use of these materials could become problematic to the company. 
• Be careful about accidental connection between the drug name and the disease awareness materials - There has been some thought given to whether sales reps should be distributing solely disease state materials as the HCP likely knows that they promote a particular drug.   I have even heard of situations where a sales rep is wearing a nametag with the drug's name on it while presenting disease state materials or, in a laptop/tablet presentation, has the drug logo as their screensaver.  Also, if your website or printed materials cites references, make sure the titles of those citations do not mention or imply a particular drug or make claims about a drug class
• Links to product promotional websites from disease awareness websites - This is an interesting area.   Some companies believe that you should keep your disease awareness totally separate and don't allow links, even indirect ones, to promotional websites from disease awareness websites.   Some companies allow these links but the link (which may read something like "Click here to find out about a new treatment for disease XYZ") must pass through an intermediate webpage with a warning message (e.g., "You will now be redirected to a product promotional website.  Click here to go back to previous webpage").  OPDP has mentioned in at least one untitled letter that direct links between disease awareness websites and product promotional websites (no intermediate webpage) are not appropriate.  However, a few companies apparently still allow that.
• Disease awareness websites that have opt-ins to receive additional information - It is not clear how many companies have this.   However, my experience is that companies that do this do not allow product promotional information to be included in materials sent to people who opt in to receive disease awareness materials as that could be construed as veiled product promotion under the guise of providing disease awareness. 
• Other types of veiled promotion - Veiled promotion could include creating a search engine result that indicates directly or implies that the reader is going to be directed to a disease state website  when, in fact, they are directed to a product promotional website.   For example, such a search engine result could say something like "Click here to learn more about disease XYZ" and then direct someone to a product promotional website homepage. 

There are probably many more examples of gray areas that have come up over the years at drug companies about what are proper and improper disease awareness materials and the practices that surround use of these materials.  I just hope that the information above stimulates you to think about what is and isn't proper use of disease awareness materials.