Higher standard set for risk presentation

June 10, 2009 – 12:39 pm by Steven Niles

Recently, FDA issued a draft guidance titled Presenting Risk Information in Prescription Drug and Medical Device Promotion. The draft guidance outlines factors FDA considers when evaluating ads and labeling for prescription drugs, providing examples to illustrate the agency’s thinking. According to FDA, the guidance was issued in response to requests for specific guidance on how FDA evaluates prescription drug and medical device promotional pieces to determine whether they adequately present risk information.

Be careful what you wish for. FDA’s examples are fairly clear, so advertisers can no longer claim to hide behind the cloak of ignorance when it comes to presenting risk information. Meanwhile, the bar appears to have been raised in terms of the explicitness of the risk information presentation.

I was curious how the industry was reacting to this document, so I asked around. Here are a couple of the responses I’ve received so far.

For consumer promotion, presenting risk information in a balanced way is an important issue that needs to be addressed, according to Nancy Beesley, executive VP, HC&B Healthcare Communications. As an owner of an ad agency, Ms. Beesley is not happy to see increasingly prominent risk information competing with the ever important marketing message, but she acknowledges it wilI probably be important for the consumer.

“That said, for the physician, less is more,” Ms. Beesley told me. “Doctors are aware of the risks and are smart enough to understand that no drug is without risks. Do manufacturers have to present this info? Yes. Do they have to go to great extremes for the physician to communicate risk information? Probably not.”

Donna Wray, a management advisor for TGaS Advisors, took an even harder line on FDA’s draft guidance document. She believes that the new guidance will profoundly affect advertising, online and offline. Here’s what she had to say:

One of my clients complained to me after DDMAC sent letters to 14 companies about paid search advertising. She said, “This is a higher standard than print promotion has to follow.” The recent draft guidance on presenting risk information clears this up – the FDA is planning on holding all promotion to the same higher standard. The guidance documents every way that pharma companies have been de-emphasizing risk information or emphasizing benefit information, and clearly says that neither will be allowed in future.

Does this new guidance help the consumer? The FDA says they are using the “perspective of a consumer acting reasonably.” However, consumers may not be able to act reasonably when presented with the resulting confusing information. Early on in DTC advertising, I had a guest from Europe and we watched some TV together. A typical pharma ad came on and presented fair balance at the end. His face grew horrified. “How could anyone possibly take such a nasty medication?” was his comment.

Over the years, we have grown deaf to some of the caveats presented, because we are used to them, but that is not sufficient reason to turn up the volume on them. When faced with a message such as “This drug can cause injury and death to an unborn fetus, but it may help your blood pressure,” what person would say, “Wow, sign me up?” And yet, untreated hypertension is clearly more of a health risk to the non-pregnant patient. Health outcomes may suffer under this new guidance. Meanwhile, a quick Google will find non-pharma ads with copy like “Did you know that Chinese herbs can easily treat hypertension?” or even “Now my BP is down to 120/75. Find out how I did it without drugs.”

Pharmaceutical marketing dollars can provide a useful source of medical information to the consumer. Excessive constraints around the way the information is presented may protect the FDA from criticism, but isn’t necessarily improving consumer decisions about medication.

The issuance of this draft guidance is another reminder of the importance of regulatory compliance and the need for marketing teams to take stock of regulatory literacy among their promotional agencies. Vendor training and certification is one way to ensure compliance with company policies, according to Ilyssa Levins, president, Center for Communication Compliance.

“It’s reassuring to see that FDA is serious about creating formal policy, with input from industry, to avoid being perceived as creating policy through punishment (e.g. 14 Untitled Letters),” Ms. Levins told me. “Given the impact promotional materials have on physician decisions and the ramifications for their patients, appropriate risk communication is critical.”

Tags: advertising, fair balance, FDA draft guidance, risk information