Nov. 17, 2017 — In response to an Office of Prescription Drug Promotion (OPDP) call for input on a “limited risks plus disclosure” strategy for broadcast direct-to-consumer (DTC) ads, the FDA received 39 comments from health professionals and consumers as of Nov. 16. Although several of the commenters call for a complete ban on DTC prescription drug advertising, others comments received state support for limiting on-air disclosures to the most significant and well-known side effects.

Understanding perspectives on both sides of the equation likely will help the OPDP move forward on this issue.

Listed here are excerpts from several comments that do not support the “limited risks plus disclosure” strategy (or DTC advertising in general, in some cases):

“Prescription drugs should NOT be advertised to consumers. There is no benefit and some potential harm by doing so.” (Health professional)

“Until drugs are no longer marketed directly to consumers, the consumer’s protection should be the prime concern for all of us. Full disclosure must forever accompany any and all prescription drug sales ads/pitches.” (Federal government)

“Current advertisements rattle off risks rapidly at the end of the commercial without giving any context of similar risks in the general population. This always feels to me that they are fulfilling the needs of lawyers in the company, rather than truly serving the consumer.” (Health professional)

“Please continue to require a full range of warnings BUT with no background distractions. The reason many people do not understand or ‘register’ the warnings is because of all the background visuals (fluttering moths, people in bathtubs, you name it). If you require the warnings to be read and at the same time appear in large print form on an otherwise white screen, people will get the message.” (Consumer group)

“A number of peer-reviewed studies have reviewed the presentation of risk information in DTC advertisements, asking the question: Is the information presented by pharmaceutical companies ‘fair and balanced’ in DTC advertisements? All in all, the consensus appears to be ‘no.’” (Consumer)

Listed below are excerpts from some of the comments in favor of at least some aspects of the “limited risks plus disclosure” strategy:

Many of those who support this strategy make suggestions about how the limited risks should be presented. For example, many state that the risk information should not be accompanied by distracting music or graphics.

“As an allergist who prescribes a lot of drugs and other treatments with well-known side-effects and other risks, I agree with the proposal to limit the listing of side-effects to only the most serious ones, but not just life-threatening events, and not more than 2 or 4 at the end of an ad. … The info on side- effects should be straight forward without distracting music, irrelevant pictures or scenes such as flying butterflies, cuddly puppies or grandpa kissing his grandchild.” (Physician)

“The current litany of side effects vomited forth on current drug advertisements is ridiculous. Let’s establish criteria which would work better, i.e., occurring more than 5% and having real significance or consequences.” (Retired physician)

“I feel, based on my patient’s feedback that there are too many side effects listed on advertisements. It tends to scare them away from even trying the drug even though I try to explain how research lists them in the PI. I think the most common side effects should be listed BRIEFLY plus the allergy reactions that can occur.  Advertising that there are more side effects that your provider can discuss with the patient is a good idea instead.” (Health professional)

“I think the laundry list of possible side effects that are mandatory in pharma drug TV commercials is excessive. Whenever that part of the commercial comes on, I tune out, even if I’m interested in what they’re saying. All I care about is if it’s going to kill me or maim me. Other than that, I’ll read more about it later.” (Consumer)

“The length of possible side effects is ludicrous. Even for someone familiar with the issues, listening to a lengthy list of possible side effects, quickly rattled off, causes rapid mental shutdown. Potentially serious or frequent side effects might be important to state. The key point to stress however, is that people respond differently to any medication, especially if they have other medical problems or are taking other drugs, and that they should discuss this with their physician. A shorter list and suggesting more attention to professional advice would be appropriate.” (Retired pharmacologist and biomedical researcher, consumer)

“As a licensed pharmacist, I support efforts to reduce the ‘density’ and concentration of adverse effect information that is literally being ‘force fed’ to our patients in direct-to-consumer TV advertisements. The data now show that ‘less is more.’ Clearly, we need to inform patients about life-threatening risks, allergic ramifications, significant drug-drug interactions, and, most importantly, that ‘this list is not all inclusive’ of the adverse event profile of Drug X. The current flood of adverse events that Pharma are required to mention in these ads is basically lost on the most important stakeholder in the healthcare continuum, the patient….I applaud Commissioner Gottlieb on this initiative.” (Pharmacist)

Comments on this issue are due to the FDA by Nov. 20.