October 29, 2014
Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
Comments of members of the Patient, Consumer, and Public Health Coalition on
Draft Guidance for Industry
“Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices”
Docket No. FDA-2014-D-0397-0001
As members of the Patient, Consumer, and Public Health Coalition, we welcome the opportunity to provide feedback on this draft guidance regarding use of internet and social media platforms for communicating about medical products. Patients and consumers increasingly rely on social media and the internet as sources of health and medical information that influence their decisions to seek medical care.
The draft guidance states, “Truthful, accurate, non-misleading, and balanced product promotion best serves the public health.” We agree. But the draft guidance as written will not result in that desired goal.
The Food and Drug Administration (FDA) recognizes throughout this draft guidance the inherent difficulty in communicating adequate risk and benefit information through platforms that have very tight space limitations. The draft guidance states, “For some products, particularly those with complex indications or extensive serious risks, character space limitations imposed by platform providers may not enable meaningful presentations of both benefit and risk.”
However, the draft guidance fails to provide any meaningful solutions to this problem. Instead, the draft guidance simply abdicates the determination of whether such a platform is appropriate to the discretion of the sponsor. Specifically, the draft guidance states, “If a firm concludes that adequate benefit and risk information, as well as other required information, cannot all be communicated within the same character-space-limited communication, then the firm should reconsider using that platform for the intended promotional message.” As firms stand to benefit from information that places their product in the most favorable light, leaving this decision to them is likely to result in information that gives short shrift to safety or risk information. The FDA has not identified any enforcement mechanisms to ensure compliance and lacks sufficient resources to adequately monitor these platforms. If finalized, this guidance is non-binding and voluntary by nature. On the other hand, that is almost irrelevant since this guidance leaves the most important decisions to the company that wants to sell its product.
The one major attempt to resolve the issue of space limitations comes at the cost of presenting adequate risk information. The draft guidance states that the firm may present the “most serious risks,” and then, rather than delineating all the risk information, it could instead provide a link to the full risk information. This plan has several fatal flaws:
- The term “most serious” is open to interpretation, and individual patients and consumers may have different views about what risks they find acceptable. Are the most serious risks the ones that are common and harm quality of life, such as nausea or dizziness, or the ones that might be rare but life-threatening, such as renal failure or potentially fatal blood clots?
- It is well known among social media experts that consumers are less likely to obtain information that requires more “clicks.” Many may not even realize that the link provides crucial, potentially life-saving information. Allowing most risk information to be available via subsequent links clearly increases the chances that consumers will not see all the risk information that is crucial for them.
Marketing studies suggest that most consumers and patients will not follow links to additional information. When social media are used to promote the use of medical products, they might not even realize that the presented information is only a very partial list of all possible risks. Therefore, allowing any presentation of risks that is not comprehensive opens the possibility for misinformation.
It is difficult if not impossible to think of many examples that could effectively communicate risks and benefits within strict space limitations without removing substantial amounts of risk information and relying heavily on links, given the complexity of risk and benefit information for most medical products. As a scientific agency devoted to public health, the FDA should not consider the policies proposed in this draft guidance without collecting data on how many consumers/patients would follow links to information about risks of medical products, compared to how many would read information that does not require one or more extra clicks to access.
The draft guidance explicitly states, “Risk information should be comparable in content and prominence to benefit claims within (emphasis added) the product promotion (i.e., a balanced presentation).” To achieve that goal, the amount of space should be comparable for risks and benefits and the reliance on links should be identical for risks and benefits.
The draft guidance notes, “The public health is best served when risk and effectiveness information about drug and device products is clearly and accurately communicated.” We agree. Unfortunately, social media platforms with character space limitations do not allow firms to provide “a balanced presentation of both risks and benefits of medical products.” On the contrary, it is a classic case of cramming a round peg in a square hole. This medium was not designed to provide enough information for patients to adequately access a product’s benefits and risks.
For these reasons, this draft guidance is unacceptable to those who care about public health and providing balanced information to patients and consumers. We strongly urge FDA to completely revise this draft guidance, so that it offers the possibility of improving the public health by providing patients and consumers with risk information on the par with promotional information.
Annie Appleseed Project
American Medical Women’s Association
Connecticut Center for Patient Safety
Mothers Against Medical Error
National Center for Health Research
Our Bodies Ourselves
The TMJ Association
Center for Science and Democracy at the Union of Concerned Scientists
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at firstname.lastname@example.org