Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852
September 16, 2014
Comments of members of the Patient, Consumer, and Public Health Coalition
on Draft Guidance for Industry on Internet/Social Media Platforms:
Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices
Docket No. FDA-2014-D-0447
As members of the Patient, Consumer, and Public Health Coalition, we are writing to express our concerns about the draft guidance for “Correcting Independent Third-Party Misinformation about Prescription Drugs and Medical Devices.”
This draft guidance only applies to companies who “voluntarily choose” to correct misinformation that appears on the Internet or through social media platforms from third party entities. However, companies should be held responsible for the accuracy and balance of all information about their product that appears to be promotional, not just for sources they voluntarily choose to correct. Companies would have no incentive to correct information that praises or over-exaggerates the benefits of their product, so there would an imbalance in the type of information that gets corrected.
Due to the fact that this guidance is voluntary in nature and that there are no enforcement mechanisms in place, it will not do enough to protect individual patients or the public health more generally. Only a strict requirement to correct misinformation would ensure that patients are not misled.
While we are sympathetic that it would be more work for companies to correct all online misinformation, we are certain that companies are aware of almost all information regarding their products that is either critical or promotional. Information in blogs, patient Web sites, and other “independent” third party sources are often bought and paid for, directly or indirectly, by the companies whose products are being praised (or whose competitors’ products are being criticized). Without any enforcement mechanism, it is impossible for patients, consumers and other stakeholders to determine the true source of the information, whether it is from an independent third party, and whether the information is accurate. For example, some blogs and forums make it difficult or impossible to determine if the author is or isn’t associated with the company that makes the product.
To help minimize the misuse of social media and internet promotions, substantial penalties should be imposed on companies that pay for any promotional materials that are biased or inaccurate.
One example that illustrates this problem is Wikipedia. It is against the Wikipedia rules for companies to promote themselves, but the reality is very different. Wikipedia is a major source of information to millions of people in America and around the world. This platform could allow someone to propagate a significant amount of information, including misinformation, to millions of consumers. Anyone, whether knowledgeable, biased, or not, is free to edit a Wikipedia article. If the person editing an article were employed or paid by the company that made the product, directly or indirectly, Wikipedia administrators would not know that unless the individual doing the editing used an ISP associated with the company. As a result, Wikipedia articles about prescription drugs and medical devices vary greatly in balance and accuracy.
It is critical for FDA to ensure balance and accuracy on such platforms, because Wikipedia is the first source of information that appears on a Google search for many medical conditions, drugs, and other medical products. Since Wikipedia has an army of volunteers whose job it is to enforce its rules aimed at reducing the use of their platform for promotional purposes, and since those rules are currently ineffective for ensuring the objectivity of information about medical products, FDA staff should reach out to Wikipedia officials to determine how the agency can provide information that would help Wikipedia determine how to improve its own efforts to ensure that information about medical products is “neutral” rather than promotional.
The draft guidance states that all corrective information provided by the drug or device companies should be “consistent with FDA-required labeling for the product.” We find this problematic because even if corrective information can be identical to FDA-approved labeling, it could also be incomplete. For example, a Web site can include exact wording about benefits but exclude or limit information about risks. The FDA’s draft guidance needs to be more specific about the importance of providing complete labeling information in posted corrections to misinformation.
In addition, the draft guidance does not address the issue of information on off-label usage of medical products. Patients could be harmed by misleading or incomplete information on the risks and benefits of off-label use of medical products. It is essential that the FDA stipulate that companies must also identify when information refers to indications not approved by the FDA and inform consumers that the accuracy of such statements has not been reviewed by the FDA.
The draft guidance recommends providing a link that goes directly to FDA-required labeling. Although we think providing a link is a great idea, information about risks should also appear on the actual Web sites and forums. One click away is one click too many. If the information about benefits doesn’t require a click, the information about risks shouldn’t require a click either. Unlike TV, radio, and magazine ads where every piece of information costs a lot of money to include, it is much easier and cheaper to include comprehensive risk information on the Internet.
A major shortcoming of the guidance is that there are no requirements for how speedily a company must correct misinformation. In the world of social media and “viral” marketing, it may only take a few hours for content to go live and reach the targeted audience. If there is no time frame in which companies must correct the misinformation, then on many platforms like Twitter and Facebook, a correction may be ineffective after a significant amount of time has gone by.
In conclusion, the Internet and social media are often the first source of information that health professionals and consumers use to find out about risks and benefits of medical products. This information has the potential to influence consumer behavior and physician treatment decisions. The FDA needs to make sure that the information available on the Internet is as accurate and balanced as possible, and should not rely on companies who make the medical products to voluntarily correct flattering or promotional material about the products they are selling. FDA should require companies to correct this information to the greatest extent possible in order to ensure that consumers are not influenced by misinformation that may harm their health.
Annie Appleseed Project
Breast Cancer Action
Center for Medical Consumers
Connecticut Center for Patient Safety
National Center for Health Research
Our Bodies Ourselves
The TMJ Association
The Patient, Consumer, and Public Health Coalition can be reached through Paul Brown at (202) 223-4000 or at firstname.lastname@example.org