by: Jeff S. Gibson, Attorney
The internet and social media can provide a wealth of information for patients and consumers of healthcare services. However, due to the way that information is created and shared, it is possible for incorrect or incomplete information to be published online which can put patients at risk. The FDA recently issued a draft guidance for manufacturers of drugs and medical devices related to user-generated (independent third-party) internet content which addresses the correction of misinformation about an FDA approved product.
The main point the FDA makes in this guidance is that the correction of third-party misinformation on the internet is completely voluntary on the part of the drug or medical device manufacturer. This means that the product maker is not required to take an action to correct misinformation that is provided by independent third-parties who are not under the company’s control or influence and that is not produced by, or on behalf of, or prompted by the company in any way.
However, if a drug or medical device manufacturer chooses to offer a correction of misinformation that is shared on an independent blog, a third-party comment on a company-sponsored discussion forum, or independent third-party website, the FDA drafted a guide for assisting manufacturers in the proper communication of drug and medical device information. The FDA is accepting public comment on this guidance for the next 90 days. Comments can be submitted electronically via http://www.regulations.gov. Written comments will be accepted as well.
The FDA stresses that a product manufacturer should:
- Limit their communication to only address the misinformation that was provided by the third party
- Be non-promotional in nature, tone, and presentation of the corrective information
- Disclose that the person providing the corrective information is affiliated with the drug or medical device manufacturer
- Be consistent with the FDA-required labeling of the product
- Be relevant and responsive to the misinformation
- Post the corrective information in conjunction with the misinformation in the same area of the forum or reference the misinformation in its response
The FDA suggests that drug and medical device manufacturers keep a thorough record of all corrective communications including the website where the misinformation was found, the date of communication between the site administrator and the product manufacturer, and the corrective information the manufacturer provided.
The FDA further states that if a drug or medical device manufacturer offers or posts corrective communications about a product that it should address all misinformation that is located in a clearly defined portion of the internet forum. This means that the manufacturer cannot choose which incorrect statements to address and should either address all or none of the statements. Also, if there are misstatements that highlight the product in a negative and a positive light within a clearly defined portion of the internet forum, the manufacturer cannot only address the negative comments. Again, the communication should address all or none of the misstatements.
The guidance also addresses websites and forums that do not allow comments. The FDA states that if a drug or medical device manufacturer provides corrective information or requests that misinformation be removed from an online source and the blog author, forum administrator or website owner refuses to make the correction, that the manufacturer has taken reasonable steps to correct the issue and cannot be held responsible for the misinformation.
Just this past week, the FDA issued a warning letter to supplement manufacturer Zarbees for posting Facebook “likes” to comments that visitors posted to its Facebook page related to the effectiveness of its supplements. The FDA found that these “likes” constituted an endorsement of the comments made by the individuals that were not consistent with marketing guidelines for supplements.
This guidance can help drug and medical device manufacturers understand their options regarding the correction of misinformation on third-party internet properties. It should also serve as a reminder and warning to the public to conduct thorough research regarding medical treatment and healthcare options rather than trusting a single source of information, specifically on the internet. Feel free to contact us now if you have any more questions and for a free consultation.