Drug Promotion on Social Media By Consumers: Can It Be Regulated?
Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here.
Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the maker of Diclegic to “raise awareness about treating morning sickness.” Other than noting that studies have shown no increased risk to the baby due to the use of this drug, Ms. Kardashian did not reference any potential complications or known side-effects of the drug in her post.
Endorsements in advertising are carefully regulated by the Federal Trade Commission. The Code of Federal Regulations, 16 CFR Part 255, sets forth what is considered an advertising endorsement, and what information must be disseminated when the product is being endorsed. When a celebrity is endorsing a product, the FTC specifies that the celebrity is subject to liability for any statement made about the product, and the advertiser is liable for any misrepresentations made through the endorsement. Further, it is the duty of the advertiser to monitor any publications (e.g. blogs) issued by the endorser that deceptively represents the product being endorsed.
As the federal agency imbued with the duty to oversee compliance with drug regulations, the Federal Drug Administration has the power to issue warning letters to drug manufacturers when it is determined that the manufacturer has failed to comply with federal guidelines, and to pull a product from the marketplace in the absence of compliance. Addressing issues such as adulterated foods, misbranded products and improper labeling, all FDA warning letters and recall notices are public documents that can easily be viewed by any consumer.
Because Ms. Kardashian failed to include in her Instagram post any information about recognized side-effects experienced by certain users of Diclegis, the FDA issued a warning letter to the drug maker, Duchesnay Inc., specifying this deficiency (www.fda.gov – NDA: 021876). Within the letter, the FDA ordered Duchesnay Inc. to “immediately cease misbranding” this drug, or “cease introducing the misbranded drug into interstate commerce.” In response, Duchesnay put out a statement clarifying that it “takes its regulatory responsibilities very seriously,” and acknowledging that “its communications, including in social media as in this particular instance, need to be in accordance with applicable rules and regulations.” Not surprisingly, the post issued by Ms. Kardashian was removed from Instagram.
Although the FDA closely monitors the information put forth by companies, containing the spread of incomplete or misleading information is a monumental task, especially now with the popularity of social media. Continued vigilance by the FDA will certainly aid in the proper dissemination of information, and may encourage more carefully crafted posts by those persons endorsing products.