Oh, to be a healthcare marketer in the digital age. It used to be enough to build a website, create a few well-placed banner ads and you were your company's go-to digital expert. Today, it is the constantly evolving, Wild West yet vitally important marketing channel of social media that medical device and biopharma companies seek to harness. At times it may seem as though there are as many rules and regulations to keep up with as there are new digital opportunities, but savvy marketers know they must engage their audience wherever they are—and social media is now a legitimate and valued promotional channel.
After successfully navigating the regulatory review process for your social media content to be posted online, you, or a representative of your company now has the responsibility of monitoring its engagement. A key component of that engagement is the user-generated responses and your obligation to report to the FDA any posted adverse events related to your product.
Any television viewer of the last decade or so could probably rattle off the popular sing-song of physical ailments commonly included in a “Side Effects May Include” list airing during TV commercials. A common list of side effects has become so mainstream in the American vernacular that it has been spoofed on Saturday Night Live over 20 times.
While we see the humor in the bit, the FDA does have a serious job of maintaining purview over all post-marketing events that may occur. Therefore, the publication and reporting of side effects and serious adverse events, or SAEs, from medical products is integral to maintaining the safety of the American public. The FDA relies on adverse event reporting to help maintain their watch over the vast amount of prescriptions, over the counter medications, medical devices and biologics on the U.S. market.
In order to help frame what an SAE is and who should be reporting an occurrence the FDA published, “Guidance for an Industry: Post-marketing Safety and Reporting for Human Drug and Biological Products Including Vaccines” in 2001. Post-marketing or Post-marketing Surveillance is the monitoring of the safety of a pharmaceutical drug or device after it has been released on the market. A safety report must be submitted to the FDA for serious and unexpected adverse experiences from all sources (domestic and foreign). The FDA considers it an SAE when the patient outcome is:
- Life-threatening (substantial risk of dying or will with continued use)
- Hospitalization as a result of the adverse event
- Disability or permanent damage
- Congenital anomaly or birth defect due to exposure
- Intervention necessary to preclude permanent impairment or damage (devices)
- Other serious important medical events (that may jeopardize patient)
Marketers must apply these FDA guidelines to social media content. To help identify how SAE reporting applies to the sometimes-murky terrain of social media and user-generated content, it is important to keep in mind the four requirements the FDA deems necessary to be considered reportable. To be reportable to the FDA, any written comment or engagement with your social media channel must include:
- An identifiable patient - Information sufficient to believe a specific patient was involved
- An identifiable reporter - Sufficient follow-up information
- A suspect drug or biological product - An adverse experience or death suspected to be due to the suspect product
- SAE or fatal outcome suspected to be due to the suspect drug or biological product
If after an attempt to uncover any of the missing information all four elements are not identifiable, a report does not need to be sent to the FDA. However, it is always a good idea to share any engagement in doubt with your compliance team for their official decision of whether all four elements are identifiable and a report should be filed.
While recognizing and reporting SAEs is critical, it should not dissuade medical device or biopharma companies from entering the social landscape as the benefits of reaching your audience outweigh the effort to monitor your social media channels. Well-crafted social media content can be valuable, educational and encourage your audience to seek more information about your product.
TEST YOUR SAE REPORTING KNOWLEDGE WITH THESE SOCIAL MEDIA EXAMPLES:
Answer) This post and its user-generated content does not need to be reported to the FDA. Though extremely bothersome, a rash that lasts for a few hours and does not require hospitalization is not a serious adverse event.
Answer) As with some social media posts, the true identity of the user behind the handle may not be easily identifiable. If the user is unable to be identified, the post does not need to be reported to the FDA.
Answer) Even though “Catwoman_Forever” and her healthcare professional can probably be identified, and the drug reaction seems extreme, the product’s Important Safety Information states that “the most commonly observed side effects are swelling, redness, pain, bruising, headache, tenderness, lump formation, and itching at the injection site”. These side effects are listed on the approved product label and do not qualify as an SAE, therefore there is no need to report to the FDA.
4. Comment posted on a product website:
Answer) Yes. This post fulfills all four requirements necessary for the manufacturer to report the SAE to the FDA. The patient and reporter are identifiable. The patient was hospitalized due to a direct reaction to product use.
If you got all four questions right then you are an expert in FDA compliance! However, if you are ever in doubt, please consult with your compliance department for direction. If you got one or more wrong, you could use a brush up on your knowledge and we can help. To speak with an expert healthcare social media strategist about your company's needs, get in touch with us at Grey Matter Marketing.