How Pharmaceutical firms can use social media within the regulatory framework
Today, while most industries are rapidly taking up Social Media to listen to and engage with customers, the pharmaceutical industry has remained cautious in its social endeavours. Owing to the lack of clarity on social media guidelines pharmaceutical firms balk at extending social presence in a highly regulated environment.
The Digital Health Monitor report analysed the online presence of 25 pharmaceutical firms, that included the names such as Pfizer, GSK and Bayer. Online presences of these firms was recorded across branded websites, blogs and apps, as well as on social media channels such as Facebook, Twitter and LinkedIn
Bayer tops the rankings for effective use of social media closely followed by Pfizer and Boehringer Ingelheim.
Most Popular Social Media
The 25 pharmaceutical firms that were analysed in the report have put more than 25,000 messages online, mainly using Twitter and Facebook. With Twitter being the most popular medium with more than 90% of the share of messages.
However this presence on social media is significantly less compared to other industries, as the pharmaceutical industry has its unique challenges with stringent regulatory restrictions on public communication and promotions.
Why pharmaceutical firms have been wary of Social Media
The pharmaceutical industry is hugely competitive, but highly regulated industry. Pharma companies today are fairly wary in their approach to social media, mainly because of the lack of clarity on regulations for social media laid down by the US FDA, UK ABPI and other bodies.
Any pharmaceutical firm considering an entry into the social media space will naturally be concerned about discussion of adverse events, off-label indications and sticking to the regulatory guidance within social media limits such as character limitations on twitter.
Adverse Events
An adverse event (AE) is defined as any unfavourable and unintended sign including abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, When a pharmaceutical firm has knowledge of any AE, it has obligation to file a report with the FDA through the Form 3500A-Mandatory Reporting.
Pharmaceutical firms have concerns with social media — are consumers sharing information online that would indicate an adverse experience? Does monitoring the social media trigger the AE reporting requirement? At this time, there is no FDA guideline or regulation that specifically covers the content of online discussion in a way that is different from reporting AE information derived from any other source.
Current FDA guidelines give four parameters for submitting information about adverse experiences:
The Life Sciences Company should have knowledge of
(i) An identifiable patient;
(ii) An identifiable reporter;
(iii) A specific drug or biologic involved in the event; and
(iv) An adverse event or fatal outcome.
According to the guideline: “If any of these basic elements remain unknown after being actively sought by the applicant, manufacturer, or licensed manufacturer, a report on the incident should not be submitted to the FDA because reports without such information make interpretation of their significance difficult, at best, and impossible, in most instances”
Off-Label promotions
According to the FDA, this is the first of multiple guidance that the agency plans to issue in response to the suggestions and comments. Following are some of the document’s key highlights:
- FDA clarifies the difference between unsolicited and solicited requests in the social media. For example, a question about off-label use posted on a pharmaceutical company’s web site, whether directed to the drug maker or others visiting the site, is an unsolicited request. On the other hand, if a pharmaceutical firm encourages people to post content on social media using one of its products and the content prompts questions about off-label use, this would be a solicited request. The FDA may consider solicited requests evidence of a firm’s intent that a drug be used for off-label purposes.
- The FDA also distinguishes between non-public and public unsolicited requests. For example, a phone call to a company’s medical affairs department is a private request, and the response should be provided only to the individual in a one-on-one communication. A question about off-label use that is posted on an social media forum is considered a public request, and if a company chooses to respond, it should give contact information only; anything else could be misinterpreted by others in the forum as off-label promotion.
- The FDA also encourages drug companies to respond to unsolicited requests that are made in a public forum because other forum participants might not provide or have access to the most accurate, up-to-date information.
- Responses to unsolicited requests should not be promotional in nature or tone, and they should not provide links to promotional content.
- Companies should respond to unsolicited requests only if they pertain to that company’s own named product.
Notably, according to the guidance, if a company responds to an unsolicited request for off-label information as per the FDA’s recommendations, the company’s response will not be used as evidence of its intent to support the product for an unapproved use. However, responses to unsolicited requests that are not in accordance with the guidance may be considered evidence of a new intended use of the product.
In the UK, the Association of the British Pharmaceutical Industry (ABPI) is responsible for setting guidelines around the marketing and promotion of pharmaceutical products
The association of the British pharmaceutical industry (ABPI) is the trade association for over 120 biopharmaceutical companies in the UK .
- ABPI has published code of practice for pharmaceutical promotions which lays out the guidance for promoting prescription drugs
- Pharmaceutical firms cannot promote prescription-only medicines and those that haven’t received marketing authorisation to the public; but facts may be shared.
- The ABPI differentiates between proactive information which is pushed at the recipients for example Ads, reference information and reactive information which is supplied to the public in response to a direct request. Furthermore, the company must disclose the sponsoring of any material.
- Pharmaceutical firms must record all adverse events and product complaint data, which may be reported to the medicines and healthcare products regulatory agency (MHRA) if reporting requirement are met.
The ABPI guidance notes on the management of adverse events and product complaints from social media activities by companies fall into three broad categories of listening, broadcasting and engaging.
- Listening involves monitoring social media sites, to allow a company to ‘listen to’ what the public discussions on social media about the company, diseases, conditions and the treatment options.
- Broadcasting involves companies initiating one-way communication to share messages with the public, where interactive dialogue is not permitted or practical.
- Engaging involves exchanging messages and participating in an interactive communication with the public.
All three can be performed on company sponsored or non-company sponsored websites, the company must always declare its presence, and must monitor the entire content on an ongoing basis, especially for adverse events and product complaints.
References:
- http://www.abpi.org.uk/our-work/library/guidelines/Documents/ABPI%20Guidance%20on%20PV%20and%20Digital%20Media.pdf
- https://www.fda.gov/downloads/drugs/guidances/ucm401087.pdf
- https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm285145.pdf
- https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm381352.pdf
- https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm401079.pdf
- https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3351868/
