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- 05/30/2017

How can pharmaceutical companies use social media without going against the FDA regulatory requirements

Pharma Horizon

How can pharmaceutical companies use social media without running go against the Food and Drug Administration (FDA) and various regulatory requirements? Is what Joanna Belbey  asked  to Colleen Tracy James, a partner in Mayer Brown’s New York office in an interview for Forbes.

Here the main points:

    • The main challenge for this kind of companies is make sure information is reliable and trustworthy, as the kind of communication they give may impact on the consumer’s health and well-being. They need to know how to handle incomplete and misinformation about their products.

      According to the FDA Guidance, when a pharma company use social media has to include the ‘good, bad and the ugly’ about the product. The social media posts need to be fair and balanced.

    • Another challenge is to control the information and the message given on the product. That’s why Colleen Tracy James, suggest to use a   “controlled environment” such as  company webpage for a drug or disease to be sure information is accurate and complete
    • Then it may be the case that a company might need to correct misinformation. How can a company respont to patients that share not correct information? It can again be used the controlled enviroment of the website providing a chat room. or allow chosen emplyees to answer to potentian consumers. 
    • Twitter, among the social media, can be the most dangerous of them all, as it has a short limit of character at disposal. Here the  FDA has given some specific guidance. Indeed the Pharmaceutical companies face serious penalties by the FDA if they don’t make the proper disclosures, and must be careful to not to mislead consumers on Twitter and always provide  benefits and downsides  of the drug.

So what a compnay as to do to use at its best social media?

As it suggested in the interview it always important to:

  • Have a clear and decisive social media advertising policy.
  • Know which platform is going to be used
  •  How the message will be controlled ( either with chat rooms or direct comments fron a chosen emplyee or both)
  • Decide  whever   patients can leave commetns or not.  
  • Chose emplyees that can answer to comments and question from potential consumers
  • Have  content strategy, so that responses are in compliance with what the FDA has approved the pharmaceutical company may say about the product.
  • It might be also necessary a team of legal advisers to confirm that content is okay to put on social media
  • Have a compliance officer tasked with making sure there’s a policy in place and it’s being complied with and updated with evolving FDA guidance


To read the interview: Forbes


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