Regulatory Affairs: Through the Looking Glass

Updated: Dec 16, 2019


Words by Kirstie Turner


The language around regulations and safety labels can leave patients feeling confounded; but a simple ‘Eat Me’ tag is not enough. Regulatory affairs is critically important in ensuring the highest standard of risk assessment and these labels are pivotal to safety. With a wonderland of information available at our fingertips, patients are being led down the rabbit hole of false information around safety guidelines, as the anti-vaxxer movement shows. Medical affairs are uniquely positioned to educate patients on regulations; is social media their ace card in conquering this challenge?


Confusion surrounding regulations can occur for a range of reasons. Deborah Ebert Long, Vice President, Medical Affairs, Vertex Pharmaceuticals, explains one challenge: “The regulations surrounding approval and promotion of medicines differ from country to country and are often not well understood by the general public.” As regulations and availability of medications differ around the world, finding a platform to address patient queries surrounding this is critical.


A lack of understanding surrounding regulations from the general public can lead to further complications surrounding patient expectations. Long goes on to explain why it is important for MA to engage patients in the conversation surrounding regulations: “Helping educate and engage the patient and caregiver community is vital so that they better understand the drug approval process. This helps set patients’ expectations about access to medicines, and better empowers them to advocate for potential changes to their local process.”


Social media offers a global platform for MA to have a conversation with patients, as Long outlines: “In contrast to the local nature of regulatory systems, patient conversations are global, thanks to social media platforms.” While MA have taken this first step on the pathway to a more patient-centric industry by engaging them in a collective conversation, the next, more challenging step is addressing concerns, particularly with regulatory affairs, where decisions are rigid and based on evidence and data. To alleviate any potential pressure on safety regulations, patients must feel that they are being listened to and seeing action based on their concerns.

Helping educate and engage the patient and caregiver community is vital so that they better understand the drug approval process

While it is important to open these regulatory conversations online, there is also the industry’s image to consider. “Industry presence on social media must be viewed as trustworthy in order to be an effective channel for credible scientific communication responses”, continues Long. The opportunities that social media offer are vast and going about this in the right way is key. Utilising open and honest communication can also help pharma on their mission to change their image and continue them on the journey to becoming a more trusted industry.

Patient conversations are global, thanks to social media platforms

Vaccinations are a topic that must be addressed; as the anti-vaxxer movement on social media takes flight, we are seeing the sharing of unreliable or misleading information with the goal of deterring patients from vaccines. “We’ve assumed that vaccines are something that every mum is going to take her child to, but we haven’t adjusted to the changing dynamic about where people are getting their information from. People have access to more information, some of it bad information. There is a changing dynamic: from healthcare providers being the primary source of information to now coming from social networks, communities, families, and friends”, outlines Daniel Carucci, Global Medical Director, McCann Health.


Social media holds a lot of power, and as the place where this misleading information is often shared, the industry should turn this around and use the platform to educate and inform patients on subjects such as vaccines to rectify the problems caused by vaccine hesitancy. However, it is important for this to be done with clarity. Carucci reminds us of the importance of authentic communication: “Everything we do has to empower trust and trust comes from authenticity and that is the foundation of communication.”


MA must take the opportunity that social media offers to educate patients, but clarity is key in achieving this. The anti-vaxxer movement online shows the potential dangers presented by a lack of education and open conversation surrounding safety labels and regulations. The role of the regulator is critical to ensure the highest level of safety for products, but it is time for patients to get an invite to the tea party and a seat at the table where MA can educate them and restore the utopia of wonderland.




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Copyright © 2018 European Medical Group LTD. All rights reserved. Copyright © 2018 European Medical Group LTD. All rights reserved. Gold & EMG-Health is for informational purposes and should not be considered medical advice, diagnosis or treatment recommendation.

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