On social media, anyone has the ability to turn themselves into a journalist, often reporting or sharing erroneous, misleading or sensationalised claims that have the power to go viral. One such market that has been at the centre of several social media storms is pharmaceuticals. ‘Fake news’ on drugs is plaguing news feeds, online misinformation is compromising pharmaceutical products.
Let’s look at one famous (incorrect) claim as an example of the power of media, concerning information published in leading medical journal the Lancet claiming that the MMR vaccine causes autism. This claim, subsequently debunked in 2010 by the Lancet itself, continues to circulate online and impact on the decisions made by parents today.
In 2013, The World Economic Forum described “digital wildfires” in our increasingly connected world as one of the top three global health risks. And as with all health risks, prevention is better than cure.
So just what is the regulatory process that drugs go through before being released onto the market? And how do you communicate the safety procedures that all drugs go through in a way that restores trust from the general public in a time when faith in public institutions in low?
In Europe, a coalition between the European Commission, the medicines regulatory authorities in EU Member States and the European Economic Area (EEA), and the European Medicines Agency (EMA) – works to ensure that patients in the EU have access to high-quality, effective and safe medicines.
All drugs, no matter what country, follow a similar development process: discovery; development/manufacturing; clinical trials; marketing. Underpinning all of these stages is constant compliance with regulatory requirements – in short; the drug must meet strict regulations at all stages.
In both the US and the EU, drugs must pass both a clinical trial application and marketing authorisation application. As a result, both countries have the most demanding and robust approvals process in the world.
Unfortunately, even with strict compliance standards and testing throughout, recalls will always happen, and companies must have their metaphorical medical kits fully stocked and ready to activate if so.
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