| When it comes to trying out new drugs, the humble case report functions as more than just an anecdote. Annabelle Jerram at Wolters Kluwer examines the importance of pharmacovigilance to the industry
Never before has the responsibility for good pharmacovigilance practice rested so heavily on pharmaceutical manufacturers. Regulators, led by the US Food and Drug Administration (FDA) and European Medicines Agency (EMEA), are becoming increasingly risk-averse; legislation recently approved in the US will give the FDA more power than ever over drug safety. For pharmaceutical companies, nowadays the mantra should be: protect the product, protect the company and protect the public. This includes finding the means to collate, detail and forward meaningful pharmacovigilance data to regulatory authorities in a timely manner, with as complete a data set as possible.
Drug safety departments, which can sometimes be seen by colleagues at the business end of the organisation as the ‘product police’ or even worse, the ‘sales prevention department’, can help safeguard against litigation, product withdrawal and the sort of public health nightmare that we saw with thalidomide in the less enlightened 1960s. As well as helping to protect health, for a drug company that means cost savings and, most importantly, the preservation of their reputation. Best practice pharmacovigilance can also become a real asset to a company’s sales and marketing arms, becoming a strong selling tool in an incredibly competitive pharmaceutical market. |
