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GRC Professional : GRC Spring 2012
IN DEPTH 22 GRC Professional • Spring 2012 Pharmaceuticals -- ingestible risk The drug industry has some of the highest regulatory and compliance hurdles to leap, making it a uniquely challenging area for governance. BY STEVEN CHONG WITH RESPONSIBILITY FOR LIVES IN their hands, taking on compliance and risk management in the pharmaceutical manufacturing business is not for the faint of heart. Many recruits will come from a medical, finance or law background, but are attracted by the unique experience gained in this highly regulated and risk-and-reward environment, as Marco Forstner, Head of Compliance for Astra Zeneca attests. "It gives you a closer view of a business I call the 'world of grey'," he says. "It is not as technically difficult as the numbers side but involves more judgment calls and subjective evaluation of language. "Policies don't always cater for everything --- new things come up all the time in how medicines are used." He wants his peers to see his role as monitoring, not policing. "I push that our business and its people own compliance -- not just us in the compliance department because we operate independently and help the business interpret regulations." His legal and commercial background fits with an industry that gets enormous publicity every time drugs are recalled when side effects lead to death, life-long disease or defor mity, and where law suits run quickly into billions of dollars, given the global nature of drug distribution. The hideous deformities of children whose mothers took the sleeping tablet Thalidomide while pregnant might be the most infamous case of drug use gone horribly wrong in the 1950s and 60s, but the last two decades have had their share Like food, medicines carry an inherent risk that we literally swallow. But their highly processed nature, potential toxicity, and express purpose for therapy raise the risk-versus- benefit stakes. of high profile drug disasters too. Eight years ago the non-steroidal anti-inflammatory drug Vioxx was recalled after evidence pointed to as many as 140,0000 users suffering cardiac heart disease and it was linked to several thousand deaths. Fenfluramine/phentermine (Fen-phen) was a popula r weight reduction dr ug, on the market for 24 years before it was recalled in 1997 because of links to heart and pulmonary disease. And DES (Diethylstilbestrol) was prescribed for more than 30 years to prevent miscarriage but recalled after it was associated with a rare tumour in daughters born to mothers who had used the drug. Putting inappropriate use or dose to one side, most successful pills, patches, solutions, lotions, sprays and injections we use to heal our bodies when ill and injured, or to prevent disease, carry the risk of unintended side effects, contamination, adulteration and substitution which can a nd do cause adverse, even fatal reactions in people. Like food, medicines carry an inherent risk that we literally swallow. But their highly processed nature, potential toxicity, and express purpose for therapy raise the risk-versus-benefit stakes. Heavy regulatory burden Internationally harmonised systems of regulation have evolved to predict, mitigate and manage these risks. But they only began in earnest from 1962 after Thalidomide, a so-called 'wonder drug' for insomnia and headaches, when prescribed during pregnancy, resulted in more than 10,000 children in 46 countries being born with shocking limb deformities. It drove the imperative for
GRC Winter 2012
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