Class of 2008 og 7års-reglen

Diverse undersøgelser til evaluering af FDAs godkendelsesprocedurer er beskrevet i et tidligere blog-indlæg. Moore & Furberg har i JAMA Internal Medicine kigget på kvaliteten af godkendelsesprocesserne i 2008 – og fulgt op ift evt krav om supplerende studier i postmarketing-fasen. Fast-track-godkendelserne gik hurtigere (surprise?) men var baseret på færre undersøgte patienter (surprise??) og sikkerhedsspørgsmål var underbelyste (surprise ???) – fem år senere manglede der stadigvæk data. Sidney M Wolfe, direktor i Public Citizen’s Health Research Group, foreslår derfor i Australian Prescriber en 7-års-regel: “You should wait at least seven years from the date of release to take any new drug unless it is one of those rare ‘breakthrough’ drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labelling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release.”

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