Healthy Skepticism Library item: 10794

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Publication type: news

Jack A.
Push to speed drug approvals
The Australian 2007 Jul 5
http://www.theaustralian.news.com.au/story/0,20867,22018117-36375,00.html

Full text:

TWO top pharmaceuticals executives have called on regulators to accelerate the approval of new medicines, claiming that intensifying demands for safety data were delaying patients’ access to them while providing no useful extra information.
Arthur Higgins, head of Bayer HealthCare and the new president of the European Federation of Pharmaceutical Industries and Associations, said regulators should allow more rapid “conditional approval” of experimental drugs, coupled with greater efforts to monitor their use in patients after launch.

His views were echoed by Fred Hassan, head of Schering Plough and president of the EFPIA’s international equivalent, who said regulators also should be more flexible in adjusting the “end points” by which safety and efficacy of clinical trials were judged.

Their comments were made as regulators, led by the US Food and Drug Administration, face pressure on the one hand from patients and drugs companies seeking swifter approval of medicines and on the other from critics arguing they are taking shortcuts at the expense of safety.

Industry executives say that – especially since the withdrawal of Merck’s painkiller Vioxx in 2004 – the FDA has proved too risk-averse, delaying approval of new medicines by requesting extended late-stage clinical trials on larger groups of patients for longer periods.

But Mr Higgins noted that even a trial with 100,000 patients would not identify a side-effect that occurred in one person in a million.

Mr Hassan called for more rapid “restricted release” of drugs, notably for central nervous system disorders such as Parkinson’s disease, for which few treatments were available. “No drug is without risk,” he said.

Mary Baker, president of the European Federation of Neurological Associations, which was working with European regulators to ease the rules, said: “Safety is vital, but I do think we could accelerate clinical trial rules unchanged for 50 years, with shorter phase-three trials and more patient monitoring.”