Regulators push for faster drug approval

Source: Healthcare Digital

Date :04/07/2007 14:48:12

Top pharmaceutical executives have called on regulators to speed up the approval of new medicines.

The two pharmaceutical executives, Fred Hassan, head of Schering Plough and Arthur Higgins, head of Bayer HealthCare and the new president of the European Federation of Pharmaceutical Industries and Associations, are claiming that intensifying demands for safety data were delaying patients’ access to them while providing no useful extra information.

Arthur Higgins, told the Financial Times that regulators should allow more rapid “conditional approval” of experimental drugs coupled with greater efforts to monitor their use in patients after launch.

The comments were made as regulators led by the US Food and Drug Administration face pressure from patients and drugs companies seeking swifter approval of medicines, and from critics arguing they are taking short-cuts at the expense of safety.

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

Mr Higgins argued that while adding costs and delaying launches, such studies were often “damage limitation that makes people feel good but is not answering the question”.

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

July 4 2007