12:00 AM
 | 
Dec 05, 2011
 |  BioCentury  |  Regulation

Commentary: Perverse effects

NICE's Rawlins says EMA, FDA data demands have perverse effect on drug prices

Biopharma companies and their investors have complained for years that an increasing regulatory burden in the U.S. and Europe has driven up the cost of drugs and delayed their availability to patients for no good reason. Surprisingly, the head one of the most controversial and powerful regulatory authorities agrees.

According to Sir Michael Rawlins, director of the U.K.'s National Institute for Health & Clinical Excellence, FDA and EMA have driven up the cost of drugs with increasing demands for data that have not translated into a public health benefit.

NICE conducts clinical- and cost-effectiveness appraisals of drugs and health services to determine what the U.K.'s National Health Service (NHS) will and will not pay for. The agency has come under fire for recommending against coverage of breakthrough drugs for life-threatening diseases.

Recent examples include preliminary decisions against covering Benlysta belimumab from Human Genome Sciences Inc., the...

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