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.