Regulation versus innovation in medicine

Two tragedies created drug regulatory authorities in the form they exist today. The marketing in 1937 of an elixir of sulphanilamide using diethyl alcohol as the solvent led to over 100 children dying from acute kidney injury. The use from 1957 of thalidomide as a treatment for morning sickness led to the development of phocomelia (and other abnormalities) in the fetuses of about 10 000 mothers who had been given it during their pregnancies. Drug regulatory authorities initially tended to be risk averse, but now recognize concern that the process of drug regulation might inhibit the development and licensing of novel products. They now pursue a more risk-based approach to regulation and seek to support safe innovation, with arrangements including scientific advice programmes, orphan drug approval processes, and expedited approval processes, although these are not without their critics.