Volume 543 Number 7644 pp152-280 9 March 2017
Show drugs work before selling them
08 March 2017
Regulation makes economic sense, argue Douglas Sipp, Christopher McCabe and John E. J. Rasko.
Under US President Donald Trump, defunct economic arguments about prescription drugs are coming to the fore. His advisers contend that today’s system is a bad deal. They want to undo regulations that require companies to show that a medical product actually works before it is sold. The advisers argue that removing the burden of large, lengthy clinical trials will cut costs and reduce delays, and that the marketplace can be trusted to sort good drugs from bad ones
Although many have raised concerns about a Trump Food and Drug Administration (FDA; see, for example, Nature http://doi.org/bz92; 2017), few have debunked the economic arguments. Here we outline what the case for deregulation gets wrong. All nations should take note — weaker standards for entry of drugs onto the US market will harm health everywhere…