Feature Briefing

21st century cures: is US medicines bill a colossal mistake?

BMJ 2015; 351 doi: https://doi.org/10.1136/bmj.h4013 (Published 23 July 2015) Cite this as: BMJ 2015;351:h4013
  1. Peter Doshi, associate editor, The BMJ
  1. pdoshi{at}bmj.com

A massive proposed US law claims to accelerate the discovery, development, and delivery of new medicines, but critics warn about the implications for drug and device safety. Peter Doshi sets out some of the more controversial changes

The 21st Century Cures Bill is so large that is it impossible to summarize it in a sentence. But that has not stopped its proponents and critics from doing so. “Improve lives, save money,” declares one press release sent out by the House Committee on Energy and Commerce, which introduced the bill to the full House of Representatives in May. “All about the patients,” declares another. Public Citizen, the health watchdog, has a different catchphrase: “Don’t buy the snake oil.” At over 350 pages, the bill is far reaching and proposes major changes to America’s central medical institutions.

What do people agree on?

One core component with broad support aims to boost funding for the National Institutes of Health by $1.75bn (£1.1bn; €1.6bn) a year for five years, with provisions to invest in younger, emerging scientists and “high-risk, high-reward” research. The increase, however, would still leave the NIH’s funding—now around $30bn a year—well below what it would have been if there had not been a 20% fall over the past decade.1

How will it affect drug regulation?

The bill encourages the FDA to broaden the types of data it considers when evaluating new drug …

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