Cookie policy: This site uses cookies (small files stored on your computer) to simplify and improve your experience of this website. Cookies are small text files stored on the device you are using to access this website. For more information please take a look at our terms and conditions. Some parts of the site may not work properly if you choose not to accept cookies.

Join

Subscribe or Register

Existing user? Login

Regulation in healthcare

US bill that heralds reform of drug approval process passed by House of Representatives

A landmark law that would boost funding for medical research, mental health and substance misuse services and speed up drug and medical device approval in the United States has passed its latest legislative hurdle.

The US House of Representatives approved the 21st Century Cures Act on 30 November 2016. The bill will now go to the Senate for consideration.

In a statement, Fred Upton, chair of the Senate’s Energy and Commerce Committee, said: “The 21st Century Cures Act is an innovation game-changer, a transformational bill to bring our health infrastructure light years ahead to best match the incredible breakthroughs that are happening by the day. And it is critical to remember that passing 21st Century Cures is the best way to ensure some of this funding occurs immediately in fiscal 2017.”

The new legislation would introduce reforms to the US Food and Drug Administration, including expedited review for breakthrough devices, increased patient involvement in the drug approval process and a streamlined review process for combination products that are both a drug and device.

The bill also proposes an additional US$1.4bn for research into genetic, lifestyle and environmental factors that influence disease, an extra US$1.8bn for cancer research and US$1.6bn for research, diagnosis and treatment of Alzheimer’s disease. Some US$1bn is also included to be spent on mental health care, especially opioid abuse services.

In a statement issued on 30 November 2016, the White House described the proposed law as “critically important legislation” but added: “Like all comprehensive legislation, the bill is not perfect, and there are provisions the administration would prefer were improved, but the legislation offers advances in health that far outweigh these concerns. The Senate should promptly pass this bill so that the president can sign it.”

Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2016.20202050

Have your say

For commenting, please login or register as a user and agree to our Community Guidelines. You will be re-directed back to this page where you will have the ability to comment.

Recommended from Pharmaceutical Press

  • Drugs of Abuse

    Drugs of Abuse

    A concise, easy-to-read guide for healthcare professionals who encounter drug abuse.

    £38.00Buy now
  • Adverse Drug Reactions

    Adverse Drug Reactions

    A practical guide to the drug reactions that affect particular organ systems, and the management of these reactions.

    £38.00Buy now
  • English Delftware Drug Jars

    English Delftware Drug Jars

    This beautiful book illustrates the art and history of the collection of English delftware drug jars in the Museum of the Royal Pharmaceutical Society of Great Britain.

    £54.00Buy now
  • Paediatric Drug Handling

    Paediatric Drug Handling

    Written for new pharmaceutical scientists, this book provides a background in paediatric pharmacy and a comprehensive introduction to children's medication.

    £33.00Buy now
  • Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics

    Introduction to Renal Therapeutics covers all aspects of drug use in renal failure. Shows the role of the pharmacist in patient care for chronic kidney disease.

    £38.00Buy now

Search an extensive range of the world’s most trusted resources

Powered by MedicinesComplete
  • Print
  • Share
  • Comment
  • Save
  • Print Friendly Version of this pagePrint Get a PDF version of this webpagePDF

Supplementary images

  • Capital Building in Washington DC

Jobs you might like

Newsletter Sign-up

Want to keep up with the latest news, comment and CPD articles in pharmacy and science? Subscribe to our free alerts.