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
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