The US House of Representatives has overwhelmingly backed (344-77) the 21st Century Cures Act, intended to accelerate the translation of discoveries into innovative therapies through a stream of new measures and funding.
Plans include the creation of an ‘Innovation Fund’, a dedicated and offset cash stream of $1.75 billion per year for five years for the National Institutes of Health to support medical breakthroughs, as well as a total of $550 million over the same timeframe for the US Food and Drug Administration to accelerate certain regulatory processes.
Under the Act, the FDA will now be able to approve ‘breakthrough’ medicines based on early safety and effectiveness data, and it strives to bring the patient perspective much closer into the review process. A priority review framework for medical devices is also be established.
On the research side, the new legislation promises greater use of patient generated registries to speed recruitment in trials, will allow researchers to screen patients in advance to determine their genetic suitability for targeted therapies, and clears the way for new and creative adaptive trial designs while significantly reducing paperwork requirements.
The Cures Act (also known as HR6), has received a wide industry welcome. According to the Pharmaceutical Research and Manufacturers of America, it will “help to enhance the FDA's ability to adapt to cutting edge technologies utilised by America's biopharmaceutical companies to bring new medicines to patients and their healthcare professionals - from new biomarkers, to the use of real world data to assess the benefits and risks of medicines throughout their lifecycle, to new communication methods in our evolving healthcare ecosystem”.
Joe Panetta, president and chief executive of Biocom, the association for the Southern California life science community, said passing of the bill “marks a historic moment for the future of innovation in the US and a promise of new treatments and cures for millions of patients”.
“This landmark legislation offers a comprehensive and targeted set of proposals that address some of the most pressing challenges that currently hinder biomedical innovation and the development of the next generation of modern medicines”, he noted.
However, critics of the bill fear facilitating earlier approvals essentially equates to loosening regulatory safeguards, while others have voiced concern over the Act’s funding.
According to the Congressional Budget Office, implementing the legislation will cost $106.4 billion over 2016-2020, but will slash federal spending by $11.9 billion to 2025.