House Passes Bill To Hasten Drug Approvals

The House of Representatives has passed legislation that aims to accelerate the development and approval of new drugs. The 21st Century Cures Act (H.R. 6) cleared the House on July 10 by a vote of 344-77. The Senate has yet to take up the bill. The legislation would establish a temporary fund for the National Institutes of Health and the Food & Drug Administration to support biomedical research in areas such as antibiotic resistance and precision medicine. NIH would get $1.75 billion per year for five years, and FDA would receive $110 million per year for five years. The bill would also allow drug companies to conduct smaller-than-normal clinical trials on subgroups of patients with serious diseases who have been screened to determine whether their genetic predisposition makes them good candidates for a particular therapy. Drugmakers support the bill. But some health care providers, clinical researchers, and consumer advocates warn the measure would allow unsafe and ineffective drugs to reach the market.