The sweeping 21st Century Cures Act, designed to accelerate the introduction of new medications by speeding up FDA approval processes and by boosting federal funding, has sailed through the Senate by a 94 to 5 vote, according to STAT News. The House passed the legislation last week, and President Obama is expected to sign it into law.
FDA officials have already complained that the agency is stretched too thin. Because the Cures Act calls on the FDA to take on new responsibilities, some argue that it’s time for the agency to hire more staff—something the FDA has wanted to do for years.
The agency is also expected to build in time for public feedback and perhaps revision of some of the new mandates.
The Cures Act requires the FDA to establish a “breakthrough device pathway” for the approval of medical devices, which will build on the existing priority review device program, and to improve the medical device classification review process, among other provisions.
The law also directs the FDA to identify five types of medical software that will not be regulated as medical devices because they are considered low risk to patients.
None of these mandates includes a deadline, however.
Other key measures also lack a timetable. The director of the National Institutes of Health (NIH), for example, is now allowed to insist that grant recipients share data that are generated from their research but is given no target date. Similarly, the FDA is charged with establishing a new pathway for biomarkers and other drug-development tools, which can be used to help shorten the time it takes to develop new medications and reduce their failure rates, but no date is specified for completion.
The Cures Act authorizes an additional $4.8 billion for the NIH. That funding, however, must be appropriated by Congress each fiscal year. Congress must also appropriate the $1 billion designated for grants to states to supplement opioid abuse prevention and treatment activities over the next two years.
The legislation is nearly 1,000 pages long.
Source: STAT News; December 7, 2016.