STAT – It took nearly three years for Congress to pass the 21st Century Cures Act. The next question is: How long will it take the Food and Drug Administration to implement it?
The legislation, designed to accelerate the introduction of new medical treatments by speeding up some FDA approval processes and boosting federal funding, passed the Senate Wednesday by a 94 to 5 vote on Wednesday. The House passed it last week, and President Obama is expected to sign it into law.
But the Cures Act, nearly 1,000 pages long, does not lay out many deadlines.
“The dirty secret is it’s going to take many years to implement these things,” said Bethany J. Hills, who runs the FDA practice at Mintz Levin Cohn Ferris Glovsky and Popeo. “There are many provisions requiring guidances, and whenever Congress has mandated that FDA provide guidance on something, FDA historically is perpetually late.”
FDA officials have already lamented that the agency is stretched thin. Because the Cures Act calls on the agency 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 first thing is making sure that capacity is in place to do all of these reforms effectively,” said one former FDA commissioner, Dr. Mark McClellan. “One of the important provisions in the laws gives FDA new hiring authority to help them acquire and keep the kinds of experts they need for executing the new provisions. That’s an important place to start.”
McClellan said he also expects the FDA to build in time for public feedback, and perhaps revision, of some of the new mandates.
There is also likely to be disagreement over Congress’s intent with some provisions. The bill, for example, calls on the FDA to provide guidance on how drug makers should collect data on patient experiences in an effort to improve “patient-focused drug development.”
But that’s a new term in the FDA vernacular and, as Hills pointed out, people differ on what it means.
“The definitions are going to take time,” she said.
The FDA is also being tasked 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. There are no deadlines yet given.
Other key measures also lack a timetable. The director of the National Institutes of Health is now allowed to insist that grant recipients share data that is generated from their research, for example, 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 drugs, and also reduce their failure rate, but no date is specified for completion.
Other provisions are on a set schedule. The secretary of the Department of Health and Human Services will have two years to oversee a review of regulations and polices regarding the disclosure of financial conflicts of interest. The NIH director must convene a working group to develop recommendations to enhance the “rigor and reproducibility” of NIH-funded scientific research and develop or update policies within 18 months.
In terms of new funding, the Cures Act authorizes an additional $4.8 billion for the NIH, chiefly for the Precision Medicine Initiative, the BRAIN Initiative, and the “moonshot” against cancer. That funding, however, must be appropriated by Congress each fiscal year.
Republican leaders haves promised to do so, but many Democrats, among them Senator Elizabeth Warren (Mass.), argued in favor of mandatory funding.
The $1 billion designated for grants to states to supplement opioid abuse prevention and treatment activities, over the next two years, must also go through Congress. But the money is authorized from $3.5 billion in cuts from the Prevention and Public Health Fund and the sale of some of the Strategic Petroleum Reserve.