Massive House legislation aimed at getting life-saving treatments to patients faster is expected to advance, but it is not clear how lawmakers plan to pay for the billions of dollars in new funding.
That is one of the pivotal questions surrounding the 21st Century Cures Act, which the House Energy and Commerce Committee is expected to advance to the full chamber on Wednesday.
The legislation enables faster approval of antibiotics and provides more market exclusivity for drugmakers to modify an existing product to treat a rare disease. It also calls on streamlining clinical trials, releasing new regulatory guidance on precision medicine and enhancing reviews of drug-device combinations, such as a stent that delivers a drug.
The bill provides an extra $10 billion over the next five years to the National Institutes of Health. A new draft released on Tuesday also gave $52 million over the next four years to the Food and Drug Administration to help pay for its new responsibilities.
A provision also allows the FDA to give biomedical researchers a more competitive salary to attract new talent.
More details on funding for the FDA could come as early as Wednesday during the markup hearing.
Committee Chairman Rep. Fred Upton, R-Mich., has made it clear there will be “additional resources for the FDA,” a committee spokeswoman told the Washington Examiner.
But where will this new funding come from? That appears to be a sticking point between the two parties.
Democrats on the panel said that benefits for Medicare and Medicaid should not be reduced to pay for the new funding.
“Additional cuts will further erode … providers’ ability to provide that care,” said Rep. Jan Schakowsky, D-Ill., during the start of the markup session late Tuesday.
The top Democrat on the committee, Rep. Frank Pallone of New Jersey, said he hoped any offsets are suitable to both parties.
Advocates for the FDA are more skeptical. Prospects for an appropriations increase for any agency is small, Steven Grossman, deputy executive director of the Alliance for a Stronger FDA, which pushes for more agency funding, wrote in a blog post.
He told the Washington Examiner it is vital the agency get more funding to implement the bill’s responsibilities.
“It is always a worry about new responsibilities diluting the resources available,” Grossman said.
