Democrats on the House Energy & Commerce Committee have withdrawn support from legislation that would loosen regulatory requirements on a broad range of new healthcare technologies, sources close to the legislative discussions say.
The sprawling 21st Century Cures Act, whose 393-page first draft was released on Jan. 27, is aimed at speeding up the adoption of next generation medical technologies. It seeks to foster drug development, including of antibiotics, by requiring the Food and Drug Administration to allow more “flexible” clinical trial design and gives medical-device makers more “innovative device review pathways.”
It also incorporates the Sensible Oversight for Technology which Advances Regulatory Efficiency (Software) Act sponsored by Rep. Marsha Blackburn (R-Tenn.), which would allow the FDA to take a risk-based regulatory approach to new healthcare information technologies. Its goal is to foster faster adoption of mobile medical applications, clinical decision-support tools and other healthcare-related software.
Rep. Frank Pallone (D-N.J.), the ranking member of the committee, said the draft legislation disappointed him because it “does not reflect true bipartisan collaboration.”
“In its current form, I am concerned that the nearly 400-page draft could create more problems for our healthcare system than it solves,” he said. “Further, the draft does not include any real dollars to fund additional basic research at the National Institutes of Health.”
Publication of the discussion draft was preceded by months of hearings and roundtables, during which Democrats on the committee rhetorically backed the bill. The Software Act, for instance, has drawn bipartisan support.
Industry officials are pushing hard for legislation that would ease their new technologies' path to regulatory approval. Dan Haley, the vice president of government affairs at Athenahealth, said that he was “pleased” with the draft. The National Venture Capital Association also applauded the bill, saying that legislative action was necessary to improve the regulatory and reimbursement environment for medical startups.
The Advanced Medical Technology Association, the trade group for device manufacturers, complimented the committee's efforts in the bill, saying that the innovation ecosystem that supports industry is stressed. “Policy improvements are essential,” the association said.
The Republican leader of the Senate's Health, Education, Labor and Pensions Committee, which would review the House bill if it passed, also praised the House efforts. “One of the committee's top priorities this year will be modernizing the Food and Drug Administration,” said Sen. Lamar Alexander (R-Tenn.), the committee chairman.
But the limited focus of the legislation puzzled some industry observers. Jeff Smith, vice president of public policy at the College of Healthcare Information Management Executives, which represents hospital health IT officials, said that he found it curious that the most pressing issues facing its members were ignored. “We have a bill here that's supposed to bring the healthcare system into the 21st century that doesn't mention meaningful use,” he said.
The sprawling bill has several sections that would have large effects on the healthcare system. For instance, one section provides for increased price transparency for citizens on Medicare Parts A and B. Another aims to stimulate development of precision or personalized medicine, a priority of President Barack Obama.
The draft is clearly incomplete. One section promises action on health IT interoperability, but only includes a note saying the legislative language is “to be supplied.”
Follow Darius Tahir on Twitter: @dariustahir
