GOP chairmen praise conservatives for boosting medical funding
The Republican chairmen spearheading a medical research bill are praising the conservative wing of their party for proposing to boost funding for the National Institutes of Health (NIH).
The ObamaCare alternative released Thursday from the conservative Republican Study Committee includes $15 billion over eight years for medical research at the NIH.
Similarly, House Energy and Commerce Chairman Fred Upton (R-Mich.), and Health Subcommittee Chairman Joe Pitts (R-Pa.) included $10 billion over five years for the NIH in the 21st Century Cures Act, which passed out of their committee last month.
{mosads}The 21st Century Cures bill could reach the House floor in June. Upton and Pitts said they hope the Republican Study Committee will work with them to pass the bill.
“We applaud the RSC’s commitment to 21st century health care and look forward to working together to bring the nonpartisan 21st Century Cures Act to the president’s desk,” the lawmakers said in a statement.
The bill, which Upton worked on with Rep. Diana DeGette (D-Colo.), has had fairly smooth sailing so far, with a rare 51-0 vote out of committee last month.
In addition to boosting NIH funding, the bill also seeks to speed up the Food and Drug Administration’s approval of new drugs.
While praising the NIH funding, two Harvard medical school professors criticized those other steps in the New England Journal of Medicine this week, arguing they lower standards for drug approvals.
The professors, Jerry Avorn and Aaron Kesselheim, point to provisions allowing “real world” observational evidence of a drug’s effects to be considered, rather than just more rigorous randomized trials.
They also point to the bill encouraging the use of preliminary measures known as biomarkers rather than waiting for more definitive results from a trial.
They argue these provisions and others “could lead to the approval of drugs and devices that are less safe or effective than existing criteria would permit.”
The FDA, they note, already “approves new medications about as quickly as any regulatory agency in the world.”
Still, the bill has received the backing of many advocacy groups, such as the National Health Council, which praises elements like the increased NIH funding and moves to incorporate patient preferences into the drug approval process.
Upton frames the regulatory changes as bringing the FDA into the 21st century.
“The 21st century has seen enormous advances in mobile medical apps and other technological tools, but our regulatory system was built before any of these technologies were even a thought,” he wrote in a Time op-ed Thursday. “This bill would provide a regulatory framework to unleash these innovations and offer new pathways for health monitoring, treatment, and communication.”