House to vote Wednesday on Cures Act
$6.3B bipartisan bill relaxes FDA regulations for faster approval of drugs, boosts medical research funding for such efforts as cancer moonshot.
House and Senate leaders came to a deal Friday on legislation that takes a comprehensive look at accelerating cures by relaxing Food and Drug Administration regulations for faster approval of drugs, and boosts medical research funding for such efforts as Vice President Joe Biden's cancer moonshot.
The 21st Century Cures Act is scheduled to go to a House vote Wednesday after the House Rules Committee takes up the $6.3 billion bipartisan bill on Tuesday. It then goes to the Senate.
In a joint statement, Senator Lamar Alexander, R-Tenn., chairman of the Committee on Health, Education, Labor and Pensions, and Fred Upton, R-Michigan, chairman of the Energy and Commerce Committee, said they expect the legislation to be approved by the end of the year.
"It is time to vote on 21st Century Cures, mental health legislation, and help fund the fight against opioid abuse. The House vote on Wednesday will be an extraordinary opportunity to help almost every American family. It will advance President Obama's personalized medicine initiative, Vice-President Biden's cancer moonshot, Alzheimer's research and move many treatments and cures more rapidly and safely through the regulatory process and into doctors' offices. It will address the needs of the one in five adult Americans who suffer mental illness," Upton and Alexander said in a joint statement.
The bill, according to the Energy and Commerce Committee website, removes barriers to access, share and analyze health data generated in research and clinical settings.
It allows the FDA to use the experience of patients with particular diseases and conditions, as well as the effect of their current therapies, to speed up the drug approval process.
It removes the regulatory burden on medical apps that generate real time patient data and provides incentives for the development of drugs for rare diseases.
It would give states $1 billion to fight the opioid crisis and increase mental health funding by $500 million.
The Cures Act has been in debate for about three years and was originally approved by the House in July
Republicans and Democrats sparred over where billions in funding for medical research at the National Institutes of Health would come from, until Trump's election. Money is expected to be freed up from funds formerly earmarked for Affordable Care Act initiatives, should Obamacare be repealed and replaced as promised by Trump and the GOP.
[Also: Healthcare industry anxious over Obamacare repeal, replacement as details are vague]
Trump has also said he favors less federal regulation.
Twitter: @SusanJMorse
