House of Representatives overwhelmingly approves sweeping health measure
- Author: Delores Daniels Dec 02, 2016,
Dec 02, 2016, 1:30
Many details of the legislation were fluid Tuesday as lawmakers traded concessions to get it passed this week.
Lawmakers announced that they had reached a compromise on the bill, known as the 21st Century Cures Act, last Friday. But some patient advocacy groups and researchers worry that a speedier FDA approval process for certain drugs and devices could endanger patients. "With today's vote, we are taking a giant leap on the path to cures".
So you might ask how I support the 21 Century Cures Act, when I fear for loss of "the basics". Critics of the bill say it lowers standards for drug and device approvals at FDA in exchange for a badly needed funding increase for NIH.
Introduced by the Republican Chair of the Energy and Commerce Committee in May of previous year, the 21st Century Cures Act funnels $5.3 billion to the National Institutes of Health and Food and Drug Administration and $1 billion to the states to fight opioid addiction.
The bill also provides $1 billion over two years to programs for opioid abuse treatment and prevention, including improving prescription drug monitoring, health care provider training, and expanded access to opioid treatment programs. The bipartisan bill is headed to the Senate for a final vote.
A spokesman did not immediately respond to an inquiry about whether Durbin will vote for the bill.
"This bill, if it were to become law, would even give more prominence to the role of the patient in this process", he says.
Joseph and Democratic U.S. Representative Diana DeGette of Colorado co-sponsored the package of bills that is created to simplify and expedite the process for approving new drugs and medical devices.
The measure, which is almost 1,000 pages long, includes a number of provisions that have some patient advocacy groups and physicians deeply concerned for the safety of their patients-particularly for underserved communities that are already struggling with access to good medical care. Representative Rosa DeLauro (D-Conn.) said the bill would weaken regulations on medical devices, allow drugs to be approved with only limited evidence of the drug's safety and efficacy, and rush the use of new and unproven antibiotics.
"The summary data could hide important information about the safety and effectiveness from the FDA scientist reviewing the data", Carome said.
"The real winners today are American families whose lives stand to be improved by the Cures legislation passed overwhelmingly today by the House and that we should pass by a wide margin in the Senate". Since then, it has been a long slog.
One of Warren's chief complaints concerned funding for federal agencies such as the National Institutes of Health - which, she said, amounted to just a "fig leaf" compared to what was initially requested.
The Energy and Commerce Committee, on which Congressman Griffith serves, has worked on this initiative since May of 2014, and held hearings in Washington, D.C. and roundtable discussions throughout the nation at which medical experts and patient advocates shared their perspective on how to best accelerate the pace of cures to help patients.
The lack of financing caused a stalemate until the unexpected happened: The Affordable Care Act was mortally wounded by the election of Donald Trump.
To cover the bill's $6.3 billion price tag, negotiators would tap the US strategic petroleum reserve and raid a pot of money created under the 2010 Affordable Care Act for disease prevention.
Mary Woolley, president and CEO of Research!America, agreed.
"We're doing the research showing there are a lot of drugs already on the market that don't work", Zuckerman said, "And it's contributing billions of dollars to the cost of Medicare, billions of dollars to the cost of health insurance, and thousands of dollars per patient".