On Monday, the U.S. Senate strongly signaled that it will approve a $6 billion investment in health and medical research that previously cleared the House with overwhelming support.
By Tracie Mauriello / Post-Gazette Washington Bureau
WASHINGTON – Help is on the way for patients with physical and mental illnesses including cancer, drug addiction, brain injuries, eating disorders, Alzheimer’s and rare pediatric diseases.
In a procedural vote Monday, the U.S. Senate strongly signaled that it will approve a $6 billion investment in health and medical research that previously cleared the House with overwhelming support.
A final vote is expected Wednesday and President Barack Obama has said he is eager to sign the bill.
The 21st Century Cures Act increases funding to the National Institutes of Health, the Food and Drug Administration and Vice President Joe Biden’s cancer “moonshot” to speed research.
Mr. Biden, who has been pressing for increased research since his son Beau died of brain cancer last year, presided over the vote.
Parts of the legislation are products of initiatives spearheaded by U.S. Rep. Tim Murphy, R-Upper St. Clair, and U.S. Sen. Bob Casey, D-Pa.
The Murphy piece, which is three years in the making, prioritizes treatment of the most serious mental illnesses, authorizes grants for evidence-based programs, expands outpatient treatment, and creates the position of assistant secretary for mental health and substance abuse.
Earlier iterations of Mr. Murphy’s legislation would have relaxed privacy protections for seriously and violently mentally ill patients who are unable to make their own healthcare decisions. Mr. Murphy wanted providers and caregivers of such patients to be able to more freely communicate.
Although the bill doesn’t go as far as Mr. Murphy would like, it does direct the Department of Health and Human Services to more clearly interpret existing law and to better educate hospital attorneys and providers, who often err on the side of caution rather than disclosure.
The Health Insurance Portability and Accountability Act, which strengthened privacy protections, is confusing, Mr. Murphy said at a press conference Monday.
Mr. Murphy, who is a practicing psychologist, said family members can be great partners in care but some providers are so afraid of running afoul of HIPPA that they won’t even take calls from them.
U.S. Sen. Chris Murphy, D-Conn., who was a partner in crafting the legislation, shares that concern.
“Existing HIPPA law allows providers to share information with parents of adult patients if it is in the best interest of that patient” but many providers don’t know that, he said. “What we’ve done … is provide more resources to tell physicians what the law really says and to clarify the fact that they have the ability to share information today.”
He said the bill “is going to give new tools to families that are in crisis. It’s going to clarify that parents can be full partners in the care of loved ones – adults – who are suffering from mental illness.”
He and and other lawmakers praised Tim Murphy for spearheading the mental health piece of the bill. “He was really the lone voice in the darkness for a long time, and we were glad to join with him as partners,” Chris Murphy said.
Tim Murphy has been working on the legislation since the Sandy Hook School shooting in Connecticut three years ago. It was, in part, his answer to stemming gun violence by getting treatment to the severely mentally ill.
“’Treatment before tragedy.’ That became our mantra,” he said Monday. “From the onset I said where there is no help there is no help. Know this now: There is help, and there is hope.”
Mr. Casey’s fingerprints also are on the bill.
It reauthorizes 2012 legislation that he sponsored along with Sen. John Isakson, R-Ga. Their legislation encourages pharmaceutical companies to research treatments for rare childhood diseases when development costs would outweigh potential profits. The “priority review voucher program” they created allows companies that research those drugs to receive an expedited review of applications for other drug approvals.
The Federal Drug Administration typically takes 10 months to review a new drug application. The Casey-Isakson provision reduces review time to six months for drugs under priority review.
Other provisions in the bill also expedite approval by loosening requirements for the size of clinical trials and allowing the Food & Drug Administration to rely on patient feedback in lieu of empirical evidence.
Some patient advocacy groups have said it’s dangerous to to allow faster and easier approval of certain drugs and medical devices.
Senators’ 85-13 cloture vote Monday was a procedural action that shuts down debate after 30 hours and allows for a vote on final passage. Sixty votes were required for the bill to advance.
Sen. Bernie Sanders, I-Vermont, who voted no, said he opposed the bill because it failed to stem the rapid growth of pharmaceutical drug costs.
Several senators from coal country also voted no. They were disappointed that a provision to protect miners’ pensions didn’t make it into the bill. They include Sens. Joe Manchin, D-W. Va.; Shelley Moore Capito, R-W.Va.; Rob Portman, R-Ohio; and Sherrod Brown, D-Ohio.
Pennsylvania’s two senators – Mr. Casey and Pat Toomey, R-Pa. -- both voted yes. “When we invest in medical research that leads to healing and hope and saving lives, and also to creating high paying jobs” in biomedical research hubs like Pittsburgh, Mr. Casey said in an interview.
“Our state can certainly be a part of the breakthroughs that cure diseases. Medical research is part of the innovation and vitality and dynamism of the Pennsylvania economy.”
Washington Bureau Chief Tracie Mauriello: email@example.com; 703-996-9292 or @pgPoliTweets.
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