Published On: Thu, Dec 1st, 2016

House Overwhelmingly Passes ‘Cures’ Legislation To Streamline Drug Approval,,,

House overwhelmingly passes ‘Cures’ legislation to streamline drug approval

© Photo by Karen Bleier/AFP/Getty Images A wide-ranging bill aimed at expediting the development of new medical treatments passed the House decisively Wednesday evening, overcoming criticism from some health policy experts who said it could put unsafe drugs on the market.The 21st Century Cures Act, which passed 392-26, would set aside $4.8 billion for biomedical research funding over a decade and contains numerous provisions intended to streamline the drug approval process and bring medicines to market more quickly.

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Patient groups and drug and medical device companies have been pushing for the legislation for more than a year. Riding a rare wave of bipartisan support in the House, the legislation is expected to be taken up by the Senate early next week.

Supporters say the bill will foster innovation and save the lives of Americans sick with diseases for which there is currently no hope.

 

“We are on the cusp of something special — a once-in-a-generation opportunity to transform how we treat disease,” said Rep. Fred Upton (R-Mich.) during a House debate on the bill Wednesday, who co-authored the legislation with Rep. Diana DeGette (D-Colo.). “With this vote, we are taking a giant leap on the path to cures.”

The final bill, running at close to 1,000 pages, contains a cornucopia of health-related provisions, including $1 billion for opioid abuse prevention. Its biomedical research funding includes $1.8 billion in financial support for Vice President Biden’s cancer moonshot, $1.4 billion for President Obama’s Precision Medicine Initiative and $1.6 billion for the BRAIN initiative, an effort to map and understand diseases that affect the brain. It also provides $500 million to the Food and Drug Administration.

Consumer groups and health policy experts support the funding that the bill provides, but have sharply criticized the bill’s regulatory changes, arguing those will allow drugmakers to furnish less rigorous kinds of evidence to get their products approved. They say the bill could erode standards that protect patients from drugs that aren’t safe or effective.

“We’re profoundly worried that this is a deregulatory bill masked under a deceptive title, and that we’re going to see more unsafe and dangerous products on the market if the bill comes law,” said Robert Weissman, president of Public Citizen, a nonprofit consumer advocacy group.

Rep. Rosa DeLauro (D-Conn.) was one of the few who spoke against the bill on the House floor Wednesday.

“It reduces the already weak regulations on medical devices, allows drugs to be approved with only limited evidence of the drug’s safety and efficacy, and rushes the use of new and unproven antibiotics,” DeLauro said.

Several senators have shared their opposition, including Sen. Elizabeth Warren (D-Mass.). But the White House issued a statement Tuesday evening saying it strongly supported the bill, noting that many of the most concerning provisions in previous drafts have been changed.

The bill also addresses some of the most pressing, and longstanding, needs in the mental health care field. It provides financial incentives for increasing the number of mental health professionals and integrating mental health services into primary care settings; it will allow waivers to use Medicare funds for short-term hospitalization of seriously mentally ill patients; and it strengthens enforcement of mental health parity with increased oversight of insurance coverage.

“At a time of heightened acrimony in Washington, and in the wake of one of the most rancorous elections we’ve ever had, isn’t it wonderful that we can come together to find cures that affect millions of Americans?” DeGette said.

Staff writer Amy Ellis Nutt contributed to this report.

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