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Regulatory News | 12 July 2016 | By Zachary Brennan
The Senate’s version of the House-passed 21st Century Cures bill will not be finished until after the Senate’s summer recess, or September at the earliest, Sen. Lamar Alexander (R-TN) said, confirming rumors that the Senate was struggling to reach agreement on the wide-ranging and heavily criticized legislation.
“Rarely do we have such an opportunity: it includes support for the President’s Precision Medicine initiative and the Vice President’s Cancer Moonshot. Speaker [Paul] Ryan [R-WI] has said that 21st Century Cures is a major part of his health care agenda. Majority Leader McConnell says he wants to pass the bill this year,” said Alexander. “This could be the most important legislation Congress passes this year, and there’s no excuse for not finishing our work in September.”
The House-passed 21st Century Cures Act, which has been in development since at least April 2014, proposes some major funding increases for the National Institutes of Health (NIH), and includes some overhauls at the US Food and Drug Administration (FDA), with the intent of speeding up drug and medical device approvals.
On the Senate side, the Senate Health, Education, Labor & Pensions Committee advanced 19 companion bills to the House-passed legislation, including ones that would “streamline” FDA’s reviews of device trial data, exclude certain types of software from FDA’s purview, expand FDA's priority review voucher programs and add other new restrictions and requirements to FDA’s workload.
Since the bills made it out of committee, a fierce battle over how much money NIH should receive has been brewing on both sides of the aisle, with some Republicans trying to make cuts to other Health and Human Services programs to pay for the new funding, while Democrats have been pushing for mandatory NIH funding.
The delay of the Senate’s version of the House-passed bill will likely be welcomed by a number of experts who warn that further accelerating FDA’s approval process of new drugs and devices could put patients at risk.
“The legislation, while containing some useful measures, is flawed. Instead of hastily agreeing to it, Congress should postpone consideration until 2017 and attach the best of the 19 bills to must-pass legislation on FDA funding through industry user fees,” three experts wrote in the Health Affairs blog on Monday. “At that time, we believe the Senate should reject those bills that lower standards for drug and device approvals and safety, and risk adding to the rising cost of prescription drugs.”
Similarly, advocacy group Public Citizen warned that orphan drug provisions in the House-passed Cures Act could increase US healthcare spending by billions of dollars over the next decade.
Despite the critiques, Alexander is pushing forward with his intention of passing the series of Senate bills, noting: “In 10 years, the head of the National Institutes of Health predicts we'll have a universal flu vaccine, hearts rebuilt from a patient's own cells so we don’t have to do transplants, non-addictive pain medication, and the ability to diagnose Alzheimer’s before symptoms, and delay the onset of this disease which causes untold family grief.”
Tags: Cures, 21st Century Cures, Alexander, NIH funding