Regulatory Focus™ > News Articles > Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

Posted 07 December 2016 | By Zachary Brennan 

Senate Overwhelmingly Passes 21st Century Cures Act Despite Patient Safety Concerns

The Senate on Wednesday passed the 21st Century Cures Act by a vote of 94-5. President Barack Obama praised the bipartisan efforts and said he will sign the bill.

The bill’s path to success, following the House’s positive vote last week, took a unique route, with the House also passing a previous iteration back in July 2015, and then the Senate trying to craft its own package of bills, which stalled and looked to be dead as recently as September.

The wide-ranging, nearly 1,000-page bill is the largest piece of health care-related legislation to be passed by Congress since the Affordable Care Act (also known as Obamacare) and it will alter the US Food and Drug Administration’s (FDA) operations to speed the approval of new pharmaceuticals and medical devices, in addition to providing the agency with $500 million.

Industry groups praised the bill’s passage on Wednesday.


Critics of the bill and its passage point to a larger trend playing out as President-elect Donald Trump comes to power: The undermining of FDA’s ability to ensure the drugs and devices coming to market in the US are safe and effective.

“It is sorely disappointing that Congress gave Big Pharma and the medical device industry an early Christmas present by passing the 21st Century Cures Act. This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” Michael Carome, director of Public Citizen’s Health Research group, said in a statement.

The bill includes several provisions that would require FDA to rely on less data and less reliable data, including patient perspectives, to bring new drugs and devices to market. The bill also creates an accelerated approval pathway for regenerative treatments, which Wired said this morning is part of a plan to "inject and see." 

In addition, as the bill was headed for a Senate vote, Bloomberg reported that Trump is considering Jim O’Neill for FDA commissioner. O’Neill, a former deputy secretary of the Department of Health and Human Services, is not a physician or scientific researcher and said at a 2014 conference that FDA should be reformed so that sponsors only have to demonstrate their products are safe (and not necessarily effective, like with the supplement industry).

Those comments were echoed in a recent Wall Street Journal op-ed from Joseph Gulfo, executive director of the Lewis Center for Healthcare Innovation and Technology at Fairleigh Dickinson University, who wrote: “Patients and their physicians, not the FDA, need to make private health decisions; the Internet of Things would ensure that they have the best information to make these choices.”

‘Cures’ Positives

Some of the benefits of the Cures legislation will be immediate: The bill provides $1 billion over two years to help states battle the ongoing opioid epidemic and almost $5 billion for the National Institutes of Health for research.

The bill also allows FDA to issue grants to further the study of continuous drug manufacturing, creates a pathway for the approval of new biomarkers, clinical outcome assessments, patient reported outcomes and animal models, requires pharmaceutical companies to have publicly accessible compassionate use policies and helps FDA hire sorely needed expertise.

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.