What You Need to Know About the 21st Century Cures Act, Which Would Fund the Cancer Moonshot

Today, Wednesday, Dec. 7, the Senate passed the 21st Century Cures Act in a 94-5 vote. The House passed the bill last week, meaning that the massive health care spending bill now heads to President Obama’s desk for signature into law.

The bill, whose passage has been strongly advocated by the Obama administration and has garnered significant bipartisan support, largely serves to fund medical research through the National Institutes of Health (NIH) and revise the system by which drugs and medical devices are approved by the Food and Drug Administration (FDA).

Most notably, the bill would allocate $4.8 billion to three initiatives begun under the Obama administration: The BRAIN Initiative, the Precision Medicine Initiative and the “Cancer Moonshot” project being helmed by Vice President Joe Biden that seeks to make huge advances in cancer research — working toward a cure for the disease — in just five years.

In his latest, and last, status report on the “Cancer Moonshot” project, Biden recommended to the Obama administration that incentives be put into place to reward individual research efforts. He also pointed out current inefficiencies that delay clinical trials — in turn, delaying the speed at which the latest cancer treatments reach the clinical environments and the physicians who actually work with and treat patients. The funding in the Cures bill would help expedite the work the vice president has recommended be done so that greater strides are made faster in treating cancer and prompting the research that yields the best treatments.

The White House’s BRAIN Initiative seeks to invest in neuroscience research, specifically around causes and treatments for Alzheimer’s disease, Parkinson’s disease, Post-Traumatic Stress Disorder (PTSD) and traumatic brain injury (TBI).

Announced by Obama in the 2015 State of the Union, the Precision Medicine Initiative aims to bring together NIH research with the Department of Health and Human Services (HHS), Department of Veterans Affairs (VA) and the Department of Defense to create tools and metrics by which health care providers can best access research to provide tailored health care treatments for their patients based on their personal medical history, including their genome sequence and microbiome composition.

The bill also includes $1 billion in funding toward treatment and prevention of opioid addiction, as well as enhanced prescription-drug-monitoring programs and training for health care providers to better detect potential prescription drug abuse. According to the Department of Health and Human Services, more people died from drug overdoses in 2014 than in any year on record and the majority of these deaths involved opioids. More than 650,000 opioid prescriptions are dispensed daily in the United States — and 3,900 people initiate nonmedical use of prescription opioids each day in the U.S. as well, with 580 people a day initiating heroin use and 78 people a day dying from an opioid-related overdose.

Speaking on the Senate floor Wednesday, Sen. Patty Murray (D-Wash), the ranking member of the Senate’s Health, Education, Labor and Pensions (HELP) Committee, thanked her colleagues for the bipartisan work that led to the bill’s passage.

Murray said: “As a result of a lot of strong bipartisan work, we are sending a bill to the president’s desk that will: invest in tackling our hardest-to-treat diseases, put real dollars behind the fight against the opioid epidemic and make badly needed changes to mental health care in our country. … There are patients and families waiting and hoping for new cures and treatments, people from every walk of life who make clear that the opioid epidemic has cost too many lives and torn too many families apart, and families who have struggled to get loved ones the mental health care they need — and our broken mental health care system got in their way rather than helping.”

With respect to the FDA, the bill sets aside $500 million for the federal agency and would allow it to approve drugs that have been approved for one thing to be used for other indications without having to first submit full clinical trial data. Instead, drug companies can submit “data summaries” to the FDA indicating why they believe that a drug can be used — and marketed — to treat something other than the condition for which it first gained approval. The bill also allows drug companies to then promote these “off-label” uses to insurance companies, to gain qualification for coverage for more areas of treatment than that which the drug was designed for — and thus potentially significantly increasing a given pharmaceutical company’s market share.

The bill also would allow the FDA to consider “real world evidence” in considering approval for new indications for already-FDA approved drugs, while de-emphasizing the need for and importance of randomized clinical trials in determining drug safety.

On the Senate floor on Tuesday, Murray said, “The bill we’re discussing today — while far from perfect — gives us a chance to build on that tradition of leadership and respond to some urgent health challenges we face right now.” She then specifically called out the funding the bill allocates to fighting the opioid crisis in the U.S. and the funding the bill provides for mental health care and mental health care reforms.

But not everyone supports the bill.

The conservative advocacy and policy group Heritage Action for America has vocally opposed the bill, urging Congressional voters to vote against it.

In a memo on the group’s blog, Dan Holler, the vice president of communications and government relations, writes that “backroom negotiators have turned the Cures bill into a Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer. Therefore, conservatives should oppose the 21st Century Cures Bill.”

Holler writes that the NIH and FDA “do not need additional funding” but should instead “spend the money they already have on critical research instead of wasteful projects.” He also notes that it would be “tone-deaf of the Republican Congress” to pass the bill since it largely provides funding for Obama administration priorities.

Another notable opponent of the bill is Sen. Elizabeth Warren (D-Mass), who spoke on the Senate floor last week against the way she believed the bill had been “hijacked” by the pharmaceutical industry.

In her floor speech, Warren emphasized that the exit polling from the recent presidential election showed that 70 percent of voters “think the American economy and lawmakers who oversee it are owned — owned — by big companies and special interests … In the closing days of this Congress, Big Pharma has its hand out for a bunch of special giveaways and favors that are packed together in something called the 21st Century Cures bill. … And when American voters say Congress is owned by big companies, this bill is exactly what they are talking about.”

Warren made it clear that medical research is essential to the kind of medical breakthroughs that lead to cures, but that combining such funding with measures that would also loosen regulations on the pharmaceutical industry creates issues. She also said that the bill also includes “a giveaway to the gun lobby. The bill cuts Medicare funding. It raids money from the Affordable Care Act. It takes health care dollars that should have gone to Puerto Rico. It makes it harder for people with disabilities to get Medicaid services. There’s a lot of bad stuff here.”

She noted that while the bill does provide “limited funding for important priorities like our national opioid crisis and the vice president’s Cancer Moonshot initiative,” in her opinion, the “bad stuff” in the bill makes it one on which she cannot compromise.

But one Democratic congressional staffer who has been involved with the 21st Century Cures Act told Yahoo Beauty that despite the partisan measures that have been introduced into the bill throughout its road to passage, that ultimately she hopes to see the bill passed.

“Let’s cure cancer. Let’s address the opioid crisis, mental health funding. Let’s pass it. Let’s take the high road,” said this staffer, who agreed to speak on the condition of anonymity.

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