The US Senate voted overwhelmingly on Wednesday (December 7, 2016) to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines. It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine, says Reuters.#Cures Act was passed by the House of Representatives, goes to @POTUS to sign into law Click To Tweet
Two years in the making, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.
“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act–a bill that will help virtually every American family.”
Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.
“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,” consumer watchdog Public Citizen said in a statement.
Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each condemned what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.
The $6.3 billion act, sponsored by Michigan Republican Rep. Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration, says Reuters.
It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday (December 6, 2016) the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61% are opioid or heroin related.
“Opioids such as heroin and fentanyl–and diverted prescription pain pills–are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”
The bill also calls for $1.8 billion in funding for Vice President Joseph Biden‘s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.
Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never show up. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.
Among those FDA changes, greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to assemble.
“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.
Under the Act patient input will be formally incorporated into the FDA’s drug review process.
Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”
The $6.3 billion 21st Century Cures bill was approved by the Senate Wednesday in an overwhelming 94-5 vote and is now headed to the White House as one of the last pieces of legislation to be signed into law by President Barack Obama.
Euphemistically called “Cures,” the above legislation has been a long time in the offing. It’s the biggest health-reform legislation passed by Congress since Obamacare and has stirred up a ragtag gaggle of industries and lobbying firms-—including big pharma (the legislation’s most ardent proponent), patient advocacy groups, mental health organizations, and medical researchers—-who fought for its passage over the last three years.
Despite its bipartisan external appearance, the law has its share of critics.
For instance, legislators like Sens. Elizabeth Warren of Massachusetts, Bernie Sanders of Vermont, and Jeff Merkley of Oregon recently warned that Cures amounts to a big pharma handout which will weaken regulatory standards on drugs, provide a mere scrap to the NIH and the FDA, and do nothing to confront the rising tide of high drug prices.
They point to the fact that the $4.8 billion in NIH funding included in Cures must be re-authorized every year, and that drug approvals which can be based on “real-world” patient outcomes (rather than rigorous clinical trials) could actually endanger patients.
The latter issue is a major point of contention among patient advocates, notes Fortune. A number of organizations who say it will expedite the availability of treatments for unmet medical needs, including the largest cancer physician group in the US, hailed its passage.
“The American Society of Clinical Oncology (ASCO) applauds the US Senate for their decisive vote today to pass the 21st Century Cures Act and authorize funding for the Beau Biden Cancer Moonshot and NIH Innovation Projects,” wrote the organization in a statement. “This landmark legislation will spur development and delivery of promising new treatments for patients.”
Others, such as consumer watchdog Public Citizen and the preventive medicine advocacy group Trust for America’s Health (TFAH), had very different views, arguing Cures mostly benefits pharma companies at the expense of other important public health initiatives.
“TFAH is deeply disappointed Congress will utilize [Obamacare’s] Prevention and Public Health Fund as an offset for the legislative package known as 21st Century Cures,” the group wrote in a statement. “Cutting the Prevention Fund will limit the nation’s ability to improve health and quality of life and prevent disease.”
There are even some pressure points for patient advocates who think Cures’ passage is a net societal benefit.
Reading some news reports, you might wonder about the benefits for patients of the 21st Century Cures Act.
Elaine Schattner of Forbes said, “I’m in favor of the Cures Act. Strongly.”
Schattner notes stories suggesting that “Cures” is all about perks for pharmaceutical companies, and that industry-funded advocacy groups are parading patients, like puppets, before legislators to promote the bill. Earlier this year, she attended a small meeting where healthcare journalists didn’t just question, but scoffed at the prospect of speeding the FDA’s approval process, which is part of the package. “Why would anyone support this bill?” a journalist asked.
The fact is, every patient with whom she’s discussed the 21stCentury Cures Act hopes it will move forward, Schattner continued. Doctors too, tend to favor this bill, because it supports more government-funded research.
“I support most of the ‘Cures’ provisions, for three big-picture reasons. First, the legislation includes significant investment for President Obama’s Precision Medicine Initiative and the real Cancer Moonshot. I agree with oncologists who observe that we’re at a pivotal moment in cancer research, ready to turn in-hand progress in science and information technology into survival and quality-of-life advantages.” Shattner said.
Finally, in gauging how this legislation has made it to President Obama’s desk, two months after the administration promised a “moonshot” to accelerate the fight against cancer, Vice President Joe Biden summoned top healthcare lawmakers to a meeting in the Old Executive Office building. Biden, whose son, Beau, died from brain cancer less than a year earlier, saw a path to fund the initiative.
According to Politico, the two-hour March meeting with Biden, Upton and the bipartisan leadership of the House and Senate’s healthcare committees was the beginning of a rare Washington partnership that would ultimately save the healthcare legacies of Biden and Upton, as well as key Obama administration research programs–a bittersweet victory for a White House that will likely see much of its healthcare agenda unraveled by Republicans next year.
The 10-year funding bill made its way through Congress because of Biden’s imposing presence–and also because it is packed with substantial amounts of money for enough pet projects, including a batch of Medicare and mental health reforms, to keep disparate lawmakers on board.
Relentless cheerleading for the project by Upton and Rep. Diana DeGette’s (D-CO) also played a key role. The duo traveled the country with other lawmakers and leaders like NIH Director Francis Collins to sell the project directly to the public.
The vote let lawmakers close the year and the 114th Congress on a dramatic high, after a divisive election and ahead of the heated battles next year over the dismantling of Obamacare.
That drama was captured Monday night, when Biden took the rare step of presiding over the Senate for a procedural vote on the bill and Majority Leader Mitch McConnell announced the Senate would rename the law’s cancer program after Biden’s late son.
In the end, the three years of political persistence, begun by Upton and carried forward by a broad cast of characters, paid off. And there still are plenty of questions on exactly how the FDA will interpret and implement 21st Century Cures, especially in the face of a new administration. But it nevertheless seems destined to be the final major legislative Act of the Obama era.
Steve's Take: #Cures Act nice sign of compromise whose prospects look dim under @realDonaldTrump Click To Tweet
“I think it shows that if you can consult, consult, consult and don’t give up, and listen to your colleagues, that we can actually solve big problems here,” said Sen. Alexander, who helped broker a critical compromise on regenerative medicine needed to satisfy McConnell and the FDA.
I do applaud Sen. Alexander’s wistful testimony to the power of congressional collaboration. I really do. But the way things are going with Trump’s new administration appointees and nominees, Alexander’s hopeful plea for congressional consultation and compromise is looking more and more like a pipe dream. And I don’t mean of the e-cig variety.