In the coming days, the Republican-controlled Congress is likely to approve legislation that will invest more than $6 billion in public health and medical research over the next decade. It will expedite basic research into new medical devices and disease-curing drugs. It will reform mental health treatment and fund research into brain injuries and Alzheimer’s. The bill authorizes $1 billion to combat the opioid epidemic and $1.8 billion for Vice President Joe Biden’s “moonshot” project to cure cancer.
Those highlights are cited with equal enthusiasm by the coalition of Republicans and Democrats who wrote the 21st Century Cures Act and by administration officials hoping it will be perhaps the final significant piece of legislation that President Obama signs.
But to Senator Elizabeth Warren, the bill is an enormous giveaway to pharmaceutical companies, a danger to the public, and a legislative license for corporate “fraud,” “bribery,” and “extortion.”
“I know the difference between compromise and extortion,” the Massachusetts Democrat declared in a fiery speech on the Senate floor Tuesday. “Compromise is putting together common-sense health proposals supported by Democrats, by Republicans, and by most of the American people, and passing them into law. Extortion is holding those exact same proposals hostage unless everyone agrees to special favors for campaign donors and giveaways to the richest drug companies in the world.”
Warren delivered her broadside in a last-minute bid to stop legislation that had been barreling toward passage in the waning days of the 114th Congress. The House initially approved the bill last year, and after negotiations produced a compromise with the Senate, the lower chamber overwhelmingly passed a new version late Wednesday afternoon, 392-26. Senate Majority Leader Mitch McConnell has vowed to send the measure to Obama before Congress recesses next week—if Warren and her allies don’t block it first. A day after her floor speech, Warren sent an urgent fundraising plea headlined “Hijacked” to her sizable donor base. Senator Bernie Sanders quickly joined her effort, issuing a statement of opposition to the bill on the same grounds.
In many respects, the Cures Act represents precisely the kind of diligent, bipartisan legislating to which members of both parties have longed to return. Aimed at a clear public need—improving medical research—it is the product of three years of work by Representative Fred Upton of Michigan, the Republican chairman of the House Energy and Commerce Committee, and Representative Diana DeGette of Colorado, a liberal Democrat on the committee.
With the encouragement of the research community and the pharmaceutical industry, both sought legislation that would make it easier to find life-saving cures by cutting barriers that hold up clinical trials and the approval of new drugs and devices those studies can lead to. Republicans prioritized an overhaul of regulations that, they argued, stifled biomedical innovation, while Democrats wanted both a boost in funding and structural reforms for basic research at the National Institutes of Health and the Food and Drug Administration.
“Those changes will last for decades after the money is spent,” DeGette said in an interview. “It’s really not just bringing devices and drugs to market more quickly, but it’s also being able to expedite the basic research behind the way we’re developing these devices.”
The bill passed by a wide margin in July 2015, drawing even more support from Democrats than Republicans. Just seven Democrats voted against it, while 70 Republicans—mostly conservatives—were opposed. In negotiations with the Senate, the legislation arguably became even more favorable to Democrats. A few provisions sought by drug companies were cut out, including one that would extend the period of exclusivity for new medications by six months and delay the introduction of cheaper generics. Biden won money for his cancer moonshot, and a coalition of lawmakers secured funding to send as grants to states fighting opioid addiction. Republicans won the inclusion of long-sought reforms written by Representative Tim Murphy of Pennsylvania to expand mental health services and prioritize treatment of serious illnesses.
The White House gave the final compromise its strong support, saying the legislation “offers advances in health that far outweigh” its concerns about the funding of the bill, which came partly from selling off oil from the Strategic Petroleum Reserve.
Yet the changes were not enough to satisfy either the far right or consumer advocacy organizations like Public Citizen, which said the bill still went too far in relaxing approval standards for drugs and devices. The conservative group Heritage Action noted that the legislation had ballooned from 300 pages last year into “an almost 1,000-page omnibus health care spending bill.” Although its specific objections focused on spending, its core critique was nearly the same as Warren’s: “In Washington terms, back-room negotiators have turned the Cures bill into a Christmas Tree, loaded with handouts for special interests, all at the expense of the taxpayer,” Heritage wrote.
On the left, Public Citizen argued that even before the bill’s relaxed regulations, Congress had already made it too easy to get drugs and particularly new medical devices to market without sufficient study. “We’ve already reached a point, we believe, where we’ve gone too far,” said Michael Carome, director of the organization’s health research group. “The existing regulations already provide a pathway for quick review for bringing drugs to market. And any further weakening would undermine where we are.”
In particular, Carome cited a provision in the Cures Act that would allow a company to win approval for a second use of an FDA-approved drug without conducting a randomized clinical trial and instead using what’s known as “real world evidence.”
He explained: “Suppose a drug is approved for rheumatoid arthritis and you have to do the randomized clinical trials to prove it was safe and effective, and now you want to have marketed for multiple sclerosis, you can rely upon real world evidence, which is a much lower standard of evidence. It’s more subject to bias and manipulation and can be very misleading. If you’re a patient, such a double standard should be very disconcerting.”
Warren seized on that same provision, arguing that it amounted to “legalized fraud.”
“Pushing treatments without scientific evidence that they work is fraud—fraud that can hurt people,” she said in her floor speech. “It also undercuts the development of real cures.”
In an unusual alliance with Republican Senator Charles Grassley of Iowa, Warren also criticized a provision that would exempted companies from having to disclose certain payments to hospitals and doctors encouraging them to prescribe their drugs. With opposition mounting, the legislation’s sponsors removed that language at the last minute, but Warren said its removal was not enough to win her support.
Her attack on the bill this week blindsided supporters like DeGette, who insisted the measure’s benefits clearly outweighed its flaws and said Warren either misunderstood or was misrepresenting the Cures Act. “There’s absolutely no weakening of any kinds of review,” DeGette told me. “We have the gold standard for safety and efficacy in the world, and we preserve those.”
She noted that the bill had strong support from many in the research community and at the NIH, and she pointed out that many provisions sought by Big Pharma that had been included in earlier versions were now gone. “To categorize this bill as a giveaway to Big Pharma is just simply not accurate,” DeGette said.
Democrats are anxious to pass the bill while Obama is in office for many reasons, none more so than the fact that they will surely lose leverage with Donald Trump in the White House. The cancer money is obviously a priority for Biden, and lawmakers in both parties say the funding for the opioid epidemic is already long overdue.
There is urgency for Republicans, too. The legislation is a legacy project for Upton, who will remain in Congress but because of GOP term limits is ending his tenure as chairman of the Energy and Commerce Committee. And once Trump takes office, this bill likely would fall further down on an agenda packed with bigger-ticket items like tax reform and repeal of Obamacare. “Not only will it get worse for Democrats next year, I think it’ll be very difficult to find that sweet spot where we agree on legislation in a bipartisan way,” DeGette said.
Warren, however, seems unconcerned with the question of timing or leverage. To the dismay of fellow liberals like DeGette, she has chosen to make the 21st Century Cures Act the first Democratic policy fight of the Trump era.
“The American people didn't give Democrats majority support so we could come back to Washington and play dead,” she said. “They didn't send us here to whimper, whine, or grovel. They sent us here to say no to efforts to sell Congress to the highest bidder. They sent us here to stand up for what's right. Now, they are watching, waiting, and hoping—hoping we show some spine and start fighting back when Congress completely ignores the message of the American people and returns to all its same old ways.
“Republicans will control this government,” Warren continued, “but they cannot hand over that control to big corporations unless Democrats roll over and allow them to do so.”
It’s a debate Democrats know they need to have—whether and when to work with Trump and the Republicans, or whether simply to fight him at every turn. But the president-elect is still weeks away from becoming president. And to the many lawmakers—172 of them in the House on Wednesday—who share concerns about corporate influence but who believe the Cures Act is a fair compromise that will on balance improve public health, Warren chose the wrong bill, and the wrong moment, to make her stand.
Two days after the Massachusetts senator called the Cures Act an example of legalized fraud and extortion, all but six House Democrats voted for it anyway.