Warren Says Big Pharma Has Hijacked Cures Bill: ‘I Know Difference Between Compromise And Extortion’
Among aspects of the legislation that Sen. Elizabeth Warren, D-Mass., finds problematic are a provision that would roll back requirements for doctors to report some “Sunshine Act” payments from drug companies, a measure that would permit drug companies to market drugs for unapproved uses as legalized fraud and provisions designed to speed approval for stem cell therapies.
Elizabeth Warren Rips 21st Century Cures Bill, Vows To Fight It
Senator Elizabeth Warren on Monday railed against legislation that would ease standards for new drugs and medical devices, saying the bill had been “hijacked” by the pharmaceutical industry. With the legislation headed for a possible vote in the House this week, the Massachusetts senator accused Republican lawmakers of trying to extort Democrats by tying additional funds for medical research to the bill, known as the 21st Century Cures Act. “I cannot vote for this bill,’’ Warren said on the Senate floor, speaking to a largely empty chamber. “I will fight it because I know the difference between compromise and extortion.” (Kaplan, 11/28)
The Associated Press:
Sen. Warren Blasts Drug Approval Bill As 'Extortion'
Sen. Elizabeth Warren has delivered a ferocious attack on congressional Republicans and Senate Majority Leader Mitch McConnell over a medical research bill, putting fellow Democrats on the spot by pushing them to oppose a measure she said "is corrupt, and it is very, very dangerous." As Congress began the final stretch of its post-election session, Warren said the 996-page measure — a top priority for GOP leaders and backed by the biomedical industry — was riddled with provisions that she called "a bunch of special giveaways" to big pharmaceutical companies. (11/29)
Warren Slams Cures Bill As Handout To 'Big Pharma'
Sen. Elizabeth Warren (D-Mass.) on Monday slammed a bipartisan medical innovation bill as a handout to “Big Pharma,” saying on the Senate floor that she would oppose the measure. Warren, a leading progressive champion, accused Republicans of going back on their deal to balance measures to speed up the approval process for new drugs with more money for medical research. She said the funding in the latest version of the bill, $4.8 billion over 10 years, is far too little for what is needed at the National Institutes of Health and other agencies. (Sullivan, 11/28)
21st Century Cures Would Require Pharma To Post Policies On Experimental Drugs
In a nod to patients clamoring for greater access to experimental medicines, the 21st Century Cures legislation would require companies to publicly disclose their policies for making such drugs available. The language in the bill, which is designed to jump start medical innovation, appeared after complaints that many drug makers make it difficult for patients and their physicians to sort out the process for gaining access to medicines that are not yet approved for use by the US Food and Drug Administration. (Silverman, 11/28)
House ’Cures’ Package Could Hit Potholes In Senate
An expansive plan to spur the development of new medical treatments that’s on the fast track in the House could encounter resistance on the other side of the Capitol over disclosure requirements and the way the legislation is funded. ... The updated package would direct $4.8 billion in funding over a decade to the National Institutes of Health. The bill would include $1.4 billion for President Barack Obama’s Precision Medicine Initiative, $1.8 billion for Vice President Joseph R. Biden Jr.’s cancer “moonshot” program and $1.6 billion for a program focused on enhanced understanding of brain-related diseases like Alzheimer’s. The bill would be paid for mostly through sales of the U.S. strategic petroleum reserve and a fund created in the 2010 health care overhaul intended to promote disease prevention and public health. While the earlier version would have provided $8.75 billion in mandatory funding for the NIH, the new text would instead create several “innovation” funds. Each year, appropriators would need to endorse any withdrawals from those accounts. The switch has caused some concern among liberals such as Democratic Sen. Elizabeth Warren of Massachusetts. (Williams, 11/29)
Grassley Threatens To Hold Up Cures If Disclosure Requirements Are Weakened
Sen. Chuck Grassley (R-Iowa) says he will object to the Senate passing a major health care bill by unanimous consent because it would weaken disclosure requirements between industry players and health care providers. The 21st Century Cures Act currently includes a provision that would exempt drug and device makers from disclosing additional payments to health care providers. Grassley says that would result in less transparency in the health care industry. (McIntire, 11/28)
The New York Times:
$6.3 Billion Measure Aims To Cure Ailing Health Care Policies
In one of the most sweeping and rare bipartisan acts of this Congress, lawmakers will move this week on a $6.3 billion bill to increase funding for research into cancer and other diseases, address problems in the nation’s mental health systems and enact potentially far-reaching regulatory changes for drugs and medical devices. The bill, known as the 21st Century Cures Act, is the product of years of debates over health care policy issues, including how to track the federal drug regulatory structure with the fast-paced world of biotechnology, streamline the unwieldy mental health care system, and stem the widespread and intractable problem of opioid drug abuse. (Steinhauer and Tavernise, 11/28)
Consumer Groups Caution Dems On ‘Cures’ Bill
Consumer groups are cautioning against approval of a medical innovation bill moving toward passage in the House and Senate, warning that it could endanger patients by lowering standards for the approval of new drugs. Groups like Public Citizen and the National Center for Health Research say the bill, known as 21st Century Cures, would unacceptably lower safety standards at the Food and Drug Administration. (Sullivan, 11/28)
Funding For Cures Bill Remains Sticking Point For Health Groups
U.S. lawmakers finally reached an agreement on legislation to fund cancer research and accelerate new drugs to market. But the plan to pay for the proposal remains a sticking point for some health groups. The $6.3 billion bill, known as the 21st Century Cures Act, gets more than half its funding by revoking $3.5 billion over 10 years that was supposed to go to a pot of money established under Obamacare to help prevent diseases such as Alzheimer’s and diabetes, increase vaccine use, and raise awareness about the harm caused by tobacco. (Tracer and Edney, 11/28)