W

ASHINGTON — 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.”

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Republicans say the legislation will help spark innovation in health care and deliver faster cures for Americans. Scores of patient advocacy groups have campaigned hard for the Cures Act, while the more consumer-oriented public health groups have raised questions about whether it was designed to help patients or drug and device companies, which have long complained about red tape and burdensome requirements for Food and Drug Administration approval. More than 1,300 lobbyists have pushed for passage.

On Friday, House and Senate leaders announced that they had finally hammered out a deal on the legislation. It would give states $1 billion to fight the opioid crisis, in addition to providing $4.8 billion for continuing three signature Obama administration research programs over the next 10 years: Vice President Joe Biden’s cancer moonshot, the BRAIN Initiative, and the Precision Medicine Initiative.

An earlier House version of the Cures Act, passed last year, called for $8.75 billion for the National Institutes of Health over five years.

The current legislation also includes $500 million for the FDA, well below the amount Democrats had sought.

In the Senate, Warren and Washington Senator Patty Murray, the ranking Democrat on the Senate Health, Education, Labor and Pensions Committee, have long argued that they would only support Cures legislation that included significant investment in basic medical research.

On Monday, Warren said the NIH funding for medical research in the current legislation amounted to only a fig leaf.

“And most of that fig leaf isn’t even real,” Warren said. “Most of the money won’t really be there unless future Congresses pass future bills in future years to spend those dollars.”

While Warren said she supported many of the provisions, she called others “huge giveaways” to the drug industry.

Warren cited several measures she viewed as especially outrageous, although she said she had countless more.

One, she said, would roll back requirements for doctors to report some “Sunshine Act” payments from drug companies. The provision would exempt companies from disclosing fees given doctors for receiving continuing medical education sessions, medical journals, or textbooks. Earlier Monday, Senator Charles Grassley (R-Iowa) said he would consider placing a hold on the legislation “unless this provision is removed.”

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Warren described another measure that would permit drug companies to market drugs for unapproved uses as legalized fraud.

And finally, Warren criticized provisions designed to speed approval for stem cell therapies. Referring to a major Republican donor who would stand to benefit from the provisions, “This megadonor has poured millions of dollars into Mitch McConnell’s personal campaign coffers and into his Republican super PAC, and now he wants his reward. So the Cures act offers to sell government favors.”

After Warren ended her speech, a stunned-looking Senator John Cornyn (R-Texas) rose and protested the senator’s language and tone. Cornyn called for more civility.

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  • My 45 year old son was diagnosed with childhood cancer (Ewing’s sarcoma) at the age of nine. There are still kids dying from this disease. If YOUR child or grandchild had childhood cancer, YOU would back more funding for the cancer moon shot and other health initiatives. Don’t let partisanship stop you!!!!

    • Looking at this as Red vs. Blue and controlling evil, big pharma is far too simplistic for such a complex human situation. To your point, there are good people dying every minute as they wait for effective drugs to treat their conditions. Nobody wants recklessness. Not the dying person. Not even the pharmas.

      It seems easy to demagogue this issue. Evil big drug companies. Corrupt politicians. Grand standing. Sticking it to big business. Saving tax dollars. Evil FDA.

      I think the task is to rationally figure out a way get effective drugs to dying people much more quickly while balancing risk and benefit.

      Can we put down the back and forth politics and try to focus on this life and death problem?

  • Warren is a megomanical twit who hasn’t got a clue about anything. Never worked in the private sector in her life, never had to produce or sell anything.

  • She’s absolutely right of course. 21CC is a travesty designed to disembowel the FDA. It will endanger, not help patients. Faster cures? Seriously? Just more snake oil.
    As for Republicans calling for civility – they cannot be serious given who they’ve put in the White House. Barbarians, all of them

  • Thank you! I think it’s about time someone started calling the pharmaceutical companies out on their BS as has been done here! This bill is a huge giveaway for pharma and does little to nothing for patient safety! Voting on it now during lame duck session when no one has had time to review 996 pages of its text would be a grave mistake.

    • Amanda, my son has a rare, genetic, degenerative disease which will lead to his death in his mid twenty’s. My family has drained our 401k’s trying to fund research to save him. The drug companies we are working with are sometimes shops of 40 or so people. This is not always big Pharma. These people poured their net-worth into a company and are risking it all. They know my son by name.

      How do we both afford and speed the process without being reckless? Can a person accept more personal risk to try to save their own lives? A bit dramatic but do people sometimes willingly jump out of burning building to try to survive the flames?

      I think it is about perspective – if you are your family are in the burning building you will accept more risk and consider jumping. If you live in a fire free/rare world logic demands safety, cost controls, perpetual reviews, and concern about the cost of fire trucks.

      Just for thought, should all fire trucks be mandated to drive at 10mph and have a meeting at every intersection? Well, I guess it depends on how serious the situation and how likely injury/death is from them arriving later. Although, the fire truck it is a risk to non-involved people – other drivers. The pharmaceutical is only a risk the person agreeing to take the drug.

      Fire trucks where I live expedite (lights and sirens) through town at rush hour to get to trash can fires, minor fender benders, and any commercial building alarms.

      I appreciate your perspective. Please consider mine. I truly, truly hope you do not end up urgently needing new drugs approved to save a child in your family. Those BS pharmas are my son’s only chance. I would like a mechanism to have pharmas get to my house with proverbial lights and sirens.

      They can have everything I own and my life itself if they would just get here in time for my son.

      Thank you.

  • The FDA Device Unit is a backwater still allowing 19th century dental devices and medical devices with less regard to patient safety than industry protection. Incompatible devices are even worse in the body than in the digital world, fueling systemic inflammation and chronic diseases when device materials are not “right for you.” Job One for Congress is to reboot the device unit with a framework for Precision Devices and Patient Safety first. We cannot continue with a regulatory framework that harms many patients’ health. Nothing should move in Congress until strong action is taken for Medical and Dental Device Safety Urgent Reform.

  • Great article on this misleading bill catering to drug and medical device companies, sponsored by “our” representatives who get top dollar from these corporations. Interesting (twisted) that Sen Warren’s speaking of the truth was considered uncivil by her sensitive colleague from Texas.

  • I’m so tired of our Government, taking money from big business, and selling out. They work for the people not big businesses.

  • Is it now established editorial policy at the Globe that every time Granny Warren opens her mouth that the paper must write an article about it?

  • Elizabeth Warren is less concerned with the safety and security of medicine than she is with her ego. Offering no rebuttal while opposing bills shows contempt and unfamiliarity with the subject. Less politics people…either help or get out of the way !!

    • On the contrary, Senator Warren is very smart.

      The entire Republican program, for the last eight years, has been to obstruct and defund everything – no matter how essential to the proper functioning of this nation, no matter the devastating consequences to the economy – so that they could paint the Democrats as failures.

      To our great shame as a nation, this strategy has succeeded and the Republicans are responsible for everything.

      So now we see what happens, and it’s both pathetic and monstrously hypocritical for the Republicans to start whining that the Democrats aren’t being as helpful as they might in passing the hyperpartisan Republican agenda.

  • the US and New Zealand only countries that allow drug ads on television bypassing mds the drug companies need more restrictions not less

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