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ASHINGTON — House and Senate leaders announced late Friday night that they had finally hammered out a deal on landmark legislation designed to speed federal approval of new drugs and devices and boost funding of medical research.

But what Republican lawmakers call the “final” version of the 21st Century Cures Act is actually still in negotiation with Senate Democrats, a senior Democratic aide told STAT on Sunday.

Despite the potential for challenges in the Senate, the House will push ahead and vote Wednesday on the $6.3 billion 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.

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The Cures Act also includes a $500 million increase for the Food and Drug Administration and a number of programs to improve mental health care, including suicide prevention on college campuses and screening pregnant women for depression.

In a joint statement Friday, Tennessee Republican Senator Lamar Alexander, chairman of the Committee on Health, Education, Labor and Pensions, and Michigan Representative Fred Upton, chairman of the Energy and Commerce Committee, said they expect the landmark legislation to be approved by the end of the year.

“America’s patients are waiting on us and we will deliver,” they declared.

The Cures Act, which passed the House by a landslide in July 2015, has been the focus of dozens of congressional hearings and endless debate among Republicans and Democrats over the past three years.

During this time, more than 1,300 lobbyists have roamed the halls of Congress, pressing for passage on behalf of pharmaceutical companies, medical device firms, and patient advocacy groups.

They were joined in their effort by a parade of celebrities, from legendary rock ’n’ roll star Roger Daltrey to former junk-bond-king-turned-medical-philanthropist Michael Milken — a major force in getting congressional leaders fired up about the issue.

Leaders from both parties have called passage of the Cures bill the most important thing Congress could do this year. Both Alexander and Upton consider it their legacies. Although Alexander will remain chairman of his committee next year, Upton will have to step down.

But there has been a major sticking point: While the House version of the bill included funding for medical research, which the Democrats required for their support, Senate Republicans on the HELP committee would not approve funding without an agreement over where the money would come from.

The lack of financing caused a stalemate until the unexpected happened: The Affordable Care Act was mortally wounded by the election of Donald Trump. With huge chunks of Obamacare now likely to be repealed, Democrats have agreed to underwrite the Cures Act with some money from the ACA, and some to be generated by sales of part of the Strategic Petroleum Reserve.

“What we have in the 21st Century Cures Act is an innovation game changer, a transformational bill to bring our health infrastructure light years ahead,” said Upton and Alexander.

The Democrats have been silent on the so-called final version of the Cures Act. They have long been worried about provisions to speed the Food and Drug Administration’s approval process — concerns that have increased with the election of Trump, who has said he plans to reduce government regulation.

Some consumer groups contacted Sunday said they still oppose the legislation. They fear the medical research money is buying the Democrats’ acquiescence on important FDA safety matters.

“While there are positive aspects of this legislation, many provisions would severely weaken the FDA’s drug and medical device approval standards and seriously harm rather than help patients,” said Jack Mitchell, director of government relations for the National Center for Health Research, which advocates for patient safety. “Congress shouldn’t sacrifice the safety and effectiveness of medical products in order to increase research monies.”

Final or not, many of the bill’s provisions are aimed at the FDA. It establishes an expedited review for breakthrough medical devices, increases patient participation in the drug approval process, and calls for streamlined review for drug-device combinations.

The Cures Act would require the FDA to evaluate the use of so-called “real-world” evidence to help support new uses for previously approved drugs, and to help support or satisfy post-approval requirements to confirm the safety and effectiveness of treatments. Many public health advocates see this as a weaker alternative to the current gold standard of randomized clinical trials.

More controversially, it would allow the FDA to accelerate approval of regenerative advanced therapies, or stem cell therapies, a measure pushed by Senate Majority Leader Mitch McConnell of Kentucky. The provision draws on the REGROW legislation originally sponsored by Illinois Republican Senator Mark Kirk, who had suffered a debilitating stroke.

The REGROW provisions in the Cures Act call for devices used with a stem cell product to be considered moderate risk, unless the secretary of Health and Human Services determines that the device or use requires a higher risk classification.

Opponents believe applications of regenerative medicine, which seek to restore or establish normal function in damaged human cells, tissues and organs, should be closely regulated and subject to clinical trials.

Correction: A previous version of this story misstated Lamar Alexander’s tenure as chairman of the Senate HELP Committee.

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  • I’m glad that Daltrey is aboard. Maybe they can now get serious about finding a 21st century cure for Tommy Walker; you know the deaf, dumb and blind kid who sure could play a mean pinball. Get that wicked Uncle Ernie to stop fiddling about so that Tommy can get better.

    Then again, it might just be all in the wrist…

  • Wow, you missed a lot of facts in this “article”. This bill is corrupt at it’s core. It contains some good stuff, but Republicans have bundled it with giveaways for drug companies, proving that they can be bought by the highest bidder. This is a horribly misleading article.

    You really should update this article with the info in your more recent article to prevent from miseducating readers. https://www.statnews.com/2016/11/28/elizabeth-warren-21st-century-cures/

  • It is a misnomer! “The Cures Act” The cures come from within when we are not subject to trace toxins from our factory food supply and our life style.
    In addition the food system needs to deliver optimum nutrients for cellular health. Our defective food system is driving the ballooning healthcare costs in the US. When will medicine speak out on this issue? The answer: When it is no longer profitable to treat the victims. The Cures Act is just another pork barrel project for profit in the medical community.

  • The house version was fine. Why can’t the senate leave it alone? As someone who advocated and spoke at one of many roundtables hosted by members of the E&C Subcommittee on Health and living with Parkinson’s Disease the 21st Century Cures Act has bipartisan support and goes a long way to aggressively pursuing cures to many chronic diseases that thusfar have eluded science and medicine for years. The time has come to step up for #cures.

    • Michael, agree more cures re drug R&D is good. But continuing harm from medical and dental devices is bad. In fact it fuels all kinds of chronic neurological, autoimmune and other diseases. So Congress needs to fix at the same time as they don’t have the will or bandwidth to visit more than once a decade or so. In addition, you would be astounded how many dentists develop Parkinson’s, essential tremor, and more. Most
      chronic diseases are the interaction of genetic susceptibilities and exposures outside and inside the body. FDA device policies and regulations are practically medieval in not recognizing harm from
      Genetic susceptibility, especially when it comes to neurotoxins like Mercury, nickel installed in people with nickel allergies, etc.

  • Job one for Congress to advance American’s health is to fully reboot the FDA Device unit with a Precision Device Framework, to ensure devices are “right for you” before they are installed. In addition to the new UDI system, patients and parents must receive information sheets for all installed products of the materials they contain and potential side effects and contraindications – no exceptions for dental fillings, other dental devices and materials – and the right of written informed consent. They should be given a card with information on how to report side effects using the MedWatcher app, which specifically notes that MedWatch covers dental as well as medical devices.

    In addition, patients should be pretested for biocompatibility – both allergic and autoimmune reactivity – before any medical or dental device – including dental fillings – is installed in the body (except in emergency situations). Tolerance vs. toxicity to mercury (dental amalgam from which it off-gases in tiny amounts), nickel and PET fibers (Essure), polypropylene (Mesh), and other metals and chemicals in devices varies greatly by gene types that influence methylation pathways. Lastly, device information should be entered and tracked in patient EMRs – the way prescription drugs and OTCs are – not only in dental records where they never see the light of day by physicians, researchers or Big Data.

    We are still using dated 19th and 20th century products and FDA processes that hold back Americans’ health, fueling inflammation and needless chronic disease, disability, dementia, health and long term care costs, and heartache.

    • Laura, Thank you for your comments. In a perfect world where unlimited funding is available your concerns are addressed and eloquently outlined in your previous response but you have to have a starting place. The chronic disease community doesn’t have time on their side. My experience with public policy has been that during the legislative evolutionary process, funding and intention don’t always match up. What seemed to be a good idea gets lost in markup and committee amendments. Your point about biocompatibilty is right on but shouldn’t slow the process. Instead be inclusive. Another point I agree with is your comment about FDA reform. I personnaly know people working in that department and they say it is past time for a “reboot.”

    • Michael, I was in the chronic disease community for two decades. I am also a cancer survivor. Now I am in the healthy community. I want more people to be able to avoid the chronic disease community, and join the healthy community.

      There is a hidden river of people with a hidden river of chronic diseases caused by a hidden river of toxins, too many of which are in FDA-approved medical and dental devices. The risk assessment estimates of Americans stealthily harmed by mercury dental amalgam is conservatively over 60 million, with the ADA burying its patent-holding conflicts of interests regarding mercury-containing dental amalgam since its founding over 150 years ago. Tens of thousands of women have been harmed by Essure contraceptive coils that were approved based on small numbers for a short time period, with thousands having hysterectomies for removal to reverse allergic, autoimmune and other inflammatory processes, as well as device misplacement, migration and failure. Transvaginal mesh also creates inflammatory messes in many, especially when made of polypropylene not approved for human use.

      A friend had to have implants removed, then her appendix when a morcellator spread uterine tissue into it. A relative had to have neck, spinal and esophageal surgery to remove metal implants due to allergies to the metal used, finally discovered after being progressively ill for over a decade. Do medical and dental devices hurt everyone? Not those in the fat and happy part of the gene bell curve, but way too many on the sides.

      There is an epidemic of medical and dental device injuries in the United States, because the FDA Device Unit stands up for device manufacturers, not patients. Congress has does the same for decades. This needs to stop now.

      So the injured and ignored patients – who have no recourse due to FDA rules and regulations designed for industry protection over patient protection – invite and ask you to be inclusive. We have been waiting for decades for the U.S. to come to its senses regarding medical and dental devices that are right each of us, and for the right to diagnosis and treatment, without FDA pre-emption rules that means the manufacturers get a free pass, with costs passed on to patients, families, employers, insurers, and governments.

    • Getting pretty conspiracy theory-ish in here. Lots of fancy words hiding the fact that just about nothing you said fits in with any findings from mainstream, peer-reviewed journals. Dental amalgam? Really? It’s been found to be perfectly safe in every major journal I can find, if you fear dental amalgam you should really fear tuna fish as even people with many amalgam fillings receive less than 1% of what the WHO calls a safe daily intake of mercury.

      As for EMRs, not sure where you live, but in the U.S. we sure don’t have a universal EMR. If you pick up an OTC at Walgreens your physician won’t have a clue unless you tell them. Same goes for prescriptions, if you get a prescription filled written by Dr. A, Dr. B won’t have a clue. Medical devices are included in any hospital EMR I’ve ever seen but again, that info stays there unless you take it elsewhere on your own volition. Heck, even the use of paper record vs. EMR isn’t universal. So if you’re pushing for a universal EMR, I think most pharmacists and physicians are right there with you, but getting that from the GOP is about as likely as getting a boost in climate research funding.

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