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The 21st Century Cures Act of 2016

The 21st Century Cures Act of 2016

In 2016, Congress passed the 21st Century Cures Act, a huge gift to the pharmaceutical and medical device industries. This legislation was a bad deal for patient safety, offering a small, temporary and non-guaranteed increase in public research funding at the expense of permanently weakening oversight by the Food and Drug Administration (FDA). Yet the final bill that was enacted should do far less harm than it could have, thanks to the work of Public Citizen and other consumer groups, as well as defenders in Congress like Elizabeth Warren and Bernie Sanders, who stood up against industry and over a thousand lobbyists who swarmed Washington seeking public handouts.

What We Fought to Remove from Cures:

  • 21st Century Cures did NOT further undermine the FDA’s ability to ensure the safety and efficacy of medical devices by increasing the FDA’s use of medical journal articles as a risky shortcut for approving the highest-risk devices.
  • 21st Century Cures did NOT include some of the worst provisions attacking FDA approval standards for antibiotics and antifungals.
  • 21st Century Cures did NOT weaken reporting requirements of the Physician Payments Sunshine Act, which would have allowed for secret influence by pharmaceutical and medical device companies.
  • 21st Century Cures did NOT hasten the rise of resistant superbugs by giving hospitals incentives to use new antibiotics rather than conserving them for appropriate use.
  • 21st Century Cures did NOT delay entry of generic medicines into the market for longer periods, which would have cost the public as much as $12 billion and denied patients access to affordable, life-saving medicines.

What Remained in Cures:

There were still provisions in this mega-bill that will be bad for patients, including:

  • Creating a double standard for new uses of already approved drugs by pressuring the FDA to approve new uses based on poorer quality evidence than the evidence that justified the drug’s initial approval.
  • Pressuring the FDA to rush approval for new medical products, including cell therapies, antibiotics and devices, based on weaker evidence of safety and efficacy.
  • Expanding industry’s ability to pressure insurance companies to cover off-label uses.
  • Making it harder for the FDA to review combination drug and device products, like drug-eluting stents that are used in heart surgery, under the higher standards used for drugs.
  • Offering National Institutes of Health (NIH) funding that is lower than the amount that was originally proposed and that remains a drop in the bucket compared with the massive decline in inflation-adjusted funding to NIH over the past decade. Worst of all, the funding is non-guaranteed, and Congress will have to pass future legislation in order to release the promised funding, opening up the possibility that NIH funding may be held hostage again in exchange for further weakening the FDA.

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