Alert: Congress May Push Dangerous 21st Century Cures Act in Lame-Duck

Nov. 3, 2016

REPORTERS MEMO

Alert: Congress May Push Dangerous 21st Century Cures Act in Lame-Duck

As Window for Passing Major Legislation Narrows, Congress May Rush Cures Act, Putting Patients at Risk

Today, Public Citizen and 12 groups sent a letter (PDF) to congressional leaders urging them to abandon the dangerous 21st Century Cures Act. As the window for passing major legislation narrows, Congress may try to rush stalled bills (21st Century Cures being one of them) through the legislative process during the lame-duck session in an attempt to show Americans they are not gridlocked.

The Cures Act has been touted as one of the most important bills to pass all year, and is being sold erroneously as a commonsense, bipartisan compromise that enables scientific innovation and medical breakthroughs for America. But in reality, the legislation includes a grab bag of goodies for Big Pharma and medical device companies that would undermine requirements for ensuring safe and effective drugs and medical devices and the affordability of these medical products. Notably, it would extend pharmaceutical monopolies and exacerbate the pricing crisis.

The U.S. House of Representatives passed the flawed legislation in July 2015. The U.S. Senate took a different approach by splitting the legislation into a series of smaller bills, which largely lack the most harmful provisions from the House legislation. Those smaller bills have been approved by the Senate Health, Education, Labor, and Pensions (HELP) Committee. The HELP Committee might try to bring its package to the Senate floor for a vote during the lame-duck session as companion legislation to the House version. If that happens, expect a conference committee to try to blend the more dangerous House-passed legislation with the less objectionable Senate version.

Throw into the mix the fight for enhanced National Institutes of Health (NIH) funding – which was included in the House legislation in an attempt to make it a must-pass bill – and you have a recipe for a bad policy outcome.

It is too soon to tell what exactly could be in any final 21st Century Cures legislative package, but it’s important that your readers understand the potential consequences for public health if certain provisions, which have been included in the House version, become part of the final package.

The harmful provisions of the House’s 21st Century Cures Act would:

  • Bar generic entry of medicines into the market for longer periods, costing the public an estimated $12 billion over 10 years and denying patients access to affordable, lifesaving medicines.
  • Undermine the U.S. Food and Drug Administration’s (FDA) ability to ensure the safety and effectiveness of medical devices, including by increasing the FDA’s use of medical journal articles as a risky shortcut for approving the highest-risk devices and allowing device manufacturers to make changes to high-risk devices without direct FDA oversight.
  • Effectively lower FDA approval standards for antibiotics and antifungals.
  • Weaken reporting requirements of the Physician Payment Sunshine Act, allowing for secret influence by pharmaceutical and medical device companies.
  • Hasten the rise of resistant superbugs by giving hospitals incentives to use new antibiotics rather than conserving them for appropriate use.

It is important to note that large sections of the bill were drafted in collaboration with regulated industry, which has continued to mount a major lobbying offensive to move the bill through Congress.

Also included in the House package is critical funding for medical research (though currently without a clear way to pay for it) and the bill’s supporters hope that this funding might be the sweetener needed for the bill to pass. This already has played out once, when the Cures Act received bipartisan support in the House, in part because the bill included a significant amount of money to fund NIH research. Congress should not jeopardize patient safety to increase NIH funding. Instead, lawmakers should restore federal investments in basic science and research while upholding standards to ensure that safe and effective treatments are approved for patient use.

As you monitor the 21st Century Cures Act during the lame-duck session, Public Citizen experts welcome the opportunity to discuss the politics and dangerous provisions of the bill, as well as alternative solutions to both protect public health and advance medicine and research in the 21st century.

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