Stopping Legislative Attacks on FDA Regulation

Stop The 21st Century Cures Bill

For more than 40 years, Public Citizen has fought to keep dangerous drugs and medical devices off the market. Each year, millions of patients are injured by medical products and billions of dollars are wasted on harmful or inappropriate treatments.

Congress has now passed the 21st Century Cures Act, a huge gift to the pharmaceutical and medical device industries. This bill remains 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 does 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.

Why Should you Oppose the 21st Century Cures Bill?

In order to ensure that…

• 21st Century Cures does NOT further undermine the FDA’s ability to ensure the safety and efficacy of medical devices by increasing FDA’s use of medical journal articles as a risky shortcut for approving the highest-risk devices.
• 21st Century Cures does NOT include some of the worst provisions attacking FDA approval standards for antibiotics and antifungals.
• 21st Century Cures does NOT weaken reporting requirements of the Physician Payment Sunshine Act, allowing for secret influence by pharmaceutical and medical device companies.
• 21st Century Cures does 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 does NOT delay generic entry of medicines into the market for longer periods, costing the public as much as $12 billion and denying patients access to affordable, life-saving medicines.

What is Still in Cures:

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

• Creating a double standard for new uses of already-approved drugs, 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/device products, like drug-eluting stents used in heart surgery, under the higher standards used for drugs.
• The NIH funding is lower than originally proposed, and 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 the possibility that NIH funding may be held hostage again in exchange for further weakening the FDA.

News Coverage and Further Information

• Public Citizen Urges Congress to Abandon the Dangerous 21st Century Cure Act, November 3, 2016
• Public Citizen joins 12 advocacy and union groups in urging lawmakers not to consider the Cures legislation until next year, October 26, 2016
• Public Citizen: Senate HELP Committee Should Reject Harmful Bills that May Become Part of the Cures Package, February 8, 2016
• Public Citizen: FDA Joined With the Medical Device Industry in Drafting Cures Legislation, December 11, 2015
• Public Citizen’s Vijay Das on CNN: Congress, don’t fall for Big Pharma’s gimmick, December 9, 2015
• Public Citizen Report on the Cures Orphan Drug Proposal: A Windfall for Pharma, False ‘Cure’ for Patients, December 8, 2015
• Pro Publica: Would Washington’s FDA Fix Cure the Patients or the Drug Industry?, October 20, 2015
• Public Citizen: Snake Oil Alert: U.S. Senate Ready to Roll Out 21st Century Cures Bill, September 29, 2015
• The New York Times: How Not to Fix the F.D.A., July 20, 2015
• The New York Times: The F.D.A.’s Medical Device Problem, July 17, 2015
• Vox: This new bill would add $9 billion for medical research. Here are 5 reasons critics are terrified., July 14, 2015
• The New England Journal of Medicine: The 21st Century Cures Act — Will It Take Us Back in Time?, July 14, 2015
• Wall Street Journal: Undue Haste Rarely Yields Good Medicine, July 12, 2015
• Wall Street Journal: 21st Century Cures Bill to Cost $869M for Rare Disease Drug Marketing, July 1, 2015
• The New York Times: Don’t Weaken the F.D.A.’s Drug Approval Process, June 11, 2015
• The Real News: New Bill Threatens Patient Safety, March 25, 2015