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.
The U.S. Senate is expected to release its version of the 21st Century Cures Act soon. If the bill resembles the version approved in July by the U.S. House of Representatives, the public should be very concerned.
Why Should you Oppose the 21st Century Cures Bill?
21st Century Cures would further undermine the FDA's ability to ensure the safety and efficacy of medical devices, including by increasing FDA’s use of medical journal articles as a risky shortcut for approving the highest-risk devices.
- 21st Century Cures would effectively lower FDA approval standards for antibiotics and antifungals.
- 21st Century Cures would weaken reporting requirements of the Physician Payment Sunshine Act, allowing for secret influence by pharmaceutical and medical device companies.
- 21st Century Cures would hasten the rise of resistant superbugs by giving hospitals incentives to use new antibiotics rather than conserving them for appropriate use.
- 21st Century Cures would bar 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.
- Large sections of the bill were drafted by industry, which has mounted a major lobbying push to move the bill through Congress.
News Coverage and Further Information
- 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
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