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The proposed 21st Century Cures Act needs an overhaul

There are ways to improve medical treatments without compromising their effectiveness or patient safety

Published: September 11, 2015 12:20 PM

Patients desperate for medical breakthroughs should never have to sacrifice safety in the name of innovation, but legislation underway in Congress could do just that.

Earlier this summer, the House of Representatives passed a medical innovation bill known as the “21st Century Cures Act”—or simply “Cures”—that has several key provisions that would significantly weaken consumer health protections and could lead to patients being exposed to potentially unsafe or ineffective drugs and medical devices.

Consumers Union, the policy and advocacy arm of Consumer Reports, has serious concerns with the bill, including:

Drug Safety

The 21st Century Cures Act would weaken the FDA’s ability to ensure safe and effective medicines by fast-tracking certain antibiotics and antifungals for approval based on less rigorous testing.                            

Medical Device Safety

The 21st Century Cures Act would allow the FDA to approve medical devices based on case studies or medical journal articles alone, rather than clinical trials. This means that real world testing would happen only after the device is already on the market and being used by patients. Additionally, the bill would allow medical device companies to make changes to the highest risk devices, like heart valves and brain stents, without first telling the FDA or proving that the altered device remains safe and effective. (Read our earlier report on dangerous medical implants and devices.)

Antibiotic Resistance

The 21st Century Cures Act includes incentives to prescribe newly developed antibiotics. Hospitals would receive a bonus for using new antibiotics, which could lead to overuse and antibiotic resistance, undermining one of the very problems the legislation is supposed to address. (Read our investigation on how your hospital can make you sick.)

Transparency in Physician Payments

The 21st Century Cures Act would create a huge loophole in the Physician Payment Sunshine Act. The Sunshine Act, which Consumers Union strongly supports, requires medical device and pharmaceutical companies to disclose payments they make to physicians and to teaching hospitals, which can include large amounts for speaking engagements, or covering large fees for doctors to attend conferences.

Access to Generic Drugs

The bill would keep certain generic drugs off the market longer, giving pharmaceutical companies extended monopoly power to sell costly, brand name drugs.

But it’s not too late to fix these issues. The Senate is working now on its version of a medical innovation bill and they want to hear from you. We can work to pass legislation focused on improved treatments that are safe and effective for patients—without compromising the effectiveness of the treatments or the safety of patients.

Consumers Union supports other options to discover the next medical breakthrough while keeping patients safe, like the Helping Effective Antibiotics Last (HEAL) Act that would protect patient safety in the FDA approval process while encouraging the development of proven and safe new antibiotics. We are urging Senators to include this approach in their medical innovation legislation.

Your senators have the chance to do the right thing, and remove these pharma giveaways while making sure innovative, safe cures reach the market. Tell your senators you support safe, effective, and affordable cures. 

This feature is part of a regular series by Consumers Union, the policy and advocacy arm of Consumer Reports. The nonprofit organization advocates for product safety, financial reform, safer food, health reform, and other consumer issues in Washington, D.C., the states, and in the marketplace.


Read past installments of our Policy & Action feature.




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