The 21st Century Cures Act is a proposed health care legislation aiming to expand research funding under the National Institutes of Health (NIH) and alter the Food and Drug Administration (FDA) approval process. Though the act has garnered bipartisan House approval, some opponents of the measure see it as detrimental to drug safety and effectiveness.

The Cures Act, which presents itself as research-focused, has become a matter of contention among health advocates and critics. While some see it as a progressive act that will provide a monumental funding boost and limit the need for off-label prescriptions, others believe it will deregulate the pharmaceutical industry and largely benefit corporate interests. 

What’s Causing The Controversy? 

Though the Cures Act has been moving through Congress since 2015, many question the act’s true purpose. Some argue the act is disguised as research-oriented, but others believe it attempts to alter Food and Drug Administration’s regulatory permissions and give more freedom to drugmakers.

“The punchline is that the regulatory rollback is real, but the funding may not be — it’s subject over the next decade to annual appropriations by Congress that might never come,” according to LA Times reporter Michael Hiltzik.

The House passed The Cures Act in July 2015, receiving support from both Republican and Democrat representatives. Some legislators, however, have rejected the measure altogether.

Elizabeth Warren and Bernie Sanders, among others, have opposed the Cures Act in an effort to focus on Big Pharma price increases, which drew attention when corporations attempted to raise the price of life-saving drugs, such as the emergency allergy treatment EpiPen. 

“When American voters say Congress is owned by big companies,” Sen. Elizabeth Warren (D-Mass.) said, “this bill is exactly what they are talking about.”

Advocacy organizations like Public Citizen have also spoken out against the Cures Act, issuing an email campaign illustrating that the legislation “will NOT make prescriptions more affordable and will NOT guarantee added funding for new research and treatments.”

In an email, Public Citizen outlined its major grievances against the legislation:

  • “Pharmaceutical companies will be able to market medicines for uses that have not been proven safe and effective.
  • Corporate shills will be able to meddle with YOUR (or a loved one’s) Medicare coverage.
  • The authority of the U.S. Food and Drug Administration, which Americans count on to keep us safe, will be compromised.”

Could The Cures Act Alter Safety Standards? 

Opponents believe the change could affect the safety and effectiveness of drugs available to the public, creating new safety concerns for consumers.

Under the act, drugmakers would be able to market for off-label uses by promoting to insurance companies. Some scientists believe the measure could legitimize a prescribing process that’s been happening for decades. 

The Cures Act also allows the FDA to expand approved uses for current medications without stringent safety review, diminishing requirements for clear-cut data from clinical trials. While some believe the change could result in expedited approval for “breakthrough” devices that could cause unknown harm, others support the measure’s ability to quickly deliver treatments to patients who need them. Others remain skeptical. 

Essure, a permanent contraception device, received expedited approval in 2002. The device, approved after “two nonrandomized, nonblinded, prospective studies that lacked a [control] group and enrolled a total of 926 women,” according to a report last year in the New England Journal of Medicine, has caused extensive harm. 

The Essure birth control device can fail, causing thousands of women to suffer from life-changing side effects. Complications such as chronic pain, irregular bleeding, and inability to have sex are among the milder effects, whereas some women will experience organ or fallopian tube perforation, requiring surgery or hospitalization.

The Cures Act will see a Senate vote on Monday.

Read about the FDA’s current expedited approval process or learn more about the permanent birth control device Essure.