House Passes 21st Century Cures Act, Critics Concerned

In an unlikely show of bipartisan support, the House has passed the 21st Century Cures Act, which may soon become law. The Act will funnel more than $8 billion into advanced medical research to help expedite new drug development and get life-saving treatments and devices to patients who need them. The Act will also facilitate research collaborations; encourage cutting-edge research by young scientists; create incentives to develop cures for rare but deadly diseases, and streamline clinical trials, making it easier for manufacturers to bring new products to market.

At first glance, the Act seems a positive step in the context of medical research and drug therapies, but critics worry that certain provisions embedded in the bill will undermine the quality of evidence used by the FDA when evaluating new medical devices and drugs, thus making it easier for substandard or faulty devices and medicines to filtrate the market, putting consumers at increased risk.

Act may undermine the FDA’s regulatory authority

In a memo published June 6, consumer watchdog group Public Citizen cautioned that such changes afforded by the Act “would put patient safety at risk and undermine the public’s health.” The memo cites Section 2222 of the Act, which would let companies put new high-risk medical devices on the market based solely on medical journal articles and case studies. This fast-track process would prevent heath regulators at the FDA from assessing adverse events and injuries incurred during clinical testing, leading to the potential for patient harm.

The Act has been likened as a Trojan Horse by Jerry Avorn, a Harvard Medical School professor. “The elevator pitch is very appealing … But it is a vehicle for some regulatory changes that are really very worrisome,” Avorn told the New York Times.

Another section of the Act allows manufacturers to make critical changes to high-risk medical devices such as artificial heart valves without proper evidence demonstrating safety and efficacy. Companies can also make these changes without first alerting the FDA.

This fundamentally re-wired approval system is worrisome for many in the medical community, especially given the current litigation and adverse event reports concerning defective drugs and medical devices. Many patients who have filed a medical device injury lawsuit contend that their hip replacements, artificial knee joints and other prosthetics suffer from design or manufacturing flaws—and these devices were subject to more rigorous FDA approval standards.

Opening the door to lower drug standards

In the New York Times, Dr. Avorn contended that the 21st Century Cures would rely on quicker measures that would take the drug approval process back to an earlier time when companies did not have to demonstrate that their products worked. Specifically, the legislation includes the Antibiotic Development to Advance Patient Treatment (ADAPT) Act, which accelerates the FDA drug approval system based on small early-stage clinical trials in humans, clinical endpoints and animal trials, and mathematical modeling. Drug manufacturers would also be able to present “preclinical data” based solely on animal trials as evidence of an antibiotic’s efficacy.

Public Citizen also warns that Section 2123 of the Act would encourage new antibiotic over-prescription and use by giving hospitals a Medicare reimbursement every time it prescribed newer treatments.  This practice may only exacerbate the problem of antibiotic-resistant strains of bacteria, which is already a huge concern. 

Advocates of the bill claim it will help expedite getting cures to patients, and speed up a slow regulatory process. However, if it passes into law, critics worry that ineffective or possibly dangerous products will make their way to patients, exposing them to unnecessary harm. Medications that are not properly tested prior to market may become the subject of defective drug lawsuits in the event of serious injury or death.

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