21st Century Cures Act Sparks Controversy

After winning overwhelming support in the House, a recent piece of legislation has inspired articles praising and criticizing its approach to speeding drug and device approvals.

Brian Buntz

In early July, the House voted 344-77 to pass the 21st Century Cures Act, a bill designed to speed the time to market for medical devices and drugs, while raising $8.75 billion in funding for medical research. Now headed to the Senate, stands a good chance of passing, but has elicited starkly contrasting reactions from commentators.

The Hill proclaims that the the legislation "will change lives for the better" and The Atlantic dubbed it a "a bipartisan victory for medical research." By contrast, a New York Times op ed titled "The F.D.A.'s Medical Device Problem" claims the act "would severely weaken, not strengthen, the F.D.A.'s already ineffective regulatory scheme for medical devices." Written by the cardiologist Rita Redberg and the internist Sanket S. Dhruva, both of University of California, San Francisco, the article claims that the amount of clinical trials used for FDA approval of medical devices is grossly inadequate to ensure their safety. In addition, it claims that FDA's authority concerning post-market surveillance of medical devices is weak, adding that it is likely that "many malfunctions and other problems remain undetected."

Furthermore, the op ed critiques the act's plan to establish a third-party nongovernment program to determine whether new medical devices can be cleared via the 510(k) program.  

As the article states, the act "would enable the device manufacturer itself to select -- and pay -- the third party from an approved list. This flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices."

This protocol is, however, similar to how many medical devices are reviewed by notified bodies in Europe.

The bill's plan to accept case studies, registries, and medical journal articles as evidence for a high-risk medical device's approval is also critiqued in the op ed as well as in a piece in the New England Journal of Medicine. That article goes on to acknowledge, however, that the bill contains "some good ideas that could streamline the development and evaluation of new drugs and devices."

Redberg, a long-time critic of the current standards for medical devices regulation, has also shared her views in NEJM. In 2011, she wrote in the journal that FDA's "device-approval system has become incapable of assuring safety and effectiveness," pointing to the metal-on-metal hip implant debacle as evidence for that. Last year, Redberg had a NEJM column published calling for sham clinical trials for medical devices.

The 21st Century Cures Act, was introduced by Fred Upton (R-MI) and cosponsored by Diana DeGette (D-CO) in May, who spent months collaborating to find common ground for the bill. It initially passed a House committee with a 51-0 vote.

In addition to its provisions to streamline the time to market for drugs and devices, the act also would boost NIH and FDA funding, help facilitate medical research collaborations, and create a fund to foster "early stage investigators, and high-risk, high-reward research."

A summary of the bill's amendments is available on congress.gov.

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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