Senate passes Cures, setting stage for regulatory rethink on combination products, device premarket approval process

The Senate side of the U.S. Capitol in Washington, D.C.

Members of the Senate have passed the 21st Century Cures Act by a vote of 94 to 5. The positive vote means landmark legislation that will reshape medical device regulation is just a signature from President Obama away from passing into law, although it will take far longer for the FDA to adopt the changes.

Some of the more contentious aspects of the legislation were stripped from the text during its long, stuttering passage through Congress. But the final text still features multiple sections that could have a big effect on the medical device sector. Whether the changes are for better or worse is a topic of debate likely to continue long after the act is signed into law.

Headline changes mandated by the act, from a medical device perspective, include amendments to the regulation of drug-device combination products. The text called for regulators to assign a primary mode of action to each combination product and then send it to the appropriate part of the agency for premarket review. Sponsors that disagree with the decision can ask for “a substantive rationale” to support the ruling—and propose to run studies to support the revaluation of the product.

Some observers fear the legislation will pressure the FDA to class combination products as devices, putting them on a regulatory pathway that is ill-suited to assessing their safety and efficacy. Some also doubt the ability of the FDA, or anyone else, to determine whether a product is a drug or a device.

“The primary mode of action is often unclear because the product is complex, not sufficiently studied, or otherwise difficult to discern. Placing the burden on the FDA to provide a scientific rationale will result in more products being classified as devices in such cases of uncertainty,” nonprofit lobbying group Public Citizen wrote (PDF) in a summary of its grievances with the legislation.

Other changes include extension of—and renewed focus on—the least burdensome approach to the regulation of medical devices. The concept was introduced in legislation almost 20 years ago to stop the FDA from requesting more information than was absolutely necessary, but its impact has fallen short of expectations.

Cures seeks to step up the impact of the approach by making the FDA train all employees involved in the review of premarket submissions in the meaning and implementation of the requirements. Further stipulations of the legislation called for the FDA to audit the effectiveness of the training no later than 18 months after the enactment of the Cures act.

While the audit is tied to a deadline, the implementation date for most of the text is open-ended. As such, it is unclear how long it will take the FDA to enact the changes set out in the document.