Bill to Curb FDA Overreach Introduced in Senate

By Jim Dickinson

Spurred by the still-unresolved dispute between FDA and the California-based marketer of over-the-counter genetic test kits 23andMe, U.S. Senators Deb Fischer (R-NE) and Angus King (I-ME) have introduced the Preventing Regulatory Overreach to Enhance Care Technology (PROTECT) Act of 2014.

FDA considers 23andMe’s Saliva Collection Kit and Personal Genome Service to constitute a medical device that does not have either PMA approval or 510(k) clearance and late last year ordered the company to halt sales of the products.

In a joint news release that did not mention the 23andMe matter, the two senators said their bill will protect jobs, reduce regulatory burdens, and provide greater certainty for health information technologies. It “offers a more specific regulatory framework for health IT that promotes innovation and job creation while protecting patient safety,” according to the release. The bill would also exempt some clinical and health software from the medical device tax.

Under current law, the statement said, FDA can use its definition of a medical device to assert broad regulatory authority over a wide array of low-risk health information technologies, including mobile wellness apps, scheduling software, and electronic health records.

“The PROTECT Act gives clarity to FDA’s regulatory process to focus on products that pose a legitimate risk to human health,” the senators said. “This more effective, risk-based framework boosts patient safety by prioritizing FDA’s attention to technologies that pose the greatest health risk. It also protects low-risk health IT from unnecessary regulatory burdens that stifle opportunities for job creation, innovation, and improved care.”

—Jim Dickinson is MD+DI's contributing editor.