WASHINGTON — The top ranking Democrat on the Senate health committee has “a number of concerns” with how the Food and Drug Administration might regulate medical software such as smartphone apps.
“It is essential that changes to FDA’s regulatory framework are done in compliance with the current statutory framework and do not compromise public safety,” the senators wrote in a letter to the FDA Wednesday.
Over the past year, the FDA has been working with companies like Apple (AAPL) and Fitbit to set up a program that would enable companies to sell some medical software, without agency reviewing it. The software could include computer programs that look at medical images or lab results and diagnose a disease, for example.
The senators raise questions about how the FDA is actually allowed to do this, how transparent the program will be, and whether the FDA will be watching companies closely enough to make sure that they comply.
The letter was led by Sen. Elizabeth Warren (D-Mass.), and signed also by Patty Murray (D-Wash.) and Tina Smith (D-Minn.). All sit on the Senate HELP committee, and Murray is the ranking member.
Under the proposed new program, in lieu of approving specific products, the FDA would “pre-certify” companies based on as-of-yet unspecified criteria. Once they are pre-certified, companies could market certain software without the FDA needing to review it, and other software with “streamlined” review, agency Commissioner Scott Gottlieb said in a speech in September 2017.
The FDA doesn’t actually have a plan yet, and the senators’ concerns are based on preliminary outlines that the FDA has compiled based on conversations with companies and others over the past year.
FDA spokesperson Stephanie Caccomo said that the agency will respond directly to the senators. She added that the FDA is “exploring ways to streamline the FDA’s oversight of digital health products to ensure patients have access to safe and effective technologies that can improve their health,” and that the agency will “explore” implementing the program within the FDA’s current legal authorities.
“We have been transparent about our proposed working model for the program, including seeking public feedback, and will be publishing the next iteration in December,” she said.
In the letter, the senators raise concerns about how this process would work. In a June “working model” of the program on the FDA’s website, the agency writes that in order to remain pre-certified and be able to sell software without review, “organizational leadership would track and monitor … adherence” to certain criteria.
“In other words, software companies could be allowed to use an entirely self-policing review system in order to maintain a status that affords them valuable access to a streamlined review process, even for high-risk software and even if they have no prior experience marketing medical devices,” the senators write. “This approach raises serious concerns about how FDA would ensure compliance with the goals and requirements of the precertification program.”
It is unclear if the senators description accurately describes how the program would work, since the program has not yet been established.
The senators also want to know how the FDA is justifying this program under the current law, and how much information the companies will have to share with the public in order to qualify for pre-certification.