The Food and Drug Administration’s (FDA) oversight of medical devices—which include products from hip replacements to pacemakers—would be loosened by a bill swiftly moving through Congress, under the radar of many of the patients that rely on access to these essential devices.
According to a Project On Government Oversight (POGO) report, the changes to the FDA’s oversight emerge from negotiations between the FDA and the very industry it is tasked with overseeing.
Federal law requires the FDA to conduct negotiations with industry every five years in return for the industry “user fees” on which the consumer protection agency depends.
“To keep the fees coming, the FDA engages in wide-ranging negotiations that give industry lobbyists extraordinary sway over how the agency does its job,” according to POGO’s report, authored by David Hilzenrath. “Much of the FDA’s money comes with strings attached, and industry gets to pull on the strings.”
In fact, during POGO’s investigation, an FDA spokesperson referred POGO to an industry-lobbying group to answer questions.
The report finds the FDA’s agreement with industry would:
● Allow medical device manufacturers to wait as long as three months before reporting that their devices have malfunctioned in ways that could kill or seriously injure patients, and permit them to report those malfunctions in “summary” form.
● Increase FDA reliance on private reviews arranged by device manufacturers, known as “third party reviews.” That “represents a potential lowering of medical device safety standards,” an expert with National Center for Health Research said at a public FDA meeting last year. The FDA has expressed dissatisfaction with third party reviews, including concern about “incompetent third parties.”
●Under certain circumstances, stop the FDA practice of requiring manufacturers to conduct “post-market surveillance studies”—analyses of how safely and effectively devices are performing once the FDA has allowed them to be sold. The agreement says the FDA won’t require such studies if it has access to sufficient “real world data.” Whether that change provides sound protection for patients depends on how conscientiously and effectively the FDA implements it.
In addition, the agreement would speed up FDA reviews of devices. For many devices, the time frame for the FDA to reach a decision on the products would decline from 124 days in fiscal year 2018 to 108 days in fiscal 2022. In fiscal 2010, it took an average of 150 days, according to FDA testimony. Shorter reviews could mean hastier reviews.
The negotiated agreement is the foundation of the FDA Reauthorization Act 2017, which has been voted out of committee in both Congressional chambers and is waiting for floor votes.
Congress has also added accommodations for the medical device industry to the legislation. For example, the House version of the legislation would require that the FDA tell the manufacturer in advance when inspectors are coming.
Click here to read POGO’s report, “Congress, FDA poised to loosen oversight of medical devices.”