On Friday, an op-ed by 2 prominent cardiologists published in The New York Times heavily criticized the FDA’s handling of medical devices, writing that the 21st Century Cures Act, recently passed by the U.S. House of Representatives, would “severely weaken, not strengthen, the FDA’s already ineffective regulatory scheme for medical devices.”
Written by Dr. Sanket Dhruva and Dr. Rita Redberg, the piece is massively critical of the FDA’s oversight of medical devices, saying it can not keep up with modern technology and is introducing unsafe devices to the American public.
Dr. Redberg, a University of California San Francisco cardiologist specializing in heart disease in women and an outspoken healthcare industry activist, helped pen a similar criticism of the FDA’s pre-market approval process in 2014.
The Times article argues that the Act, which in part allows for faster approval processes for ‘breakthrough technologies’ and the submission of non-clinical-trial data, “would allow a device to be approved based on even lower standards of evidence than are currently used, on the theory that the need outweighs the risk,” according to the article.
Redberg and Dhruva argue that the newly passed act will put the burden of clinical trial data on post-market studies, which the authors claim are often delayed for months and years after devices gain approval. Many such studies are never completed, and even if such a trial finds a device dangerous, it is still difficult for the FDA to remove the device from the marketplace, the authors argued.
The authors also decried the FDA’s approval of devices with only 1 clinical trial, as compared to pharmaceuticals which usually require 2. Only a small percentage of medical device clinical trials are randomized, controlled and blinded, said the authors, which should be the gold standard for medical testing, Redberg and Dhruva argued.
Medtronic‘s (NYSE:MDT) Sprint Fidelis leads were referenced in the most recent article, as well as the 2014 piece co-authored by Redberg, as a representative of the issues the authors believe will be exacerbated by the new Act. Recalled in 2007, the Fidelis leads were implicated in a number of deaths and injuries due to fracturing of the implanted cable, causing failures to the system that could lead to failed unit function or uncontrolled shocks.
The authors also criticized the establishment of a 3rd-party non-government authority to oversee manufacturer device changes, claiming a “flagrant conflict of interest would make it impossible for physicians or patients to have trust in the safety or effectiveness of updated medical devices.”
Dhruva and Redberg concluded by urging the Senate to alter the bill to push for stricter evidence standards and increased funding for the FDA, saying it was necessary “to ensure that innovative medical devices lead to better health.”
In Redberg’s earlier article, published in the Annals of Internal Medicine, the cardiologist argues that the FDA’s more-stringent pre-market approval process fails to be stringent when reviewing modifications to already-approved products. The authors claim the modification application process is much lighter than original pre-market review, and allows manufacturers to pass minor changes through without having to put up the same levels of clinical data.