FDA Criticized Over Implanted Medical Device Approval Process
Researchers criticize FDA for lax oversight; agency defends its approach
TUESDAY, Sept. 30, 2014 (HealthDay News) -- Patients are receiving medical implants that may not have been rigorously tested before or after their approval by the U.S. Food and Drug Administration, two new studies contend. The findings were published online Sept. 29 in JAMA Internal Medicine.
According to a review conducted by the nonprofit National Center for Health Research, manufacturers didn't submit any scientific evidence on the safety or effectiveness of 42 out of a sample of 50 new implants in their applications to the FDA. The FDA cleared the implants for use in humans. A statement from the FDA disputed these findings, noting that the "publicly available information" upon which the authors based their conclusions "is generally limited because manufacturers are only required by law to provide either a safety summary or a safety statement for the public."
The second report by the Pew Charitable Trusts states that the FDA doesn't appear to rigorously pursue companies regarding required postmarket studies intended to verify the safety of medical implants following their approval. The Pew researchers found that months pass before regulators and manufacturers can even agree on the parameters for these studies, and that the studies rarely result in any action beyond a change in a device's labeling.
The author of an accompanying editorial, Joshua Sharfstein, M.D., current secretary of the Maryland Department of Health and Mental Hygiene and a former principal deputy commissioner at the FDA, told HealthDay that "there are some areas for further progress, but the agency has done a lot toward moving toward innovation as well as identifying safety problems earlier." Sharfstein said the FDA has undertaken a new postmarket surveillance plan that will label every implant with a traceable code. This code will allow regulators and scientists to better track the implants and note any safety problems that might crop up.
Abstract - National Center for Health Research
Abstract - Pew Charitable Trusts
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