Only 1 in 12 patients think the FDA should revoke its approval of a medical device if the instrument is later found to be harmful to patients, according to a survey commissioned by NEHI.
The survey, the NEHI Innovation Barometer, revealed that most patients are surprisingly forgiving of side effects and adverse events when it comes to devices and drugs, provided that the product is still helpful to some patients.
Only 8% of respondents agreed with the statement that if the FDA "approves a product that later turns out to be harmful to some patients, it should withdraw its approval even if the product still helps some patients."
Fourteen percent of those polled said they think the FDA should’t approve a product that shows "any evidence that it will harm any patient."
But most of the respondents believed it was up to the federal watchdog agency to disclose the risks of a product and determine the best course of action if it finds out that a product is harmful to patients, with only 16% saying that the decisions should be left up to physicians and healthcare providers.
FDA commissioner Dr. Margaret Hamburg, commented on the study during a visit to Boston last week for the institute’s annual conference.
"It’s always valuable to gain these insights," she said. "I’m pleasantly surprised that the healthcare opinion leaders seemed to appreciate so much of what the FDA does."
The survey was conducted in late March with more than 500 "opinion elites from randomly selected households in the U.S.," according to the surveys authors. Interestingly, nearly half of all respondents gave a negative evaluation to the U.S. healthcare system.
