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FDA Commissioner Scott Gottlieb, MD, announced in a tweet on Wednesday that the agency planned to publish hundreds of thousands, if not millions, of unprecedented reports of injuries and malfunctions related to approximately 100 medical devices.
"We are now giving priority to making ALL this available," tweeted Gottlieb.
It is an old database where historical information was not easily accessible electronically due to the age of the system. But it is imperative that all security information is publicly available. We are now prioritizing the provision of ALL this data. https://t.co/T1c3qQQQ3E
– Scott Gottlieb, M.D. (@SGottliebFDA) March 27, 2019
A recent Kaiser Health News survey revealed the scope of a hidden reporting mechanism for device manufacturers, with the agency having accepted more than 1.1 million such reports since early 2016 .
For nearly 20 years, device manufacturers have been able to discreetly request an "exemption" from the standard rules for public reporting of damage. Devices that benefit from such exemptions include surgical staplers and balloon pumps used in the vessels of patients who have undergone cardiac surgery.
Gottlieb's tweet also mentioned the challenge of opening the database, saying that "it was not easily accessible electronically because of the age of the system. But it is imperative that all security information is publicly available. "
The agency made changes to the "Alternative Synthesis Report" program in mid-2017 to require a public report summarizing the data filed within the FDA. But nearly two decades of data remained confidential from doctors, patients, and device safety researchers who claim they could use them to detect problems.
Gottlieb's announcement was greeted by Madris Tomes, who testified before the FDA's Device Review Committees about the importance of making summary data on patient damage publicly available.
"This is the best news I've heard in years," said Tomes, president of Device Events, which makes the FDA's data harmful to devices more user-friendly. "I'm really happy that they are taking note and realizing that doctors who could not see this data used previously devices that they would not have used if they had these data in front of them." . "
Since September, KHN has filed Freedom of Information Act applications for all or part of the "Alternative Synthesis Reports" database and other special reports on "exemptions", with little effect. A request to expedite the delivery of these documents has been denied and the FDA has invoked the lack of "compelling need" for the public to dispose of the information. Officials noted that it may take up to two years to obtain such records via the FOIA process.
As recently as Friday, however, the agency began publishing previously undisclosed injury reports, suddenly updating the number of breast implant malfunctions or injuries sustained over the years. The new data has been presented to an advisory committee of the FDA, which examines the safety of such devices. The panel, which met Monday and Tuesday, saw a chart showing hundreds of thousands of other tales of wrongs or dysfunctions that had not been acknowledged before.
Michael Carome, MD, director of Public Citizen's health research group, said his initial response to the news is "better late than never."
"Yes [Gottlieb] is committed to making all this data public, so it's certainly a positive development, "he said. "But these are security information that should have been available years ago."
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