FDA to end controversial “alternative summary reporting” of medical devices in bid to boost transparency
pharmafile | May 10, 2019 | News story | Medical Communications, Research and Development, Sales and Marketing | FDA, US, adverse events, medical devices, pharma
The FDA has revealed that it plans to terminate its “alternative summary reporting” programme which has allowed the manufacturers of medical devices to keep undesirable reports of malfunctions and adverse events out of public knowledge.
The controversial programme allowed makers of products such as breast implants to report to the agency and circumvent the public, meaning hundreds of thousands of reports detailing injuries resulting from malfunctioning products were never fully revealed. It has been reported that the two-decade-old programme had collected 1.1 million reports since 2016.
Dr S Lori Brown, a Former FDA official, called the decision “a victory for patients and consumers”, commenting: “The number one job of the FDA – it shouldn’t be ‘buyer beware’ – is to have the information available to people so they can have information about the devices they are going to put in their body.”
The move will also end exemptions still in place for manufacturers of cardiac defibrillators, pacemakers, and tooth implants, as confirmed by FDA spokeswoman Angela Stark. In the future, manufacturers of medical devices will need to file individual reports describing each case of patient harm relating to their product.
Principal Deputy Commissioner Amy Abernethy and Device Center Director Jeff Shuren announced the decision as part of a statement released with the aim of increasing transparency in the ssafety of breast implants.
“We believe these steps for more transparent medical device reports will contribute to greater public awareness of breast implant adverse events,” the statement read. “This is part of a larger effort to end the alternative summary reporting programme for all medical devices.”
The decision means that previously concealed records will thus be made available to the public in a matter of weeks, the US agency confirmed.
Matt Fellows
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