FDA to shut down secret recording program

Back in the beginning of May, the Food and Drug Administration shut down a reporting program that allowed medical device manufacturers to hide millions of reports from the public.

When the FDA made the announcement, it said it would open past records within weeks.

So why did the FDA have such a policy and why was it secret?

“To our knowledge, the secret summary reporting system was ‘allowed’ because very few people outside of industry knew about it. We don’t think it was publicly discussed or debated,” Deb Zuckerman, president of the National Center for Health Research, told the FDA Reporter.

“The justification was that it would reduce the large number of individual adverse reports which FDA did not have the resources to review in a timely manner. However, that does not explain why the info from the summaries were not made public, whereas individual reports are public. For that reason, we think the convenience to FDA and to industry was not the only reason for this program.”

According to Kaiser Health News, its investigation said the program had collected 1.1 million reports since 2016. Former FDA official called ending the program a victory for consumers and patients.

“Such changes in reporting requirements are apparently the prerogative of CDRH,” Zuckerman said. “That would explain why a former FDA Commissioner was quoted in the Kaiser story as being unaware of the program — apparently it was not cleared through the Office of the Commissioner.

“As Jack Mitchell said in his statement at the public FDA meeting, which he sent to you, the repercussions were that tens of thousands of adverse events were ‘bundled’ and reported to FDA in such a manner that they were probably indecipherable.”

Mitchell shared his statement with the FDA Reporter.

“Under this previously little-known policy, a medical device manufacturer could apply to FDA to file thousands of adverse reports in summaries that were not available to the public,” Mitchell wrote. “Dozens or even hundreds of these adverse events were sometimes bundled into one single report, or a few reports. In 2016, according to the article, only 84 injuries or malfunctions were identified in the public database as being attributed to surgical staplers, or staples used in them.”

Meanwhile, nearly 10,000 additional stapler-related malfunctions were included in the non-public database, according to information FDA provided to Kaiser Health News. The article also quoted a former FDA Commissioner as stating he was unaware of the non-public data base device reporting program.

Zuckerman said that companies could summarize the information in ways most people might consider inaccurate.

“For example, companies have previously referred to psychotic adverse events as ‘mood swings’ and suicide attempts as ‘labile mood.’ They have referred to injuries caused by defective devices as ‘surgeons’ error.’” Zuckerman said. ”Jack has pointed out that as far as we know, the recent meeting of the FDA medical devices advisory committee last week was the first time the non-public statistics had been revealed.”

Zucerkman said the FDA was the entity which had access to the hidden database.

“FDA was the only entity which had access to this hidden data base, so it was entirely up to FDA to review these adverse events, make them public, and take action to protect patients. They did none of those things until the KHN expose,” Zuckerman said.

Two different issues are in play — unsafe staplers and a coverup of adverse events of many devices, Zuckerman said.

“The agency is now taking action on the surgical staplers, by recommending an up-classification to Class II, but that is probably inadequate given the number of deaths from staplers,” Zuckerman said.

“On the broader issue of the cover-up, the FDA also said they will no longer allow summaries, announced shortly after the initial Kaiser Health News story that was critical of the hidden data base. This announcement is exactly the opposite of a recent decision announced by the FDA to allow all device companies to summarize their adverse events.”

FDA spokeswoman Angela Stark told PBS that the agency will end “alternative summary reporting” exemptions for makers of implantable cardiac defibrillators, pacemakers and tooth implants.