Under the current rules, pharmaceutical companies have an obligation to report serious and unexpected adverse events to FDA within 15-days of receiving a report. Serious adverse events are defined by their outcome – events that resulted in death, hospitalization, disability, or other life threatening outcomes. Unexpected adverse events are defined as those adverse events not currently listed on the drug’s label. When an adverse event report comes into a pharmaceutical company that is both serious and unexpected, it is required by law to report that case to FDA within 15-days. In the past, delays or failures to abide by these reporting requirements have led to fines and other punishments.
The JAMA study reviewed 1.6M case reports filed in FAERS between 2004 and 2014 and found that 9.94% of serious and unexpected cases were not reported to FDA within the required 15-day window. The authors also found that adverse event cases reported with death outcomes had a slightly higher rate of failing to comply with the 15-day reporting window.
The authors of the study – and the media who reported on it – rightly lambasted the pharmaceutical companies for failing to adhere to the reporting requirements. But these failures shouldn’t be a surprise. We’ve written extensively about how pharma companies outsource their adverse event reporting requirements to the lowest offshore bidder and how that practice has led to a series of failures in our national drug safety efforts.
Instead what peaked our interest was the Editor’s Note that accompanied this research paper in JAMA. In it, Dr. Rita Redberg writes:
“Such reporting delays should never occur, as they mean that more patients are exposed to potentially avoidable serious harm, including death…Clearly, the lack of consequences contributed to a lack of deterrence for these illegal and dangerous delays…Physicians and their patients must be knowledgeable of benefits, harms, and alternatives for a wide choice of treatments, especially those recently approved for which clinical experience is limited”
While we entirely agree with her statements, we feel that the indignation is misplaced. Should pharmaceutical companies fail to file these serious and unexpected adverse event case reports within the required 15-days? Of course not.
But that’s not the real problem. Not by a long shot.
The first real problem is the much more extensive delay FDA has in releasing these data to the public. Currently, the most recent publicly available FAERS data includes case reports received by FDA through December 31, 2014. That means that critical, potentially life-saving, data is currently 7 months out of date. And we’re not talking about 10% of the data being late. We’re talking about 100% of the data being late. While pharmaceutical companies have a requirement to report adverse event cases to FDA in a timely manner, FDA has no such obligation to release those data to the public in a timely manner.
Some could argue that the delay in public data release is critical so that FDA can examine the case reports, perform analysis and issue relevant warnings and label changes. And in fact that does happen from time to time. But not nearly the way it should.
Which leads to the second real problem. An analysis of our safety signaling system shows that it takes on average a full 5 years for FDA to issue a label change after a safety signal is detected from FAERS. We know this because we track active safety signals from FAERS data and record the delays in FDA labeling changes. Why does the issue of label changes matter? Specifically because of the reasons Dr. Redberg cites – patients and physicians need to understand the real world risks. And in the current healthcare system they simply won’t know until FDA issues a label change.
So, is the fact that pharmaceutical companies fail to report 10% of serious and unexpected adverse events within the 15-day window a problem? Sure. But it’s a little problem.
The much bigger problem is that FDA has not fundamentally changed the way it handles drug safety in decades. Hundreds of millions of dollars and thousands of hours are wasted on expeditions seeking new solutions – Sentinel, OpenFDA, and social media monitoring – while the best and only system we have for monitoring drug safety issues today remains underfunded and underutilized. Which is why it takes FDA 7+ months to disclose important drug safety data and 5+ years to take meaningful safety action on those data. That’s not just a problem, it’s a public health disaster.
And what makes the situation truly obscene is that there are simple fixes that can happen today. FAERS is the most valuable asset we have to monitor post market drug safety. FDA needs to dramatically improve its existing FAERS data collection, dissemination, and review. Reporting of drug side effects needs to be easier. FAERS data should be publicly released in real-time. Healthcare providers and systems that are on the front lines of the drug safety battle need to be properly educated and incentivized to directly report serious adverse drug events to FDA. Other countries have found a way to improve their systems. So can we.
We need to stop being surprised and shocked by these studies and we need to start taking action. Healthcare policy on drug safety in America needs to change and it needs to change now.