Drugmaker Floods FDA With Patient Death Reports

Drugmaker Floods FDA With Patient Death Reports

October 7th, 2011 // 1:45 pm @ jmpickett

Two years ago, the FDA inspected Actelion Pharmaceuticals offices and found the drugmaker failed to follow proper procedures for reporting adverse events and, as a result, about 3,500 patient deaths were never filed with the agency. A follow-up warning letter was issued and, in response, Actelion went to the other extreme – every adverse event mentioning ‘death’ was effectively dumped with the FDA, regardless of whether there was a reasonable likelihood that its drug was involved.

How many reports are we talking about? A mere 4,133 for its Tracleer med, which is used to treat pulmonary aterial hypertension, and they went back five years. In fact, the reports contained little or no useful information about the events, according to the Institute for Safe Medicines Practices. Actelion also submitted another 228 patient death reports for its other PAH drug, Ventavis. And United Therapeutics followed suit by submitted 458 reports for its own Remodulin PAH drug.

At the time the FDA chastised Actelion, the drugmaker argued that death reports were submitted as line listings in periodic safety updates, there was a lack of responsiveness by healthcare providers to requests for info about deaths and disease progression in patients treated with Tracleeer leads to death. But the agency maintained Actelion assumed that patient deaths were not caused by the drug and did not properly follow up with investigations (back story). Now, the non-profit charges the drugmaker has unnecessarily made it difficult for the agency to sort out the reports. We have asked Actelion for a comment and will update you accordingly.

The net result is that the FDA reporting system “is being flooded with low quality, uninformative reports of patient deaths in which any drug role was undetermined,” according to the non-profit watchdog, which is calling for new industry guidelines for investigating and reporting patient deaths that are learned through marketing or patient programs. “Not only do the reports have no value in postmarket safety surveillance, they obstruct the assessment of genuine potential threats to the public health by diminishing report quality.”

Thomas Moore, who heads drug safety research at ISMP, also told us that “it is counterproductive if the result of the FDA enforcement is that companies simply send thousands of vague and uninformative reports into the FDA system for death cases where no one knows whether the drug played a role or not. The FDA needs to think about how manufacturers should investigate and report when they learn of patient deaths not through consumer or physician complaint, but incidentally through direct patient contact for marketing or other purposes.”

“In another case, Roche had to report hundreds of deaths for 85-to-95 year old patients on Boniva, (an osteoporsis drug), because reminder postcards and e-mails were returned indicating that the patient had died. There is no point in bloating AERS (the Adverse Events Reporting System) with thousands of vague, uninformative case reports where any drug role was unknown, undetermined or not investigated”

Source: Pharmalot