Pharma adverse event FDA reports are inadequate
pharmafile | February 5, 2015 | News story | Sales and Marketing | FDA, Gilead, Solvaldi, US Institute for Safe Medication Practices, pharma, sofosbuvir
Reports of adverse drug events submitted to the FDA by pharma firms are often incomplete and lacking in detail, a new study has found.
Researchers from the US Institute for Safe Medication Practices looked at 847,039 adverse event reports submitted via the FDA’s Adverse Event Reporting System (FAERS) over 2013-2014 and found that only 49.4% of serious reports submitted by drug manufacturers could be considered ‘reasonably complete’.
In contrast, 85% of serious reports submitted directly to the FDA from patients and healthcare workers were considered reasonably complete. Over 96% of the cases were collected and written by drug manufacturers.
The study classified a report as ‘reasonably complete’ if it contained the age and gender of the patients and the date of the adverse event – however 36% of the cases did not report the patient’s age and 44% gave no date.
“We can’t think of a good reason why the quality and completeness of serious adverse event reports collected by drug manufacturers is so much worse than those collected online at the FDA,” the authors say.
“To interact with a consumer or health professional about a serious adverse drug event without getting the patient’s age in 36% of the cases signals inadequate quality control and weak systems. Providing FDA feedback to companies submitting large numbers of reports with missing data is elementary quality assurance in the digital data era.”
In addition, the researchers raised concerns that many reports did not assume that the drug itself had caused the disease, which could confuse data, and that reporting for generic drugs and for events in children was very limited compared to branded drugs in adults – despite branded drugs often having comparatively small sales.
They also note that the FDA’s regulations for adverse event reports – which have not been revised since 2001 – were outdated for a time where the regulator is approving more and more drugs for small patient populations or restricted distribution schemes. These situations often require firms to be in constant contact with patients, leading to larger volumes of reports.
Sovaldi case study
The researchers used Gilead’s blockbuster hepatitis C drug Solvaldi (sofosbuvir) as a case study, noting that there were “concerns about the report quality from the manufacturer”.
Only 39% of adverse event reports for the drug were found to be reasonably complete, compared to 71% for Vertex Pharmaceuticals’ competing drug Incivek (telaprevir).
“With limited pre-approval testing and weak adverse event reporting, the safety profile of sofosbuvir remains uncertain,” they added. In response, Gilead has said that they adhere to industry standards and note that the reports they received from postmarketing sources often lacked detail.
The authors concluded: “It makes no sense for drug manufacturers to be required to spend millions collecting and submitting adverse drug event reports promptly when so many reports contribute little to the assessment of drug safety.”
“The FAERS system, for all its flaws, nevertheless remains the primary source for detecting new, serious adverse effects in approved drugs and identifying other risks to patients. Improving FAERS should be a higher priority.”
George Underwood
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