One in every three new drugs triggers side effects discovered only after Food and Drug Administration approval, new data reveals. And that statistic begs a crucial question: How can we really ensure patients’ safety in an age of sophisticated medications and accelerated approval processes?
Published in the Journal of the American Medical Association, the study surveys drugs approved by the FDA between 2001 and 2010. Findings include:
- Of 222 novel therapeutics, 71 prompted a safety event after approval.
- Post-market safety events were more frequent among:
- Medications for psychiatric disease
- Drugs receiving accelerated approval
- Drugs whose approval fell near the regulatory deadline.
FDA responded to these safety events by:
- Withdrawing the drug due to safety concerns (3 drugs)
- Issuing black-box warnings (61 drugs)
- Issuing safety communications for physicians and patients (59 drugs).
Implications for Patients and Policymakers
Critics point to the limited size and duration of some clinical trials. Others argue that trial facilities “cherry pick” participants who do not collectively represent the real-world patient population. Yet few patients would argue for slower approval processes or clinical trials procedures that delay access to new treatments.
Likewise, few can argue this data’s implications for pharmacovigilance – post-market monitoring systems that allow patients and physicians to report adverse events caused by a new drug. As the study’s authors explain, “Postmarket safety events are common after FDA approval, highlighting the importance of continuous monitoring of the safety of novel therapeutics throughout their life cycle.”
Pharmacovigilance has been central in policy debates around biological medicines in particular. The importance of being able to quickly, accurately report adverse events, for example, was a key argument for biosimilars and their biologic reference products having distinct names.
Inaccurate or incomplete reporting can cripple regulatory agencies’ efforts to collect, respond to and communicate details on drugs’ safety post approval. New research on the European Union’s track and trace efforts, for instance, show that underreporting of adverse in some EU countries is a serious problem. The study’s authors suggest several possible causes: lack of awareness of adverse reactions, complexity in terms of the reporting process, fear of litigation and/or failure, and budgetary limitations. The study suggests awareness programs to increase patients and health care professionals’ understanding of medication safety and public health.
A lead author of the Journal of the American Medical Association study also highlighted the importance of ongoing efforts, telling CBS News that “identifying these events is hard work.” As he explained, the job of keeping patients safe “doesn’t stop at [FDA] approval.”