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Just thirty percent of FDA regulations are supported by research

Drug safety is dependent on monitoring a drug's security after it is made available to patients (a process known as post-marketing pharmacovigilance).

Less than one-third of the regulatory decisions made by the US Food and Drug Administration (FDA) are backed by published research findings or public assessments, according to a study that was just published in The BMJ.

The researchers asserted that their findings, which were based on an analysis of drug safety signals identified by the FDA from 2008 to 2019, demonstrate that the FDA is either acting on information that has not been made public or that when potential safety signals are identified, more thorough safety evaluations may be necessary.

Through its Adverse Event Reporting System, the US Food and Drug Administration (FDA) receives approximately two million reports of adverse events each year (FAERS). For the purpose of determining whether or whether regulatory action is required, the FDA assesses all potential safety signals. According to the FDA Amendments Act of 2007, the FDA must disseminate quarterly updates on safety signals from FAERS so that the public can review them and gain more knowledge about this pharmacovigilance system.

Consequently, a group of US academics made the decision to examine safety signals found in the FAERS database. They questioned how frequently these signals led to regulatory actions as well as whether any other studies had supported them. They discovered that between 2008 and 2019, the FDA reported 603 potential safety signals from the FAERS, of which roughly 70% were resolved and over 80% resulted in regulatory action, frequently modifications to drug labelling. A separate in-depth investigation of 82 potential safety signals reported in 201415 revealed that for around 75% of the signals, at least one pertinent study had been identified in the literature; nevertheless, the majority of these studies were case reports or case series.

However, according to the Sentinel Initiative, only 30% of regulatory actions were supported by at least one pertinent published research study, and none of the regulatory actions were supported by a public assessment.

These findings are based on observation, and the researchers are aware of certain significant restrictions.
For instance, they were unable to take into account unpublished studies or other data that was available to the agency but not made publicly available, or they were unable to assess regulatory actions taken in other nations in response to these safety signals, which may have informed the FDA’s actions.

Still, they claim that these results highlight the continued need for thorough post-market safety studies to strengthen the quality of evidence available at the time of regulatory action, as well as the importance of ongoing efforts to leverage real-world data sources to evaluate and resolve signals identified from the FAERS and support FDA regulatory decisions. To lessen harm and maintain the public’s confidence in medicines, experts contend in a related editorial that regulators should make all information supporting their responses to drug safety signals public.

They write that the covid-19 epidemic has revealed the conflict between regulatory decisions and the public’s right to know about significant hazards related to medical interventions. In terms of medicine safety more generally, there is a similar tension.

Authors conclude that while safety signals are a crucial first step, reducing the harm caused by medications would require radical transparency about the information that is now available and the foundation for regulatory judgements, as well as an adequate follow-up to ensure safer use.


Just thirty percent of FDA regulations are supported by research
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