Are Regulatory Agencies Approving Drugs Too Quickly?

January 10, 2022

Study Reports Clinical Trials Were Missing for Newly Approved ADHD Medication


According to a new study, regulatory agencies approved extended-release methylphenidate, a drug used to treat adult ADHD, without reviewing all relevant clinical trial documents. In fact, the study demonstrated that the omitted trials accounted for a median of 45% of all data from participants in relevant studies. This finding raises a concern that regulators are not looking at all applicable trials when assessing the safety and efficacy of new pharmaceuticals. The research showed that six international regulators did not consistently list all relevant trials in public approval documents. These regulators include:

The study reported that only Health Canada explained why certain trials were omitted in their regulatory process. The authors acknowledge that it is possible that regulators excluded some trials from public documents after it was determined that they were not relevant or reliable data sources. However, they also noted that in the past, there have been instances in which regulators have failed to take relevant trials into consideration. The authors concluded that regulatory agencies should systematically search for trials themselves rather than relying on pharmaceutical companies to identify all relevant studies. They also suggest that drug companies should be held accountable if they fail to inform regulatory agencies about all available evidence.

Original Article

Original Study

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