Integrated Drug Reviews at the US Food and Drug Administration—Legal Concerns and Knowledge Lost

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Health Policy, Regulatory Agencies, Drug Development


When the US Food and Drug Administration (FDA) approves a new drug, federal law requires public disclosure of the review documents prepared by scientific disciplines (eg, clinical, toxicology, statistical) during the review. These scientific reviews are published on the FDA Drugs@FDA website. In many cases, the data and analyses contained in those reviews have proved useful to public health.

A well-known example involves the Celecoxib Long-term Arthritis Safety Study (CLASS), which was published in 2000. The article reported that after long-term follow-up (6 months), treatment with celecoxib (Celebrex) “was associated with a lower incidence of symptomatic ulcers and ulcer complications combined”(p1247) compared with ibuprofen and diclofenac, thus offering support for the claim that celecoxib was a safer alternative to other nonsteroidal anti-inflammatory agents. The CLASS trial was funded by celecoxib’s manufacturer and authored by its employees and academic researchers who were also consultants to the manufacturer. However, independent researchers used the FDA’s publicly available scientific reviews to question the safety claim for celocoxib.