Accelerated approval of drugs: ethics versus efficacy.

Abstract

To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile. This observational study was carried out between January 2016 and June 2016. The details of the time taken to approve drugs were collected from the official website of United States Food and Drug Administration (FDA). The average time taken to review drugs and take a decision following the review were ascertained from the FDA's annual release of novel drugs from 2011 to 2015. Information on adverse drug reactions noted after approval was gathered from the FDA Drug Safety Communication and FDA Adverse Event Reporting System (FAERS). In the last five years, 166 products were approved by expedited review. Of these, 45 (27.1%) did not meet the stringent criteria framed for expedited review. Reports of serious adverse event alerts were submitted for 79 (47.5%) of the 166 molecules. Fourteen (8.4%) drugs were associated with inducing severe autoimmune disorders. It can be observed that a lower average time of review is positively correlated with a greater number of adverse events (p<0.05). Thirty-seven (45.7%) of the molecules failed to be of any benefit in the treatment scenario. Drug approval by accelerated review should be stringent. Beneficence and non-maleficence are applicable to the global population, and should apply equally to subjects involved in trials. Approving drugs on the basis of trivial evidence is non-scientific and absolutely unethical, since it can lead to clinical failure and produce serious adverse events.