Accelerated approval of drugs: ethics versus efficacy

Abstract

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.

Fast Track Usa Regulatory Approval for Drugs to Treat Emerging Infectious Diseases

“…Drug development and review processes had been streamlined in a manner that permits for treatments demonstrating early promise to attain patients faster [29]. While analyzing new molecules, not only must their efficacy be cross-checking with safety issues, however, ethical characteristics should also be taken into consideration earlier than fast track designation is granted [30]. Fast tracks are often exhilarating, however, accelerating too fast can motive a crash [31].…”

Brief Overview of Approaches and Challenges in New Antibiotic Development: A Focus On Drug Repurposing

“…Critics argue that expedited approval has been granted for drugs that did not meet qualifying criteria (i.e. life-threatening/serious, urgent unmet medical need, breakthrough) and have also pointed out a lack of oversight (or enforcement) of post-marketing surveillance studies for approvals based on surrogate markers (Herper;Frank et al, 2014;Kim and Prasad, 2016;Chary and Pandian, 2017;Mostaghim et al, 2017). Others have questioned how safety and efficacy can adequately be assessed from such limited data (Light and Lexchin, 2015).…”

Evidence-based pharmacotherapy.

“…The approval process can be abbreviated when drugs are evaluated under expedited review, but concerns regarding assessments of efficacy and safety often arise (Chary & Pandian, 2017;Moore & Furberg, 2014). Drugs considered under expedited approval are more likely to use surrogate outcome measures in trials of short duration, some shorter than 6 weeks (Downing et al, 2014), thereby risking underestimating the incidence of adverse events that may require longer latency to appear.…”