31 / 32
Page 67
Notes:
conferenceseries
.com
Volume 4
Toxicology: Open Access
ISSN: 2476-2067
Toxicology Congress 2018
March 12-14, 2018
March 12-14, 2018 Singapore
14
th
World Congress on
Toxicology and Pharmacology
Drug development: Ethics versus efficacy
Kumaresh Pandian and Krishnan V
Saveetha Medical College, India
Objective:
To analyze the post-marketing status of molecules approved through the expedited review process in the last quintile.
Methods:
The 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 on the United States Food and Drug Administration (FDA). The average
time taken to review drugs and take a decision following the review was ascertained from the FDA’s annual release of novel
drugs from 2011 to 2015. Information on adverse drug reaction noted after approval was gathered from FDA Drug Safety
Communication and FDA Adverse Event Reporting System (FAERS).
Results:
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.
14 (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) and 37 (45.7%) of the molecules failed to be
of any treatment scenario.
Conclusion:
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.
Biography
Kumaresh Pandian is currently pursuing his MBBS from Saveetha Medical College, SIMAT. His area or research is drug development under the mentorship of Dr.
V Krishnan, Department of Pharmacology, SIMATS in India.
kumaresh_90@ymail.comKumaresh Pandian et al., Toxicol Open Access 2018, Volume 4
DOI: 10.4172/2476-2067-C1-005