Dublin Core PKP Metadata Items Metadata for this Document
 
1. Title Title of document Accelerated approval of drugs: ethics versus efficacy
 
2. Creator Author's name, affiliation, country Krishnan V Chary; Saveetha Medical College, Thandalam, Chennai, Tamil Nadu, 602 105, India
 
3. Subject Discipline(s)
 
3. Subject Keyword(s)
 
4. Description Abstract Objective

To analyse the post-marketing status of molecules approved through the expedited review process in the last quintile


Methods

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).


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. 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.


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.

 
5. Publisher Organizing agency, location Forum for Medical Ethics Society
 
6. Contributor Sponsor(s)
 
7. Date (YYYY-MM-DD) 2017-06-27
 
8. Type Status & genre
 
8. Type Type
 
9. Format File format HTML , PDF
 
10. Identifier Uniform Resource Identifier http://www.issuesinmedicalethics.org/articles/accelerated-approval-of-drugs-ethics-versus-efficacy/
 
11. Source Title; vol., no. (year) Indian Journal of Medical Ethics;: The right to life
 
12. Language English=en en
 
13. Relation Supp. Files
 
14. Coverage Geo-spatial location, chronological period, research sample (gender, age, etc.)
 
15. Rights Copyright and permissions

All articles published in IJME are available on its website free of charge. The copyright for published material belongs to IJME/FMES. IJME freely permits the reprint (or reproduction on a website) of articles from the journal, as long as this is for non-commercial use and appropriate credit is given to the author and the journal and publication details are mentioned. The commercial use of our content can be made only after obtaining permission from and on payment to IJME. This is intended to support production of the journal.