Examining Changes to FDA Approval, Regulation of Pharmaceuticals Over 4 Decades



Media advisory: To contact corresponding author Jonathan J. Darrow, S.J.D., J.D., M.B.A., email Elaine St. Peter at estpeter@bwh.harvard.edu. The full study and editorial are linked to this news release.

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Bottom Line: Publicly available and Food and Drug Administration (FDA) data were used in this observational study to describe the number and types of prescription drugs approved from 1983 to 2018 and how the approval process and regulation of drugs changed during this period. Approvals of new generic drugs and biologics increased over this time, as the median annual number of generic drugs approved was 284 from 1985 to 2012 and 588 from 2013 to 2018. The authors report that the average annual number of new drug approvals, including biologics, was 34 from 1990-1999, decreasing to 25 from 2000-2009, and increasing to 41 from 2010-2018. There has been an expansion in the number of expedited development and approval programs since 1983, while the amount of evidence used for approvals has decreased. The proportion of new approvals supported by at least two pivotal trials declined from 81% in 1995-1997 to 53% in 2015-2017. The amount of industry-paid user fees collected, funds used to accelerate review times, have increased to an annual average of $820 million in 2013-2017. FDA drug review times declined from more than three years in 1983 to less than one year in 2017. A limitation of the study is the difficulty in comparing the size of the clinical benefit of drugs across different indications and populations.

Authors: Jonathan J. Darrow, S.J.D., J.D., M.B.A., of Brigham and Women’s Hospital, Harvard Medical School, Boston, and coauthors.



Editor’s Note: The article includes funding/support disclosures. Please see the article for additional information, including other authors, author contributions and affiliations, financial disclosures, funding and support, etc.

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