Boston—New-medication approvals by the FDA have accelerated in recent years, according to a new study.
The review published in JAMA also notes that approvals of new generic drugs and biologics increased from the 1980s to 2018, with the median annual number of generic drugs, at 284 from 1985 to 2012, jumping up to 588 from 2013 to 2018.
Brigham and Women’s Hospital, Harvard Medical School–led authors report that, overall, the average annual number of new drug approvals, including biologics, was 34 from 1990 to 1999, decreasing to 25 from 2000 to 2009, and increasing to 41 from 2010 to 2018.
In addition, the study determined that, with an expansion in the number of expedited development and approval programs since 1983, the amount of evidence used for approvals has dropped. The authors point out that the proportion of new approvals supported by at least two pivotal trials fell from 81% in 1995–1997 to 53% in 2015–2017.
At the same time, the amount of industry-paid user fees collected—i.e., funds used to accelerate review times—rose to an annual average of $820 million in 2013–2017. The bottom line, according to the study, is that FDA drug-review times declined from more than 3 years in 1983 to less than 1 year in 2017.
“U.S. requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks,” the authors write. “A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.”
To reach its conclusions, the review looked at principal federal laws and FDA regulations (1962–2018) and FDA databases of approved new drugs (1984–2018), generic drugs (1970–2018), biologics (1984–2018), and vaccines (1998–2018); special development and approval programs (Orphan drug [1984–2018], Fast-Track [1988–2018], Priority Review and its predecessors [1984–2018], Accelerated Approval [1992–2018], and Breakthrough Therapy [2012–2018]); expanded access (2010–2017) and Risk Evaluation and Mitigation Strategies (2008–2018); and user fees paid to the FDA by industry (1993–2018).
“Over the last four decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged,” the authors conclude. “The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.”
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The review published in JAMA also notes that approvals of new generic drugs and biologics increased from the 1980s to 2018, with the median annual number of generic drugs, at 284 from 1985 to 2012, jumping up to 588 from 2013 to 2018.
Brigham and Women’s Hospital, Harvard Medical School–led authors report that, overall, the average annual number of new drug approvals, including biologics, was 34 from 1990 to 1999, decreasing to 25 from 2000 to 2009, and increasing to 41 from 2010 to 2018.
In addition, the study determined that, with an expansion in the number of expedited development and approval programs since 1983, the amount of evidence used for approvals has dropped. The authors point out that the proportion of new approvals supported by at least two pivotal trials fell from 81% in 1995–1997 to 53% in 2015–2017.
At the same time, the amount of industry-paid user fees collected—i.e., funds used to accelerate review times—rose to an annual average of $820 million in 2013–2017. The bottom line, according to the study, is that FDA drug-review times declined from more than 3 years in 1983 to less than 1 year in 2017.
“U.S. requires testing of new drugs before approval to ensure that they provide a well-defined benefit that is commensurate with their risks,” the authors write. “A major challenge for the US Food and Drug Administration (FDA) is to achieve an appropriate balance between rigorous testing and the need for timely approval of drugs that have benefits that outweigh their risks.”
To reach its conclusions, the review looked at principal federal laws and FDA regulations (1962–2018) and FDA databases of approved new drugs (1984–2018), generic drugs (1970–2018), biologics (1984–2018), and vaccines (1998–2018); special development and approval programs (Orphan drug [1984–2018], Fast-Track [1988–2018], Priority Review and its predecessors [1984–2018], Accelerated Approval [1992–2018], and Breakthrough Therapy [2012–2018]); expanded access (2010–2017) and Risk Evaluation and Mitigation Strategies (2008–2018); and user fees paid to the FDA by industry (1993–2018).
“Over the last four decades, the approval and regulation processes for pharmaceutical agents have evolved and increased in complexity as special programs have been added and as the use of surrogate measures has been encouraged,” the authors conclude. “The FDA funding needed to implement and manage these programs has been addressed by expanding industry-paid user fees. The FDA has increasingly accepted less data and more surrogate measures, and has shortened its review times.”
« Click here to return to Weekly News Update.
