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A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role

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Abstract

Background

The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds that the speed of innovation is sluggish, pressure for changes in the regulatory environment intensifies.

Methods

A systematic evaluation of the course of innovation in this industry was performed by applying a formula derived from economic market share theory to estimate the innovative contribution of each new molecular entity approved since 1938. The total and average innovation scores per year are described based on the therapeutic class, mechanism, and drug target. These data are compared to the number and percent of first-in-class drugs per year.

Results

The average annual score based on therapeutic class novelty has been declining; however, the therapeutic class total innovation score has been stable since the mid-1970s with occasional significant peaks of activity. While the average score based on mechanism or target experienced a decline beginning in the 1950s and 1960s, it has begun to rise since the early 1990s. Notably, the total innovation score has steadily increased since the 1970s. These variations closely parallel the number of first-in-class drugs approved on an annual basis.

Conclusions

While the reasons underlying these activities are likely complex, there is a temporal association between regulatory efforts to expedite drug development and approval. These findings should be considered when considering future incentivizing regulations and policies.

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Funding

This study did not receive external funding.

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Authors and Affiliations

  1. Advanced Academic Programs, Regulatory Science Program, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC, 20036, USA

    Mark Robberson MBEE & Christopher D. Breder MD, PhD

Authors
  1. Mark Robberson MBEE
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  2. Christopher D. Breder MD, PhD
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Corresponding author

Correspondence to Christopher D. Breder MD, PhD.

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Conflict of interest

While this work was completed while MR was an employee of miRagen Therapeutics and CDB was an employee of the US Food and Drug Administration, MR is currently an employee of Viveve Medical, Inc., and CDB is an employee of Sunovian Pharmaceuticals, Inc. The opinions in this paper represent those of the authors and not necessarily those of the FDA or any of their places of employment.

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Robberson, M., Breder, C.D. A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role. Ther Innov Regul Sci 55, 262–269 (2021). https://doi.org/10.1007/s43441-020-00210-7

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