Moderating Innovation to Equipoise Risk

While his focus was on balancing personal freedom versus state power, 18th century political theorist John Locke’s following thought could arguably be applied to current pharmaceutical regulators’ attitudes when he famously declared, “the end of law is not to abolish or restrain, but to preserve and enlarge freedom” (1). While those currently reading sundry observations listed on an FDA Form 483 will feel significantly “retrained”, the intent of regulations is to allow a fair and equal access to a playing field that encourages participation by as many novel and creative solutions, as applied to disease states, as humanly possible.

Anshul Mangal, president and general counsel of Project Farma, stated, “The FDA aims to streamline the approval process for platform technologies, leveraging the Omnibus Appropriations Act of 2023 to facilitate referencing prior manufacturing data during the review process. Encouraging more gene therapies to seek accelerated approval and improving harmonization with global regulators, especially for rare diseases will be of critical importance. Additionally, the FDA is launching the START pilot to support small companies developing gene therapies for rare pediatric diseases, drawing lessons from the COVID-era Project Warp Speed. If the pilot is successful, it could become a permanent program dedicated to supporting the mission. The agency’s continued support will be paramount in propelling the therapeutic pipeline forward and teeing up the sector for another year of groundbreaking achievements” (2).

As innovation accelerates, pharmaceutical regulators continue their path of maintaining proportion, balance, and restraint. Please enjoy the following articles which, in many ways, fully embody that ethos.

References

1. Locke, J. Second Treatise of Civil Government 1690.
2. Mangal, A. JP Morgan Healthcare Conference Summary. LinkedIn (accessed Jan. 18, 2023).

About the author

Chris Spivey is editorial director of Pharmaceutical Technology®.

Article details

Pharmaceutical Technology/Pharmaceutical Technology Europe
Regulating Innovation, Quality, and Risk eBook
Issue 1

Page 4
January 2024

Citation

When referring to this article, please cite it as Spivey, C. Moderating Innovation to Equipoise Risk. Pharmaceutical Technology/Pharmaceutical Technology Europe, Regulating Innovation, Quality, and Risk eBook January 2024.