One of Joseph Schumpeter’s profound subtle points in the key chapter 7 of Capitalism, Socialism and Democracy is that the kind of thinking and rules that aim for optimization, restrict the kind of creative, inspired thinking or improvisational pivoting that results in the greatest and fastest progress and flourishing. (My interpretation of Schumpeter.)
Great leaps forward have tended to originate from small startups. But increasing the size, length, and costs of mandated clinical trials, as the F.D.A. is doing with “Project Optimus,” will make it harder for small startups to survive, let alone flourish.
(p. B2) For years, Food and Drug Administration officials have expressed concern that cancer drug doses are often too high, leading to unnecessary side effects. An FDA program launched in 2021, Project Optimus, requires companies to re-examine how they set doses of cancer treatments.
This typically involves larger clinical trials to test doses to find those that optimally balance safety and efficacy. Entrepreneurs support the aim, but some fear the initiative will add time and cost to drug development, putting startups at a further disadvantage to larger competitors.
“I don’t think anybody disagrees with the idea that we’re trying to find the best thing for the patient,” said David Bearss, chief executive of biotechnology startup Halia Therapeutics. “I hope it doesn’t have unintended consequences of actually suppressing innovation.”
. . .
Because Project Optimus is still relatively new it will take a while for its full impact to be known. But it will likely add six to 12 months to the drug-development process, said Tara Raghavan, a pharmaceutical patent lawyer and partner with law firm Benesch Friedlander Coplan & Aronoff.
For the full story, see:
(Note: ellipsis added.)
(Note: the online version of the story has the date August 29, 2024, and has the title “FDA Wants Safer Cancer Drugs, but Some Startups Fear Unintended Consequences.”)
In my comments I mention Schumpeter’s chapter 7 on creative destruction that can be found in his messy, inspired masterpiece:
Schumpeter, Joseph A. Capitalism, Socialism and Democracy. 3rd ed. New York: Harper and Row, 1950.