"Conditional approval" draws dissent
Could new drugs be less expensively and more rapidly brought to market if premarket clinical trials for proof of effectiveness were scaled back?
That has been the drumbeat from former FDA commissioner Andrew von Eschenbach, but former Pfizer R&D president John LaMattina disagrees.
In a Forbes online post, LaMattina said that the proposal would save money and get drugs to market faster, but at a cost of increased safety risks.
Now head of the Manhattan Institute's Project FDA initiative, von Eschenbach insists that reducing Phase 3 requirements “would be particularly effective for some chronic diseases.”
But LaMattina, who is also a senior partner at PureTech Ventures, writes that this “would likely result in more drug recalls and more liability costs.”Phase 3 trials are needed to understand a drug's risk/benefit profile before it hits the market, LaMattina says. “The FDA does a good job in evaluating the risks and benefits for new drugs under the current paradigm,” he concludes.