The drug development and approval process is about much more than the final “okay”

Tina Stow
Tina Stow August 24, 2015

The drug development and approval process is about much more than the final “okay”.

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A recent Forbes story not only presents an oddly limited look at the U.S.’s drug development process, it also sends a misleading message to America’s patients and health care professionals.

“The FDA Is Basically Approving Everything. Here's The Data To Prove It,” the story headlines. But when you read further, the piece’s thin thesis falls apart – mainly because it only looks at one, final moment in the drug development process: the approvals themselves.

Were a reader to open the aperture to include the entire drug development and approval process, they would find that the data – and the story – change dramatically.Biopharmaceutical_Research_Development_Process

One reason is that the cited data do not include the thousands – or even millions – of molecules and investigational drugs studied that never make it into the FDA review pipeline, including those that go through phase 1, 2 or 3 clinical studies but fail for safety or efficacy reasons (and thus the company never submits a new drug application to the FDA). In research for treatments for Alzheimer’s disease over the past 16 years, for example, only four new medicines have been approved for Alzheimer’s out of 123 treatment attempts that were tested in clinical studies. That’s a 3 percent approval rate.

But failure doesn’t stop the continued search for cures. That is because new treatments approved by 2025 that delay the onset of Alzheimer’s by five years would reduce the number of people with the disease by approximately 40 percent and cost for care of patients by $367 billion a year by 2050.

A second nuance in recent drug development is also missing from Forbes’s account. And that is that – thanks to the Prescription Drug User Fee Act (PDUFA) and recent advances in regulatory sciences – the FDA, patients and drug developers are better at communicating prior to and during the drug review phase. This communication extends to a structured evaluation of benefits and risks leading to higher first cycle approval rates, which allows FDA to focus its resources on protecting and advancing the public health, rather than second cycle reviews.

The biopharmaceutical industry invests more in research and development than any other industry in the world. To understand why and how, one needs to look at the entire R&D process.

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Topics: Medicines in Development, Research and Development, FDA, Clinical Trials, PDUFA