Study Calculates Value of Time Lost in FDA Approval Process

Tomas Philipson

Tomas Philipson

The Manhattan Institute’s latest report, “Cost of Caution: The Impact on Patients of Delayed Drug Approvals,” looks at the unreasonably cautious FDA regulatory process, and demonstrates that the cost of slowly bringing new medicines to market most significantly effect the patients that need them. The report, released on Monday, was authored by Tomas Philipson, PhD (pictured above), and Eric Sun, MD, PhD.

The study examined three classes of approved and marketed drugs of significant medical value: highly active antiretroviral treatment (HAART), an HIV/AIDS drug; Herceptin, a breast cancer treatment; and Rituxan, a treatment for non-Hodgkin’s lymphoma.

Applying calculations developed specifically for this analysis, the authors quantified the cost of these three life saving medicines not being available sooner: The value of offering HAART one year earlier was found to be $19 billion; access to Herceptin a year earlier would have been worth $8 billion; and providing Rituxan a year earlier would have been worth $310 million.

Philipson – the winner of Research!America’s Garfield award in 2007 – and Sun also determined that drug companies would have increased their profits by $4.9 billion if these drugs would have reached market a year earlier. The authors effectively translate the value of a speedier review into dollars and highlight that a streamlined FDA regulatory process benefits the patients far more than the drug companies.

In order to increase the speed at which the FDA regulates drug development and certification, this report recommends the following reforms:

• Allowing stipends to be paid to clinical-trial volunteers in hopes of reducing the shortage of medically qualified and available participants

• Relying on biomarkers such as genetic tests, white blood cell counts or measures of cholesterol levels to estimate the likelihood of a treatment’s success before completion of full clinical trials

• Offering FDA regulators performance incentives in order to expedite the identification of promising new treatments

• Establishing an ombudsman to officially review the impact of FDA regulations and practices on drug development timelines

This study can be accessed online at

- Ryan Davison

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