NCPA - National Center for Policy Analysis

Food and Drug Administration Approval Times Vary Widely

April 30, 2014

There is wide variation in drug approval times within different sectors of the Food and Drug Administration (FDA), according to a new report from Joseph A. DiMasi, Christopher-Paul Milne and Alex Tabarrok for the Manhattan Institute.

As the agency responsible for approving new pharmaceutical drugs as "safe and effective," the FDA's Center for Drug Evaluation and Research (CDER) is split into multiple divisions, based upon the medical sector at issue. For example, one FDA division focuses on drugs that affect a person's metabolism, while another division is responsible for regulating anti-infective agents.

Looking at drug approvals from 2004 to 2012 across 12 divisions (representing 80 percent of all drug approvals during the period), the researchers found that these divisions -- and there are more than a dozen of them -- have markedly different performance times.

  • The Oncology and Anti-Viral sectors each took less than 200 days to approve a drug, the fastest divisions within the FDA.
  • The Neurology division, on the other hand, took 600 days to approve a drug. Neurology covers drugs for Alzheimer's disease, strokes, multiple sclerosis and Parkinson's disease.

The authors explain that these differences cannot be chalked up to differences between the drugs themselves -- complexity of the drugs was not the reason for the variation, nor was workload among the divisions. The Oncology and Anti-Viral divisions actually had higher workloads than the units, such as Neurology, that performed below-average.

  • Oncology is 60 percent faster in approving drugs than are all of the other divisions taken together.
  • Slicing that performance gap in half would reduce the cost of developing a new drug by a whopping $46 million, adding up to $874 million per year, according to the study.

Lower development costs mean that companies have greater incentives to develop new drugs, ultimately improving and saving the lives of patients.

Source: Joseph A. DiMasi, Christopher-Paul Milne and Alex Tabarrok, "An FDA Report Card: Wide Variance in Performance Found Among Agency's Drug Review Divisions," Manhattan Institute, April 2014.


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