(Many deaths from slow approvals are less threatening to bureaucrats than a few deaths from mistaken approvals)
Past criticism of the U.S. Food and Drug Administration centred mostly on what arguably remains the agency's most important shortcoming: the delay and escalating expense of getting drugs through the development pipeline and into the market, says Henry I. Miller, a senior fellow with the National Centre for Policy Analysis. The development of drugs in the United States is in real trouble, says Miller:
Costs to bring an average drug to market have skyrocketed and now exceed $800 million.
Fewer than one-in-three approved drugs ever recoup their development costs.
Ominously, the number of applications to the FDA to approve the marketing of new drugs has decreased steadily since 1995.
Although drug and biotech companies spend more than $30 billion a year on research, regulators are continually raising the bar for approval and the number of drugs approved by the FDA each year has fallen.
One reason is that FDA reviewers are conditioned to be risk-averse: As former FDA General Counsel Peter Barton Hutt has observed, "FDA employees have been praised only for refusing to approve a new drug, not for making a courageous judgment to approve a new drug that has in fact helped patients and advanced the public health."
As a result, regulators, nearly phobic about risks, make decisions defensively, at the cost of denying patients drugs that can cure diseases and save lives. They tend to delay or reject new products of all sorts, from fat substitutes to vaccines to painkillers. That's bad for public health and for consumers' freedom to choose, says Miller.
Henry I. Miller, Patients' Right to Choose,
National Centre for Policy Analysis, Brief Analysis No. 536, October 25, 2005.
For text: http://www.ncpa.org/pub/ba/ba536/
For more on Health: http://www.ncpa.org/iss/hea/
FMF Policy Bulletin/ 1 November 2005