Kill the FDA — Before It Kills Again

The U.S. Food and Drug Administration’s (FDA) drug approval procedures need to be reexamined, says Nick Gillespie, editor-in-chief of Reason.com.

The FDA takes a very conservative approach to granting approval for drugs, meaning that plenty of medicines never make it to the market.

– FDA procedures are incredibly time-intensive, and new drugs take 10 to 15 years to finally reach the market. The cost? $800 million, on average.

– A study by the Government Accountability Office (GAO) in 2006 found that while drug research and development increased by 147 percent, the number of new drug applications submitted between 1993 and 2004 increased by only 38 percent.

– Why? The GAO cited numerous factors, including “uncertainty regarding regulatory standards for determining whether a drug should be approved,” making companies more likely to improve their existing drugs rather than create new ones.

Today, drugs can be tailored to fit an individual’s specific needs and genetics. Oncologists, for example, can match a specific treatment to the biochemistry of a patient’s cancer. The FDA approval process, on the other hand, looks at the average response to a drug, not at the opportunities for success in individual cases.

Peter Huber of the Manhattan Institute says that drug-approval procedures need to be completely revamped. “The search for one-dimensional, very simple correlations — one drug, one clinical effect in all patients — is horrendously obsolete. The FDA should allow other drugs aimed at other complex diseases to follow the trail that HIV and, to a lesser extent, cancer drugs have already blazed.”

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