Drug Testing May Become More Expensive

Regulation Policy

Drug Testing May Become More Expensive

Critics say a Food and Drug Administration regulation proposed in 1994 and expected to take effect soon will greatly increase the cost of clinical trials for new drugs. The new rule would require clinical researchers to report drug side effects more quickly and to presume that a drug undergoing trials is to blame any time a patient gets sick or sicker during a study.

Medical researchers at the Johns Hopkins University Center for Clincal Trials carefully compared two clincal trials, one under the old reporting requirements and one under the new rules.

They concluded the FDA's changes would increase the cost per patient and the paperwork generated per patient.

They estimated the costs of a single trial would be increased by $24 million -- with no comparable benefit for patients.

In 1997 Congress passed and the president signed a bill to speed up the FDA's drug approval process and reduce the cost of developing new drugs-- which had increased from an average of $359 million in 1990 to $500 million in 1993.

But some of the changes in the bill are cosmetic only, charge critics. For instance, the new law permits -- but doesn't require -- the FDA to approve a drug for marketing on the basis of a single clinical trial. The FDA could have done that under existing rules, but has chosen not to. The number of trials performed to support approval of a new drug currently averages more than 40.

Source: Henry I. Miller (Hoover Institution), "Still Hazardous to Your Health," Consumers' Research, January 1998.

For more on Henry I. Miller
http://www-hoover.stanford.edu/BIOS/miller_h.html

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