Hazards of the FDA.

ITEM: Over-the-counter drugs aren't risk-free, the April 13 HealthDay reported. Too much acetaminophen, the active ingredient in many medicines, "can lead to liver damage, and even death, the U.S. Food and Drug Administration warns. So the agency advises consumers to avoid taking multiple medications that contain the same active ingredient together ..." Accordingly, the "FDA has launched an educational campaign to promote the safe use of over-the-counter pain relievers and fever reducers."

BETWEEN THE LINES: This seemingly benign suggestion just hints at the FDA's influence. The agency regulates products worth a staggering $1 trillion annually, about 25 cents of every consumer dollar, notes former FDA official Henry I. Miller.

Others pay for mistakes generated by the agency's risk-adverse bureaucrats, who would rather say "no" than allow a drug on the market that might distress someone, somewhere, sometime. For example, while the FDA dithered over approving the drug Interleukin-2 (already approved in at least nine other countries), some 25,000 Americans died of kidney cancer. Commented the president of the American Kidney Cancer Association, Eugene Schoenfeld: "IL-2 is one of the worst examples of FDA regulation known to man." That's more the rule than the exception. How many more people have died or suffered waiting for drug approval by the FDA than have been saved by its prevention of unsafe or ineffective drugs'?

FDA-induced delays obviously add to costs. The time needed to bring a drug to the market has more than doubled since 1964, from 6.5 to some 15 years, writes Hoover Institution researcher Henry Miller. And the development cost for a new drug jumped from $138 million to over $800 million between 1970 and 2003, according to the Tufts University Center for the Study of Drug Development.