Drug Safety -- What's Your Standard?

Tons of press coverage for this morning's Government Accountability Office report criticizing the Food and Drug Administration's safety system. Much of the critique hinged on three easily rectifiable problems: a lack of independence for the too small safety office (its paltry staff is currently housed within the new drug approval division); a lousy post-marketing monitoring system; and a lack of resources. In other words, the FDA cannot fix its own problems. Only Congress, which controls the purse strings and the agency's legislative authority, has that power.

Bottom line: If you're worried about drug safety, remember to vote this November.

I was intrigued by one comment, though, which was contained in the Washington Post coverage. Caroline Loew, senior vice president of the Pharmaceutical Research and Manufacturers of America (PhRMA, the industry trade group), defended the FDA's record by saying only 3 percent of all aproved drugs were later withdrawn for safety reasons.

Hmmm. What other industry is proud of a 3 percent defective rate? Automakers or electronics equipment manufacturers, who expect 6 sigma quality from their suppliers? (That's 3.4 errors per million or 3.4 ten-thousandths of a percent.) Your favorite local restaurant? (Hey, you can't shut us down. Only 3 percent of our customers got food poisoning last week). How about the kid who mows the lawn? Okay, if he gets 97 percent of the grass, I'm satisfied.