Too Much FDA Intervention Equals Too Few Drugs



FDA-300x225The Food and Drug Administration reports that the U.S. has shortages of 246 drugs — a record number. Oncologists and anesthesiologists are increasingly concerned, with more than 90 percent of the latter saying they have experienced shortages.

In a September 2010 survey, by the Institute for Safe Medication Practices, one in four respondents reported that shortages had caused medical errors during the previous year. More alarmingly, one in five reported adverse patient outcomes.

Doctors have had to respond to shortages by substituting drugs that are not as effective, and by making wrenching decisions about which patients get access to which drugs. The consequences can be dire. Cytarabine is a drug that is effective in the treatment of leukemia and lymphoma — but it has to be administered quickly, and it’s one of the drugs in short supply. One middle-aged woman reportedly fell into a persistent vegetative state because anesthesiologists ran out of epinephrine. There are also anecdotal reports of “gray markets,” which charge high prices for the affected drugs.

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