The General Accounting Office says that the Food and Drug Administration isn't doing a very good job of protecting you from dangerous drugs. The FDA is supposed to monitor drugs, especially new ones, to see which can cause adverse reactions.
Here's how the system is supposed to work. When a drug causes an adverse reaction, the drug's manufacturer or the patient's doctor sends a report to the FDA, which enters it into its computer bank and begins monitoring it. If enough adverse reactions are reported, the FDA may require the manufacturer to put a warning label on the drug or withdraw it from the market.
Well, that sounds great, but it isn't what has been happening, GAO says. When GAO investigators checked 21 drugs and 2,200 adverse reaction reports, they found that 42 percent of the reports had been lost or misplaced by the FDA and had never reached the office that monitors adverse drug reactions. "Not only did many reports not get to the right division, but those that did took over five months to be entered into the system after they were received by FDA," said GAO. It added that FDA had a backlog of more than 7,000 adverse reaction reports that had not been checked.
Investigators cited several examples of dangerous reactions going undetected at FDA. GAO said it found one drug, for example, that had caused five adverse reactions involving hypoglycemia, an abnormally low blood sugar level that, in severe cases, may cause a coma or death. Yet, the FDA's computerized reporting system only listed one case of hypoglycemia caused by the drug. Alone, that single case was not enough to trigger FDA action, GAO said, but had FDA known about the other four cases, the drug probably would have been investigated.
In response, the FDA said it would change the way the reports are routed and possibly institute a toll-free number to receive adverse drug reports.