FDA Fails to Stop Sales of Unapproved Drugs

October 2007

Attention prescription drug users – there is a serious loophole in the Food and Drug Administration (FDA) drug approval process that allows doctors to write 65 million prescriptions a year for unapproved medication. Many of these unapproved drugs could have dangerous side effects that may result in adverse events or even worse, death.

When manufacturers submit a drug for FDA approval, they are given a 10-digit code that appears the same for both approved and unapproved drugs. Consumers, doctors, and pharmacists are often unaware of a drug’s approval status. According to a recent survey, nine out of 10 pharmacists were not aware that they could potentially be dispensing unapproved medicine.

The FDA has only recently begun to crack down on this error in the system. Last year, medication containing quinine was pulled from the market. Quinine has been linked to birth defects, hearing impairment, fluid build up in the lungs, paralysis, and more. Because quinine was in unapproved medication dispensed by pharmacies, the FDA received reports of 665 related adverse events, including 93 deaths.