NEW YORK According to a report by CNN, each year doctors write about 65 million prescriptions for drugs not yet approved by the Food and Drug Administration.
“There’s a regulatory black hole that makes it possible for the pharmaceutical companies to get these drugs to the stores that sell them without the FDA being able to monitor it,” said Rep. Ed Markey, a Democrat from Massachusetts.
The NDC number given to track a drug by the FDA through the approval process is the same number as the one pharmacies use to order the medications; the trick is the number is given to the drug before it is approved. Most doctors and pharmacists are not aware that they might be dispensing drugs not approved by the FDA.
An example of one of these drugs is quinine, which is approved for use against malaria, but was never approved for the treatment of leg cramps, which is was it was often used for.