Good question, how does this happen and why doesn't the FDA make a public list available? BD
Many doctors and pharmacists seem unaware of this wrinkle in the approval process. "I think most doctors, maybe all doctors, assume that if a medication is on the market, it has been approved by the FDA, it must be safe and effective," American Medical Association President Ron Davis said.
Every year, doctors write approximately 65 million prescriptions for drugs not yet approved by the U.S. Food and Drug Administration, the federal agency that regulates prescription drugs. Autor Deborah Autor of the FDA says it is doing everything it can to target unapproved drugs that might be dangerous. Click to view previous image 1 of 3 Click to view next image These drugs, some of which the FDA admits could be dangerous, slip through a "black hole" in the drug approval system, according to one U.S. congressman.
"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. When a pharmaceutical company submits a new drug for approval, the FDA gives it a 10-digit number called a National Drug Code. The FDA provides the number before the drug is approved in order to track it through the approval process. But pharmacies use this same number as an order number that works whether or not the drug is FDA-approved.
Jacque Gibson White said her daughter was killed by an unapproved drug more than 20 years ago. She can't believe any unapproved drugs are still on the market.
"I did not realize there are still drugs out there that weren't being monitored or approved," she said. "I still to this day do not understand how they get out there."