In the middle of all the hubbub about increased FDA oversight over the pharmaceutical industry, there's still a weird loophole open that allows doctors to write prescriptions for drugs that haven't even been approved yet, and allows manufacturers to supply these drugs through a seemingly legitimate process:
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....
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....
"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.
Pharmacists would appear to be no better informed about the status of their drugs. A recent survey showed more than nine out of 10 retail pharmacists didn't know they could be dispensing drugs not yet approved by the FDA.
Apparently the FDA has known about this for, oh, 40 years, but hasn't really bothered to do anything about it until now. Awesome! Have people been killed by taking these unapproved drugs? The FDA's official response is "go away, kid, you're bothering me," but anecdotally, it's clear that certain drugs linked with adverse events (including death) were sold this way.
The best part of this article, of course, is the response of a man who heads up two small pharmaceutical companies, and who thinks the whole thing is overblown:
Malik said he believes concerns about unapproved drugs are overblown. He thinks the FDA's testing procedures are too expensive and cumbersome for small companies like his. And despite the lack of FDA approval, Malik said he's not ashamed of his drugs and believes some of them should be brought back to market.
"I'm a man of integrity," he said. "And I'm morally obligated to give you a product that is good."
Whew! Thank god moral obligation will protect us while the FDA putters around for another 40 years until they get around to plugging up a loophole.
Unfortunately, the FDA will not provide a full list of known unapproved drugs that might be working their way through the system. The article does try to help, though, noting, "Some common unapproved drugs include phenobarbital, an anti-convulsant, and chloral-hydrate, a sedative." So there you go, all you phenobarbital and chloral-hydrate users: the FDA is on your trail... probably... I mean, you know, eventually...
