FDA Struggles To Rein In Unapproved Drugs
11 CommentsBy Ed Silverman // September 26th, 2007 // 3:12 pm
The drugs, some of which the FDA admits could be dangerous, slip through the approval system and the FDA has only recently begun to address the problem. “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,” Ed Markey, the Massachusetts congressman, tells CNN, which airs a segment tonight.
How does this happen? When a drugmaker 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.
Many doc and pharmacists seem unaware. “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 tells CNN. And 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.
[UPDATE: However, an astute reader reminds us that a large number of drugs were being marketed before Congress made successive changes to the law that required drugs to be subject to FDA approval. This occurred back in 1962. In other words, the problem isn't new and we aren't suggesting that bunches of new experimental meds are finding their way to pharmacies.]
Though the FDA has known about this problem for more than four decades, it has only recently started cracking down on the practice. FDA officials said they are issuing more warnings and even pulling some drugs off the market. Last year, for example, the FDA ordered firms to stop marketing unapproved meds containing quinine. While approved for use against malaria, a life-threatening illness, quinine was never approved for its other common usage - treatment of leg cramps. The drug has been linked to 665 reports of “adverse events,” including 93 deaths, according to the FDA.
“It’s not that simple to just sweep all these drugs off the market,” says Deborah Autor, director of compliance at the FDA. “Some of these products, not the majority, but some of these products are medically necessary.”
Jacque Gibson White says 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 says. “I still to this day do not understand how they get out there.”
In 1984, White had her first and only baby, Rachel Ann. Although she was born 14 weeks early, doctors told White her daughter had an 85 percent chance of survival. But less than a month later, Rachel Anne died from what doctors said was kidney and heart failure. White lived with the guilt of losing a child early. “I thought it was my fault,” she tells CNN.
Eleven years later, a lawyer told White her daughter may have been killed by a drug called E-Ferol, which was used on her daughter. Given intravenously, E-Ferol was used to correct or prevent blindness in premature babies. So White joined one of the more than 130 lawsuits the manufacturer wound up settling.
The FDA won’t say how many people have been killed or injured by unapproved drugs or even which unapproved drugs are the worst culprits. But FDA officials said some unapproved drugs that are still available could pose risks. “There may be some, and we are working very hard to target those as quickly as we can,” Autor says.
Muhammad Malik, head of two drugmakers in upstate New York, has felt the FDA’s sting. He had to stop selling seven drugs to major pharmacies after the FDA took him to court. Technically, it is illegal for manufacturers like Malik to sell unapproved drugs, but some manufacturers took the FDA’s lack of enforcement as a sign of tacit approval of the practice.
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 says. “And I’m morally obligated to give you a product that is good.”
Despite knowing which drugs haven’t been approved, the FDA refuses to release a full list to the public. Some common unapproved drugs include phenobarbital, an anti-convulsant, and chloral-hydrate, a sedative.
Markey said the FDA should do more to keep the public informed. “In a modern era, in an Internet era, it makes no sense that a list cannot be put together to determine whether or not a drug has been approved by the FDA,” he says.
Tom
Very misleading spin on this publication. As I recall from reading other articles on the topic, most of the products involved were put on the market before the 1962 Food & Drug Act, at which time they did not have to be approved by FDA. This article implies there is a flood of new, experimental compounds coming onto the market through illegal channels, when in fact some of these compounds have been around for nearly a century. That doesn’t mean they should be excluded from safety monitoring, however. The FDA is attempting to deal with the so-called monograph drugs but, as is so often the case, it’s yet another unfunded mandate thrust upon them by politicians and the media. Perhaps a new infusion of PDUFA money will now allow them to get the job done.
Jack
I agree. As I read through the post I had to ask myself if this problem was only limited to these “ancient” drugs listed. The article doesn’t even mention the reason behind this, which Tom succinctly explained.
If these drugs will get a full safety workup then it will fall to government money to do the study. Is it worth it for them to do the study - let alone monitor this illegal manufacturing of these drugs? At the risk of sounding cold, and without any real data, I doubt it.
Lisa
just watched the CNN segment…OMG..
Laurie
” This occurred back in 1962. In other words, the problem isn’t new and we aren’t suggesting that bunches of new experimental meds are finding their way to pharmacies”
According to this broadcast this is going on today. Once an NDC number is assigned to a drug, the drug can then be purchased, regardless of lack of FDA approval. Yes, some of these drugs are older, but this is a current practice that continues today.
Ed Silverman
Hi Laurie,
Yes, its still going on today. The reference to 1962 is when the law was passed, setting in motion the creation, if you will, of this unapproved group of drugs. I think we’re saying the same thing only in slightly different ways.
Cheers
ed at Pharmalot
Nick
Are we safer with approved drugs? Not necessarily. Avandia, Vioxx, Zelnorm, Hismanal, Baycol, Vioxx, Celebrex, Zyprexa, Meridia, Bextra. All removed due to safety concerns, yet all approved by the FDA prior to introduction. Only later did we learn of their poor safety profile.
Do the math. Pre 1962 (Pre FDA)medications have been thoroughly tested by now.For decades. We appear to be safer trusting the old meds than we are trusting the current ‘news’ gatherers. Sensationalism sells.
Laurie
Nick, I totally agree. I think what bothered me with this report was the interview with the generic drug maker, and the total lack of concern about having no clinical trial to prove efficacy. Yet these were being sold to big drugstores and then on to the unsuspecting public.
I’m a big believer in the older drugs are time tested, but that doesn’t excuse a company from making and distributing drugs today with no regard for the process of approval.
Reality
Celebrex, Zyprexa, and Meridia (I think) are still on the market, as is Avandia (for now — Steve Nissen is doing his best to get it booted).
I wouldn’t generalize that old meds are safer, though. You can get yourself a real nice MI or stroke with any number of NSAIDs (at least comparable to what was seen with Vioxx), and naproxen is particularly good at tearing holes in your stomach. Heck, even little old acetaminophen is associated with CV events, CHF, and hypertension, not to mention the live toxicity. And let’s not even start with aspirin….
Garden Fountain Freak
Garden Fountain Freak…
Although i totally disagree with you, i still appreciate you\’re post. (but you\’re wrong here :) )…
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