Healthy Skepticism Library item: 11598

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Publication type: news

Gruber A.
Many drugs slip through regulatory 'black hole'
CNN.com 2007 Sep 26
http://www.cnn.com/2007/HEALTH/conditions/09/26/unapproved.drugs/index.html?iref=mpstoryview

Full text:

NEW YORK (CNN) — 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.

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.

Many doctors and pharmacists seem unaware of this wrinkle in the approval process. Dangers of unapproved drugs »

“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.

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 medicines 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,” said 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 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.”

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 said.

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 said.

Muhammad Malik, head of two pharmaceutical companies 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 said. “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 said.