On May 23, Able Laboratories, a big manufacturer of generic drugs, suddenly ordered one of the largest drug recalls in history — all of its products, probably affecting millions of people.
On Tuesday, Margaret Galvin, the FDA's head of regulatory affairs, said the company's announcement came as a surprise. The company simply told the FDA, says Galvin, that they were recalling every drug that they make.
“This was a new issue coming up,” says Galvin. “It’s enormously concerning to us.”
Should the FDA have been surprised? Able Laboratories refused to comment for this story. But records show it has had a history of regulatory citations from the FDA and has withdrawn other drugs from the market.
An even bigger question: Why did the FDA wait five days to tell the public about the recalled drugs? It only put out a press release and posting on its Internet site after 6 p.m. EDT on Friday, May 27, the day before the long Memorial Day weekend — a time guaranteed to get the least public attention.
Galvin says the FDA needed the entire week to gather as much information as possible. She denies that releasing the recall before a holiday weekend was an attempt to hide the information.
“If it looks like that, that’s not what we were about,” says Galvin. “What we were about was trying to get information that consumers could use.”
That's a daunting task, because the recall covers 46 different drugs — pain killers, anti-inflammatories and many other kinds of drugs in different doses and formulations.
Dr. Sidney Wolfe, a consumer advocate and frequent critic of the FDA, says the agency should have acted much faster.
“They should be thinking public health service first, and they should be thinking about putting it out at a time when it’s going to get the most coverage instead of the least,” says Wolfe. “They didn't do that.”
And what should consumers do? The FDA says people should not suddenly stop taking any medications, but check with their pharmacist or doctor to see if their medication is affected by the recall.