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Study: U.S. Needs a More Effective Drug Recall System

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Medicine Cost (drug recalls)

"The FDA favors a tracking system that would scan medicine bottles individually, but has met with resistance from manufacturers, distributors and pharmacies over how to cover the cost of such a program." -- Andrew M. Seaman, Reuters

Although pharmaceutical drugs are recalled in the U.S. about once a month, news of the recalls does not always reach physicians, according to a new study by researchers at Brigham and Women’s Hospital in Boston. The study, published on June 4 in the Archives of Internal Medicine, found that the U.S. Food and Drug Administration (FDA) did not issue public recall notices for one-fifth of the most serious recalled drugs, called “Class I” recalls.

Class I recalls are those with the greatest risk of causing major harm to patients, even death, as Carrie Gann reports for the ABC News blog Medical Unit. Researchers write that the most common reasons for drug recalls were contamination and wrong dose or release mechanism.

In conducting the study, epidemiologist Joshua Gagne, one of the study’s authors, and colleagues analyzed eight years of data from the FDA’s “Enforcement Reports” and the archives of the agency’s two main drug recall reporting systems, the Recall Alert System and the FDA MedWatch Safety Alert database. Of the more than 1,700 drug recalls that the study found in the eight years of FDA enforcement reports, 91 were Class 1 recalls, as Andrew M. Seaman writes for Reuters in HuffPost Healthy Living.

The Recall Alert System sent alerts for only 55 of those 91 Class I recalls, and MedWatch sent alerts for another 18 of the Class I recalls. But 18 (one-fifth) of the Class I recalls were never reported through either system, Seaman writes.

Seaman goes on to say:

There is no way to know if the lack of notifications was linked to any patient harm, Gagne said. He added that the FDA has moved to address communication problems, including recall notifications. […]

The FDA favors a tracking system that would scan medicine bottles individually, but has met with resistance from manufacturers, distributors and pharmacies over how to cover the cost of such a program.

“Equally problematic,” the study says, “the Class I recalls that are communicated through the Recall Alert System become buried in a system that is also used for recalls that have little or no bearing on patient care (eg, veterinary drug recalls).”

The FDA communicated with Gann:

Responding to the article, FDA spokeswoman Sarah Clark-Lynn said the agency used many different methods of communicating information about drug recalls and safety, including email list serves, news releases, Twitter and text messaging.  And recalls, she said, were not up to the FDA alone.

‘The recall system depends on full and open disclosure [by manufacturers], trust and the industry’s acceptance of its responsibilities to protect the public from violative products,’ Clark-Lynn said in an email.

In addition, Gann spoke with Dr. Carl Furberg, a professor of public health sciences at Wake Forest University, who said:

[T]he FDA did not have a sterling record of communicating efficiently with medical professionals and the public. But the agency can only do so much when it comes to drug recalls. The FDA has no legal authority to force companies to recall their products.

‘I think the manufacturers should be ultimately responsible because the problem is with them. They should be the ones communicating about recalls,’ Furberg said.

The study recommends the following:

In addition to improving communication of drug recall information, a system is needed to track the distribution of affected products throughout the supply chain to the patient level. Electronic tagging systems, such as radio frequency identification technology, would enable pharmacies to quickly identify and notify affected individuals as soon as a recall is initiated, helping minimize exposure to potentially harmful products.

In the publication FiercePharma, which calls itself “the pharma industry’s daily monitor,” Tracy Staton writes: “The problem of recall notice could be obviated by an active, electronic drug-tracking system, but that’s another story altogether.”

The FDA’s automatic email notices about recalls are available at or on Twitter: @FDArecalls, as Seaman writes.

Image by, used under its Creative Commons license.


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