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Food and Drug Administration and Compliance Issues
Tuesday, February 19, 2013
Buyer beware of faux pharmaceuticals Medicine Victoria Colliver Published 5:56 pm, Tuesday, February 19, 2013
Federal regulators earlier this month discovered another batch in a string of fake versions of Genentech's cancer drug, Avastin.
Last month, a doctor in La Jolla pleaded guilty in federal court to treating patients with unapproved drugs.
Tainted steroids produced by a Massachusetts compounding pharmacy led to a fungal meningitis outbreak in September that killed 45 people and sickened more than 650.
The problem of fake, contaminated or prescription drugs that don't meet proper quality standards may be worse in developing countries, but drug security is clearly a concern here, too.
Even in the United States, medicines change hands many times and the path these drugs take from manufacturer to the pharmacist or doctor is not tracked, making it possible for illegitimate products to infiltrate the supply chain from within or outside U.S. borders.
"As we become more globalized, I think it's reasonable to expect the problem caused by this will only increase," said Dr. Patrick Kelley, director of the Institute of Medicine's Board on Global Health, in introducing a report last week that called for a global effort to beef up drug surveillance and tracking.
Tough to quantify
Quantifying the problem in the United States is difficult, but the trade of adulterated prescription drugs is considered more profitable than that of illicit drugs, like heroin, said the authors of the 360-page report, which was sponsored by the U.S. Food and Drug Administration.
"Many of these fake drugs are the subject of sophisticated criminal networks," said Larry Gostin, professor of health law at Georgetown University, who headed the committee that produced the report.