The drugs can end up in doctors' offices, but often are purchased via the Internet or in local black markets. There's no duty to report "fake" drugs, and they're often impossible to detect, he added.
"We had people show us two different drugs in two different packages. We're a sophisticated [scientific] committee, and we couldn't tell the difference," Gostin noted.
The unanswered question is whether such immense changes can be made.
In a statement released Wednesday, FDA Commissioner Dr. Margaret Hamburg commended the IOM for its recommendations.
She said her agency is currently "transforming from a predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world."
"In this context, many of the IOM recommendations support actions and efforts already underway at the FDA," Hamburg added, "including advancing technology, strengthening global regulatory capacity, strengthening surveillance, developing science-based standards and engaging in global dialogue."
Gostin conceded that the recommendations were also likely to benefit international pharmaceutical companies that sell legitimate drugs, but "that's not our purpose. Our purpose is to make sure that people, when they're taking medications, can have some confidence that the medication will work and won't poison them."
The World Health Organization has more on substandard drugs.
SOURCES: Lawrence Gostin, J.D., O'Neill Professor of Global Health Law, Georgetown University Law Center, and director, World Health Organization Collaborating Center on Public Health Law and Human Rights, Washington, D.C.; Otis Brawley, M.D., chief medical officer, American Cancer Society, Atlanta; Feb. 13, 2013, Institute of Medicine report, Countering the Problem of Falsified and
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