Magazine article Clinical Psychiatry News

IOM: Falsified and Poor-Quality Drugs a Global Problem

Magazine article Clinical Psychiatry News

IOM: Falsified and Poor-Quality Drugs a Global Problem

Article excerpt

Falsified and substandard drugs are a global public health threat that needs to be addressed cooperatively by governments, manufacturers, and other health organizations, according to an Institute of Medicine report.

This is "a grave public health problem because [falsified and substandard drugs] are ineffective, promote drug resistance, and even cause severe illness and death, particularly in developing countries where they regularly flood the market," chair of the report committee, Lawrence Gostin, O'Neill Professor of Global Health Law, Georgetown University Law Center in Washington, said in a statement.

"Given the international nature of modern manufacturing and trade, every nation has a stake ... in ensuring the production and sale of high-quality medications," he said.

The IOM called on the World Health Organization (WHO), other international organizations, governments, and stakeholders to collaborate on "a global code of practice, build national regulatory capabilities, and promote international cooperation."

The committee was convened by the IOM at the request of the Food and Drug Administration. In a statement, Commissioner Margaret A. Hamburg noted that the FDA is transforming from a "predominantly domestically focused agency to one that is fully prepared to help ensure product safety and quality within a globalized world," and that many of the recommendations in the IOM report are already underway, including having a presence in 12 countries in seven regions of the world.

Quite simply, the first thing that needs to be done, according to the report, is for the WHO's World Health Assembly to adopt consistent definitions, using "substandard" to describe drugs that do not meet pharmacopeia or manufacturer sped-fications, and "falsified" for those products with a "false representation" of identity and/or source. …

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