Health experts are urging the United States and other countries to boost
their ability to identify fake or sub par medicines and close loopholes that
allow products to be falsified or diluted.
In an international system in which different companies in many countries
make ingredients for single treatments, no country alone can effectively enforce
quality control on drugs that can be the fine line between life and death,
stressed a report by the independent Institute of Medicine (IOM).
"Falsified and substandard medicines are a grave public health problem
because they are ineffective, promote drug resistance, and even cause severe
illness and death, particularly in developing countries where they regularly
flood the market," said Lawrence Gostin, health law expert at Georgetown
University Law Center who led the group of 12 experts who did the study.
"We're calling on WHO, in collaboration with regulators, companies, and civil
society worldwide, to adopt a global code of practice, build national regulatory
capabilities, and promote international cooperation," Gostin said.
Fake versions of the cancer drug Avastin were given to US patients in 2011
and 2012, for example, but similar problems occur even more frequently in poor
countries, the committee found. Avastatin is made by Switzerland's Roche.
"Given the international nature of modern manufacturing and trade, every
nation has a stake and a role to play in ensuring the production and sale of
high-quality medications," said Gostin, who is director of the World Health
Organization (WHO) Collaborating Center on Public Health Law and Human
Counterfeit and substandard medications with little or no active ingredients
can hasten drug resistance, do not treat disease, and boost health care costs.
In addition, products that contain dangerous ingredients have sickened and
killed people around the world, the report explains.
It urges the WHO to increase its cooperation with regulators worldwide.
"What we're seeing in the United States -- and doubly so in developing
countries -- is a race to the bottom," Gostin said. "Unscrupulous drug suppliers
seek the state or country with the weakest regulatory and law enforcement
standards. We need to encourage a status competition for the finest regulatory
So the report urges a mandatory drug tracking system.
Prepared to help
US "agreement on a federally mandated tracking system has been slowed by
costs associated with changing drugs' primary packaging and labels as well as
wholesale repackaging, the report found. "Without a national system, however,
companies face the burden of meeting competing state demands. For example,
California will require unique serial numbers on bottles and vials by 2015," it
The report also urges adoption of the terms "substandard" and "falsified" to
refer to products that pose a public health risk, asking parties to refrain from
using the term "counterfeit" except in trademark infringement cases.
"Consistent use of terms would improve nations' abilities to document the
extent of the problem, determine causes, and discuss possible solutions," it
FDA Commissioner Margaret Hamburg commended the report and said many of its
recommendations already were being carried out by the US Food and Drug
"To meet the challenges of today's global marketplace, 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 globalised
world," she said in a statement.