"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 global health law expert Lawrence O. Gostin, of Georgetown University Law Center, who also directs the World Health Organization Collaborating Center on Public Health Law and Human Rights, in a statement released with the report. "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. 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 told reporters that fake and substandard drugs are a bigger profit-maker than the illicit drug trade.
The issue is not drug counterfeiting, which refers not to the quality of a medication but to trademark infringement. The issue is cheap-quality, ineffective or contaminated versions of drugs, as well as those that are simply bogus. The panel called for consistent use of the terms "substandard" and "falsified" across international borders.
The IOM panel suggests:
— States only license wholesalers and distributors who meet accreditation standards set forth by the National Association of Boards of Pharmacy.
— Creation by the U.S. Food and Drug Administration of a database where violations and disciplinary actions could be maintained.
— Tougher tracking of products, each one with a unique identifier, so all medications are accounted for and come from proper sources. That includes consistent standards across government entities.
— Financial assistance to help drug manufacturers in developing countries manufacture to internationally accepted standards.
FDA Commissioner Dr. Margaret Hamburg issued a press release praising the report. "The IOM report spotlights a critical global public health issue," she said. "Falsified and substandard medicines adversely affect the lives of millions around the world, and the issue must be elevated to the highest levels of international discourse."
The FDA, she said, already has some of the proposals underway, including better technology, more global regulatory capacity, stronger monitoring and development of science-based standards.
The committee included pharmacists, doctors, policymakers, legal experts and others, most from the United States. But there were also panelists from Netherlands, South Africa and Brazil. The study was sponsored by the FDA.
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