The growing dangers from substandard and falsified medicines around the world has prompted a blue-ribbon panel formed by the Institute of Medicine (IOM) to call for clear international standards for higher quality medical products, plus an electronic tracking system in the US to uncover bogus products in the supply chain.
The report, which was requested by the Food and Drug Administration, supports the agency’s preference for a mandatory drug track-and-trace system able to identify products at the unit level through unique serial numbers on genuine drugs. This tracking initiative would be supported by tighter state regulation of drug wholesalers and distributors, including a public database on distribution firms that have had licenses suspended or revoked. And the federal government would help low- and middle-income countries detect substandard products by identifying new detection, sampling and analytical technologies through a central repository at the National Institute of Standards and Technology (NIST).
International capacity critical
Much of the report describes the greater threat of fake medicines to developing countries, which often lack the regulatory expertise and capability to detect unauthorized products and enforce quality standards. Falsified and substandard medicines can be ineffective, promote drug resistance and even cause severe illness and death, said panel chairman Lawrence Gostin, Georgetown University Law Center professor and director of the WHO Collaborating Center on Public Health Law and Human Rights. He and his colleagues urged efforts to build national regulatory capabilities and adopt guidelines on surveillance, regulation and enforcement of standards, including technical quality standards developed by the International Conference on Harmonization.
Clear definitions for “substandard,” “falsified” and “unregistered” drugs provide a basis for regulatory agencies to strengthen their detection systems, which can benefit from use of common product registration documents, participation in joint inspections under harmonized procedures, and adoption of a “code of practice” for addressing substandard medicines in all regions.
Of particular note is the panel’s decision to drop the term “counterfeit” in describing fake drugs that pose a public health risk. The aim is to narrow the use of “counterfeit” to refer to products that infringe on trademarks and intellectual property protections, but are not necessarily substandard or adulterated.
The panel also calls for international development and financing agencies to support drug manufacturers in low-income countries that seek to invest in upgrading facilities to meet good manufacturing practices, efforts that would counter fake drug marketing by boosting local capacity for quality drug production.
Although an international treaty enforcing drug quality standards is the ultimate goal, publication of guidance on best practices as an interim step “is more realistic,” noted panel member Hans Hogerzeil, professor of global health at Groningen University in the Netherlands. The IOM panel also is asking the World Health Assembly to support its basic recommendation at its May 2013 annual meeting.
Cost is an issue in implementing regulatory and oversight programs, Gostin acknowledged. However, he noted that limiting use of substandard drugs would bring notable benefits everywhere in terms of lower hospital costs and fewer drug-resistant medicines. Adopting the panel’s recommendations, he said, is “a very good investment.”
There’s some optimism that the IOM report may spur FDA, manufacturers, distributors and pharmacists to reach agreement on establishing an effective track-and-track system for pharmaceuticals, an issue that has generated heated debate for more than a decade. Congressional action is needed to authorize both mandatory tracking, as well as to require states to support a public database on licensed drug wholesalers. Added resources for FDA to take on these and other related tasks also is a real challenge.
The global nature of drug sourcing and production speaks to the need for international cooperation in tackling all these issues related to substandard drugs. “No country acting alone,” the panel states, “can protect its citizens against the health risks posed by illegitimate medications.”