Institute of Medicine says: Adopt a mandatory national track-and-trace system soon, and a voluntary program now

Last year, at the request of FDA, the Institute of Medicine undertook a study of “approaches to mitigating the problems of substandard, falsified and counterfeit pharmaceuticals” and to focus specifically “on the public health aspects of the problem.” Issued in mid-February, the resulting report, Countering the Problem of Falsified and Substandard Drugs, makes unambiguous recommendations about national (US) policy, but also recognizes the difficulties of getting an international policy in place, and therefore recommends a code of practice for addressing fake medicine production and distribution. It characterizes this recommendation as a “soft-law” solution that “would give member states clear, consistent guidelines and benchmarks.”

Here’s the key US recommendation:

Congress should authorize and fund [FDA] to establish a mandatory track and trace system. In the interim, the FDA should convene a working group of stakeholders including the International Federation of Pharmaceutical Manufacturers and Associations and the Generic Pharmaceutical Association to promote voluntary track and trace for all supply chain actors in accordance with existing guidance.

In discussion of this recommendation, the IOM committee noted that “consumers and governments have demanded for a stronger chain of custody … This problem has been lingering for years and should be addressed promptly,” and that “There is risk to allowing a piecemeal approach to pharmaceutical track and trace. Any track and trace system will be an expense to manufacturers and industry, but the expense can be contained by making one national requirement.” Meanwhile, having noted that some supply chain participants (generic manufacturers, wholesalers) operate on thin margins, IOM recommends that “FDA bring all industry stakeholders together to work towards voluntary use of track and trace technology. This can help control the burden an inevitable shift to drug tracking will pose on these businesses.” (emphasis added)

Banned word: counterfeit

A significant part of the IOM report is devoted to analyzing the problems around the word everyone uses in describing fake medicines: counterfeit. Noting that the committee was empaneled to look specifically at public health issues, and recognizing the geopolitical climate, the committee recommends banning the word “counterfeit” because of its entanglement with intellectual-property debates over patented drugs that are produced by generic manufacturers in several developing-world markets. An interesting table in the report shows 16 definitions of “counterfeit” that have been in use in recent years, and also three somewhat conflicting definitions from FDA and the US government as well. The term currently in use in World Health Organization circles is “SSFC” (Substandard, Spurious, Falsified, falsely labeled, Counterfeit)—but the committee doesn’t like that term either, and recommends simply “falsified and substandard.”

Those definitional issues are a microcosm of the geopolitical issues around falsified and substandard drugs, and are what leads to another key recommendation from the committee:

The World Health Assembly, in partnership with the United Nations Office on Drugs and Crime and the World Customs Organization, and in consultation with major stakeholders, should institute an inclusive, transparent process for developing a code of practice on the global problem of falsified and substandard medicines. The code should include guidelines on surveillance, regulation, and law enforcement, empowering states and the international community to prevent and respond to drug quality problems.

In its discussion, the committee notes that “The political climate is not conducive to a hard-law solution, such as a multilateral treaty, against falsified and substandard drugs,” but that a code would better protect the international distribution system if enough countries participated in it.

The IOM committee comprised academics in public health and policy, officials of several NGOs, one industry consultant, and one retired pharma industry executive (John Theriault, a former chief security officer at Pfizer). It was led by Lawrence Gostin, JD, PhD, a professor of law at Georgetown University, who consults with WHO (among many other activities). What is interesting in this lineup is the absence of active WHO participation (although WHO has an ongoing initiative on falsified medicines that met as recently as last November). FDA Commissioner Margaret Hamburg, in a release when the report was issued, noted that “In order 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 globalized world. In this context, many of the IOM recommendations support actions and efforts already underway at the FDA.”