FDA eyes 'toolkit' to combat fake meds in supply chain

The US FDA has teamed up with a group of global partners to create and launch a new initiative designed to combat the scourge of illicit and potentially dangerous prescription drugs.

The new project, an effort led by the FDA, aims to create a supply chain security toolkit for medical products.

Ilisa Bernstein, deputy director at the Office of Compliance at the FDA, said this toolkit: "Is a comprehensive resource that covers the entire supply chain and lifecycle of medical products – from raw materials to patient use. It focuses on developing and implementing processes and procedures designed to enhance global medical product quality and supply chain security."

The aim is to provide info on track and trace, Internet sales, detection tech, and more, in the hope that it will spur on global industry stakeholders and regulators from around the globe to adopt best practices, while also strengthening laws and regulations to protect consumers.

The FDA believes it has much of its own house in order, but as Bernstein notes, around four billion prescriptions were filled at US retail pharmacies last year, with a large percentage of these meds being made outside of the US.

It hopes this semi-educational toolkit will help keep the global drug supply chain secure against fraudulent medicines, and reduce their number from entering into the US.

Collaborators on the project included regulators from the 21-nation Asia-Pacific Economic Cooperation (APEC), non-APEC countries, industry stakeholders, representatives from non-governmental organizations, international organizations, and academia.

Bernstein says: "We all will benefit from this hard work. Together with our global partners, we will continue to combat supply chain problems as they arise and increase confidence in the legitimacy of the life-saving prescription drugs that patients rely on."

According to the FDA, the toolkit contains training materials intended to educate regulators, industry, healthcare professionals, and others on a particular part of the supply chain in 10 categories:

• good manufacturing practices;

• good distribution practices;

• good import/export practices;

• clinical/retail pharmacy practices;

• product security;

• detection technology;

• Internet sales;

• track and trace systems;

• surveillance and monitoring; and

• single points of contact.

The toolkit has grown out of an earlier roadmap project which brought together regulators, industry stakeholders, representatives from non-governmental organizations (NGOs), international organizations, and academics with common purpose of fighting falsified and substandard medicines.