Hamburg exits US FDA calling on increased international co-operation

31-Mar-2015 - Last updated on 01-Apr-2015 at 10:45 GMT

Hamburg spoke on the importance of international collaboration among regulators in her last two addresses

Margaret Hamburg has called for increased regulatory co-operation to tackle the issues raised by globalisation of the drug industry as she steps down as Commissioner of the US FDA.

As of today, the US Food and Drug Administration (FDA) has a new leader with FDA chief scientist Stephen Ostroff taking over as Acting Commissioner, replacing Margaret Hamburg who held the role for six years.

In her final public address as Commissioner, Hamburg told delegates at the National Press Club one of her key priority areas had been to address the challenges of globalisation and its implications in the regulation of drug products.

“We really had to step beyond our borders to the places where these products are being manufactured, processed, distributed, and that has caused us to have to undertake a whole new shift as to how we do business,” the departing Commissioner said last week.

She spoke of how the FDA had approached this task by “working closely with counterpart regulatory authorities to harmonise standards, share information and share the workload of inspections and assessments,” and stressed how such global partnerships were key throughout her tenure and for the future.

This echoed Hamburg’s recent address to the European Medicine Agency (EMA) as part of the agency’s 20^th anniversary conference in which she warned further cooperation between international regulators would be needed.

“Globalisation has multiplied the scale of our responsibility and heightened the need for us to work together to ensure safety, efficacy of the medical products that we oversee, and to promote the needed research in innovation in medical science,” she said.

International co-operation and ICMRA

The relationship between the FDA and the EMA has strengthened over the past six years, she said, giving examples of the agencies’ Quality by Design (QbD) harmonisation pilot, joint inspection programmes being initiated, and an increase of regular communications to jointly address scientific and regulatory issues.

However, Hamburg stressed collaboration needs to be extended across other regulatory bodies and stakeholders, such as the World Health Organisation (WHO), and suggested the newly formed International Coalition of Medicines Regulatory Authorities (ICMRA) could lead the way.

“ICMRA offers a unique and vital mechanism to convene around issues of strategic interest, to establish more effective channels of information sharing and communication and a new framework for leadership, governance and for action,” Hamburg said.

“Such efforts move us from the outdated paradigm where individual regulatory agencies act in isolation focusing solely on their own jurisdiction to the modern model of a globally focused regulatory enterprise that works closely and collaboratively with other agencies around the world.”

Hamburg’s final overseas trip had brought her to London, and fittingly she took the opportunity to make her point by quoting Winston Churchill: “There’s only one thing worse than fighting with allies, and that is fighting without them.”