Hamburg: Global Regulatory Authority in the Works

To help improve drug safety and quality, the FDA and other countries’ drug industry regulators are considering forming a global authority dubbed the International Coalition of Medical Regulatory Authorities (ICMRA), Commissioner Margaret Hamburg says.

The goal of the ICMRA would not be to develop identical standards, but to provide the public with “high-level, strategic advocacy” around quality, Hamburg said at a recent conference in London hosted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).

“It can provide direction for a range of areas and actions that are common to many medical product regulators; identify areas for potential synergies to be made; and, wherever possible, leverage existing efforts to maximize global impact,” she added.

“We must ask ourselves how we can weave our various efforts into a coherent and sustainable global system of governance, oversight and safety.”

The proposal comes as the FDA, the European Medicines Agency, Health Canada and other regulatory authorities have begun to share data from quality inspections of industry facilities.

The proposal for the ICMRA has been kicking around for years, Alasdair Breckenridge, former chair of the MHRA, tells Drug Daily Bulletin. “While in principle it sounds attractive, in practice there are several major problems, not the least of which is which regulatory authorities would be involved,” he said.

“Would there be a premier division of regulators and a series of lower leagues?”

He also wonders who would fund it, noting that industry, “the usual cash cow,” hasn’t shown great enthusiasm for the idea. “The devil will be in the detail,” he said. — Johnathan Rickman

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