News Feature | March 13, 2014

FDA Considers Forming Global Regulatory Authority

By Estel Grace Masangkay

The U.S. Food and Drug Administration is considering forming a global regulatory authority with other countries’ drug industry regulatory authorities. The global regulatory body is proposed to be named International Coalition of Medical Regulatory Authorities (ICMRA).

In a speech at a recent conference in London hosted by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), FDA Commissioner Margaret Hamburg said globalization has “…fundamentally altered the economic and security landscape and demands new ways for regulatory authorities and systems to fulfill their missions to ensure the safety and quality of the products they oversee.” According to the commissioner, regulatory authorities struggle with current issues such as:

  • Rapid advances in science and technology
  • Growing complexity of medical products and product development
  • Responsibilities that outstrip human and dollar resources
  • Increased demands for public accountability and transparency in regulatory agency operations, spending and decision-making, including an often skeptical or frankly hostile attitude towards regulation
  • Growing economic and political pressure to cut public spending, including for regulatory oversight

The ICMRA’s goal would not be to establish identical standards around the globe, but to supply the public with high level and strategic advocacy as well as leadership entity. The global regulatory body could provide direction for a range of areas and actions common to medical product regulators and identify areas for potential synergies. ICMRA could also leverage existing efforts to maximize global impact.

“The advantages of globalization are real, and as regulators we must work to catalyze these.  Consumers can benefit greatly from global sourcing of products. Certainly, in the United States, health professionals and their patients can draw on drugs and medical devices developed anywhere in the world, assuming they have been approved for use in the U.S.,” Commissioner Hamburg said.

The proposal for the establishment of ICMRA comes at a time when regulatory authorities such as the FDA, the European Medicines Agency (EMA), Health Canada, and others have started to share information from quality inspections of industry facilities.