Global Drug Regulatory Harmonization Needed: Hamburg
Former FDA commissioner Margaret Hamburg and former NIH director Elias Zerhouni say that global drug regulatory harmonization is a public health imperative. Writing in an online Science Translational Medicine editorial, the two argue that “in this world of growing public health needs, limited resources, and incessant demand for more, faster, cheaper, and better treatments, regulatory harmonization would have many benefits. Certainly it could increase efficiencies and reduce costs, avoiding, for example, the duplication of effort when regulatory authorities perform overlapping reviews and inspections of clinical or manufacturing sites for similar purposes. Great harmonization could enhance R&D, as discordant rules and regulatory approaches add significantly to the cost, complexity, and time needed to bring therapies to patients…. Most importantly, enhanced collaboration and coordination would benefit patients by ensuring the best possible science, standards, and practice drive the regulatory process, resulting in improve safety, innovation, and access.”
The two note that nations have sovereign approaches to legal-regulatory frameworks based on their own history, politics, and sociocultural values. The degree of acceptable risks and benefits, disease burden, vulnerable populations, privacy concerns, and the social and economic costs that vary across borders all can lead to regulatory divergence. They also say that many regulators are under-resourced and struggle to acquire and maintain the necessary quality and number of experts to fully engage with stakeholders and keep pace with rapid advances in the volume and complexity of the products before them.”
However, progress is being made and solutions are being sought, the two write. “Regulatory authorities are working more frequently with each other, sharing inspection and safety information, and even conferring over discrete product approvals,” they say. “Various bilateral and multilateral arrangements seek to enhance collaboration, learning, and sharing of best practices as well as efforts to strengthen the regulatory science that underlies regulations and oversight.”
Hamburg and Zerhouni conclude that the need for more drug regulatory harmonization has never been greater or more possible. But, they caution, the nature of bureaucracy often maintains the status quo and transformation can be slow without a top-down impetus. “The regulation of drugs can either grease the wheels of progress or throw a wrench in the works,” they write. “We believe that harmonized drug regulation has the potential to be the unsung hero in driving improved health along with global economic and social development. We would challenge governments, including congresses and parliaments, presidents and prime ministers, to put harmonization on their agendas and those of the G-8 or G-20 as a critical and transformative next step in advancing public health for all.”