Former US Food and Drug Administration (FDA) Commissioner Margaret Hamburg and former National Institutes of Health (NIH) Director Elias Zerhouni are calling for more global regulatory drug and device harmonization in an editorial posted Wednesday in Science Translational Medicine.
The call comes as nearly 40% of drugs and half of all medical devices used in the US are made elsewhere, while 80% of the active pharmaceutical ingredients in US drugs are manufactured in foreign countries.
“Globalization has fundamentally altered the economic and innovation landscapes. This comes at a time when many regulatory authorities are already struggling to keep up with rapid advances in science and technology as well as the growing complexity of medical products and product development, manufacturing, and supply. Additional pressures come from mounting economic and political desire to manage public spending and product cost,” Hamburg and Zerhouni write.
Current Harmonization Efforts
Zerhouni, current president at Sanofi, made a similar plea to mark the 20th anniversary of the European Medicines Agency (EMA) in March 2015, as did the Institute of Medicine in 2013, both of which said such moves could particularly help countries with limited regulatory capacity.
And this dream of regulatory harmonization is becoming more of a reality with organizations like the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which is helping to standardize the manufacturing inspection process across borders, and the International Council on Harmonisation (ICH), which offers international guidelines on how to collect data scientifically for the marketing authorization of drugs, and which recently pushed for a more global approach.
On the device side, the International Medical Device Regulators Forum (IMDRF) has convened a voluntary group of international medical device regulators to build on and accelerate international device regulatory harmonization and convergence.
And more regional efforts, like those between the US and Canada, via the Regulatory Cooperation Council (RCC), and India's Central Drugs Standard Control Organization work with the UK's MHRA, are helping to spur more collaboration.
Issues to Address
But one of the issues Hamburg and Zerhouni point to in terms of not making more progress on international harmonization is the fact 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.”
The fault lines between regulators mean drugs and devices are often approved in the US but not the EU or other jurisdictions, and vice versa. The rising tide of marketed biosimilars is one particular area where gaps between the EU and US persist, as FDA has only approved two biosimilars so far while dozens are available in the EU.
“Many regulators are also underresourced 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. Gaps in both the development of a unified body of regulatory science and the availability of a well-trained regulatory workforce also make global alignment more challenging,” Hamburg and Zerhouni write.
And they also note the dangers of deregulation, particularly as pharmaceutical and device innovation is proceeding at a rapid clip.
“The regulation of drugs can either grease the wheels of progress or throw a wrench in the works,” Hamburg and Zerhouni conclude. “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.”
Editorial: The need for global regulatory harmonization: A public health imperative