The history of the US Food and Drug Administration is marked by significant revisions in its rules and policies in response
to major crises in drug, food, and vaccine safety. Now, a surge in overseas production of FDA-regulated products is driving
major changes in how the agency does business. Deaths due to adulterated heparin from China in 2008 jolted the regulators
into action. FDA ramped up foreign inspections and opened its first foreign offices.
Deborah Autor
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That crisis, along with evidence of economically motivated drug adulteration, widespread drug counterfeiting, and extended
supply chains that aggravated drug shortages at home, prompted FDA to recognize the need for further changes in agency operations.
FDA Commissioner Margaret Hamburg responded by issuing a special report last year on the "Pathway to Global Product Safety
and Quality" that outlines four main strategies for fundamentally revising FDA's approach to ensuring product safety and quality
in a world of international outsourcing and soaring imports. The subsequent report on "Global Engagement" describes more specifically
how FDA will seek to regulate food, drugs, and medical products through international collaboration and information sharing.
These documents reflect the reality that FDA will never have the resources to inspect every foreign producer of food and medical
products or to monitor the growing volume of products crossing US borders. Thus, FDA officials seek to work more closely with
their regulatory counterparts to reduce redundant plant inspections and extend regulatory oversight.
In addition, Hamburg restructured FDA's leadership last year by creating four overarching directorates to manage main program
areas. These directorates include the new Office of Global Regulatory Operations and Policy, headed by Deputy Commissioner
Deborah Autor. She is in charge of FDA's Office of International Programs (OIP), which manages the agency's foreign offices
and deals with international trade, policy and regulatory issues, and the Office of Regulatory Affairs (ORA), which operates
FDA's 4400-person field force that inspects manufacturers, clinical researchers, and food producers in the US and overseas.
An attorney who has been a litigator in the Department of Justice and previously headed the Office of Compliance in FDA's
Center for Drug Evaluation and Research, Autor is well positioned to take on the challenge of transforming FDA into a more
data-driven, strategic, collaborative operation. She understands the pressures and incentives on biopharmaceutical manufacturers
striving to adjust to the global economy, and told BioPharm International Washington Editor Jill Wechsler in a recent interview that industry must do more to ensure the quality and safety of its products.
BioPharm: Why is it necessary to transform FDA to reflect global developments, and how will the agency accomplish this?
Autor: I think the starting point is to recognize how much the world has really changed and how much globalization has fundamentally
changed trade, the economy, and FDA's responsibilities. For example, imports of FDA regulated products have quadrupled over
the course of a 10-year period, rising from 6 million to 24 million import lines. We now regulate products from hundreds of
thousands of facilities in over 150 different countries. We import 10–15% of all food consumed in the US, 40% of finished
drugs, 80% of active ingredients, and half of all medical devices.
So that fundamentally alters the challenge that FDA faces. In 1938, when President Theodore Roosevelt established the modern
FDA, we lived in a domestic economy. Our structure, our statutory paradigm, and our practices were all developed around domestic
production of products. That production changed fundamentally over time, and the agency needs to adjust accordingly.
One of the major steps is the Global Pathway report, with its four pillars: forming global coalitions of regulators to strengthen
the product safety net around the world; developing global data systems for sharing information across markets; using advanced
risk analytics and modernizing IT capabilities; and leveraging the combined efforts of public and private third parties.
It recognizes that we can't do it all, and that we have to be smarter and more information-driven and more technology-driven.
We have to learn to rely on others because it will never be possible for FDA to have enough resources to be everywhere, to
see everything, to do everything.
When we talk about global coalitions and global data, I think that we would like to get to a point where we really are able
to have inspectional reports from inspectorates around the globe, and we're able to share our inspection reports so that we
can work with our counterparts to leverage resources.
