For many, the concept that we live in a globalized, "flat" world is one that was popularized over the course of the last decade by author Thomas Friedman. For the US Food and Drug Administration (FDA), however, this isn't so much an abstract concept as it is a constant challenge to which the agency needs to adapt.
Speaking before the annual meeting of American Association of Exporters and Importers, Deborah Autor, deputy commissioner for global regulatory operations and policy, tried to put recent changes into perspective.
"Just consider -- about 25 years ago, the Internet was little more than an idea on a sheet of paper," Autor said. "Today, every person in this room is carrying the tremendous power of the Internet in a handheld device. We are instantly connected to people, places, and ideas around the world with the touch of a button."
And that connectivity extends to the non-digital world as well, she added. A drug might have its raw ingredients supplied in one country, its active ingredients manufactured in another, its final product finished in a third, be packaged in a fourth and exported to any number of countries thereafter.
"It is undeniable that the world has changed in fundamental ways," contends Autor.
New Congressional Support
But if those challenges are mounting, Autor said the agency is in receipt of new support from Congress intended to help it accomplish an increasingly difficult mission. On the food and dietary supplement side of the agency, FDA has new funding and authority by way of the Food Safety Modernization Act (FSMA), which aims to make the food supply safer by taking a proactive approach to preventing contamination.
On the pharmaceutical and medical device side of the agency, the FDA Safety and Innovation Act (FDASIA) is geared toward giving FDA the resources it needs to enhance reviews, improve regulatory science, alleviate drug shortages and increase global inspections.
It's the latter which Autor highlighted most prominently in her speech. Thanks to the generic drug provisions of FDASIA, FDA will soon be given hundreds of millions of dollars each year to make sure it can devote more resources to inspecting generic pharmaceutical manufacturers, the majority of which are located outside the US.
Active pharmaceutical ingredient manufacturers, too, will be subject to inspections, whereby before FDA had to take a resource-limited approach toward cracking down on the most egregious violators of federal law.
The scope of challenges facing FDA is extraordinary, Autor said, citing data showing FDA-regulated products coming from more than 150 countries, 130,000 importers and 300,000 facilities. Shipments, she added, are up 300% over the last decade.
What's more, "40% of finished drugs come from overseas," she continued. "And for medical devices, more than 50% of all medical devices used in the US are imported."
"With the rising influence of globalization, we have reached a point where trade, economic development, and public health intersect as never before," Autor explained. "And central to the goal of each is the safety, quality, and security of the products that provide a livelihood for you and enhance the quality of life for consumers worldwide."
And as the supply chain for regulated products goes global, so do the challenges: language barriers, the origin and identity of a product, the conditions used to manufacture and package a product, and the potential intersection of a product with criminal and even terrorist activity, Autor explained.
"Hence, for FDA to continue achieving its mission of protecting the public health, we must not use our borders as the primary line of defense against unsafe imported products, but ensure that we position our borders as the final checkpoint on a long line of prevention controls throughout the supply chain," she added.
Autor explained that FDA is in the midst of working with numerous other agencies, including under the auspices of the Border Interagency Executive Council (BIEC)-a council of agencies dealing with the importation of products and national security officials meant to improve trade and regulation.
Cooperation among US regulators and agencies, too, could prove crucial, Autor added. "If federal agencies share information and analyze data quickly about importers who consistently pose the greatest risks, we all benefit. This type of system will lead to a 'One US Government Approach to Import Safety' trusted trader program."
An Expanding Circle of Trust
But that's just on cog in a larger plan, she said. "On a larger scale, we must push towards mutual reliance…and get to a point where we can rely on each other, on foreign regulators, as well as on private third parties…to improve both product and import safety."
Another cog: cooperating with global regulatory authorities more closely to share data. Autor touted the use of a program she called STARGO-the Strategic and Risk Based Global Industry Oversight and Enforcement.
"Within this system, our goal is for FDA and our global regulatory partners to gather and share enhanced information, use analytics to identify risks, and then adopt tailored, flexible strategies to address these risks," she explained.
The gravity and importance of getting it right are not lost on FDA, Autor concluded. "At stake is nothing less than the vibrancy of trade enhancing the daily lives-and the safety-of the American public."