US regulators are increasingly reaching out to partner with their foreign counterparts, transitioning from a domestic agency to one with a global focus, said US Food and Drug Administration (FDA) Commissioner Margaret Hamburg in a lengthy appearance sponsored by the Center for Strategic and International Studies (CSIS).
Hamburg's 1 October appearance at CSIS was meant to be a retrospective look at the commissioner's four-year tenure as head of the agency, and she offered a wide-ranging look at a number of topics including globalization, regulatory science, partnering with global regulatory agencies and protecting US consumers.
More than anything else, Hamburg said she was particularly struck by the efforts FDA has made to ramp up its global capabilities in the last four years.
"It's only in the last few years that we're really developed a whole new strategy where we no longer view ourselves as a domestic agency," she said. "We believe that we have to be a global agency with a global mission with partnerships within government and industry and the scientific community that are global as well."
This, she added, has required the agency to rethink how it sees itself as best protecting US consumers from dangerous products.
"The major reality is that we live in a globalized world," Hamburg said. "We have to recognize that our responsibilities extend far beyond our shores," she added, citing the estimated 80% of drugs originating outside of the US ultimately consumed by US citizens.
The globalization of product manufacturing is a powerful driver of FDA's responsibility, Hamburg continued, "And really requires changing our model for our regulatory and public health goals."
Hamburg cited the examples of contaminated Heparin as being a chief example of the dangers to US consumers when global regulatory regimes are lax, and said the episode has led to FDA constructing a new risk paradigm in which it places a greater emphasis on supply chain safety and integrity. Other non-drug problems, such as the presence of melamine in milk and poisoned pet treats, have only served to reinforce their resolve to see the approach though, she remarked.
Global Partnerships Start to Take Shape
Part of protecting the global supply chain involves working closely with global regulatory partners, and even relying on them to conduct some of the groundwork on behalf of FDA staff.
Hamburg said FDA is currently working on developing new ways to share information, regulatory workflow and risk-based approaches with their foreign counterparts.
"We need to be able to share the best science, the best experience and expertise to target the highest risk products and to use our resources in ways that will make the greatest difference identifying and addressing the critical vulnerabilities in a product's supply chain," she said.
"If we can help to raise the level of capacity in these countries, we have less work to do because we can be confident that these products are being manufactured to standards that are roughly equivalent to ours."
But it's one thing to partner with foreign regulators, and quite another to rely on them, conceded Hamburg. Reliance poses unique risks that could have enormous political consequences for the agency if it fails even once.
"If we rely on an inspection done by another country and then there's a problem, everyone's going to say, 'How could you possibly have let that happen?' We do have to be realistic about that."
Working More Closely with Industry
Beyond just regulators, Hamburg said has been eager to partner with the life sciences industry to help bring new regulatory capacity to under-resourced foreign regulatory agencies.
"We simply need to have new models, and those models have to build on the notions of partnership, both with other regulatory authorities and with industry to raise standards and share information in new ways. I think that building regulatory capacity, either by helping other nations strengthen their capacity or doing so on a region basis, is absolutely critical."
FDA is working on several projects with members of the development community, including the World Bank, which Hamburg said is bringing together regulators and industry to find new models to build regulatory capacity.
Though Hamburg said she doesn't expect all countries to emulate FDA when boosting regulatory capacity, she said it's clear to her that FDA remains the "gold standard" for global regulatory excellence.
Regulatory on an International Stage?
Hamburg also said she hopes to elevate the role of regulatory on the international stage, and in particular at high-profile meetings such as the G8 and G20.
That elevation, however, will require regulators to develop models of excellence.
"I think we're still striving to figure out what kinds of global governance models exist that we could use to inform our thinking best to work together as a community as regulators," explained Hamburg.
Which isn't to say outside-the-box thinking shouldn't be used to leverage untapped resources, she added.
"Frankly, I believe that we need to integrate this thinking about regulatory capacity and the role of product safety into other investments that we as a nation and other nations are making-how we're spending development dollars and how we're using strategic diplomatic resources."
The chief limiting factor at the moment is funding, said Hamburg. Though FDA is increasingly global, she conceded agency staff is worried about expanding FDA's mandate without having the staff or funding resources to make sure all its bases are covered.
"Suddenly, we're working on an international scale," concluded Hamburg. "The circumstances demand it."