Under Development: FDA Globalization Strategy And State Partnerships
This article was originally published in The Tan Sheet
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FDA looks to rely less on its staff and more on data and resource sharing with other countries to cope with the increasingly global food, drug and medical device industries, according to the agency's acting second-in-command and its top food programs official.
A portion of the agency's domestic regulatory strategy also is under development as FDA implements directions Congress included in the recent food safety law to work more closely with state and local agencies. FDA estimates that U.S. imports of regulated products including medical devices, drugs, food and cosmetics have increased threefold over the last decade. John Taylor, who became acting principal deputy commissioner in January and is counselor to FDA Commissioner Margaret Hamburg, and Deputy Commissioner for Foods Michael Taylor spoke recently about the global spread of the industries FDA regulates and the agency's outlook for having a global enforcement footprint. "FDA's traditional model of manufacturing site inspections and border examinations is simply not adequate in today's transformed world," John Taylor said at the Health Leaders Dialogue conference Feb. 10 in Washington.
"The truth of the matter is that the increase in imports is just far outstripping the resources to address this issue," he emphasized at the event sponsored by public affairs and consulting firms Venn Strategies and Greenleaf Health. Michael Taylor emphasized FDA's growing workload due to the burgeoning global food supply network in recent speeches in Washington and London. In both presentations, he described the additional authority FDA gained in the Food Safety Modernization Act (Also see "Final Item On Congress' Food Safety Menu: Passing Enforcement Reform" - Pink Sheet, 3 Jan, 2011.). At a Food and Drug Law Institute conference Jan. 17, he said the act gives FDA a "multi-faceted tool kit" that will "improve our confidence that food produced overseas is meeting our standards." "If we think we're going to get in this global food system, 150-160 countries sending food here, a very diverse field, we got to come at it in multiple ways as opposed to today's regime, which is almost exclusively based on the port of entry in our attempts to find the problems." Third-Party Certifiers Prominent A significant tool is authority to establish an accredited third-party certification program to help FDA audit and inspect food facilities and manufacturing processes, said Michael Taylor, appointed in early 2010 to head all FDA food programs (Also see "Prevention Advocate Taylor Named FDA Deputy Commissioner For Foods" - Pink Sheet, 18 Jan, 2010.). Foreign governments, he added, could be among the third parties FDA works with in food safety enforcement. He noted that in the law, Congress directed FDA to increase its inspections of foreign food manufacturers. "This toolkit envisions where we can rely on foreign governments either as certifiers, or rely on what we know of the foreign [regulatory] regimes to have some confidence that they are comparative in terms of food safety outcomes," he said. "That's a tall order, but we intend to meet it," the food programs chief said at the Global Food Safety Conference Feb. 17 in London. He also included a plug for international cooperation in his London presentation. The food safety law "heightens the importance that we in the United States work in partnership with the global food safety community to meet the public's high expectations for the safety of food, no matter its origin," Michael Taylor said.
John Taylor also noted cooperation with foreign regulatory agencies to meet growing globalization challenges, pointing out other countries have mounting problems with insufficient resources to handle them. "A global problem like this requires a global solution and global responsibility," he said. FDA wants to create a "global coalition of regulators" able to share data globally, thus increasing their scope and reducing redundancies for manufacturers.
The acting principal deputy commissioner also spoke about the agency's plans to rely more on third-party inspectors to fill the gap. "Third-party inspection programs need to be a bigger part of the discussion so that we don't have to do the work all ourselves. We simply cannot do it alone," said John Taylor, who was named acting second-in-command when Josh Sharfstein left the agency (Also see "John Taylor Temporarily Replaces Sharfstein As FDA's Second-In-Command" - Pink Sheet, 10 Jan, 2011.). At the FDLI event, Michael Taylor said third-party food facility inspectors must have training in performing inspections and must meet agency criteria for independence from industry and transparency in sharing data with FDA. State Agencies Figure In Food Safety He added that "one of the really transformational features" of the food safety law is the direction Congress gave FDA in the area of working with states. "Investment in building a state partnership is high on our priority list," Michael Taylor stated. FDA's food safety enforcement programs will "focus on understanding state and local capacities and needs, and working to meet those needs." "You can't have the kind of presence in food facilities that is necessary to get compliance" from firms that are not already compliant without state and local assistance, he added. "A good chunk of industry is there, a good chunk of industry isn't there. You've got to have increased presence in the facilities for inspection. We can do that if we invest in the states' capacities, ensure the states are conducting the inspections with the right training, the right tools, the right quality standards, so that we can in fact rely on those inspections as Congress strongly encourages us to do in this legislation." Similarly, John Taylor noted that the long-term global regulatory plan FDA is formulating is centered on greater data sharing and collaboration with state agencies in addition to other countries. FDA's Global Development Precursors He also pointed out the global oversight strategy will build on ongoing international efforts at the agency, such as the move to establish FDA offices overseas. The agency now has foreign posts in China, Europe, India and Latin America. FDA also created a cadre of inspectors to deal specifically with foreign facilities – including 10 staffers to date. But FDA's international work so far has been limited, and remains superimposed on FDA's old model of inspections-based oversight, John Taylor said. "We need to do more." For one, FDA is working toward safety standards that are comparable, if not equivalent, to other countries "so that when we take a look at products from overseas and we need to determine the status of those products, we're not solely relying on our own investigators." |
