- Speech by
Remarks of Mark Abdoo
Acting Deputy Commissioner for Global Regulatory Operations and Policy
U.S. Food and Drug Administration
Association of Food and Drug Officials 2018 Conference
International and Government Relations Committee Meeting
It’s a pleasure to be here with you in Vermont, where I have spent some very rewarding times. I studied Chinese at Middlebury College and used that knowledge when I lived and worked in the Far East. Asia, as you might imagine, provides an ideal place in which to view up close the tremendous power of Globalization.
Globalization has had profound effects on the regulatory landscape. We are now in an environment in which food and drugs are produced and travel within complex supply chains throughout countries all over the globe. Unfortunately, many of these nations, as you know, have less developed regulatory systems than ours. What is required, to borrow the Conference’s theme, is truly a Pathway to Global Unity.
I will speak today on the topic of International Recognition systems, covering FDA’s progress in both the pharmaceutical and food realms. For the former, we continue to implement the Mutual Recognition Agreement, a ground-breaking achievement. And, this cooperation with our European counterparts is finding, in a related fashion, a complement in Systems Recognition engagement.
Last, I’ll outline the importance of distinguishing between systems recognition and equivalence.
II. The Mutual Recognition Agreement
As its name implies, the Mutual Recognition Agreement, or MRA, is truly and substantively a model of international recognition efforts. Put simply, the MRA between FDA and the European Union allows the drug inspectorates of each entity to rely upon information from drug inspections. At this time, the FDA and EU are focused on inspections conducted within our respective territories.
However, the FDA and EU have the option to rely on inspection reports issued by a recognized authority for manufacturing facilities located outside our respective territories.
The MRA story goes back two decades, to 1998, when the U.S. and the European Union signed a broad Mutual Recognition Agreement, which included, among other things, a Pharmaceutical Annex providing for anticipated and limited reliance on each other’s Good Manufacturing Practices (GMP) inspections. However, for various reasons, this Agreement was never fully implemented. In fact, the only provision that was implemented was the rapid alert notification, whereby authorities would share information regarding poor quality products within the market place, such as Class 1 recalls.
Fast forward to 2012: Congress passes the Food and Drug Administration Safety and Innovation Act (FDASIA), which gave FDA the authority to enter into agreements with foreign governments and to recognize their pharmaceutical manufacturing facility inspections, once we deem the relevant regulatory authority as “capable.”
Two years later, we launched the U.S.-EU Mutual Reliance Initiative, which was a strategic collaboration to evaluate whether we could rely on each other’s inspections reports so that we did not have to inspect the same drug companies within our own territories.
We had conducted a review of FDA’s inspection history and found that between 2011 and 2016, FDA inspected drug facilities in the EU more than any other country. This made sense at the time because we had the most number of FDA registered facilities in the EU.
But the drug manufacturing landscape has changed. Between 2011 and 2017, there was a 70 percent increase in registered drug facilities in China; for India, the number was 65 percent.
Indeed, pharmaceutical experts from FDA and the EU acknowledged that reliance on each other’s GMP inspection information would allow each regulatory authority to have greater oversight in higher risk areas.
During negotiations in 2015 and 2016, led by FDA’s Dara Corrigan, the U.S. and EU worked to amend the 1998 MRA so that it could be fully implemented. On January 19, 2017, the U.S. and EU formally amended the agreement and it has been operational since November 1 of last year.
In practical terms, this means that the EU and FDA will use inspection reports and other related information obtained during drug manufacturing facility inspections, whether conducted by an EU inspectorate or by the FDA, to help determine whether a facility is manufacturing high quality drugs.
Then, if necessary, the FDA or EU can require further inspections or take other action to protect the public. The benefits of the MRA include greater efficiencies, minimizing duplication, and reallocating resources to areas of higher risk.
The FDA and the EU reserve the right to inspect at any time and in any country. It is however expected to be the exception rather than the rule since, following positive capability assessments, the FDA will recognize the EU inspectorates as capable and thus recognize their drug manufacturing facility inspections.
In July 2017, the EU found FDA capable. As of nine days ago, FDA has found 14 EU countries capable. FDA is committed to conducting assessments of all EU countries by July 2019.
III. Systems Recognition and Europe
We know that there are other countries, besides the U.S., that produce safe food. We also know that there always will be more regulatory work to do than FDA has the resources to perform. With this in mind, FDA established a policy for assessing and recognizing the food safety work done by our regulatory counterparts in other nations with highly developed and reliable food safety systems.
Systems Recognition (SR) is a program FDA developed to increase regulatory cooperation and build reliance between FDA and a counterpart nation’s food safety authority. This cooperation includes measures such as facility inspections and follow-up to food-borne outbreaks. Our goal is to strengthen our regulatory partnerships with those countries that have the best-performing food safety systems.
After conducting a rigorous assessment and determining that a foreign food safety system achieves outcomes comparable to those of FDA, FDA can rely on the work of recognized counterparts and refocus FDA resources on food imported from nations with less-developed food safety systems.
As all of you know, regulatory partnerships are by nature a two-way street. Hence, with Systems Recognition, we specifically seek to know: (1) Whether another country’s food safety system - both domestic and export – is able to provide the same level of public health protection that we have in the United States, and (2) Whether the other country’s food safety authority provides similar oversight and monitoring activities for food produced under its jurisdiction.
Let me be clear that the focus of Systems Recognition is about bilateral regulatory partnership - not market access or trade facilitation.
And, while Systems Recognition is intended to provide a level of assurance regarding the foreign competent authority’s food safety system, it is not intended to be an equivalency tool. I’ll have more on that shortly.
Currently, we have Systems Recognition agreements with Canada, New Zealand, and an agreement with Australia is pending. And now, our focus is on Europe.
For background purposes, let me note that the FDA food systems recognition process uses the International Comparability Assessment Tool (ICAT), which includes a comprehensive review of key elements of a national food safety control system such as its relevant laws and regulations, inspection programs, response to food-related illness and outbreaks, compliance and enforcement and laboratory support.
The ICAT is based on the Manufactured Food Regulatory Program Standards, which as you know, FDA uses to assess State programs, with a few adjustments to take into account that the regulatory partner in the case of Systems Recognition is a foreign government. So there is consistency in our approach to assessing foreign and domestic food programs.
In February of 2016, the European Commission submitted their ICAT, which presented the food standards that the Commission sets for EU Member States and the Commission’s oversight of Member State food programs. We reviewed the completed ICAT, along with analyses of compliance information collected by FDA regarding products imported from individual Member States, including the volume of trade from the individual countries under review and the percentage of refusals. We also conducted on-site audits to determine how Member States implement and enforce standards set by the Commission.
Because the food safety control system in the European Union is implemented by both the Commission and the Member States, both the Commission and individual Member States submit an ICAT, and we audit both parts of the system. To date, we have completed audits the European Commission and reference laboratories, and assessments of three Member States: Denmark, Hungary, and Italy. FDA recently received ICAT submissions from Ireland and Spain, which we will start assessing next month. Because Systems Recognition is a bilateral regulatory partnership, EC officials will be auditing FDA’s food safety system as well.
Once these tasks are complete, FDA looks forward to discussing with Commission officials the next steps in the Systems Recognition process.
IV. Equivalence in Food Trade Matters
Equivalence is one of the tools that the World Trade Organization (WTO) created to promote global unity in food trade matters. Members of the WTO are required to accept the food safety measures of another Member as equivalent, even if they are different, if the exporting country objectively demonstrates that its measures achieve the importing country’s level of consumer protection. The purpose of this obligation is to facilitate trade between countries even where their food safety measures differ, so long as the exporting country is able to produce food as safe as food produced by the importing country.
FDA only requires equivalence as a condition of import for two FDA-regulated commodities: molluscan shellfish and Grade A milk products.
By statute, FDA cannot permit the entry of these commodities into the United States unless FDA has found the exporting country’s food safety control system for those commodities equivalent to ours.
FDA just completed its first equivalence assessments of two European countries seeking to export molluscan shellfish to the United States. This assessment entailed a paper review of the ICAT submitted by the European Commission and by the Netherlands and Spain. FDA also conducted on-site audits of the shellfish safety control systems in these countries. The results of our work are published in the Federal Register where we proposed to find equivalent shellfish exported from the Netherlands and Spain. We are reviewing comments on this proposal and intend to finalize our determination soon.
At the same time, the European Commission has assessed the U.S. control system and is proposing to find equivalent shellfish exported from Massachusetts and Washington state.
Moving forward, FDA and the Commission have discussed a process for adding States after the initial determinations are finalized.
V. The Difference Between Systems Recognition and Equivalence
In our international work, we have encountered a fair amount of confusion about the difference between equivalence under the WTO Agreement and FDA’s Systems Recognition, so I’d like to spend a moment outlining the distinction.
The objective of an equivalence arrangement is to facilitate trade. The WTO obligation does not envision equivalence as a bilateral arrangement although Members can engage bilaterally if they wish. This means that food exported from the United States may be found equivalent by another WTO Member even if the United States has not deemed equivalent food exported from that country to the United States.
By contrast, Systems Recognition results in a regulatory partnership between FDA and a foreign counterpart who agree to work together and share information about foodborne outbreaks, including investigations of outbreaks, and facility inspections. Along with a Systems Recognition arrangement, FDA enters into a confidentially commitment that governs the sharing of information between the two countries to ensure that trade secret and other non-public information is not disclosed.
This partnership allows FDA to rely on the other agency’s work and to redirect FDA inspection and investigation resources to other countries. Unlike an equivalence arrangement, a Systems Recognition arrangement does not directly affect FDA’s decision at the border whether to permit entry into the United States of food produced in the partner country.
All of us here this afternoon know well – indeed, from personal experience – that the volume of imported food and medical products will only increase in the foreseeable future. This torrent of commerce is perhaps the most prominent manifestation of the globalization I noted at the beginning of my remarks. That’s why it’s essential we work with our foreign counterparts on effective and efficient regulatory standards.
In fact, Systems Recognition agreements in food and the Mutual Recognition Agreement in pharmaceuticals are concrete successes and underscore nicely the overarching theme of the AFDO conference – Pathways to Global Unity.
Moreover, these successes are proof that international recognition efforts are picking up pace and demonstrate how we can build, and help other nations build, a common food and drug safety culture of prevention and verification. Thank you again for being here today.