Guam Series: FDA Presence and Impact in Pacific Islands Pt. 1 of 5: FDA’s ACRA describes regulation in the Pacific Islands

Host Ulysses Garrett: Hello and welcome to a brand-new episode of ORA Speaks, the podcast for ORA where we dig deep and explore the impactful work being done to protect the public health. I'm excited to present to you this five-part series focusing on the FDA presence in the Pacific Islands and how important that relationship is.

I'm your host, Ulysses Garrett, from the Office of Regulatory Affairs. My guest for the first of five episodes in this series is none other than the Associate Commissioner for Regulatory Affairs within FDA in ORA, Mr. Michael Rogers.

Michael, thank you for joining me today. How are you, sir?

ORA’s Associate Commissioner for Regulatory Affairs Michael Rogers: I'm fine, and thanks for having me. It's a pleasure to be here.

Mr. Garrett: Absolutely. Let's get into it, Michael. Can you provide an overview for the Pacific Islands Territories Project and explain why it's important for both the FDA and the people of Guam that the FDA have a presence in this strategic location?

Mr. Rogers: Yes, thanks for that question. This is an important initiative, and I applaud Dan Solis, who is the assistant commissioner of our Office of Import Operations for establishing this novel program and approach that quite frankly, addresses the potential gap in our regulatory oversight for imported products from the region and to that region.

It's estimated that 95% of the FDA-regulated products in Guam are imported. So, this includes essential medical products, and foods, and cosmetics, and dietary supplements, and tobacco products. And enhancing our import related engagement in this region will ensure that we continue to protect the public by keeping unsafe and unregulated products out of the supply chain before they enter all U.S. ports. It's also our responsibility to protect the health of those who live on the islands. So, our presence there is strategic and long overdue.

Guam and neighboring Pacific Islands are all U.S. territories, but they don't have the same robust import screening procedures that we have at local ports of entry. And our presence there closes the gap in the FDA import process and provides regulatory oversight and public health protection for U.S. citizens that live on the island as well as the mainland.

We also know that this channel, as I mentioned, has been a gateway for products to come to the mainland, and we're now closing these gaps by applying our import tools, our knowledge and expertise, and sharing information with our federal partners on the island. And we're seeing a lot of successes.

Mr. Garrett: Now, what are some of the biggest opportunities that you see on the horizon for the FDA as we continue to grow our presence in this region?

Mr. Rogers: We're seeing that this is an opportunity to expand the program and leverage what we're learning. I can tell you that the Guamanian government has also expressed appreciation for our presence in the region. We've been there continuously in Guam since June of 2022, with temporary staff engaging with local customs and health authorities. And we've talked about some planned expansions for 2024 and 2025 that will include hiring a long-term supervisor, as well as continued temporary staffing from various offices around FDA. The Guamanian Environmental Protection Agency and the FDA are working towards the development of a lab partnership agreement anticipated to be signed in the summer or fall of this year.

And part of our strategy also involves providing training. We continue to work with the Guamanians to provide additional courses on traceback and foodborne outbreak investigation, import product examination, pest control, retail food code, and the Association of Food and Drug Officials training.

And so, the FDA will also partner with Guam Behavioral Health and Wellness to establish an Opioids Taskforce to share information and gather supply chain data related to opioid issues. And we're strengthening the capacity for emergency response and the use of Narcan, also known as Naloxone.

Meanwhile, we continue to gather intelligence on operations that will enable us to move forward with increasing the FDA presence in the Pacific, including other US territories like the Commonwealth of Northern Mariana Islands.

The FDA also plans to have the Division of Food Defense Targeting CSOs offer around the clock coverage for bioterrorism review of imported FDA products coming from around the globe into our ports of entry in US territories.

Mr. Garrett: Now, what other accomplishments can you share with us?

Mr. Rogers: I can tell you that as a result of our presence, we have a better understanding of the products that are moving through Guam's ports. And the FDA and the government of Guam signed a partnership agreement on October 2023 that formalizes our mutual commitment to coordinate oversight activities related to a wide range of products that people use and depend on every day.

Our presence has also resulted in our ability to protect American consumers from a wide range of dangerous products by examining what's offered for import into the U.S. and analyzing samples in our laboratories. With our partners, we've identified numerous violative and illegal products and prevented them from reaching U.S. consumers. We've also issued public notices to warn consumers about these products when we encounter these violative conditions.

Mr. Garrett: Now, I know with a project this big, this might be an issue here or there, but can you tell me about just a few of the challenges the agency has to the agency has overcome while establishing a more solid presence in Guam?

Mr. Rogers: Yeah, we've learned a lot from the FDA Health Care Fraud and Abuse Control Guam Pilot. We've learned that products imported into Guam and other Pacific Islands don't undergo the same level of oversight as other U.S. ports of entry. And quite frankly, our lack of presence there has been a regulatory gap in our import admissibility process. And so, our presence there now addresses this issue.

Whenever a violation is found, we do take action to prevent products from entering the U.S. but we also allow and facilitate the entry of compliant products into the country. And so, that's the primary reason we're there and we're seeing a lot of success.

Mr. Garrett: Well, Michael, as we wrap this up, my last question to you is how would you define success in Guam and what are the next steps to ensure that we are able to maintain the critical regulatory oversight that we've been able to establish in the Pacific Islands?

Mr. Rogers: We've taken steps to increase the scope and effectiveness of our mission through several initiatives, including educational and community outreach related to the oversight of imported products. I think to succeed, we're going to need to keep identifying opportunities to enhance criminal investigations, laboratory engagement, import operations in the form of identifying FDA products that can be sampled and tested, and help local partners in investigation training in the areas of, for example, traceback to support foodborne outbreak investigations.

We'll also continue to work closely with our public health partners in Guam. Without them, we can't fully achieve our mission to protect public health by preventing unsafe products from entering and passing through this region.

And with that, I just want to thank you for the opportunity to highlight this important work, and I encourage this audience to stay tuned to this podcast series for more exciting news and accomplishments from this partnership agreement and relationship.

Mr. Garrett: Well, thank you, Michael. Thank you for being the very first guest on this five-part series as we highlight the work that is being done in the Pacific Islands. And thank you once again, doing a wonderful job and all that you do as the ACRA here in the FDA and ORA.

And I want to thank you for listening to ORA Speaks. This is part one of a five-part series as we showcase and highlight the work that is being done in the Pacific Islands.