FDA approved Singapore work trip during government shutdown, records show

SINGAPORE — Sentosa Island boasts the luxury, five-star Ora and Michael hotels, with palm-tree-lined pools, lobbies flanked with luxury stores, and a casino that adjoins both hotels and buzzes with gamblers. The Singapore resort is also where a group of federal employees from the U.S. Food and Drug Administration were sent for a work trip in the final hours of the government shutdown. 

Internal FDA records obtained by CNBC show 31 agency staffers traveled to Singapore in mid-November for a conference of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use, or ICH — a trip that cost more than a quarter of a million dollars, or upward of $8,000 per person, according to the documents. The travel was approved when the agency was operating with reduced staffing and limited resources in part due to the shutdown. 

The FDA is under significant pressure. The Trump administration proposed an 11.5% cut to the FDA’s budget this year. Nearly 1,900 staffers were laid off, and around 1,200 others took early retirement packages, according to May testimony from FDA Commissioner Marty Makary. In addition, senior leadership has been in upheaval, and former FDA chiefs have publicly questioned the agency’s handling of key issues such as vaccine policy. 

The FDA attendees at the Singapore conference ranged from deputy directors to a program coordinator, records show. Their travel was approved about one week before the end of the government shutdown — the longest in U.S. history, at 43 days. Most staffers departed on Nov. 12, the same day the U.S. House of Representatives voted to end the shutdown, and the remaining travelers left Nov. 13 and 14, according to the documents. 

The ICH, registered as a nonprofit under Swiss law, says it aims to unify the global standards for drug development and approval. The conference, held Nov. 18-19, took place in a series of meeting rooms on the island resort grounds.

ICH told CNBC in an email that “approximately 500 people attended in person,” including regulators and pharmaceutical industry experts from around the world. It also wrote that the “FDA is one of the founding members of ICH” and helps develop the requirements for “safe, effective, and high-quality pharmaceuticals.”

As part of the November assembly, three guidelines were adopted that aim to streamline global drug development and safety monitoring, according to the ICH. In a follow-up email, the organization said the first guideline provides a template to eliminate “inconsistent formats” in clinical trial protocols and ease electronic data sharing. The second seeks to ensure post-approval safety reports are “complete, accurate and timely” by aligning definitions and reporting practices, it said. The third adopted guideline sets international standards for noninterventional, real-world data studies to ensure they are “scientifically sound” and comparable across regulators.

FDA staffers contributed to all three of these guidelines, according to conference documents.

The FDA said in a statement to CNBC that sending staffers to the meeting was “mission critical” and that the purpose of the conference was to “support global alignment on drug development, approval standards, and regulatory science.” A spokesperson for the agency said the conference required approval from leadership, including the FDA’s chief operating officer, Barclay Butler. Attendance by FDA delegates in the prior two years ranged from 47 to 49, the spokesperson said, noting this year the agency sent 31.

Dylan Hedtler-Gaudette, acting vice president of policy and government affairs at the Project On Government Oversight, a nonpartisan watchdog group that champions government accountability, said the optics of sending dozens of FDA staffers to an overseas conference during a government shutdown are not good. 

“FDA is a critical organization that does really important work as far as our health-care system, our food system, our medical device system,” Hedtler-Gaudette said. “I would hope that FDA leadership and the administration would place a higher degree of priority on making sure the organization, the agency is resourced completely rather than needing to attend specific conferences or events.”

Hedtler-Gaudette said that even if the conference is important, that does little to quiet questions about the agency’s priorities. 

“At a minimum, it’s a kind of bad look and it’s poor optics,” Hedtler-Gaudette said. “At the worst, it could be a kind of a dereliction of duty and a misuse of public resources.”

The FDA told CNBC the trip did not rely on taxpayer dollars, saying it was funded through the agency’s carryover user fees — money collected from companies that make drugs, devices and other medical products to pay for regulatory work such as product reviews and inspections. 

“Those dollars are still public dollars,” Hedtler-Gaudette said. “They still need to be treated and guarded with as much respect as direct tax dollars do.”

An internal email from Butler, dated Oct. 1, said user fees should be applied only to work that is permitted to be funded by user fee carryover and “activities that are necessary to address imminent threats to the safety of human life or protect property.” 

The FDA itself seemed to be aware that any travel during the shutdown could be poorly received.

“Due to the optics of business travel conducted during a shutdown, conference approval will be handled by FDA’s senior leadership on a case-by-case basis,” the FDA said in a document that was posted on its website as recently as mid-November. On Dec. 3, the day after CNBC asked the agency for comment on the document, it was no longer available on the website.

“The agency routinely updates its webpages to ensure information remains accurate and consistent with current policy,” an FDA spokesperson told CNBC.

In an internal email chain between FDA directors and Chief Financial Officer Benjamin Moncarz, obtained by CNBC, Director Michelle Tarver sought to “come to an agreement for legal and optics consistency on how we are handling travel during the lapse in appropriations.” Tarver proposed to “cancel conference attendance and the associated local, domestic, and international travel.” She went on to say that the FDA would “allow virtual speaking on exempt (i.e., user fee) topics only.”

In a Nov. 6 email exchange about the ICH conference, the discussion of whether to send staffers to Singapore rose to the highest ranks of the FDA. In the email, FDA Deputy Chief Financial Officer Sahra Torres-Rivera wrote that the agency had “agreed to limit in-person participation at conferences” but noted that “the final decision ultimately rests with … leadership.”

Next year, the biannual conference will be held in Rio de Janeiro and Prague.