Commissioner Makary Renews Tough Talk About Instituting Unannounced Foreign Inspections

Foreign drug manufacturers are having a time of it these days. On top of the confusion and controversy caused by tariffs, layer FDA’s increasingly aggressive and renewed promises to dramatically expand its foreign drug inspection program. These moves are potentially a potent one-two punch of compliance headaches that could reshape the international drug manufacturing landscape. A coming court ruling on tariffs will be public, but the results of any promised foreign inspection buildup may take years to compile and fully understand. That isn’t stopping Commissioner Marty Makary from talking tough about changes he wants to see happen in this space.

At a recent conference, Makary reiterated his announcement from May that he plans to end what he calls a “double standard” between domestic surveillance inspections that are announced and those conducted overseas, which are often done with advance notice. He remarked that he wanted to ensure that FDA stops “putting companies through the ringer in the United States and then letting companies overseas have a much lighter inspection load.”

FDA has long struggled with the logistical, diplomatic, and legal complexities that prevent robust surprise inspections at foreign establishments. Even before the current Administration vowed to take regulatory relief to promote the domestic production of drugs, FDA’s foreign inspection program was under scrutiny. The Government Accountability Office noted the inherent difficulties in two different 2024 reports. Foreign inspection work is rigorous, with investigators not only on the road constantly but also facing language barriers and security concerns. GAO found that these conditions contribute to high turnover rates, and that investigator workforce shortages have hampered effective oversight. Inspections in China were backlogged in part by that country withholding visas. And because inspections are conducted under the authority of  21 U.S.C. § 374, FDA staff have no legal authority to demand entry at foreign sites. While FDA has other means to ensure compliance, such as the threat of import alerts or other regulatory warnings, it still needs to coordinate with health authorities in-country to conduct these reviews.

FDA has been publicly grappling with these issues for years. Noting the GAO’s reports, the House Energy and Commerce Committee has conducted a lengthy investigation into FDA’s foreign inspection program, including several hearings. Former Commissioner Robert Califf weathered intense Congressional criticism while defending the agency’s foreign inspection program and calling for additional authority and resources, acknowledging that FDA needed to “pick up the rate of its foreign inspections.” Pilot programs in India and China have made some progress; as we noted in a previous post, CDER’s Office of Pharmaceutical Quality recently reported that foreign inspections were on the rise as of FY 2024.

But there are also the RIFs. Though Commissioner Makary has repeatedly tried to distance himself from the April 1 reductions in force at FDA, the elimination of staff has been reported to have had an impact on the foreign inspection program. The logistical and diplomatic issues that have traditionally haunted the program probably aren’t going to be made better by the loss of dozens of critical support staff, despite agency promises that inspectors themselves would be protected. FDA, perhaps acknowledging this, has reportedly re-hired staff to help.

Commissioner Makary’s renewed tough talk about expanded unannounced foreign inspections is a politically potent narrative that perhaps oversimplifies a complex reality rooted in significant logistical constraints, diplomatic protocols, and international law. Nonetheless, he promises that whatever hurdles FDA needs to overcome, this focus is not going away under the current Administration. For foreign drug makers, then, the message is clear: the era of relying on advance notice to prepare for an inspection is ending. The move towards more unannounced inspections, even if gradual, requires a corporate mindset that may need to evolve from “inspection readiness” to a culture of continuous compliance and, if needed, expert advocacy to the FDA once inspections are complete.

We’ll report back with updates.