HP&M Counsel John Claud Provides Testimony to House Subcommittee on FDA Foreign Inspections

February 7, 2024By Kurt R. Karst

The House Committee on Energy and Commerce Subcommittee on Oversight and Investigations invited Hyman, Phelps & McNamara, P.C. Counsel John Claud to testify yesterday about FDA’s foreign inspection program. Mr. Claud frequently counsels foreign and domestic clients on issues relating to inspections and cGMP remediations.

We’ve blogged previously on the troubles FDA has faced ramping up its foreign inspections program after the pandemic. Yesterday, Mr. Claud went to Capitol Hill to participate in a hearing called “Protecting American Health Security: Oversight of Shortcomings in the FDA’s Foreign Drug Inspection Program.”

Mr. Claud was joined in his testimony by Mary Denigan-Macauley, a Director for Health Care at the Government Accountability Office (GAO) and Dinesh Thakur. Mr. Thakur is a public health advocate and a former executive at Ranbaxy Laboratories in India. FDA was invited to attend but did not.

GAO wrote a thorough 2022 report that assessed relative lack of foreign inspections for drug making facilities, and dissected the complex problems that make foreign inspections difficult for FDA. The Subcommittee majority has held prior hearings and written letters about these problems, as the issue has vexed FDA in recent years. In fairness, we’d note that FDA reports that inspections are on the rise—but definitely not back to pre-pandemic levels.

In its 2022 report, GAO recommended that FDA initiate pilot programs that assess unannounced international inspections. At the hearing yesterday, several Subcommittee members expressed dismay that FDA announces international inspections, an Agency policy due in part to the logistical burden of getting inspectors to foreign sites. The Chair of the Subcommittee, Morgan Griffith (R-VA), noted that “It’s alarming that—given this advanced warning—the FDA still found deficiencies during 66 percent of foreign inspections, including serious deficiencies in 16 percent of those inspections.”

The hearing also featured discussion about high turnover in FDA’s inspector employment ranks. GAO found that “vacancies among investigators available to conduct foreign inspections represent another challenge” for FDA, and that in some cases FDA relied on translators supplied by the inspected facilities. The Subcommittee members discussed how the Agency might make those jobs less apt to turnover. Several minority members called for flexible appropriations so that international inspectors could be fairly compensated.

In his remarks, Mr. Claud noted that FDA might make more efforts to gather evidence using technology. Teleconferences, document review, and other remote tools may not be a full inspectional cure for a bad actor, he said, but using remote inspections to “contribute to FDA’s risk assessment” might allow the Agency to divert resources to other, more dire inspectional priorities that require an in-person presence.

He also noted the outsized impact that the foreign inspection issue has on the generic industry, which faces stiff competition from many foreign manufacturers for already thin profit margins. Finally, Mr. Claud noted that FDA should also rely on its like-minded foreign counterparts and its cadre of mutual recognition agreements to ease the foreign inspection burden.

The Members of the Subcommittee and the witnesses all acknowledged that these are complex issues, and the Chairman went out of his way to say that “The FDA . . . is trying to do the best they can. We just need to figure out how to make them a little quicker and more agile.” Mr. Claud closed his testimony echoing that sentiment. He said that resolving the obstacles to successful international inspections that FDA faces “are vitally important challenges in a global marketplace.”