FDA’s Drug Office Handling Disputes, Complaints Goes Dark (1)

The FDA’s office that investigates complaints and disputes between reviewers and the drug industry is currently unavailable following US Health Secretary Robert F. Kennedy Jr.’s massive layoffs across federal health agencies.

The office, known as the Center for Drug Evaluation and Research Ombuds, receives questions and investigates complaints from regulated industry, law firms, and health-care providers to informally resolve disputes between those entities and the FDA’s drug reviewers.

Bloomberg Law received an automated email Friday from CDER Ombuds that said its “services are currently unavailable at the Food and Drug Administration.”

“We recommend that you email us again in May, at which time we hope to have more information,” the email said. A source familiar with the matter also confirmed that staff in that office were part of the reduction-in-force and placed on administrative leave.

The disputes handled by CDER Ombuds range from regulatory and scientific issues to administrative topics. The office serves as a “one-stop-shop” for quick and informal advice or referrals, according to the agency.

The inactivity of the office comes after the Department of Health and Human Services executed massive layoffs April 1 across federal health agencies, aiming to drastically reduce the size of its workforce. The cuts targeted 3,500 employees at the FDA, which broadly hit staff working in program management, human resources, technology, policy, and communications, as well as several top leaders with years of institutional knowledge.

Virginia Behr, who served as CDER’s ombudsman for over 18 years, retired from the agency April 10, according to a separate automated email received by Bloomberg Law.

The office is “very well respected within FDA and with industry,” said Howard Sklamberg, a former director of compliance at CDER.

“They have helped resolve issues with important drug applications that have enabled patients to have access to new drugs,” said Sklamberg, who’s now a partner at Arnold & Porter Kaye Scholer LLP. “If the office has been shut down, that would be a huge loss and would be an impediment to timely and thorough review of drug applications.”

The office is also a way to resolve process issues with the agency, said James Ravitz, co-head of McDermott Will & Emery’s life sciences practice and head of McDermott’s FDA group.

“If that office isn’t active, then the industry will have a really difficult time addressing complaints and process disputes,” Ravitz said.

The HHS did not respond to requests for comment.