FDA Inspectors Say Conditions Still Hard
Ten current and former FDA staff members and leaders who spoke anonymously with the investigative journalism newsroom ProPublica say agency inspectors continue to suffer from the impact of significant staff cuts and reorganizations, even as the Trump administration officially denies that the cuts had an impact on inspections. In its report, ProPublica says the issue is that dozens of people who helped coordinate travel for complex inspections of foreign drug manufacturing facilities have been let go, although some have been rehired. Inspectors told the media outlet that the ongoing strain of inspecting an industry spread across more than 90 countries has exhausted staff and could compromise the safety of medications.
One veteran inspector said that nearly 70 people who helped arrange travel, budgets, translators, and contingency plans for investigations were laid off, and only about one-third have been brought back. “It’s difficult to get inspections done,” the inspector said. The pace has slowed down. You can’t inspect as many sites.”
An HHS spokesperson responded to ProPublica that inspections have not been affected by the downsizing. The story says the agency did not address questions about how many people were let go or reinstated, or whether additional help will be brought on.
“To be clear,” HHS said, “FDA inspectors were not impacted, and this critical work continues.”
However, former acting commissioner and CDER director Janet Woodcock reads the situation differently. “It’s like saying, ‘Oh, we didn’t fire any of the doctors and nurses at the hospital, but we fired all the lab techs, all the orderlies, all the phlebotomists ... but the doctors and nurses are still left, so it’s fine,” she said. “A lot of the connective tissue that deals with drug safety and similar things is going to be missing.”
Two inspectors told ProPublica that FDA needs an additional 100 to 200 experienced investigators to be able to do its work.
“I am in utter shock that they don’t support and promote those of us who can do a decent inspection,” one anonymous investigator who looks at facilities producing vaccines, cell therapies, and other biologic products said. “You’re adding to the chaos.”
Former commissioner Margaret Hamburg said, “You can’t just expect the inspector to take care of all the complexities of organizing their trips overseas. Even though it might be said we’ve kept the inspectors, that doesn’t mean that they’ve kept the infrastructure … that actually supports safe and meaningful inspections.”