Hearing focuses on FDA’s ability (or lack thereof) to inspect overseas facilities.
One of the big issues that the COVID-19 pandemic has brought to the forefront is America’s dependence on imports for its medicine.
The Senate Finance Committee met on Tuesday to examine this exact issue, specifically looking at the role of the Food and Drug Administration (FDA) in inspecting these imports. There were serious quality concerns about imported medicine even before the pandemic began, and now there are continued worries that U.S. reliance on countries like China for our pharmaceutical manufacturing could lead to drug shortages.
Committee Chairman Chuck Grassley (R-Iowa) noted that according to the FDA, roughly 50 percent of sites making finished drugs (like say, a tablet) are located abroad, while more than 70 percent of factories making the ingredients that go into that medicine are overseas. Some believe that number is even higher – healthcare expert Rosemary Gibson estimates that 80 percent of the key ingredients in America’s drug supply originates in China or India.
The FDA is charged with conducting oversight of all that medicine, but doing so has been difficult because of the pandemic; the FDA suspended foreign inspections in March.
But even before the coronavirus there were worries. Mary Denigan-Macauley, the director of health care at the Government Accountability Office, testified that her agency has had “long standing concerns about FDA’s ability to oversee” the supply chain around the globe.
For one, the FDA inspects “relatively few” foreign facilities, Denigan-Macauley said. From fiscal year 2016 through 2018, foreign inspections decreased by 10 percent. Part of the problem is that the FDA has significant staff vacancies in its foreign inspection workforce, Denigan-Macauley testified.
When the inspections do happen there are issues. Unlike in the United States, the FDA gives these manufacturers “significant notice”—up to 12 weeks – before it conducts an in-person inspection, which is plenty of time to cover up any issues. There's nothing to compel a foreign manufacturer to agree to an inspection, either, although the FDA can take steps to block the importation of a product if there is a concern.
Language barriers also cause problems. Often, the FDA’s inspector must depend on a translator provided by the manufacturer when conducting their inspection, which also could lead to misleading findings.
There are now growing calls to reshore much of this critical pharmaceutical manufacturing, with some calling it a national security issue. Sen. John Cornyn (R-Texas) pointed out that there were major issues acquiring needed personal protective equipment (PPE) from China during the pandemic. “It seems to me the same thing could happen to our drug supply,” he added.
Douglas Throckmorton, the deputy director for regulatory programs at the FDA’s Center for Drug Evaluation and Research, testified that advanced manufacturing processes developed by American companies could help bring some of this manufacturing home. Doing so has the potential to reduce costs and improve security by condensing the supply chain. It could even reduce the environmental impact of these manufacturing processes.
“We think the U.S. has an advantage in those areas,” he testified.
You can find testimony from the hearing here and watch the entire hearing here.