WASHINGTON — Senators from both parties blamed the Food and Drug Administration and manufacturers for keeping Americans in the dark about where exactly their prescription drugs are made, during a Senate hearing Thursday.
While food and clothing products commonly include “Made in” tags, drug manufacturers can keep their sourcing locations confidential as per current FDA regulations. Some companies voluntarily disclose the location a drug is manufactured, but this doesn’t mean the active ingredients were also sourced there. The latter is not required to be disclosed to the public because FDA considers the information as trade secrets.
“I find it unconscionable, though, that we require transparency for our dinner and for our denims but not for the critical drugs that save people’s lives,” said Stephen W. Schondelmeyer, a witness and professor at University of Minnesota’s College of Pharmacy.
Lawmakers framed the issue as not just one of consumer transparency, but also a potential health risk. Kirsten Gillibrand, D-NY., called the U.S. “extremely vulnerable” when relying on foreign sources for essential drugs.
Republicans emphasized that the U.S. depends too heavily on China and India in particular, amid geopolitical conflict.
“If the government of communist China, a self-described enemy of the United States, wants to stop the supply of prescription drugs to the United States, they can do so at any moment,” said Sen. Rick Scott, R-Fl.
Schondelmeyer testified that India does not currently collaborate in the International Council of Harmonization of Regulation, unlike China. The council is a global collaboration that aims to set uniform drug standards, of which India was not a founding regulator. He asked senators to begin to “pressure them” to join.
“Many Americans who rely on prescription medications, particularly seniors… have no way to determine where medications are manufactured, denying them to choose American-made drugs,” Moody said.
Moody again pointed toward insufficient FDA enforcement. The FDA’s current regulations allow for China and India to exert control over drugs that Americans need “in order to stay alive,” she said.
Scott introduced the Clear Labels Act, which would require finished drugs to be labeled with their country of origin and where active ingredients were made.
Scott specifically proposed a QR code system, where every prescription drug package would have a QR code linking to a public, searchable database with more comprehensive information that cannot fit on the limited space available on packaging.
The bill has not yet been referred to committee action.
