Representative Greg Walden (R-Hood River) spoke at an Energy and Commerce Subcommittee on Health hearing on the safety and national security concerns over the U.S. reliance on drugs and pharmaceutical ingredients manufactured abroad.
As Republican Leader of the Energy and Commerce Committee, Walden has been committed to working to provide government agencies with the tools necessary to ensure the safety and quality of the U.S. drug supply. Walden started out by speaking about the recent recalls of certain drugs used to treat high blood pressure and how these recalls have led to increased concern about America’s sourcing of drugs.
“Historically, medicines intended for use in the United States have been produced in the United States,” said Walden. “However, over the last several years, more drug manufacturing has moved offshore. Much of this shift can be attributed to low wages and less regulation in other countries, resulting in lower production costs for drug manufacturers. With this shift overseas, it has become more difficult for us to verify these products are made in compliance with what I would say are the world’s best standards, those are the United States.”
The Energy and Commerce Committee has a history of providing oversight of the U.S. drug supply. Congress passed the Food and Drug Administration Safety and Innovation Act in 2012, which provided FDA with new resources needed to inspect both domestic and foreign generic drug facilities. Recent data from the GAO report in 2016 found that FDA had increased its foreign drug inspections and enhanced its ability to prioritize drug establishments for inspection. For example, GAO found that FDA foreign inspections increased from 333 in 2007 to 842 in 2015.
“However, it has been reported that FDA surveillance inspections of foreign facilities have declined in the past two years, including in China where inspections fell by almost 11 percent,” said Walden. “While inspections are not the only means for ensuring the drug supply is properly protected, it is an important piece of the puzzle and we must ensure the FDA has the appropriate oversight measures in place.”
Walden continued on and requested an update on FDA’s current practices from GAO.
“If there are gaps in the agency’s ability to properly oversee these facilities, action must be taken to resolve those shortcomings and protect the public health,” said Walden.
“The United States’ reliance on overseas manufacturing not only raises quality concerns, but it also poses national security risks as well,” said Walden. “Foreign manufacturing of medical products critical to the Strategic National Stockpile are subject to the same quality and safety concerns, but dependence on foreign countries for drugs used as medical countermeasures could also leave Americans vulnerable to chemical and biological threats, among others. Further, reliance on foreign suppliers, particularly in those countries with which we have unstable relationships, poses an increased risk to Americans.”
Walden concluded by emphasizing that the U.S. cannot let other countries monopolize the production of the U.S. drug supply.
“If a country monopolizes the production of a drug and wishes to retaliate against the U.S., they could substantially increase drug prices or reduce supply in an attempt to cause shortages, limiting access to critical medications,” said Walden. “And that is in the absence of a crisis. In a time of crisis, such possible actions could mean American lives.”