Fort Report: Are Our Drugs Safe?

Drug Administration (FDA) gets on inspection of our drugs, according to the director of health care at the Government Accountability Office (GAO).

The GAO recently conducted an extensive study on the safety of our drug supply and discovered that FDA is failing to inspect drug manufacturing facilities overseas. Some facilities have not been inspected for five years or more. Some have never been inspected.

“This is fascinatingly scary,” one Nebraskan told me after my questions as Ranking Member of the House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration (FDA).

We learned early on in the pandemic, in an irony of ironies, that we were over-dependent on China and other foreign countries for our drug supply. In the name of global profiteering, the steady outsourcing of pharmaceutical production to foreign countries—a significant portion of it to the very place of origin of the coronavirus in China—has led to 75 percent of active drug ingredients and 50 percent of finished drugs on the American market being produced outside the United States. From ibuprofen to antibiotics, the question can be asked: are our drugs safe? I invite you to view my line of questions from the hearing.

It’s not difficult to discern why so much of our drug manufacturing moved overseas. Big pharmaceutical companies have likely capitalized on low wages and lax environmental, safety, and labor standards in foreign countries and the unfair duality in how the FDA’s foreign and domestic inspections are carried out. FDA inspectors normally conduct surprise inspections in the United States to ensure that drug companies are producing medicine in a safe, clean, and responsible manner. When it comes to foreign inspections, the FDA customarily gives companies advance notice, often as much as 12 weeks, enabling drug suppliers plenty of time to clean up their acts.

This creates an unlevel playing field for companies trying to manufacture drugs in the United States.

Last year, we changed the law: the FDA now has the power to refuse drugs at the border when it is not granted sufficient access to information about how medicines are produced in foreign-based facilities. Now we need to see an increase in the FDA’s unannounced inspections of foreign-based drug manufacturing facilities to ensure they meet the highest American production standards.

As the pandemic has taught us, putting the health outcomes of our citizens in the hands of other countries is not just an FDA problem, it’s a national security problem.

We know now that China suppressed news about the origins, severity, and timing of COVID-19. If we passively accept the continued overseas manufacturing of a significant portion of our drugs and medical supplies, it creates a significant vulnerability for America.

To be fair, the GAO also said the U.S. enjoys the best inspection regime in the world, and there is a high level of confidence in our drug supply. However, I’d like to see ‘Made in America’ on every prescription bottle. I’d feel a whole lot better.

Congressman Jeff Fortenberry (NE-01) is the Ranking Member of the House Appropriations Subcommittee on Agriculture, Rural Development, and Food and Drug Administration (FDA)