The pill in your medicine cabinet is a national security issue

A red speck on an allergy pill may have been the only thing standing between American patients and potentially deadly medication reactions.

In July, batches of cetirizine, the generic version of Zyrtec, were recalled after being contaminated with another drug during manufacturing in India. The contamination was not caught at the factory. It was not caught by FDA import screening. It was caught because a pharmacy technician happened to notice something looked wrong.

It is alarming that systems currently in place were not adequate to ensure drug purity and safety.

Before I became a member of Congress, I worked for more than 30 years as a physician, and I prescribed medications like Zyrtec countless times. Parents brought their children into my office with seasonal allergies, asthma, eczema, and other conditions, and I wrote those prescriptions without wondering whether patients could trust that the medicine inside the bottle was exactly what the label said it was.

Today, that trust is increasingly dependent on factories thousands of miles and an ocean away.

America has pushed more of its pharmaceutical supply chain overseas, leaving us heavily dependent on countries like China and India. More than 80 percent of the ingredients used to make essential medicines are produced overseas , including 90 percent of the raw materials used to produce critical drugs, like the antibiotics penicillin and amoxicillin. China dominates the production of many of those raw materials, while India uses Chinese inputs to manufacture generic medicine. There are serious questions about whether we can trust this supply chain.

American drug manufacturers face strict, unannounced FDA inspections. Foreign facilities have historically received advance notice and are inspected less frequently, despite supplying a large share of the medicines Americans rely on. Even with that warning, foreign plants are still cited for serious quality problems at significantly higher rates than American facilities.

When the medicine our children take, the antibiotics hospitalized patients depend on, and the drugs that millions of Americans use to manage chronic conditions are manufactured abroad, we no longer have just a health care issue. We have a national security vulnerability.

We should be concerned that any foreign nation should have that kind of leverage over the health and safety of the American people. Much more so an adversary like Communist China.

An adversary would not need to fire a single shot to harm millions of Americans. It could simply cut off our supply of life-saving medicines or contaminate them before reaching our shores. Americans deserve to know just how much of their health and safety rests in the hands of other countries.

That is why my colleagues and I have been working with President Trump to take important steps to confront this vulnerability. Making more medicine here at home would not only strengthen our pharmaceutical supply chain but create American jobs, improve oversight, and ensure patients have safe, reliable access to the medicines they depend on.

The Trump administration has put an end to advance notice for overseas FDA inspections, helping ensure that foreign pharmaceutical plants are held to the same rigorous standards as manufacturers here at home. President Trump signed the executive order , “Regulatory Relief to Promote Domestic Production of Critical Medicines,” directing the FDA to improve its risk-based inspection models, strengthen oversight of foreign pharmaceutical facilities, and remove unnecessary barriers standing in the way of producing critical medicine in this country.

However, strengthening oversight of the drugs we import is only part of the solution. We also need to rebuild our capacity to manufacture critical medicines here in the U.S., and I am proud that Missouri is part of the solution.

Sentio BioSciences , based in Maryland Heights, has partnered with the St. Louis API Innovation Center , which received a $14 million Defense Production Act award , to help rebuild our nation’s domestic drug manufacturing capacity.

Sentio BioSciences is working to produce key drug ingredients here in the United States using domestic supply chains. Through advanced technology, the company has found a way to manufacture those ingredients affordably while maintaining the flexibility to quickly shift production when needed to respond to national drug shortages.

Bringing that production back to the United States, and especially to Missouri , will allow innovators to help secure our drug supply, protect patients, and restore the domestic manufacturing capacity our country should never have surrendered.

Americans should not be at the mercy of foreign countries for the medicines they rely on. We should be making more here at home, where we can oversee how they are made and hold manufacturers accountable. At the end of the day, every American should be able to open their medicine cabinet and trust that what is inside is safe.

Bob Onder represents Missouri’s 3rd District in Congress. He is a member of the GOP Doctors Caucus.