Chairman Rick Scott Calls for Transparency of Foreign-Made Generic Drugs, Announces CLEAR LABELS Act to Require Country-of-Origin Labeling

WASHINGTON, D.C. - Today, Chairman Rick Scott led a hearing entitled "Truth in Labeling: Americans Deserve to Know Where Their Drugs Come From," in which he exposed the serious risks of America's overreliance on foreign-manufactured, generic drugs and announced his CLEAR LABELS Act, legislation requiring country-of-origin labeling for prescription drugs in the United States.

A significant portion of prescription medications are manufactured in Communist China and India, often under limited regulatory oversight, leaving patients and health care providers with little clarity about where their medicines originate. Committee members and expert witnesses evaluated the risks this poses to patient safety and supply-chain resilience and offered potential legislative solutions to curb this crisis and protect America's drug supply chain.

Chairman Scott has been a leading voice in strengthening oversight of America's pharmaceutical supply chains and confronting the United States' dangerous overreliance on foreign-manufactured generic drugs. Today's hearing followed a bipartisan investigative report he led to expose these vulnerabilities and advance greater accountability on these generic drugs. Building on this report, Chairman Scott and Ranking Member Gillibrand have sent more than a dozen letters to federal agencies and industry leaders seeking information and pressing for greater transparency into the generic drugs Americans rely on every day. The committee's recent hearings on September 17, October 8, and November 19 further examined the risks posed by foreign dependence and explored policy solutions to expand domestic manufacturing and ensure Americans' access to safe, high-quality medicines.

Chairman Scott's witnesses for today's hearing included Dr. John Gray, Ph.D., dean's distinguished professor of operations at Fisher College of Business at The Ohio State University; Dr. Michael Ganio, Pharm.D., senior director, pharmacy practice and quality, at ASHP; and Dr. Stephen W. Schondelmeyer, Pharm.D., Ph.D., professor of pharmaceutical management and economics, College of Pharmacy at the University of Minnesota. Their testimonies highlighted critical vulnerabilities in the U.S. drug supply chain, outlined the risks created by limited visibility into foreign manufacturing practices, and emphasized the need for stronger reporting and country-of-origin labeling requirements to protect patients, support health care providers, and incentivize domestic pharmaceutical manufacturing.

Watch Chairman Scott's full remarks HERE. Read Chairman Scott's remarks as prepared for delivery below:

"The U.S. Senate Special Committee on Aging will now come to order.

Last year, this committee exposed the public health risks and national security threat posed by America's overreliance on Communist China and India for generic drugs and the drug ingredients that make them - known in the medical industry as APIs.

Together, Ranking Member Gillibrand and I led a bipartisan effort to demand accountability.

We sent letters to the Food and Drug Administration, the Department of Veterans Affairs, and key industry stakeholders, including large drug purchasers, distributors, and major pharmacies.

The Aging Committee sounded the alarm and exposed the dangers in Americans' medicine cabinets.

Our committee also released a bipartisan report detailing the extent of these threats and held three hearings; in the first hearing, we heard from experts about the problems we face for our massive reliance on foreign-made generic drugs.

We heard horrifying stories from a former FDA inspector about how dangerous and unregulated these drugs from Communist China and India can be. And we learned about the tragic deaths caused by failures to make sure the medicines Americans rely on to heal and treat them are actually safe.

In the second hearing, we discussed solutions that create safer medicines, secure our supply chains so we aren't dependent on adversaries like Communist China for our medicines, and create good-paying American jobs by bringing drug manufacturing BACK TO AMERICA.

And in the third hearing, we heard from American drug manufacturers about the hurdles they face when they try to ramp up domestic production.

What we uncovered during this investigation will shock you…

91% of prescriptions in the United States are generic drugs.

Of those drugs, almost 94% use APIs, produced and processed overseas in factories, predominantly in Communist China and India, that have little to no FDA oversight.

When the FDA does make it abroad to inspect these facilities, they often warn them in advance, which gives them time to cover up any longstanding issues before inspectors see them.

Somehow, even with all of this time to prepare, we still see reports of skittering lizards and birds flying around foreign facilities. Does that sound safe and sanitary to you? NO.

Here's the deal…we face two problems that every American needs to understand…

One is that foreign-manufactured generic drugs are made with untested and dangerous APIs from countries like India and Communist China. That means we can't trust these drugs because we know they are less safe than those made in American.

And the second, is that fixing that problem is made difficult by our own government bureaucracy that blocks American drug manufacturers and fuels our overreliance Communist China and India to make generic drugs.

We face not just a serious public health risk, but a massive national security threat as well.

Think about it: if the government of Communist China, a self-described enemy of the United States, or India, wants to stop the supply of prescription drugs to the United States, they can do so at any moment.

If that happens, the United States has no plan to keep these generic life-saving drugs needed by millions of Americans available.

This may sound far-fetched, but we're seeing it play out in real time: Communist China has already limited exports of items like rare earth minerals, and during the COVID pandemic, India blocked the export of critical pharmaceutical ingredients.

It can happen again.

If we can't solve this problem, it is only a matter of time before more American lives are unnecessarily lost.

We cannot allow that to happen. We MUST act now.

This is why I am taking action to address these threats immediately, with the introduction of my CLEAR LABELS Act.

This bill would require country-of-origin labeling for pharmaceuticals, so that physicians, pharmacists, and most importantly. the American families taking these medicines, know where these essential drugs are coming from.

Every American deserves honesty and transparency about what they put into their bodies. We label food, clothes, and other products, but we don't require that same standard for medicines that Americans, and especially our aging population, rely on.

Can anyone really disagree with that? It is wholly irresponsible that we are living in the dark when it comes to where our medicines are made.

My bill changes that. Under my bill, finished drug products prescribed and sold in the United States would need to identify the name and location of each included API's original manufacturer, as well as the packer or distributor, right on the label or through a searchable electronic portal.

This is a simple and commonsense reform that will bring transparency and accountability to our generic drug supply.

The fact is, most Americans would prefer to buy American when they can. Unfortunately, with drugs, too often the information about the country of origin isn't readily available. They want to know that what they're taking is safe. And they want to support American jobs.

By labeling these essential drugs, Americans will have more information to help them make well-informed decisions for themselves and their families.

It will also encourage more domestic drug manufacturing, making sure generic medicines that our aging population and all Americans rely on are more effective and readily available.

Country-of-origin transparency is not just a consumer right; it's a matter of national security, public health, and American pride, and I invite all members of the committee to join me and cosponsor this legislation.

We can get country-of-origin labeling done now, to allow stakeholders at every stage of health care, especially the patient, to be confident and informed about the medications they take.

I look forward to hearing from witnesses today on how we can empower patients to make the best choices for themselves and their families when it comes to where their medicines come from."

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