Securing a healthier future through generic drugs

Last year, the U.S. Senate Special Committee on Aging launched a bipartisan effort to expose the public health and national security risks America’s overreliance on foreign-made generic drugs poses to families.

However, a recent piece in Real Clear Markets tried to spin our lifesaving efforts as playing political games, claiming there was little evidence or reason for concern.

This isn’t a game to me, and to suggest as much downplays the very real risks of relying on adversaries like Communist China and countries like India for much-needed medicine to live. This shouldn’t be a game to anyone – it’s about making sure parents and grandparents can trust the medicines they’re giving to their kids and grandkids. It’s about ensuring you never have to rely on other countries for the prescriptions you need to stay alive.

Generics make cost-effective, lifesaving medicine readily available for every American. Families deserve to know their generic drugs are safe, so they can make a choice about what’s best for them – even one instance that proves otherwise is one too many.

The truth is, most of our generic drug supply comes from overseas, produced in underregulated markets and in factories with far less oversight than those in the United States, and the danger of our overreliance on foreign-made medicines and Active Pharmaceutical Ingredients (APIs) from India and Communist China cannot be overstated.

Most people don’t understand how vulnerable our country’s pharmaceutical supply chain is, even though they’ve experienced it themselves. We all remember COVID and the scramble to find medicines and medical supplies. We simply did not produce enough of these vital items in the U.S. Shortages were felt across the supply chain, as doctors ran out of lifesaving cancer drugs and asthma inhalers, and parents scrambled for Tylenol and specialized baby formula.

Even now, Communist China – a self-declared enemy of the U.S. – has banned exporting rare earth minerals to the U.S. as retaliation for basic policy decisions. It is not out of the realm of possibility that Xi and his thugs could extend that ban to APIs or specific medicines in an attempt to bring our country to the negotiating table, or to its knees. We can’t wait for them to do so before we ramp up domestic manufacturing of these life-saving drugs.

Scarcity and quality are also tied together. When faced with shortages, the Food and Drug Administration (FDA) has been known to allow imports of drugs from foreign factories flagged for quality and safety concerns. Patients and doctors are not told when those exemptions are made – they just have to trust and be grateful to have any drugs at all.

Several reports also show that relying on foreign-manufactured drugs results in higher rates of serious adverse events – like hospitalization and death – than drugs made in and with ingredients from the U.S. Not too long ago, contaminated Heparin from Communist China resulted in over 100 deaths, and spoiled eye drops from India led to serious health complications, including death and vision loss in patients.

Just recently, we saw a recall of Indian-made cholesterol drugs due to manufacturing defects. While this issue was caught, not all of them are. The FDA is still dealing with an inspection backlog from COVID, and when a former FDA inspector testified before our committee, he described significant hurdles that slow overseas inspections. He also testified to horrifyingly unsanitary conditions at some of these factories, including water dripping from pipes and cats roaming the floors, and how factories exploit loopholes to shift production without fixing these issues.

That means moms picking up a prescription for their kids or families taking care of their aging parents are just expected to hope and pray that the medicines they’re giving their loved ones are some of the good ones. I refuse to accept that for my family, and neither should you.

This issue won’t be solved overnight, but we are working to find bipartisan, commonsense solutions that keep drugs safe, affordable, and accessible. Our CLEAR Labels Act is a first step in the right direction. This bill, which I announced at our most recent Aging hearing, would provide transparency to families by requiring country-of-origin labeling for final drug products and APIs. As one of our witnesses testified, he’d take a drug from India or China over no drug at all, but he would take an American-made drug over a Chinese or Indian one every time.

Families deserve to have confidence that the medicines they take are safe, regulated, and clearly labeled so they can feel comfortable knowing what’s in their medicine cabinet.

This is just the start. I plan to keep working with experts across the political spectrum and around the country to address this threat and ensure Americans never have to worry about getting affordable, safe medicines when they need them.