One of the great triumphs of health policy is America’s generic drug market. Nine out of ten U.S. prescriptions are filled with generics. That overwhelming share saves patients and taxpayers hundreds of billions of dollars annually — and fuels innovation. Pharmaceutical companies know that their exclusivity on new therapies won’t last forever — typically only 12 to 14 years — which incentivizes them to keep developing new treatments instead of relying on older ones.

This achievement rests on one crucial principle: generics compete on cost, not by cutting corners on safety or effectiveness. Patients and providers trust these medicines because the law requires them to be clinically equivalent to their branded counterparts in every meaningful way — from active ingredients and dosage to method of administration, therapeutic outcome, and safety. The 1984 Hatch-Waxman Act cemented this balance, ensuring that American generics are world-leading in affordability, access, and quality.

But the FDA is now threatening that trust.

The agency recently issued new draft rules regarding aluminum contamination in certain injectable drugs, which are the foundation of intravenous nutrition for premature infants who cannot yet feed normally. For these newborns, high aluminum exposure isn’t a minor issue — it can slow bone growth and impede brain development.

For decades, the FDA has insisted that aluminum levels be kept as low as possible — but its new proposal loosens those standards. It grants wide allowances for each ingredient, even if the cumulative total comes perilously close to the danger line. The draft also permits so-called “skinny labels” — narrow instructions that assume hospitals will use the drugs only as directed. Yet the FDA knows it can’t control how medications are used in real-world hospital settings. The reality is that some manufacturers could market products with substantially more aluminum than the safest options currently available.

This shift opens the door to two major problems.

First, premature babies often require more than a handful of these nutritional components. When combined, the FDA’s calculations don’t hold — total exposure can easily exceed safe thresholds. Worse still, neither physicians nor parents will know the true aluminum levels these infants are exposed to — the kind of detail critical to providing safe care.

Second, it undermines drugmakers committed to safer manufacturing. One brand-name producer has proven it can slash aluminum levels by nearly 98%. Instead of rewarding such advances, the FDA’s approach tilts the playing field toward less responsible competitors.

The agency defends its plan as a way to stave off shortages. But its own analysis has shown that shortages are driven by razor-thin profit margins and subpar manufacturing practices — not by safety standards. Lowering the bar won’t solve those issues. It will, however, drive responsible manufacturers out of the market and put fragile infants at risk.

And the implications extend far beyond neonatal care. If regulators are willing to compromise protections here, what’s to prevent similar moves elsewhere? The genius of Hatch-Waxman was its clarity: generics had to match brand drugs in safety and efficacy. Once that line is blurred, trust begins to unravel. Physicians grow reluctant to prescribe, patients hesitate to switch, and costs climb for all.

More than 7,000 American babies are born prematurely each week. They deserve the highest level of protection. But the FDA’s proposal signals the opposite — that safety is negotiable.

If regulators allow savings to come at the expense of quality, the entire generic drug system is at risk. The FDA should withdraw this flawed guidance before it endangers vulnerable infants and erodes the trust that built the world’s greatest generic market.

Sally C. Pipes is President, CEO, and Thomas W. Smith Fellow in Health Care Policy at the Pacific Research Institute. Her latest book is The World’s Medicine Chest: How America Achieved Pharmaceutical Supremacy — and How to Keep It (Encounter 2025). Follow her on X @sallypipes.