How Government Controls Generic Drug Prices in the U.S. Today

How Government Controls Generic Drug Prices in the U.S. Today

When you pick up a prescription for generic lisinopril, metformin, or atorvastatin, you probably assume the price is low because competition keeps it that way. But what if the price suddenly jumps 300%-and there’s nothing you or your doctor can do about it? That’s not a hypothetical. In 2024, a simple generic drug called pyrimethamine (Daraprim) went from $13.50 a pill to over $40, and the reason wasn’t inflation. It was lack of competition.

How Generic Drug Prices Are Really Set

The U.S. doesn’t have a single agency that sets drug prices. Instead, it relies on a patchwork of rules, rebates, and market forces. For brand-name drugs, manufacturers can charge whatever the market will bear-until Medicare starts negotiating prices under the Inflation Reduction Act (IRA). But for generics? The system is even more complicated.

Most generic drugs are priced by competition. When a brand-name drug’s patent expires, dozens of companies can make the same pill. That usually drives prices down-often to 80-85% below the brand version. But that only works if there are enough manufacturers. When only two or three companies make a drug, they can quietly coordinate prices-or one can drop out, leaving the rest to raise costs without fear of losing customers.

The government doesn’t set those prices directly. But it does control how much it pays. Medicaid, Medicare Part D, and the 340B program all rely on a formula tied to something called the Average Manufacturer Price (AMP). Every quarter, generic drug makers report their AMP to the Centers for Medicare & Medicaid Services (CMS). Then, CMS calculates how much rebate the manufacturer owes Medicaid based on the higher of two numbers: 23.1% of the AMP, or the difference between the AMP and the best price the company gave to any private buyer. In 2024, these rebates totaled $14.3 billion-78% of all Medicaid drug rebates.

What Medicare Part D Really Costs for Generics

If you’re on Medicare, your out-of-pocket cost for a generic drug can be $0-or $45-depending on your plan. That’s because Medicare Part D plans negotiate their own deals with drugmakers and pharmacy benefit managers (PBMs). The government doesn’t set those prices, but it does set the rules for how plans structure their coverage.

In 2025, the standard Part D benefit requires you to pay 25% of the drug’s cost during the initial coverage phase. But the IRA changed everything. Starting in 2025, your annual out-of-pocket spending on all drugs-including generics-is capped at $2,000. That’s huge for people taking five or six generics a month. Before, someone on multiple medications could easily hit $8,000 in out-of-pocket costs and enter catastrophic coverage. Now, they’re protected long before that.

Low-Income Subsidy (LIS) beneficiaries pay even less: between $0 and $4.90 per generic prescription. That’s because the government covers most of the cost. But here’s the catch: the price you see at the pharmacy counter isn’t the real price. The manufacturer might sell the drug to a wholesaler for $1.50, but your plan pays $15. The rest goes to PBMs in rebates and fees-none of which usually reaches you.

The Hidden Middlemen: How PBMs Keep Prices High

Pharmacy benefit managers (PBMs) are the invisible middlemen between drugmakers, insurers, and pharmacies. They negotiate rebates, manage formularies, and set what pharmacies get paid. But their system is built on opacity.

A 2025 Senate HELP Committee report found that 68% of the so-called "savings" from generic drug rebates never reach patients. Instead, PBMs keep the difference as profit. One common trick: they tell your plan a drug costs $10, but the manufacturer actually sold it to them for $3. They pocket $7, and your copay stays at $5. You think you’re getting a deal. You’re not.

Independent pharmacies, especially small ones, are caught in the middle. They’re paid based on the plan’s reimbursement rate, not the real cost of the drug. If the PBM changes the reimbursement rate overnight, the pharmacy loses money. That’s why some pharmacies refuse to fill certain generics-they can’t afford to lose money on them.

Phantom middlemen weave through a city, crushing generic pills while patients reach helplessly upward.

Why Some Generics Cost Way More Than Others

Not all generics are created equal. Some, like metformin or hydrochlorothiazide, cost pennies because dozens of companies make them. Others, like nitrofurantoin or cyclophosphamide, can cost $50 or more because only one or two manufacturers remain.

This happens for a few reasons:

  • Low profit margins make it unattractive for manufacturers to produce certain drugs.
  • Complex manufacturing requirements (like sterile injectables or controlled substances) limit who can make them.
  • Consolidation has reduced the number of generic manufacturers from 2,100 in 2015 to just 1,500 in 2025.

When competition disappears, prices spike. The case of pyrimethamine is extreme, but not unique. In 2024, the FDA identified 37 generic drugs with only one manufacturer. For 12 of them, prices rose more than 200% in the previous year. The government doesn’t step in unless someone complains-and even then, it’s slow.

What’s Changing in 2026 and Beyond

The Inflation Reduction Act didn’t just cap out-of-pocket costs. It also opened the door for Medicare to negotiate prices on certain high-cost drugs. But here’s the twist: generics are mostly exempt. The law targets brand-name drugs with no competition. But in September 2025, CMS announced it would include generic versions of two blockbuster drugs-apixaban (Eliquis) and rivaroxaban (Xarelto)-in its 2027 negotiation list.

Why? Because even though they’re generics, only one company makes them under patent exclusivity. That’s a loophole. If Medicare can negotiate prices on these, it could cut costs by 25-35% for over 5 million beneficiaries. That’s a $40.7 billion market. If it works, expect more generics to be added in future years.

Meanwhile, the 340B program continues to help safety-net clinics. Hospitals and community health centers that serve low-income patients buy drugs at 20-50% off the AMP. For many, it’s the only way they can afford to stock essential generics. Patients at these clinics report 87% better adherence to medications because they can actually pay for them.

A celestial scale balances brand drugs against generics, with golden light illuminating two newly negotiable pills.

What You Can Do About High Generic Drug Costs

You can’t control what manufacturers charge. But you can control what you pay:

  • Use the Medicare Plan Finder every year. Your plan’s formulary changes. A $2 generic this year might be $25 next year.
  • Ask your pharmacist if there’s a different generic manufacturer available. Sometimes switching brands lowers your copay.
  • Check if your drug is covered under 340B. If you get care at a community health center, you might qualify for deep discounts.
  • Use mail-order pharmacies. Many Part D plans offer lower copays for 90-day supplies.
  • Report surprise bills. If your copay suddenly jumps, contact your plan and the state insurance department. These cases are being tracked.

Also, talk to your doctor. Sometimes, switching to a different generic-or even a different drug entirely-can save you hundreds a year. Don’t assume your prescription is fixed. The system is broken, but you still have power.

Why the U.S. System Is So Different From Other Countries

In Canada, the UK, and Germany, the government directly negotiates or sets drug prices. In the U.S., we rely on competition. But that only works when there’s real competition.

U.S. generic prices are 1.3 times higher than the average of 32 other wealthy countries. For brand-name drugs? We pay 3-5 times more. But here’s the trade-off: we get generics faster. Ninety percent of U.S. prescriptions are filled with generics. In Europe, it’s about 65%. That’s because the FDA approves generics quickly-1,247 in 2024 alone.

The problem isn’t speed. It’s sustainability. When profit margins shrink below 10%, manufacturers leave the market. And when they leave, prices rise. The U.S. system rewards volume, not stability. That’s why some of the most essential drugs are the most vulnerable.

What Experts Are Saying

Dr. Peter Bach from Memorial Sloan Kettering says the U.S. pays 138% more for generics than other rich countries because we don’t have the buying power of a single-payer system. He points to the VA, which gets 40-60% discounts by negotiating as one big buyer.

The Congressional Budget Office estimates that letting Medicare negotiate prices for select generics could save $12.7 billion over ten years. That sounds small compared to the $500 billion U.S. spends on drugs annually. But for the 12 million Medicare beneficiaries who take five or more generics? It’s life-changing.

On the other side, industry groups warn that price controls could hurt innovation. If manufacturers can’t make money on generics, they’ll stop investing in new delivery systems, like extended-release pills or easier-to-swallow forms. That’s a real risk. But so is leaving patients to pay $90 for a drug that should cost $15.

Why are some generic drugs so expensive even though they’ve been around for years?

Many generic drugs are cheap because dozens of companies make them. But if only one or two manufacturers remain-due to low profits, manufacturing complexity, or market consolidation-the price can skyrocket. There’s no competition to keep it low. Drugs like pyrimethamine and nitrofurantoin have seen 200-500% price hikes because of this.

Does Medicare negotiate generic drug prices?

Generally, no. Medicare doesn’t negotiate prices for most generics because they’re considered competitive. But starting in 2027, Medicare will negotiate prices for generic versions of apixaban and rivaroxaban-because only one company makes each under patent exclusivity. This is a new exception, and it could set a precedent for more generics in the future.

Why does my generic drug cost more this month than last month?

Your plan may have switched to a different generic manufacturer with a higher price. Or your pharmacy benefit manager (PBM) changed the reimbursement rate. PBMs often keep the rebate money instead of passing it to you. Always check your Explanation of Benefits (EOB) and ask your pharmacist if a different brand is available.

Can I buy generic drugs cheaper outside the U.S.?

Yes, in many cases. Generic drugs from Canada, India, or the UK can cost 70-90% less. But importing them is illegal under U.S. law, unless it’s through a certified pharmacy like those approved by the FDA’s International Drug Purchase Program. Some states are piloting legal importation programs, but they’re not widely available yet.

What’s the difference between AMP and Best Price?

AMP stands for Average Manufacturer Price-it’s the average price manufacturers charge wholesalers. Best Price is the lowest price a manufacturer gives to any private buyer (like a pharmacy chain or PBM). Medicaid rebates are calculated using the higher of 23.1% of AMP or the difference between AMP and Best Price. This system is designed to ensure Medicaid gets the same discount as the best private buyer.

If you’re taking multiple generics, your annual out-of-pocket cost dropped from $412 in 2022 to $327 in 2024 thanks to the IRA. That’s progress. But the system is still rigged for the middlemen-not the patient. Until we fix the rebate structure and force transparency, high prices will keep popping up where no one’s watching.