Skip to Content

AHIP Files Amicus Brief: Let Anti-Kickback Statute Stand

Press Release

Published Apr 4, 2022 • by AHIP

AHIP files an amicus brief in Pfizer v HHS, noting there are other lawful ways Big Pharma can make medications more affordable for patients today.

Washington, D.C. – April 4, 2022 – Out-of-control drug prices are a leading driver of health care costs, and they are an increasing burden on hardworking American families. Now, Big Pharma is working to find new ways to line its own pockets – seeking to overturn long-standing protections provided by The Anti-Kickback Statute, which will cause premiums and out-of-pocket costs to go even higher.

In the case of Pfizer v. The Department of Health and Human Services (HHS), which centers on the issue of copay assistance programs, AHIP filed an amicus brief supporting HHS’s interpretation of The Anti-Kickback Statute, an important protection for patients, consumers, and taxpayers. Here are the highlights.

Big Pharma is “Solving” a Problem They Themselves Created

“Drug manufacturers alone set and control the launch price and every price increase for the prescription drugs they sell, and make ample profits doing so. Manufacturers should not be able to leverage the access problems they themselves create to undo a vital protection for government programs and the beneficiaries who utilize them. Indeed, the Anti-Kickback Statute was designed precisely to address this and similar practices.”

If The Anti-Kickback Statute Is Weakened, Americans Will Pay the Price

“[The Anti-Kickback Statute] provides vital guardrails against the risk of fraud, waste, and abuse that otherwise inheres in permitting manufacturers to subsidize patients’ up-front costs to induce purchases of their products. These protections are essential because those same patients – and U.S. taxpayers – would otherwise pay the unchecked multi-billion dollar price tag and resulting higher health insurance premiums.”

“Coupons work, first and foremost, for the drug manufacturer. They increase sales volume of the couponed drug, increase revenue, and give drug manufacturers free rein to keep raising their prices. Any short-term benefit to patients is overwhelmed by higher total drug costs over time. And patients ultimately pay the price in the form of higher premiums or cost-sharing.”

There Are Many Ways Big Pharma Can Lawfully Make Drugs More Affordable

“One better, lawful way to support patient access to essential medications is for drug manufacturers to donate to independent charities – including potentially those targeted for specific diseases. … Conversely, as experience in the commercial market shows, permitting manufacturers to directly subsidize patients’ cost-sharing of their own drugs leads to higher profits for drug manufacturers and higher premiums for everyone, including the patients who are ostensibly helped.”

“Although this urgent affordability problem persists, solutions to delivering patient access to needed medications abound – including many that drug manufacturers could support under current law, if they chose. To start, drug manufacturers could support cost sharing assistance provided by charitable organizations that are free from their influence or control. Drug manufacturers could also reduce their prices – which far outpace what they spend on research and development. They could also refrain from anticompetitive practices that extend the monopolies for brand-name drugs well beyond the timeframes intended by Congress – a solution that would advance innovation and patient well-being. One thing is clear. Any sustainable solution does not lie in opening the door to drug manufacturers paying patients directly if – and only if – the patients purchase the manufacturer’s drugs.

About AHIP

AHIP is the national association whose members provide health care coverage, services, and solutions to hundreds of millions of Americans every day. We are committed to market-based solutions and public-private partnerships that make health care better and coverage more affordable and accessible for everyone. Visit to learn how working together, we are Guiding Greater Health.