AbbVie moves to close loopholes and strengthen accountability in 340B program

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NORTH CHICAGO, Ill., April 8, 2026 - As a longstanding participant in the 340B program, AbbVie believes the program's original mission remains a noble one: to help safety-net hospitals and clinics serving vulnerable populations stretch scarce resources for the patients most in need.

However, an outdated and overly broad definition of a 340B "patient," based on guidance issued in 1996, has led to significant and troubling program abuses. This broad definition has created loopholes that allow covered entities to claim discounts on minimal or unrelated patient contact thousands of miles away, or even for the same prescription multiple times. As a result, resources and savings meant for those most in need are being diverted elsewhere, used as a discretionary revenue stream instead of being tied to a tangible patient benefit. This ultimately leads to higher healthcare costs for employers, taxpayers, and patients, while diluting the program's intended impact.

Today, AbbVie filed a lawsuit asking a court to address this outdated guidance. Manipulating "patient definition" beyond a commonsense interpretation of the law, as is currently the case, does not mean that more patients get access to discounted medicines. In fact, patients are almost never aware if they have been identified as a "340B patient" and rarely see a difference in what they owe at the pharmacy counter. Aligning on a clear patient definition will not impact access to or affordability of our medicines, nor should it impact the 340B-derived revenue of hospitals and clinics who are using the program in good faith. Our legal action simply advocates for a clear and sensible definition grounded in the statute - a change that would only restrict access to discounts for entities that are qualifying non-patients as 340B eligible. This will help mitigate manipulation, overprescription, and profit-driven schemes that do not serve the safety net.

We recognize that changes to the program may prompt strong debate among stakeholders. AbbVie has a long-standing track record of engagement, open dialogue, and a commitment to better patient care. We welcome good-faith discussions with 340B hospitals, clinics, and all stakeholders as we work toward a stronger, fairer 340B program.

What does AbbVie believe is the proper interpretation of patient under the statute?

A prescription should only qualify for a 340B discount if all the following are true:

1. The prescription is connected to care at that facility. The medication was prescribed because of an appointment or treatment received at the 340B facility - not from a different doctor or for an unrelated reason.
2. The patient received real and substantive medical care. The visit was thorough enough for the provider to properly diagnose and treat the patient's condition for which the drug was prescribed.
3. The provider is managing the patient's care. The healthcare professional who prescribed the drug is directly responsible for treating the patient's condition - not just passing along a referral from another doctor.
4. The care is recent. The patient has seen the healthcare provider within the past 12 months for the condition being treated, and the healthcare provider is still actively involved in the patient's care - not just claiming 340B discounts for a patient that was seen years ago at the 340B facility.

Media statement:

The following may be attributed to AbbVie:

As a longtime, proud participant in the 340B program, AbbVie has seen firsthand how a nebulous interpretation of "patient" can undermine - and ultimately destroy - the altruistic goals of the program. Our filing seeks to establish a clear, sensible patient definition to realign 340B with its original intent - serving vulnerable individuals and true safety net providers, not padding revenue streams that increase overall healthcare costs.

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, neuroscience and oncology - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

Forward-Looking Statements
Some statements in this news release are, or may be considered, forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, changes to laws and regulations applicable to our industry, the impact of global macroeconomic factors, such as economic downturns or uncertainty, international conflict, trade disputes and tariffs, and other uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2025 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

Media:
Suzanne Barston
+1 (224) 290-4159
[email protected]

Investors:
Liz Shea
+1 (847) 935-2211
[email protected]