ABBV · Earnings call · 2026Q3T · Full report

Regulatory Environment

AbbVie Inc. · 2026-10-30 · Importance 23 · Surprise 24

CEO Rob Michael said AbbVie supports the original purpose of the U.S. 340B program but believes its broad patient definition has enabled abuse and increased healthcare costs for employers, taxpayers and patients. He cited bipartisan proposals in the U.S. House and Senate to improve transparency and accountability, and said AbbVie is participating in a rebate pilot intended to support those aims. Management said it was too early to estimate the pilot’s financial impact and noted that the program has grown substantially across the industry.

Key facts

• AbbVie said the FDA complete response letter for TrenibotE concerned CMC assessments, not safety or efficacy, and it plans to resubmit at the end of 2026 with a six-month review and a U.S. decision expected in mid-2027.
• AbbVie is working with the FDA to resolve outstanding matters in Boey's complete response letter; resubmission is anticipated before the end of 2026 and a regulatory decision in mid-2027.
• AbbVie updated the Skyrizi label to give providers discretion over whether tuberculosis evaluation is appropriate before treatment, rather than requiring it for all patients.
• The IRA price for Vraylar will begin in 2027.
• AbbVie does not expect a Botox price to be published while the IRA eligibility issue plays out.
• AbbVie’s position is that Botox is ineligible for IRA selection because one of its 3 ingredients is human serum albumin extracted from human blood plasma.
• AbbVie says Botox contains 100,000 times more human serum albumin than toxin and argues that this makes Botox ineligible for IRA selection.
• AbbVie said it is participating in a 340B rebate pilot to promote transparency and accountability, but that it is too early to estimate the financial impact.