FDA Requests Additional Liver Injury Data on Eli Lilly Obesity Pill Foundayo

The FDA has requested additional liver injury data from Eli Lilly regarding Foundayo, a once-daily oral obesity medication targeting the GLP-1 hormone that received expedited approval under the Commissioner's National Priority voucher program. In an April 1 letter posted on the agency website, the FDA also mandated post-marketing trials assessing cardiovascular events, delayed gastric emptying, and a lactation study measuring drug concentrations in breast milk. Separately, the U.S. Court of Appeals for the Fourth Circuit vacated a lower court decision and remanded for review a case involving Maryland law H.B. 1056, which requires manufacturers to distribute discounted drugs to unlimited contract pharmacies under the 340B program. AbbVie, Novartis, AstraZeneca, and PhRMA argue the Maryland law improperly expands federal requirements and violates constitutional principles.

FDA's Post-Approval Requirements for Eli Lilly's Foundayo Obesity Pill

• ▪Foundayo won approval earlier than April 15, 2026 under the Commissioner's National Priority voucher program
• ▪Foundayo is a once-daily oral medication that targets the GLP-1 hormone
• ▪Eli Lilly is required to conduct a milk-only lactation study in lactating women who have received a dose of Foundayo
• ▪The Commissioner's National Priority voucher program aims to speed FDA decisions on drugs deemed critical to public health or national security
• ▪The U.S. Food and Drug Administration asked Eli Lilly for more data on liver injury linked to Foundayo
• ▪Eli Lilly must conduct post-marketing trials to assess risks related to cardiovascular events for Foundayo
• ▪The U.S. Food and Drug Administration's request to Eli Lilly regarding Foundayo was posted in an April 1 letter on the agency website

Legal Challenge to Maryland's 340B Drug Discount Law

• ▪AbbVie, Novartis, AstraZeneca, and PhRMA argued that Maryland law H.B. 1056 improperly forces drug companies to supply contract pharmacies as part of the 340B Drug Discount Program
• ▪AbbVie, Novartis, AstraZeneca, and PhRMA argued that Maryland law H.B. 1056 violates the U.S. Constitution
• ▪Maryland law H.B. 1056 requires manufacturers to distribute discounted drugs to an unlimited number of pharmacies that contract with health providers under the 340B Drug Discount Program
• ▪The U.S. Court of Appeals for the Fourth Circuit remanded the Maryland drug discount law decision for review
• ▪AbbVie, Novartis, AstraZeneca, and PhRMA argued that Maryland law H.B. 1056 is illegal because it is preempted by federal law
• ▪The U.S. Court of Appeals for the Fourth Circuit ruled that the lower court erred in denying the preliminary injunction motion against the Maryland drug discount law
• ▪The U.S. Court of Appeals for the Fourth Circuit vacated an order rejecting AbbVie, Novartis, AstraZeneca, and PhRMA's request to block a Maryland drug discount law

Perspective of Eli Lilly

• ▪Foundayo received expedited approval through the Commissioner's National Priority voucher program before standard timelines
• ▪Eli Lilly must now provide additional safety data on Foundayo after the drug has already entered the market

Perspective of AbbVie, Novartis, AstraZeneca, and PhRMA

• ▪Pharmaceutical manufacturers contend Maryland law H.B. 1056 forces them to serve an unlimited number of contract pharmacies beyond federal requirements
• ▪Maryland law H.B. 1056 expands obligations beyond what the federal 340B Drug Discount Program requires from manufacturers
• ▪The Fourth Circuit Court found the lower court made legal errors in rejecting pharmaceutical companies' challenge to Maryland law H.B. 1056

Perspective of U.S. Food and Drug Administration

• ▪The FDA required Eli Lilly to conduct multiple post-marketing studies addressing cardiovascular, gastrointestinal, and lactation safety concerns for Foundayo