PFIZER INC (PFE) Risk Factors

Recent key developments

Concrete developments — dated events, named agreements and instruments, legal proceedings — that PFIZER INC surfaced in its latest filing.

• The IRA MDPNP selected Eliquis in August 2023 with new Medicare price effective January 1, 2026.2026-01-01
• CMS selected Ibrance and Xtandi in January 2025 for Maximum Fair Price effective January 1, 2027.2027-01-01
• CMS selected Xeljanz on January 27, 2026, for Maximum Fair Price effective January 1, 2028.2028-01-01
• In September 2025, Pfizer entered a voluntary agreement with the Trump Administration for a three-year grace period from Section 232 tariffs, conditional on further U.S. manufacturing investments.2025-09-01
• The May and July 2025 Trump Administration MFN Initiatives.2025-07-31
• The September 2025 MFN Agreement with the Trump Administration to make certain U.S. drug prices more comparable to those in other developed countries.2025-09-01
• EU Pharma Package agreement in December 2025, the largest reform of EU pharmaceutical legislation in 20 years, expected to apply from 2028.2025-12-01
• The European Regulation on Health Technology Assessment took effect in January 2025, introducing a single EU-level submission for joint clinical assessments for oncology medicines.2025-01-01
• The OBBBA, passed on July 4, 2025, includes significant funding cuts to Medicaid, the Health Insurance Marketplaces, and the Medicare Physician Fee Schedule, and the CBO estimates it will lead to a 10 million increase in the U.S. uninsured population.2025-07-04
• In January 2026, the CDC unilaterally reduced the number of immunizations routinely recommended for all children in the U.S.2026-01-01
• In December 2025, HHS issued proposed rules for mandatory CMMI pilots that could require additional price concessions.2025-12-01
• In September 2024, Pfizer voluntarily withdrew Oxbryta in all markets based on clinical data showing overall benefit no longer outweighed risk in the approved sickle cell patient population.2024-09-01
• In October 2025, the EMA adopted a negative opinion on benefit-risk for Oxbryta for hemolytic anemia due to SCD, recommending the marketing authorization remain suspended.2025-10-01
• In 2021, Pfizer recalled Chantix due to the presence of a nitrosamine, N-nitroso-varenicline, at or above acceptable intake limits.2021-01-01
• In 2025, Chantix returned to market in the U.S. and in certain international markets following issuance of updated guidance on acceptable intake limits for N-nitroso-varenicline by regulatory authorities.2025-01-01
• Pfizer's acquisitions of Seagen and Metsera, financed in part by long-term debt and short-term indebtedness.
• Pfizer’s engagement with the FDA regarding Oxbryta is ongoing.