Biopharma company now required to seek approval before attempting further buyouts.
The Federal Trade Commission (FTC) revealed an agreement with Amgen on a proposed consent order over its $27.8 billion deal to acquire Horizon Therapeutics. As part of the deal, the agency will throw out the previous court actions in conjunction with attorney generals from six states that also filed lawsuits against the organization. Also included in the proposed order, Amgen will be prohibited from entering into a buyout agreement without FTC consent and bundling products with Tepezza or Krystexxa, its medications used to treat thyroid eye disease (TED) and chronic refractory gout (CRG).
“Consolidation in the pharmaceutical industry has given companies the power and incentive to engage in exclusionary rebating practices, which can lead to sky-rocketing prices on essential medications,” said Henry Liu, director, bureau of competition, FTC. “Today’s proposed resolution sends a clear signal that the FTC and its state partners will scrutinize pharmaceutical mergers that enable such practices and defend patients and competition in this vital marketplace.”
Reference: Biopharmaceutical Giant Amgen to Settle FTC and State Challenges to its Horizon Therapeutics Acquisition. FTC. September 1, 2023. Accessed September 5, 2023. https://www.ftc.gov/news-events/news/press-releases/2023/09/biopharmaceutical-giant-amgen-settle-ftc-state-challenges-its-horizon-therapeutics-acquisition
Understanding the FDA's Exemption for DSCSA Compliance
November 12th 2024In the quest for achieving full traceability, the exemption applies to certain trading partners under the Act, and postpones enforcement of final compliance requirements while acknowledging progress and ongoing challenges.