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kaggle-ho-028420House Oversight

Celgene accused of using REMS to block generic drug approvals while Menendez campaign faces poll backlash

Celgene accused of using REMS to block generic drug approvals while Menendez campaign faces poll backlash The document outlines specific alleged anti‑competitive tactics by Celgene that could be pursued through FDA and antitrust investigations, and it links the issue to a high‑profile Senate race (Sen. Bob Menendez). While the claims are supported by court filings, they lack direct evidence of wrongdoing by the senator, limiting the immediate investigative payoff but still offering a concrete lead on corporate conduct and political optics. Key insights: Celgene allegedly refused to provide drug samples to generics, citing REMS, and demanded FDA written permission.; Court documents show Celgene made repetitive, irrelevant requests that delayed generic approvals for Mylan, Lannett, and Barr Laboratories.; Two generic firms settled; Mylan's case is headed to trial, providing a potential source of discovery.

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Unknown
Source
House Oversight
Reference
kaggle-ho-028420
Pages
1
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Summary

Celgene accused of using REMS to block generic drug approvals while Menendez campaign faces poll backlash The document outlines specific alleged anti‑competitive tactics by Celgene that could be pursued through FDA and antitrust investigations, and it links the issue to a high‑profile Senate race (Sen. Bob Menendez). While the claims are supported by court filings, they lack direct evidence of wrongdoing by the senator, limiting the immediate investigative payoff but still offering a concrete lead on corporate conduct and political optics. Key insights: Celgene allegedly refused to provide drug samples to generics, citing REMS, and demanded FDA written permission.; Court documents show Celgene made repetitive, irrelevant requests that delayed generic approvals for Mylan, Lannett, and Barr Laboratories.; Two generic firms settled; Mylan's case is headed to trial, providing a potential source of discovery.

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kagglehouse-oversightmedium-importancepharmaceuticalsgeneric-drugsantitrustfdapolitics
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