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Ain’t That A Sham: US House Bill Tries To Thread The Needle On Citizen Petitions

 
• By Michael McCaughan

For years, brand industry critics have decried the use of “sham” citizen petitions to delay generic drug approvals. But one person’s “sham” is another person’s First Amendment right to petition the government. A House bill tries to thread that needle.  

Capitol House

A House bill that is intended to join a package of drug pricing measures moving through Congress this year attempts to address one of the thorniest and longest-standing complaints about patent defense strategies: the perceived abuse of the citizen petition process to delay generic entry.

The Stop STALLING Act (H.R. 2374, or the “Stop Significant and Time-wasting Abuse Limiting Legitimate Innovation of New Generics Act”) was one of four bills that cleared the Energy & Commerce Committee on 30 April, as momentum continues towards a package of consensus drug pricing bills to move through Congress this year

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US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
• By Michael McCaughan

The FDA struck an upbeat tone during its annual Generic Drugs Forum despite an unprecedented period of cutbacks and disruptions and reiterated a desire to continue meeting user fee goals.

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• By Neena Brizmohun

A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

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