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  • Regulatory NewsRegulatory News

    FTC Continues Crackdown on Pay-for-Delay Agreements

    The Federal Trade Commission (FTC) on Monday announced several steps taken against Allergan, its subsidiary Watson Laboratories and Endo Pharmaceuticals to fight pay-for-delay settlements between brand-name and generic drug manufacturers that keep generics from entering the US market. According to a complaint filed in the US District Court of Northern California against Allergan, Watson and Endo, FTC is challenging an anticompetitive reverse-payment agreement between En...
  • Regulatory NewsRegulatory News

    EU Pharma Patent Settlements Still Limiting Entry of Generics

    Almost three-quarters of 125 patent settlements in the EU in 2015 between originator pharmaceutical and their generic competitors resulted in a lengthening of time to bring the cheaper generic version to market. But of those 74%, only 10% were settlements limiting generic market entry and including a payment or transfer of value from originator to generic company, while 64% were settlements limiting generic entry but with no value transfer. The remaining 26% of settlemen...
  • DOJ Says Corporate Integrity Agreements Are Cornerstone of New Compliance Approach

    The pharmaceutical industry's reputation has been heavily battered over the course of the last two decades, in part because of a seemingly endless stream of massive multibillion-dollar settlements over charges of off-label marketing claims. Those fines, which have seemingly done little to curb illicit behavior, have been seen by at least some industry analysts as cost of doing business-not a deterrent. But the Department of Justice (DOJ) seems poised to change that dyn...
  • Congress Advances Legislation Limiting Consent Decrees, Settlement Agreements

    • 26 June 2012
    A legislative proposal to limit the ease with which regulatory agencies are able to compel companies to enter into consent decrees is rapidly advancing in the House of Representatives. The Sunshine for Regulatory Decrees and Settlements Act ( SRDSA ) of 2012 (H.R. 3862) received approval from the Committee on the Judiciary on 27 March 2012 in a 20-10 vote. As Regulatory Focus reported in February, consent decrees are often used by the US Food and Drug Administratio...