• Medical Device Firm Accused of Selling Unapproved Medical Devices Fined $1 Million

    Globus Medical Inc., a Pennsylvania-based medical device manufacturer , has reached an agreement with the US Food and Drug Administration (FDA) to pay a $550,000 fine for reportedly violating the federal law by distributing unapproved medical devices . The firm's Chief Executive Officer, David C. Paul, will reportedly pay FDA an additional $450,000, bringing the total fines collected by FDA for the infraction up to an even $1 million. "The device-clearance process ass...
  • Reps. Waxman, Rush Introduce Bill to Stop 'Pay-For-Delay' Settlements

    • 13 February 2012
    A bill introduced by Representatives Bobby Rush (D-IL) and Henry Waxman (D-CA) on 9 February would end so-called "pay-for-delay" settlements used by pharmaceutical companies to delay competition from generic competitors. The bill, Protecting Consumer Access to Generic Drugs Act of 2012 (H.R. 3995) , declares it "unlawful for any person to directly or indirectly be a party to any agreement resolving or settling a patent infringement claim in which (1) an [Abbreviated ...
  • Proposed Bill Would Limit Use of Consent Decrees, Settlement Agreements

    A bill introduced in the US House of Representatives by Reps. Ben Quayle (R-AZ), Dennis Ross (R-FL) and Howard Coble (R-CA) would place "limitations on consent decrees and settlement agreements by agencies." Consent decrees are voluntary judicial judgments entered in to by two or more willing parties, usually in return for the dismissal of other charges. The US Food and Drug Administration (FDA) frequently uses consent decrees against manufacturers. A recent example of t...