Pharmaceuticals and Biologics Selected Representations
02/01/13 Comparative Effectiveness Research: Impact on Biopharmaceutical Development, Pricing, and Promotion, presented at the Biotechnology Industry Organization General Counsels Committee Winter Meeting, San Francisco
01/16/13 Minimizing FCA Liability Attaching to Price Reporting when Making Reasonable Assumptions, presented at the American Conference Institute’s 10th NationalRx Drug Pricing Boot Camp
07/25/12 FDA User Fee Act Full of Surprises for Pharma and BiotechView all publications
FDA user fee reauthorization law expands fees to include generic and biosimilar applications, and includes a new emphasis on drug supply chain safety and incentives for development of new therapies.
05/15/13 Pharma Cos. Smell Victory In Push For Drug-Tracking System, Law360
Life Sciences partner Stephen Paul Mahinka is quoted.
05/08/13 Draft Senate Bill on Drug Compounding Does Not Go Far Enough, Stakeholders Say, BNA's Health Care Daily Report
FDA & Healthcare associate Lee H. Rosebush is quoted.
04/23/13 FDA's OxyContin Ruling May Spur New Battles Over Generics, Law360View all news
FDA partner Rebecca Dandeker comments on the recent FDA ruling to block generic versions of the painkiller OxyContin.
- Represented pharmaceutical manufacturers regarding FDA, healthcare regulation, antitrust and state regulatory requirements relating to drug pricing, distribution and promotion programs.
- Litigated market exclusivity issues for a major pharmaceutical manufacturer concerning FDA approval of a generic version of its product.
- Negotiated a multistate consent settlement and related FDA enforcement action involving the promotion of prescription drugs and provision of pharmacists’ information services.
- Successfully represented a major pharmaceutical manufacturer in switching a combination drug from prescription to over-the-counter.