Morgan Lewis

Pharmaceuticals & Biologics Selected Representations

Related Publications

05/02/12 Update on the Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at the BioNJ Diamond Circle Board of Trustees Meeting
(pdf)
04/18/12 Manufacturers Affected by Recent Medicare Part D Rule
CMS formalizes its Medicare Part D Coverage Gap Discount Program rules as part of an omnibus Medicare Part C and Part D rulemaking.
03/09/12 Pharmacies and Suppliers Beware: It Is Not Just the Pill Mills They Are After
DEA's recent position against a national pharmacy chain and a wholesale distributor expands the proactive monitoring and auditing requirements for pharmacies and wholesale distributors to include site visits and possibly medical necessity reviews.
View all publications

Related News

05/04/12 Regulatory Policy: CBER Importance Boosted With Attention To Biologic Drugs, Biosimilars, Speakers Say
Life Sciences and Healthcare partner Stephen Paul Mahinka is quoted.
04/05/12 Biosimilars Naming and Labeling: An FDLI Dialogue, Update Magazine
Life Sciences and Healthcare partner Stephen Paul Mahinka is quoted.
View all news
  • 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.