Publications of Interest > Pharmaceuticals and Biologics > Pharmaceuticals & Biologics > FDA & Healthcare > Practices : Morgan, Lewis & Bockius

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

Presentation | Speech
Stephen Mahinka

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

Presentation | Speech
Andrew Ruskin

07/25/12 FDA User Fee Act Full of Surprises for Pharma and Biotech

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Phoebe Mounts, Alexis Miller

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.

June 2012 An Overview and Update on Biosimilars, LMG Life Sciences 2012

Outside Publication | Article
Stephen Mahinka, Kathleen Sanzo

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

Presentation | Stephen Mahinka, Kathleen Sanzo

04/18/12 Manufacturers Affected by Recent Medicare Part D Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Andrew Ruskin, Donna Lee Yesner

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

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

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.

11/16/11 Avoiding Anti-Kickback Challenges Related to Pricing and Contracting, presented at the 8th National Rx Drug Pricing Boot Camp, New York

Presentation | Speech
Andrew Ruskin

Topics presented include: Types of PAPs PAP Features Legal Concerns Price Reporting OIG PAP Guidance PAP Decision Points more

06/08/11 Transparency Update: Vermont Revises Disclosure Form and Seeks Comment on 2011 Draft Consolidated Disclosure Guide

LawFlash/Client Alert | FDA and Healthcare LawFlash
Lee Rosebush, Kathleen McDermott, Michele Buenafe

The State of Vermont regulates expenditures and gifts to healthcare professionals and entities by manufacturers of prescribed products (medical device, pharmaceutical, and biological products entities). Such entities with repor... more

06/07/11 The Compliance Revolution Will Be Televised: As Government Turns Up Heat on Healthcare Fraud, OIG Videos Offer Practical Compliance Pointers

LawFlash/Client Alert | FDA and Healthcare LawFlash
Kathleen McDermott, Arianne Callender

The U.S. Department of Health and Human Services (HHS) Office of Inspector General's (OIG's) Health Care Fraud Prevention and Enforcement Action Team (HEAT) has garnered headlines for its coordinated Medicare fraud criminal swee... more

06/06/11 New Government Healthcare Policies - Impact on Growth and Investment in the Biopharma Industry, presented at the US – Japan Health Sciences Dialogue 11th Annual Meeting, Philadelphia

Presentation | Speech
Stephen Mahinka

05/23/11 FDA Requests Comments on the Development of a User Fee Program for Biosimilar and Interchangeable Biological Products

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Kathleen Sanzo, Phoebe Mounts, Lee Rosebush, Stephen Mahinka

On May 10, the Food and Drug Administration (FDA) issued a Federal Register notice requesting comments relating to the development of a user fee program for biosimilar and interchangeable biological product applications submitt... more

12/07/10 Bioequivalence and the "Same Active Ingredient" vis-à-vis Patentability, presented at the Paragraph IV Disputes West conference, San Francisco

Presentation | Speech
Robin Silva

05/28/10 FDA’s Transparency Proposals Would Disclose Product Applications and Significant Information on Status and Content

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

As part of President Obama's Open Government Initiative, the U.S. Food and Drug Administration (FDA or the Agency) launched its own Transparency Initiative in June 2009. FDA commissioner Dr. Margaret Hamburg created and charged... more

01/23/09 CMS Regulation Addresses Protected Drug Categories and Classes

LawFlash/Client Alert | FDA and Healthcare LawFlash
Andrew Ruskin

Some pharmaceutical manufacturers will be affected by a rule just issued by the Centers for Medicare & Medicaid Services (CMS) regarding how the Medicare program determines which drug categories and classes will receive favo... more

01/22/09 FDA Issues Guidance for Good Reprint Practices for the Distribution of Publications on Unapproved New Uses of Approved/Cleared Medical Products

LawFlash/Client Alert | FDA and Healthcare LawFlash
FDA and Healthcare Practice

FDA announced the availability of a final guidance for "Good Reprint Practices for the Distribution of Medical Journal Articles and Medical or Scientific Reference Publications on Unapproved New Uses of Approved Drugs and Approv... more

11/08/07 How Are New Safety Concerns Affecting FDA Approvals and CMS Reimbursement of Bio/Pharma Products, presented by The Center for Business Intelligence

Presentation | Speech
Stephen Mahinka

07/18/07 CMS Proposes Changes to Its Policies Governing Off-Label Uses of Anticancer Drugs and Biologicals

LawFlash/Client Alert | FDA and Healthcare LawFlash
Andrew Ruskin

A recently issued proposed change to Medicare policy could significantly affect Medicare payment for anticancer drugs and biologicals. The Centers for Medicare and Medicaid Services (CMS) has proposed a laundry list of changes ... more

02/14/07 The Anatomy of a Deal: Dissecting the Bio-Bucks, presented at the BIO CEO and Investor Conference, New York

Presentation | Speech
Randall Sunberg

04/17/06 Creative Financing for Biotech and Pharma Drug Development and Commercialization, presented at the New York Biotechnology Association Annual Meeting

Presentation | Speech
Randall Sunberg

March/April 2004 Strategic Implications of FDA’s Proposed Safety Reporting Requirements, On Drugs: Legislation, Litigation, and Policy Proposals

Outside Publication | Article
Michele Buenafe

02/03/04 "Off-Label" Communications at Risk: Changes and Challenges to Reimbursement for Prescription Drugs, presented to the Washington Legal Foundation, Washington D.C.

Presentation | Speech
Stephen Mahinka