Publications of Interest > Life Sciences > Practices : Morgan, Lewis & Bockius

05/22/12 Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges, presented at the AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law

Presentation | Speech
Andrew Ruskin

Morgan Lewis partner Andrew Ruskin presented on "Manufacturer Patient Support Initiatives: Current Practices and Recent Challenges" at AHLA/FDLI's Intersecting Worlds of Drug, Device, Biologics and Health Law. more

05/09/12 Eleventh Circuit Rejects FTC Challenge to Reverse Payment Settlement

LawFlash/Client Alert | Antitrust LawFlash
J. Everett, Jr., Sean Duffy, Steven Reed, Scott Stempel

Decision by court of appeals affirms that settlements that do not expand the exclusionary scope of a patent are not subject to antitrust challenge.

05/03/12 HHS Plugs Payment Suspensions as Key Tool in Latest Takedown

LawFlash/Client Alert | Life Sciences & Healthcare LawFlash
Kathleen McDermott, Arianne Callender, Howard Young, Eric Sitarchuk

The Medicare Fraud Strike Force's use of a pivotal ACA regulation to suspend payments during criminal investigations signals a turning point in its prosecution strategy.

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.

04/10/12 FDA Issued ACA Industry Submission Specifications User Guide for ACA §6004

Marketing Material | Supplemental Info

04/10/12 Health Industry Compliance Brochure

Marketing Material | Brochure

04/03/12 Food Products Coverage: The Communicable Disease Exclusion Lacks Bite

LawFlash/Client Alert | Insurance Recovery LawFlash
Kevin Dreher, Christopher Loeber

State and federal courts reject efforts to categorize salmonella as a "communicable disease."

04/02/12 It’s Not Just Pill Mills The DEA Is After, Law360

Outside Publication | Article
Kathleen Sanzo, Lee Rosebush, Michele Buenafe

03/21/12 Personalized Medicine Patents Rejected by U.S. Supreme Court

LawFlash/Client Alert | Intellectual Property LawFlash
Robert Smyth, Ph.D.

Court ruling applies law of nature; impacts patents directed to personalized medicine.

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.

February 2012 Co-author, Compliance Certifications and the Era of Accountability—A Forecast to Debate, Journal of Health & Life Sciences Law, Vol. 5, p. 158

Outside Publication | Article
Kathleen McDermott, Arianne Callender

02/13/12 2011 Year in Review: Selected Federal Securities Litigation Developments

LawFlash/Client Alert | Securities LawFlash
Anthony Fassano, Laura Hughes, Nicholas Schretzman, Brian Herman, John Vassos

In 2011, the Supreme Court and the federal circuit courts issued a number of important decisions concerning securities fraud class actions. These decisions address pleading standards, statutes of limitations defenses, class certification, and a number of other critical topics.

02/09/12 FDA Issues Three Draft Guidances for Biosimilars

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

Initial guidance provides insights on regulatory pathway for biosimilars, but does not address many critical issues.

02/06/12 CMS Proposes Major Changes to AMP Rule

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

The Proposed Rule provides provisions that will significantly impact pharmaceutical manufacturers' rebate liability, price reporting calculations, and possibly their operations.

02/03/12 Class Action Arbitration Waiver Rejected by Federal Appellate Court

LawFlash/Client Alert | Class Actions LawFlash
Litigation Practice

Second Circuit sidesteps Concepcion and holds that the ability to enforce federal statutory rights mandates that a plaintiff be allowed to pursue a class action in court notwithstanding the parties' agreement to mandatory arbitration.

01/25/12 2011 American Health Lawyer’s Association Annual Meeting

Presentation | Speech
Kathleen McDermott

Morgan Lewis's Kathleen McDermott presented "The Era of Individual Accountability-Is A Liability Hailstorm On The Way?" at the 2011 American Health Lawyer's Association Annual Meeting. Ms. McDe... more

01/11/12 FDA Gets (Un)Social

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

FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.

2011 Co-author, Prescription, Drug Promotions and Marketing, FDLI’s Food and Drug Law Regulation 2011, 2nd edition

Outside Publication | Article
Kathleen Sanzo, Stephen Mahinka

12/21/11 CMS Issues Transparency Reporting Proposed Rule

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Rebecca Osowski, Kathleen McDermott, Jonathan Havens, Michele Buenafe

The Centers for Medicare and Medicaid Services' proposed rule, which will implement Section 6002 of the Patient Protection and Affordable Care Act, clarifies several definitions, provides further information on reporting requirements, and offers guidance on submitting required information.

12/05/11 Comparative Effectiveness Research: Impact on Pharmaceutical Pricing and Marketing, presented at the QI Productions Conference on Integrating Comparative Effectiveness Research, Philadelphia

Presentation | Speech
Stephen Mahinka

Topics presented include: Structural Changes in Pharmaceutical Industry Stimulating Focus on Comparative Effectiveness Research Potential Changes by Healthcare Reform Law Affecting Demand Levels and Prices/Payments ... more

12/02/11 Spotlight On Physician Owned Distributors: Stay Tuned For Agency Guidance, Health Lawyers Weekly

Outside Publication | Article
Arianne Callender, Howard Young

Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers. more

12/01/11 Government Program Integrity Enforcement and Child Behavioral Provider Focus Areas, presented at the National Association for Children’s Behavioral Health 2011 Technical Meeting, Orlando, FL

Presentation | Speech
Howard Young

10/31/11 FTC/DOJ Final Policy on Accountable Care Organizations: Important Antitrust Issues Remain Uncertain for Healthcare Collaborations

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay

The Federal Trade Commission (FTC) and Department of Justice (DOJ) (together, the Agencies) issued their final "Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Sha... more

October 2011 Where Will Biosimilars Fit in Federal Drug Pricing Programs?, BNA's Pharmaceutical Law & Industry Report

Outside Publication | Article
Donna Lee Yesner

10/06/11 Physician-Owned Distributors and Agency Guidance: Still Waiting

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Arianne Callender, Howard Young

Agencies' recent responses to Senate call for action on physician-owned distributors offer few details on policies. Stakeholders must await CMS rulemaking and OIG study for possible answers.