FDA & Healthcare Publications of Interest

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

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

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

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324 Publications Found

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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.

01/26/12 Transparency Compliance Webinar

Presentation | Webinar
Rebecca Osowski, Kathleen McDermott, Jonathan Havens

Morgan Lewis hosted a webinar focusing on the Centers for Medicare and Medicaid Services' (CMS) long-awaited proposed rule, "Transparency Reports and Reporting of Physician Ownership or Investment Interests." This webinar pr... more

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FDA draft guidance on responding to requests for off-label information foreshadows restrictive policies on use of social media.

01/04/12 Physician-Vendor Relationships Under Heightened Scrutiny: Avoiding or Minimizing Liability Under False Claims, Stark, and Anti-Kickback Laws (a Strafford webinar)

Presentation | Webinar
Arianne Callender

Federal regulators and prosecutors are aggressively pursuing allegations of improper financial relationships between physicians and vendors. Areas of concern include the use of free samples, "sham" consulting and advisory payment... more

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 FTC/DOJ Final Policy Statement on Accountable Care Organizations: Important Antitrust Issues Remain Unanswered, BNA's Health Law Reporter

Outside Publication | Article
Stephen Mahinka, J. Everett, Jr., David Brenneman, Albert Shay

The Federal Trade Commission and the Department of Justice ("agencies") issued their final Statement of Antitrust Enforcement Policy Regarding Accountable Care Organizations Participating in the Medicare Shared Savings Program ("... 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

2011 Seminal Fraud, Program Integrity and Transparency Provisions Complement the PPACA Reform Provisions (Chapter 5, co-author), Health Care Rulemaking Guide, Administrative Rules Implementing New Healthcare Laws (2011-2012 edition, West Publication)

Outside Publication | Chapter
Kathleen McDermott

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

11/03/11 Implementing a CIA: Challenges and Lessons Learned, presented at the 12th Annual Pharmaceutical Regulatory and Compliance Congress and Best Practices Forum, Washington, D.C.

Presentation | Speech
Scott Memmott

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.

09/28/11 Don't Shoot the Messenger—Effective Compliance Strategies in View of Enhanced Whistleblower Incentives and Protections, Plus a Summary of Select Recent Enforcement Actions (a Blue Cross Blue Shield Association webinar)

Presentation | Webinar
Scott Memmott

09/28/11 Medical Necessity of Cardiac Implants: The New Enforcement Priority (a West Legal Education webinar)

Presentation | Webinar
Scott Memmott, Albert Shay

09/23/11 The Biosimilars Competition and Innovation Act: Overview and Life Cycle Planning for Biosimilars, presented at American Conference Institute’s FDA Boot Camp, Boston

Presentation | Speech
Stephen Mahinka

08/09/11 FDA Issues Draft Guidance on 510(k) Device Modifications: New Emphasis on Potential Impact of Modifications

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Phoebe Mounts, M. Elizabeth Bierman, Michele Buenafe

On July 27, the Food and Drug Administration (FDA) issued a draft guidance titled "510(k) Device Modifications: Deciding When to Submit a 510(k) for a Change to an Existing Device."[1] Once ... more

07/28/11 New FDA Draft Guidance on Mobile Medical Apps Provides Some Clarity, But Raises Many More Questions

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
M. Elizabeth Bierman, Michele Buenafe

On July 19, the Food and Drug Administration (FDA) issued a new draft guidance document, titled Mobile Medical Applications , describing FDA's position on the regulation of mobile applications, i.e., software applications inten... more

07/13/11 Supreme Court Strikes Vermont Data Mining Law and Protects Pharmaceutical Marketing

LawFlash/Client Alert | Life Sciences and Healthcare LawFlash
Life Sciences and Healthcare Practice

On June 23, the U.S. Supreme Court issued a 6–3 decision in Sorrell v. IMS Health Inc., declaring a Vermont law designed to prevent data mining unconstitutional. The Vermont Prescription Confidentiality Law at issue restr... more

07/12/11 Third Party Reimbursement of Covered Entities: Manufacturers' Perspective, presented at the 15th Annual 340B Coalition Summer Conference, Washington, DC

Presentation | Speech
Donna Lee Yesner

06/30/11 Physician-Owned Distributors in the Crosshairs: Senate Committees Call on OIG and CMS to Take Action

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

In a strong signal that physician-owned distributors (PODs) may be in the line of enforcement fire, on June 9, five senators, representing the Committees on Finance, Aging, and Judiciary (Committees), signed joint letters to the... more

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