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A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships with Specialty Pharmacies: Part II
A Special Type of Government Scrutiny: Pharmaceutical Manufacturer Relationships with Specialty Pharmacies: Part II
April 07, 2017
Gary F. Giampetruzzi
,
Jonathan Stevens
The manufacturer/specialty pharmacy relationship and attendant risks should be on the agenda of every compliance officer in the life sciences industry. Specialty pharmacies are uniquely positioned to connect manufacturers, prescribers, and patients. In Part I of this two-part series, we covered the wide-ranging role of specialty pharmacies in the dispensing of specialty drugs, and the increased risks of government scrutiny and enforcement around them. The risk areas potentially implicated by these relationships include inappropriate inducements, off-label promotion, switching/interference with clinical decisions, underreporting of adverse events or product quality complaints, misuse, overuse, and privacy. These risks warrant a tailored compliance program directed at specialty pharmacy activities, as we will now cover in Part II of this series.
This article was originally published in Bloomberg Law.
Click here for a PDF of the full text
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FCC Releases Order Imposing New Privacy Rules on ISPs and Telcos
11/7/2016
Previous
The CFPB’s Project Catalyst: Is It Worth the Risk?
11/4/2016
Next
Making the Grade: Negotiating IP Licenses with Academic Institutions
11/4/2016
Previous
Market Intersection: A Quarterly Look at The U.S. Credit Markets - 3Q16
11/3/2016
Next
Preparing for Co-investments
11/3/2016
Previous
SEC Requires Hedge Funds to Prevent Insider Trading Despite Unsettled Legal Definition
11/1/2016
Next
Law Firm of the Future: The American Lawyer Spotlights Our Innovative Approach
11/1/2016
Previous
Market Abuse Regulation - Investment Recommendations
10/31/2016
Next
SEC Is Misguided On Disgorgement From Portfolio Managers
10/26/2016
Previous
The Government Loses Round 1
10/26/2016
Next
United States of America v. Reza Zarrab: The Long Reach of U.S. Sanctions May Have Just Gotten Longer
10/26/2016
Previous
Insider Trading Conviction Likely To Stick
10/24/2016
Next
DOJ Voluntary Disclosure Guidance Signals Expanded Role in Export Control & Sanctions Investigations
10/24/2016
Previous
Winter Is Coming: Responding to a Chilling Enforcement Landscape in Russia
10/21/2016
Next
SEC Approves New Liquidity Risk Management Rules for Certain Open-End Funds and Rules to Modernize and Enhance Reporting By Registered Investment Companies
10/14/2016
Previous
Cyberattack Reporting Rule for Federal Contractors Finalized
10/11/2016
Next
China Streamlines Foreign Investment – New Filing Regime
10/11/2016
Previous
New California Laws Impose Greater Burdens and Higher Risks of Liability for Employers
10/7/2016
Next
Money Transmitters Face New Requirements under Proposed New York Cybersecurity Rule
10/6/2016
Previous
Borrower in Distress? A Toolboxfor Secured Lenders
10/5/2016
Next
Justices to Weigh Tippee Liability
10/5/2016
Previous
New California Law Limits Choice of Law and Forum Selection Clauses in IP Agreements
10/4/2016
Next
SB 1241: California Employees May Soon Be Able to Void State Venue and Choice of Law Provisions
10/3/2016
Previous
Cox Comm’ns, Inc. v. Sprint Comm’n Co.: Federal Circuit Reverses District Court Finding of Indefiniteness and Concurring Opinion Raises Concerns That the Majority Adopts a “New Mode of Analysis” for Indefiniteness
10/3/2016
Next
Online Lenders Beware—CashCall Decision another Example of True Lender Risks
9/29/2016
Previous
Final Regulations Clarify Definition of “Real Property” for REIT Purposes
9/28/2016
Next
What Trends are Dominating the China Theme Park Space?
9/28/2016
Previous
U.K. Real Estate Quarterly Bulletin – September 2016
9/27/2016
Next
Supreme Court’s Determination of ‘Personal Benefit’ Test Under Insider Trading Laws Raises Practical Implications for Financial Market Professionals
9/26/2016
Previous
FCPA Enforcement: Tech Companies and the Pilot Program
9/23/2016
Next
Federal 6-in-1 Poster Update
9/22/2016
Previous
Top Five Private Equity Practices Grabbing SEC Attention
9/22/2016
Next
McRO, Inc. v. Bandai Namco Games America: Federal Circuit Revives Software Patents Held Ineligible
9/21/2016
Previous
They Keep Coming: The SEC Enters a $5.5M Settlement with AstraZeneca PLC Resolving FCPA Allegations
9/12/2016
Next
PERE Roundtable: Beyond Brexit
9/12/2016
Previous
Going Out with a Roar: Final Regulations and Guidance Issued Under Fair Pay and Safe Workplaces Executive Order
9/8/2016
Next
The Challenges of Working with First-Time Experts
9/7/2016
Previous
Italy: The New “White List” Paves the Way to Direct Investments from Former Offshore Jurisdictions
8/29/2016
Next
FinCEN’s Proposed AML Requirements on Investment Advisers Pose Imminent Burdens and Risks
8/29/2016
Previous
Addressing ECOA Risk in Marketplace Lending
8/25/2016
Next
Latin American Issuers Advised to Consider Effects of Revamped EU Market Abuse Regulations
8/18/2016
Previous
SEC Enforcement Hammer Protects Whistleblowers
8/18/2016
Next
Were Prosecutors Too Harsh on Matthew Keys? (Perspective)
8/17/2016
Previous
Supreme Court Review and Judge Barry Russell Awards
8/15/2016
Next
IRS Finalizes Regulations Eliminating Requirement to File §83(b) Election with Tax Return
8/15/2016
Previous
Are You Ready to Comply with the CFPB’s Final Amended Mortgage Servicing Rules?
8/10/2016
Next
Salman V. US: Will It Change The 'Personal Benefit' Test?
8/3/2016
Previous
Are Buyers of Assets Acquired from Debtors in Section 363 Bankruptcy Sales Protected from Product Liability Claims?
7/27/2016
Next
CJEU Finds Withholding Tax to Be Contrary to EU Law
7/26/2016
Previous
NYDFS Issues New AML/Sanctions Program Requirements
7/25/2016
Next
IRS Releases Guidance under Section 50(d)
7/25/2016
Previous
SEC ALJs Continue to Draw Scrutiny
7/22/2016
Next
CMS Takes the Lead in Cardiology Payment Reform
7/22/2016
Previous
When Minority Stockholders Take Control: Recent Delaware Cases Shine a Light on Fiduciary Obligations of Controlling Stockholders
7/22/2016
Next
From Lehman to Bloxham: What Next for the Special Administration Regime?
7/21/2016
Previous
Information Returns for Employers: Deadlines Moved Up and Penalties Increased
7/21/2016
Next
European Derivatives Regulation in a Post Brexit World
7/20/2016
Previous
EEOC Announces Proposed Revisions to EEO-1 Pay Data Collection Tool
7/19/2016
Next
Private Fund Report—Summary of Key Developments—Spring 2016
7/14/2016
Previous
Five Ways that Privacy Shield is Different from Safe Harbor and Five Simple Steps Companies Can Take to Prepare for Certification
7/14/2016
Next
The European, Middle Eastern and African Investigations Review 2016 - Italy
7/12/2016
Previous
Federal Circuit Rejects Application of the On-Sale Bar to Contract Manufacturers
7/11/2016
Next
Ministerial Decree Sets Out Revised Incentive Regime for Renewable Plants in Italy
7/11/2016
Previous
Federal Circuit Upholds Patent Eligibility of a Method of Preserving Liver Cells, Giving Guidance on Applying Section 101’s Exclusion of Natural Laws
7/7/2016
Next
Take Two—The SEC Adopts Section 1504 Reporting Requirements for Payments to Governments by Oil, Gas, and Mining Companies
7/5/2016
Previous
First Italian REMIT Case
7/5/2016
Next
Avoid Five common mistakes in contract environmental clauses
7/1/2016
Previous
Market Intersection: A Quarterly Look at the U.S. Credit Markets - 2Q16
7/1/2016
Next
OFCCP Issues Final Rule on Sex Discrimination Guidelines
6/27/2016
Previous
UK Votes for Brexit – Key Considerations for International Businesses
6/24/2016
Next
Maryland Follows California in Expanding Equal Pay Protections; Hints of More to Come
6/23/2016
Previous
Supreme Court Upholds the BRI Standard and Provides Guidance on Judicial Review
6/23/2016
Next
Not Guilty, Again: Individual Corporate Liability in the Wake of the Reichel Acquittal
6/22/2016
Previous
The Delaware Supreme Court Provides Guidance to the Second Circuit Regarding Investor Holder Claims
6/22/2016
Next
From Life-Saving to Lethal: Product Liability After a Cyberattack
6/21/2016
Previous
The Supreme Court Instructs District Courts to Put Substantial Weight on the Reasonableness of a Losing Party’s Position in Determining Fees in Copyright Cases
6/21/2016
Next
Brexit's Implications for International Employers
6/20/2016
Previous
Recent SEC Enforcement Action Merits a Second Look by Private Equity Firms and Fundless Sponsors at Broker-Dealer Registration
6/20/2016
Next
Delaware Bankruptcy Court Refuses to Dismiss Chapter 11 Case Despite Existence of Secured Lender’s “Golden Share” in Debtor’s Delaware LLC Agreement: Could Bankruptcy-Remote Structures Be at Risk?
6/16/2016
Previous
Federal Circuit Provides Guidance on the APA’s Procedural Safeguards for PTAB Proceedings
6/16/2016
Next
Delaware Legislature Acts to Limit Appraisal Rights
6/15/2016
Previous
NYS Department of Labor’s Proposed Rulemaking Greatly Impacts the Use of Direct Deposit and Payroll Debit Cards
6/15/2016
Next
NTIA Seeks “Streamlining” of Team Telecom Process; FCC to Propose Rules
6/15/2016
Previous
CFPB Proposes New Rule Targeting Small Dollar Loans, Relies on UDAAP Rulemaking Authority for First Time
6/14/2016
Next
Halo Electronics, Inc. v. Pulse Electronics, Inc.: U.S. Supreme Court Rejects “Unduly Rigid” Seagate Test for Willful Infringement and Enhanced Damages
6/14/2016
Previous
Spotlight on CFIUS: Current Challenges for China Outbound M&A
6/13/2016
Next
Ever Active and Perhaps Not So New—The SEC Awards Three Dodd-Frank Whistleblowers
6/9/2016
Previous
Proportionality in Discovery – Taking Stock after Six Months
6/9/2016
Next
Hard Balance Sheet Guarantees and Their Construction Under German Law
6/9/2016
Previous
Intellectual Property Outlook: Cases and Trends to Follow in 2016
6/6/2016
Next
The Seventh Circuit Holds that Class Action Waivers in Employee Arbitration Agreements Are Unenforceable
6/6/2016
Previous
SEC Taking Hard Look at Private Equity
6/2/2016
Next
Critical Issues for Foreign Defendants in International Trade Secrets Litigation - Parts I and II
6/1/2016
Previous
A Quick Guide Comparing the Defend Trade Secrets Act and the EU Trade Secrets Directive
6/1/2016
Next
The New Federal Trade Secrets Law: Top Takeaways for Employers
5/31/2016
Previous
Historic Reforms to the French Civil Code: Ordinance No. 2016-131 and Forthcoming Changes to French Contract Law
5/27/2016
Next
Spokeo
and Article III Standing: You May Be Particularized But Are You Concrete?
5/26/2016
Previous
The Uncertain Implications of
Luis v. United States
5/25/2016
Next
Informing Investors of Climate Risk: The Impact of Securities Laws in the Environmental Context
5/25/2016
Previous
EEOC Issues Final ADA and GINA Wellness Program Regulations
5/25/2016
Next
Doing Deals: UK TUPE Case Law Update
5/25/2016
Previous
Third Circuit Overturns JSA Attribution Rule and Orders FCC to Complete Stalled Ownership Proceedings
5/25/2016
Next
Italy Moves Towards the Admissibility of Punitive Damages
5/24/2016
Previous
Patent Office Issues Updated Guidelines on Section 101 Subject Matter Eligibility Determinations
5/23/2016
Next
There’s a New Federal Trade Secrets Statute—Now What?
5/20/2016
Previous
The Basics: UK Employment Law E-Guide
5/19/2016
Next
Department of Labor Issues Final Rule Significantly Increasing Salary Thresholds for Overtime Exemptions
5/19/2016
Previous
Recent Developments Strengthen Chinese Anti-Bribery Law
5/19/2016
Next
Italy Introduces New Tools for Securing Financings and Strengthens Enforcement Procedures
5/19/2016
Previous
Privacy and Data Security Issues in M&A Transactions - A Checklist
5/17/2016
Next
IRS Releases New Guidance Regarding the "Beginning of Construction" Requirement For Qualified Facilities
5/17/2016
Previous
Enfish v. Microsoft
: Not All Software Is Abstract Through
Alice's
Looking Glass
5/16/2016
Next
Non-U.S. Investment Crowdfunding Platforms Can Offer Securities to U.S. Investors under Current Securities Laws
5/16/2016
Previous
China Tightens Controls Over Foreign NGOs with New Law
5/16/2016
Next
The Federal Government’s Ability to Initiate Criminal Proceedings Against Foreign Corporations is About to Get Easier
5/16/2016
Previous
New York Court of Appeals Adopts Delaware Standard in Evaluating Controlling Shareholder Going-Private Mergers
5/13/2016
Next
Class (Not) Dismissed: CFPB Proposes New Rule Prohibiting Mandatory Arbitration Clauses, Encourages Consumer Class Action Law Suits
5/12/2016
Previous
Supreme Court to Consider Abolishing Laches Defense for Patent Cases
5/11/2016
Next
Delaware Supreme Court Revisits Jurisdictional Impact of Foreign Corporations Registering to Do Business in Delaware
5/9/2016
Previous
UK Real Estate Quarterly Bulletin – May 2016
5/5/2016
Next
Seal the Deal: Four Steps to Effective FCPA Acquisition Due Diligence & Integration
5/4/2016
Previous
“Obama Out?" Not So Fast. President Obama Presented With Legislation that Would Create a Federal Civil Remedy for the Misappropriation of Trade Secrets
5/4/2016
Next
Class X Litigation: A Review of the Recent Windermere VII and Titan Judgments
5/3/2016
Previous
The Panama Papers Problem: Global Financial Institutions Face Increasing Liability for Clients’ Tax Evasion
5/2/2016
Next
What Are the Consequences Arising from MIFID II for Energy Operators?
5/1/2016
Previous
Calm Before the Storm: Financial Institutions Should Expect a Wave of Civil and Criminal Investigations Following the Next Panama Papers Release
4/29/2016
Next
The Supreme Court Hears Oral Arguments on the Implied Certification Theory of False Claims Act Liability: Universal Health Services v. United States ex rel. Escobar
4/28/2016
Previous
You Can Bank On Your Incentive Pay - Eventually: Proposed Regulations Would Require Sweeping Changes
4/26/2016
Next
California Taxes Based Upon Information Returns: Using a California Address for Out-of-State Workers Causes California Assessments
4/26/2016
Previous
The Gatekeeping Function of Patent Eligibility as Part of a More Complete Understanding of § 101 Principles
4/26/2016
Next
Avoiding FIFA’s Footsteps
4/22/2016
Previous
Post-Halliburton II Update: Eighth Circuit Denies Class Certification Based on Lack of Price Impact
4/20/2016
Next
Top Trends for Media and Entertainment Dealmakers
4/18/2016
Previous
DOJ’s FCPA Enforcement Plan Highlights the Need for Robust Anti-Corruption Compliance Programs
4/13/2016
Next
Unprecedented Private Equity Court Decision Collapses Related Funds Triggering Their ERISA Withdrawal Liability for Portfolio Company’s Union Pension Obligations
4/12/2016
Previous
The Judgment of the ECJ: Partial Payment of VAT Debt in Case of Arrangement with Creditors is Compliant with European Law
4/12/2016
Next
California Supreme Court Rules for First Time on Requirement of Suitable Seating for Working Employees
4/8/2016
Practice Areas
Life Sciences and Healthcare
For More Information:
Gary F Giampetruzzi
Email
+1 212 318 6417
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