Life Sciences

2016 PorzioLS Year-End Report: The Ever-Changing World of Life Sciences

2/24/2017| News

Porzio Life Sciences ("PorzioLS") has been a leading resource for the life sciences industry for over 12 years. As such, the company has been front and center for the exciting changes that continue to drive the evolution of the industry. Porzio proudly offers the 2016 Porzio Life Sciences Year-End Report as an overview of many of the year’s key events.

Topics include:

  • Licensing and Distribution
    • Drug Stewardship Programs
    • New Massachusetts Legislation
    • Implementing the Drug Supply Chain Security Act
    • Making Moves: Update on Third-Party Logistics Provider Licensing
    • The Logistics: Key Changes
    • New Jersey Enacts Legislation Clarifying Licensing Requirements
    • New Jersey Proposes Legislation to Restrict the Provision of Discounts, Rebates, or Product Vouchers
  • Enforcement Actions
    • PhRMA and BIO Published Principles of Off-Label Communication
    • FDA Public Hearing on Off-Label Communication
    • OIG Final Rules on Anti-Kickback Safe Harbors and Civil Monetary Penalties
    • FDA’s Office of Prescription Drug Promotion
  • International Transparency
    • A Milestone Moment for the Global Transparency Movement
    • EFPIA 2016 Overall Total Spend by Country
    • 2017 Projected Reporting Dates by Country
    • Porzio GST
  • Mid-Level Regulations
    • Key Changes for Mid-Level Professionals
  • U.S. Transparency and Limitations
    • Sunshine Act Statistics: 2015 Open Payments Data
    • Price and Cost Transparency
    • Chicago Adopts Licensing Ordinance for Pharmaceutical Representatives
    • The New Kid on the Block: The First Disclosure Reports for Connecticut Will Be Filed in 2017
    • D.C. Introduces Temporary and Emergency Legislation to Amend the Pharmaceutical Detailer Licensure Exemption

 

 

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Porzio Welcomes Todd Roth to the Life Sciences Department

2/13/2017| News

Porzio is pleased to welcome counsel Todd D. Roth to the Life Sciences Compliance and Regulatory Counseling Department.

Todd's broad practice includes counseling pharmaceutical, medical device and biotechnology companies regarding legal compliance, product warnings, risk management and litigation avoidance, including strategy development and review of physician-facing, direct-to patient and internal marketing and promotional materials. As a litigator, he has represented manufacturers, distributors and retailers of various products, including pharmaceuticals, medical devices, industrial equipment, recreational vehicles and automobiles in all aspects of products liability litigation in both state and federal courts. 

Todd is also Director of Compliance Services for Porzio Life Sciences, LLC, a subsidiary of the law firm. In this role, he counsels life sciences companies on a variety of compliance issues, including federal and state fraud and abuse laws, FDA promotional regulations, industry standards regarding interactions with healthcare professionals, and sampling requirements. 

Todd completed his J.D. degree at the Seton Hall University School of Law in Newark, New Jersey. He earned a B.A. in Political Science from the University of New Hampshire.

11th Annual Porzio Compliance Forum: "Compliance Monitoring and Risk Mitigation"

2/10/2017| Event

 

Porzio, Bromberg & Newman and Porzio Life Sciences, LLC, along with the Seton Hall Law School Center for Health & Pharmaceutical Law & Policy, were proud to sponsor the 11th Annual Porzio Compliance Forum. The program took place on February 10, 2017 from 8:30 AM to 2:00 PM at Seton Hall Law School in Newark, NJ.

Compliance Monitoring and Risk Mitigation

Attendees gained valuable insight into the next level of compliance from leaders in the life sciences industry.

This year's agenda included:

Best Practices for Risk Assessment

  • Objectivity While Leveraging Resources
  • Focus vs. Response to Environment
  • Assessing Risk Within Your Culture

The Evolution of Company Compliance Programs With An Eye Towards Monitoring

  • Industry Trends
  • Prioritization of Compliance Budgets
  • Auditing and Monitoring

Proactive vs. Reactive - A Changing World for Compliance Officers

  • The Emerging/Dynamic Commercial Realities for Healthcare Providers and the Life Sciences Industry
  • The Proactive Approach to Life Sciences Compliance in this New Challenging World

This program is pending approval for 4-5 total New Jersey and New York CLE credits. 

This was a complimentary event.

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Expert Panel Discussion on EFPIA Transparency and Physician Consent Management

2/2/2017| Video

Porzio principal and Porzio Life Sciences vice president Brian P. Sharkey presented during the webinar "Expert Panel Discussion on EFPIA Transparency and Physician Consent Management," hosted by qordata, on February 2, 2017. 

Webinar panelists explored topics such as: implications for future disclosure reporting; consent rate forecasts and factors affecting HCP consent decisions; anticipated regulatory updates; and existing legal and regulatory consent management differences across European markets.

Mr. Sharkey counsels life sciences companies on a variety of compliance-related issues, most significantly those relating to ex-US marketing disclosure and gift limitation laws and industry codes. In particular, he focuses on helping companies understand and comply with global reporting requirements for transfers of value to healthcare professionals, healthcare organizations, and patient organizations.  

 

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A Milestone Moment (or a Dead Jellyfish) for the Global Transparency Movement

8/15/2016| Article

By D. Jeffrey Campbell and Brian P. Sharkey

For the past several years, Porzio Life Sciences, LLC (PorzioLS) has published an annual White Paper analyzing the evolution of the global transparency movement.

2016 represents a seminal moment in the global transparency movement for several reasons, the most significant being that this is the first year of reporting under the European Federation of Pharmaceutical Industries and Associations' ("EFPIA") "Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations" ("Disclosure Code"). Since EFPIA, which is comprised of thirty-three national member associations and forty-two full and affiliate corporate members, first adopted the Disclosure Code in 2013, there has been a great deal of speculation about what the reports would reveal and what the reaction would be from key stakeholders.

This White Paper not only examines the build-up to the first round of EFPIA disclosures that took place just a few months ago, but also the initial responses to the reported data from the press, advocacy groups, and, in some instances, governmental officials. It also reviews the debate between supporters and critics of EFPIA's approach, which is reflected by the title of this year's White Paper. As discussed more fully infra, the title references a statement from the Chief Executive of the British member of EFPIA, who believes that the first round of disclosures represent a milestone moment, whereas one critic characterized the voluntary industry initiative as a charade that "has all the thrust of a dead jellyfish."

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Principal Frank Fazio Testified Before the NJ Senate Health Committee in Support of Bill S2024

5/16/2016| News

Porzio principal and Porzio Life Sciences Vice President of Distribution and Licensing Services Frank Fazio testified before the New Jersey Senate Health Committee in support of bill S2024, which he also drafted. S2024 was introduced in the Senate on April 18, 2016 and referred to the Senate Health, Human Services and Senior Citizens Committee.

The bill clarifies that product approval from the U.S. Food and Drug Administration (FDA) is not required in order for a drug manufacturer to file a registration statement. If a registrant's product has not been approved by the FDA prior to filing, the registrant must submit a statement confirming that an application has or will be filed with the FDA within 12 months. FDA approval will not be a condition of registration. S2024 further requires the Department of Health to review registration statements and reply to the registrant within 30 days of receipt. 

The committee voted unanimously to release it for a second reading before the full senate. The bill is co-sponsored by Senator Fred H. Madden, Jr. of District 4 (Camden and Gloucester) and Senator Steven V. Oroho of District 24 (Morris, Sussex and Warren). 

The full text for S2024 may be found here.

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Porzio Named Top "Notable Smaller Firm" in Life Sciences Law Firm Index

1/18/2016| News

Porzio, Bromberg & Newman P.C. is honored to be recognized as the top "Notable Smaller Firm" in the inaugural edition of the Life Sciences Law Firm Index, created by Lake Whillans and Breaking Media.

In the Index, it is noted that "Porzio’s diverse life sciences practice demonstrates that sophisticated transactional, regulatory and compliance services throughout a company life cycle are not exclusive to the legal industry’s Goliaths."

The Index was created to identify the most active and relevant law firms for life science companies.  Data was collected regarding firms' corporate, intellectual property and regulatory practice areas, in addition to their work with life science startup companies.

Lake Whillans is a litigation finance and distressed venture capital firm based in in New York City; Breaking Media is the publisher of MedCity News and Above the Law.

To read the full Life Sciences Law Firm Index results, please click here.

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The Last Two Years: A Summary of 2014 - 2015 Office of Prescription Drug Promotion (OPDP) Enforcement and Relevant FDA Guidance

3/1/2016| Article

By Jennifer A. Romanski and Kim C. Capone

The past two years have created a bit of uncertainty for life sciences promotional review professionals. With fewer enforcement letters, high-profile lawsuits, and a shift in marketing focus as a result of the Affordable Care Act, companies are struggling for a greater understanding of the Food and Drug Administration's ("FDA") enforcement objectives and some predictability to help with sales and marketing initiatives.

In 1998, FDA's Division of Drug Marketing, Advertising, and Communications ("DDMAC"), now the Office of Prescription Drug Promotion ("OPDP"), issued 158 enforcement letters. Over the years, the number of letters issued has decreased drastically. In stark contrast to the late 1990s, OPDP issued ten letters in 2014 and nine letters in 2015. Despite fewer letters, there is still much to be learned from the content of the communications and related FDA actions.

Also noteworthy, the past two years have demonstrated that OPDP enforcement is not reserved for larger pharmaceutical companies. In both years, a greater number of "small pharma" companies have received warning and untitled letters than "big pharma."

Please click here to read the full summary, published by Porzio Life Sciences.

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Seven Porzio Attorneys Recognized by "Who's Who Legal 2016"

3/29/2016| News

Porzio proudly congratulates our seven attorneys who have been selected for inclusion in Who's Who Legal 2016 and the Who’s Who Legal 2017 – Compendium Edition:

Lisa M. Bromberg: Environment

D. Jeffrey Campbell: Product Liability Defence

Roy A. Cohen: Life Sciences - Product Liability; Product Liability Defence

Todd A. Denys: Trademarks

Lauren E. Handler: Litigation; Product Liability Defence

John P. Oroho: Life Sciences - Regulatory

Thomas Spiesman: Environment

 

Since 1996, Who's Who Legal has identified the foremost legal practitioners in 34 areas of business law in over 100 countries. The selections for this esteemed list are made by the research team at Law Business Research Ltd. in London, England. Nominees are selected based upon comprehensive, independent survey work with both general counsel and private practice lawyers worldwide. Only attorneys who have met independent international research criteria are listed.

To learn more about Who's Who Legal and their selection process, please click here.

No aspect of this advertisement has been approved by the Supreme Court of New Jersey.

Ready Or Not, Full Speed Ahead For The Global Transparency Movement

8/17/2015| Article

For the past several years, PorzioLS has published an annual White Paper analyzing the evolution of the global transparency movement.  A primary catalyst for the rapid acceleration of the transparency movement was the adoption by the European Federation of Pharmaceutical Industries and Associations ("EFPIA"), which is comprised of thirty-three national member associations and forty pharmaceutical companies, of the "EFPIA Code on Disclosure of Transfers of Value from Pharmaceutical Companies to Healthcare Professionals and Healthcare Organisations" ("Disclosure Code").

The transparency movement goes well beyond EFPIA, however, as there have been legislative reporting developments recently in France, Denmark, Portugal, Romania, Greece, England, and Scotland.  Geographically, the global transparency movement extends to the Pacific Rim, as the Japanese and Australian pharmaceutical industry groups modified their individual-level reporting requirements in 2015. 

There were also many developments over the past year in the United States, the birthplace of the transparency movement.  Transparency of HCP interactions is affecting not only innovative pharmaceutical companies but other parts of the life sciences industry as well.

To read the full white paper, click here.