Pharmaceutical

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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Legislation Easing The Registration Process For Pharmaceutical Companies Enacted In New Jersey

12/5/2016| News

Porzio is pleased to announce that Porzio-supported legislation was signed into law by New Jersey Governor Chris Christie.  As a result, product approval from the U.S. Food and Drug Administration (FDA) is no longer a condition for a pharmaceutical company to receive registration approval by the State Department of Health.  As registration in a company's home state is one of the necessary first steps in the process for a new drug to be brought to market, the requirement imposed by the State Department of Health was particularly burdensome on companies based in New Jersey.  This legislation further requires the Department of Health to review registration statements and reply to the registrant within 30 days of receipt.

Porzio Governmental Affairs, LLC and Porzio Life Sciences, LLC initiated the introduction of this legislation by Senators Fred H. Madden, Jr. (D-Gloucester) and Steven V. Oroho (R-Sussex) and Assemblyman Tim Eustace (D-Bergen).  Designated as S2024/A3793, the legislation passed both houses of the legislature unanimously before heading to the Governor's desk. 

Frank Fazio, Porzio principal and Porzio Life Sciences Vice President of Distribution and Licensing Services, testified in support of S2024 before the New Jersey Senate Health, Human Services and Senior Citizens Committee, and before the Assembly Health and Senior Services Committee in support of A3793.  Prior to the introduction of the legislation, he brought the issue before the Red Tape Review Commission in September of 2015, outlining the obstacles being faced by biotech companies with the existing registration process.  Stated Senator Madden, "This legislation will allow New Jersey biopharmaceuticals the same advantage of registering their products while they wait for FDA approval, as is the policy in many of our neighboring states."  

Lobbying efforts were spearheaded by Porzio Government Affairs Executive Vice President Lynn Nowak.  She was recently featured on Senate Majority Leader Weinberg's annual list of the most powerful and influential women in New Jersey civic affairs.  Ms. Nowak has represented the interests of a wide variety of clients before the legislature and executive branch for over two decades. 

Porzio is grateful to Senators Madden and Oroho and Assemblyman Eustace for their leadership on this issue.  Stated Assemblyman Eustace, “New Jersey is the medicine box of the world and we must make every effort to allow for new drugs to get to the marketplace quicker and cheaper.  Working together we can find ways to deliver needed therapies to patients at lower costs.”

According to Senator Oroho, “This law will reduce the time it takes for drug companies to set up shop in New Jersey…  If we can make government more efficient, we can make the state better for business and cheaper for residents. This law is another step toward that goal, but we must continue our efforts in order to ensure our economic prosperity."  

Porzio is proud to support our clients' goals and to be able to enact significant changes that will aid New Jersey businesses and industry going forward.