Webinar: Regulatory Pitfalls & Business Opportunities in Behavioral Health

Recent rapid growth in the behavioral health industry has been driven by national awareness of the opioid crisis, including the Support for Patients and Communities Act.

Join Alicia Macklin and Robert Miller from Hooper, Lundy & Bookman as they discuss the expansion potential in behavioral health as well as the unique licensing, regulatory, and compliance concerns in this space. Get practical tips for both day-to-day operations and due diligence for mergers/acquisitions.

Register here for the educational webinar taking place March 18, 2020 at 1:00 PM ET.

NGE IP Focus Life Sciences issue now available

As intellectual property practitioners working in the life sciences industry, we are positioned to engage with innovative scientific advances as well as emerging legal issues impacting the ability to secure and maintain patent protection for these advances. The legal issues encountered run the gamut from niche issues specific to the life sciences industry to intellectual property issues of general applicability across industries. In this issue of NGE IP Focus, we highlight some recent legal decisions in the life sciences industry that illustrate the depth and breadth of legal issues encountered in the field.

Wolters Kluwer Holiday

We will not be posting on October 9 in commemoration of Columbus Day. The Wolters Kluwer Legal and Regulatory U.S. Health Law Editorial Team wishes you a safe and happy holiday. We will resume our regular posting schedule on Tuesday, October 10.

House committee takes interest in ‘NotPetya’ malware attack fallout

House Energy and Commerce Committee leaders are concerned that a malware attack from late June 2017, known as “Petya” or “NotPetya,” may have lingering effects on Merck & Co, Inc. The leaders sent letters to Merck’s CEO and HHS Secretary Price expressing this concern and requesting additional information about the attack and the effects on the company.

NotPetya

The malware infection began on June 27, 2017, and spread across the world, infecting businesses from a variety of sectors. At the time of the attack, the extent of Merck’s vulnerability was not precisely known, although an employee reported that they were told to stop working and some computers appeared to be wiped and that all U.S. offices were affected by the attack. The committee letters referred to information provided in Merck’s second-quarter 2017 financial outlook, which stated that packing operations were mostly restored, formulation operations were partially restored, and active pharmaceutical ingredient operations were partially restored but bulk product was not yet being produced.

Patient risk

The committee’s interest in the matter stemmed from concern that patients may have been negatively impacted by manufacturing disruption. Although evidence of such risk was not present, the committee pointed to an announcement from the Centers for Disease Control and Prevention (CDC) that certain formulations of Merck’s Hepatitis B vaccine would not be available. The committee requested that Merck provide a formal briefing to the committee on the initial infection and Merck’s steps to recover and resume manufacturing by October 4, 2017. The committee also requested an HHS briefing on the agency’s steps to understand and respond to the situation as well as plans for addressing drug shortages or other consequences stemming from cyberattacks.