FDA’s enforcement landscape continues to evolve as the agency implements its new legislative authorities, advances its regulation of cutting-edge issues, addresses significant supply chain concerns, and deals with the fallout from the COVID-19 public health emergency. Despite the evolving landscape, enforcement related to manufacturing and data integrity-related deficiencies and unapproved new products remain at the core of the agency’s enforcement priorities.
Price fixing, industry consolidation, and other anti-competitive business practices have long been the subject of intense antitrust scrutiny. To address these perceived flaws and abuses, President Biden issued an executive order on “Promoting Competition in the American Economy,” which calls for measures to ensure the strict enforcement of antitrust laws across several key industries, particularly in healthcare and life sciences.
While healthcare professionals grapple to save lives in the midst of the pandemic, medical malpractice lawsuits have also evidently increased. According to experts, the growing number of malpractice cases implies the pressure that hospitals are facing due to the current health crisis. The year 2020 has significantly reshaped the medical negligence arena and more changes are expected to come this 2021 and beyond.
Group health plans are governed by a number of state and federal laws including, but not limited to, Health Insurance Portability and Accountability Act (HIPAA), Employee Retirement Income Security Act (ERISA), and Consolidated Omnibus Budget Reconciliation Act (COBRA).
