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.
In recent years, psychedelics have been gaining popularity when it comes to treating an array of mental health issues. With its promising medical and therapeutic benefits, psychedelic-assisted psychotherapy (PAP) is generating significant interest among policymakers, medical professionals, and the public. As it provides an alternative treatment for refractory mental health concerns, several cities in the U.S are starting to decriminalize some psychedelics.
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.
Pharmaceutical and biotechnology patents have increased aggressively in recent years. Consequently, this upward trend has posed a greater risk for the U.S. pharma patents. Political and economic troubles such as claims of patent evergreening abuse have also added complexity on existing challenges.
The current COVID-19 pandemic has created unprecedented challenges for health care providers and their business associates. This public health emergency has changed the way health care providers operate and deliver health care, including the increasing reliance on telehealth. Privacy officers for covered entities and their business associates need to keep abreast of notices and guidances issued by Department of Health and Human Services regarding compliance with Health Insurance Portability and Accountability Act (HIPAA) during this public health emergency.
Inter partes review (IPR) proceedings have been an attractive ground for drug companies seeking to challenge the patentability of pharmaceutical products. The IPR allows challengers to maximize the streamlined process of the Patent Trial and Appeal Board (PTAB) while also taking advantage of the benefits provided by the Hatch-Waxman Act. Given this backdrop, the number of challenges utilizing the IPR process is predicted to continuously climb this year and beyond.
The COVID-19 pandemic has resulted in a major shift in FDA regulatory and enforcement priorities and has had a drastic impact on the broader regulatory landscape. At the end of 2019, the agency was focused, among other issues, on opioids, youth vaping, food safety, compounding and overhauling the regulatory framework for dietary supplements. Today, FDA is focused on helping industry bring to market drugs, devices and vaccines critical to fighting the pandemic. Its enforcement efforts are focused on those who peddle false cures or distribute counterfeit or otherwise poor quality products. The world has changed, and with it the regulatory environment.
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.
The impact of COVID-19, along with the accelerated rise in expectations from patients regarding the quality of the digital experience, places tremendous pressure on health systems.
As the biosimilar industry continues to grow, significant legal developments and trends also continue to emerge and pose challenges to market participants. Questions currently hounding the future of the Biologics Price Competition and Innovation Act (BPCIA) litigation and regulatory pathway include the newly introduced Biologic Patent Transparency Act, the ongoing debates on the constitutionality of the Affordable Care Act (ACA), and the potential unavailability of inter partes and post-grant review proceedings for biosimilar manufacturers.
The COVID-19 pandemic has posed unique risks and challenges in almost all sectors around the globe, including the healthcare industry. Because of this, changes in the way that healthcare is delivered have also been significantly evident.
The security risk analysis and management obligations required by the Health Insurance Portability and Accountability Act (HIPAA) Security Rule are intended to play a crucial role in mitigating risks and vulnerabilities to the security and confidentiality of patient protected health information (PHI). Organizations that fail to implement these measures may be more susceptible to potential PHI breaches and could be confronted with costly regulatory fines.
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).
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