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Eve Costopoulos

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Eve Costopoulos is special counsel in the Life Sciences Team in the firm's New York office.

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On January 18, 2024, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued its first untitled letter of the new year to Novartis Pharmaceuticals Corporation (Novartis) regarding a promotional, direct-to-consumer broadcast advertisement (TV Ad) for KISQALI® (ribociclib) tablets, for oral use, indicated for the treatment of adult patients with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with:Continue Reading FDA’s Office of Prescription Drug Promotion Issues Its First Untitled Letter of the Year to Novartis for Misleading Statement Relating to KISQALI®

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although there was no single moment like the passage of the Affordable Care Act in 2010, there are numerous distinct events that will loom large in 2024 and beyond.Continue Reading 2024 Top-of-Mind Issues for Life Sciences Companies

In late April this year, the Office of Inspector General, Department of Health and Human Services (OIG) announced that it would make changes to its existing body of healthcare compliance program guidance (CPGs) as part of its current Modernization Initiative.[1] These CPGs were directed at various segments of the health care industry and provided specific guidance on risks posed by industry practices. To kick off the initiative, OIG indicated that it would first issue a new general compliance program guidance (GCPG) by year end applicable to individuals and entities in all segments of the health care industry that would address overarching compliance elements regarding federal fraud and abuse laws, compliance program basics, compliance program effectiveness and general process and procedures. Thereafter, OIG said it planned to update existing industry-specific compliance program guidance (ICPG), which would include tailoring each to address fraud and abuse risk areas specific to a particular industry and describing the compliance measures that industry could take to reduce these risks[2].Continue Reading OIG General Compliance Program Guidance November 2023

The Sheppard Mullin Life Sciences Team decided to take a different approach to our year-end review. We surveyed and considered issues most important to our clients, asking the experts across the various specialties in our Life Sciences Practice the following question: What do life sciences companies need to keep top of mind in 2023?Continue Reading 2023 Top-of-Mind Issues for Life Sciences Companies

Effective January 1, 2023, the recently enacted California Assembly Bill 1278,[1] requires a physician and surgeon (defined as a physician and surgeon licensed pursuant to the Medical Practice Act or an osteopathic physician and surgeon licensed by the Osteopathic Medical Board of California under the Osteopathic Act, but not a physician or surgeon working in a hospital emergency room) to provide a written or electronic notice of the Open Payments database to a patient at the initial office visit. The written or electronic notice shall contain the following text:Continue Reading California Passes First State Law Requiring Physicians to Disclose Open Payments Database to Patients

The US Food and Drug Administration (FDA) Office of Pharmaceutical Quality (OPQ) of the Center for Drug Evaluation and Research (CDER) recently published a White Paper laying out a framework to evaluate the Quality Management Maturity (QMM) of pharmaceutical manufacturing sites. The White Paper supports CDER’s long-held vision for pharmaceutical quality in the 21st century, described as a “maximally efficient, agile, flexible manufacturing sector” that is able to reliably produce high-quality drug products without extensive regulatory oversight.[1] The Agency is hosting a two-day workshop on May 24 and 25 for stakeholders to provide feedback on the proposed QMM, which may be a welcome shift towards a more holistic, metric-based review of manufacturers with mature quality systems.Continue Reading FDA White Paper Signals Shift to Performance-Based Reviews of Mature Quality Systems

On March 31, 2022, the Office of Prescription Drug Promotion (OPDP) of the U.S. Food and Drug Administration (FDA) issued an untitled letter to Bausch Health Companies Inc. regarding a promotional video and healthcare professional website for DUOBRII™ (halobetasol proprionate and tazarotene) lotion, indicated for topical treatment of plaque psoriasis in adults (DUOBRII). The video[1] content aired on a popular television network and the website[2] content was directed at healthcare professionals.  This is only the second untitled letter from OPDP this year, both of which were focused on false and misleading promotional messaging.
Continue Reading FDA Issues Untitled Letter to Bausch Health Companies for Misleading Statements Relating to DUOBRII™