Natasha Leskovsek joined the firm in 2001 and has a practice emphasizing Food and Drug Administration (FDA) regulatory compliance and strategic counseling. She is a member of the FDA Regulatory Group of the Life Sciences Practice Group and is additionally a member of the firm’s Corporate/VLG and Intellectual Property Transactions Practice Groups.

Experience

Ms. Leskovsek advises pharmaceutical, biotechnology, medical device and food/dietary supplement industry clients on regulatory, legislative and reimbursement matters. Ms. Leskovsek has also advised health care professional associations on legislative and reimbursement issues as well as provided pro bono counsel to cancer and autoimmune patient groups.

Before joining Heller Ehrman, Ms. Leskovsek worked for an FDA specialty law firm in Washington D.C. from 1996-2001. Prior to entering the law, Ms. Leskovsek worked as a registered nurse in pediatric oncology research at the National Institutes of Health (NIH) and with adult medical and surgical patients. Ms. Leskovsek worked as a consultant for international pharmaceutical and biotech clients while attending Georgetown University Law Center. Her direct clinical trial experience in nursing and project management offers her a unique perspective in advising clients on the conduct of clinical trials in product development and postmarketing studies. She has authored numerous healthcare and FDA-related publications and regularly speaks on a broad range of FDA regulatory topics for national conferences and meetings.

Representative Engagements

• Development of product approval and lifecycle management strategies for prescription and OTC drugs, medical devices, and biologics.
• Counseling on clinical trial issues, including clinical trial agreements, informed consent, HIPAA patient privacy, IRB relations, reporting of AEs, and removal of clinical holds.
• Preparation of Orphan Drug designation requests.
• Preparation of drug, device, and biologic product sponsors for meetings with FDA and participation at FDA meetings to ensure that client rights are preserved.
• Advise on compliance strategies for federal and state regulatory matters, including labeling review, records retention and state permitting requirements.
• Development and drafting of comments to FDA proposed rules and Citizen Petitions.
• Draft and review FDA regulatory representations and warranties sections of licenses and other contractual agreements.
• Conduct FDA regulatory due diligence for venture capital and public financing, both as corporate and underwriter’s counsel.
• Participate in IP litigation (Hatch-Waxman lawsuits) on issues involving interpretation of FDA statute and regulations.
• Respond to FDA inspection reports and warning letters, as well as preparing clients for inspections and audits.
• Advise on advertising, labeling, and promotional claim compliance for FDA regulated products; prepare competitive strategies regarding competitors’ claims, including business-to-business solutions (cease and desist letters) and Agency involvement.
• Medicare/Medicaid fraud and abuse compliance and Qui Tam litigation.
• Development and implementation of strategies to stop importation of counterfeit goods.

Publications

• "Valuable Rewards for Children's Medicines,"  Pharmaceutical Law Insight  03.2007
• James N. Czaban and Natasha Leskovsek, "Trying to Sell Same"  Legal Times  5.17.2004
• "FDA Holds Groundbreaking Public Meeting on Innovative Drug Delivery Systems"  Drug Delivery Technology  9.1.2003
• Regulatory Compliance: A Heightened Concern for Corporate Directors & Officers  Drug Delivery Technology  1.1.2003