FDA and Healthcare

Dan Kracov heads the FDA and healthcare practice. He assists clients, including start-up companies, trade associations, and large manufacturing companies, in negotiating the challenges relating to the development, approval and marketing of drugs, biologics, and medical devices. His experience in US Food and Drug Administration (FDA) strategic advice and crisis management won him a spot on the Fall 2005 Legal Times list of "Leading Lawyers in Food & Drug Law."

Mr. Kracov regularly handles product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions. He has a widely-recognized experience in biomedical product-related public policy matters, including Congressional investigations and FDA-related legislative strategies.

FDA and Healthcare Representative Matters

• Represent major pharmaceutical and medical device companies in responding to critical regulatory matters, including approval strategies, inspections, investigations, and FDA Advisory Committee meetings.
• Currently lead counsel in multiple Congressional investigations relating to drug safety and off-label marketing.
• Counsel to major pharmaceutical companies in a variety of FDA legislative initiatives, including the reauthorization of the Prescription Drug User Fee Act and amendments to Hatch-Waxman generic drug legislation.
• Represented leading medical device company in responding to regulatory aftermath of product-related public health crisis.
• Counsel in the leading case determining the distinction between a drug product and dietary supplement.
• Counsel to scientific investigators in the aftermath of the death of clinical study subject. Represented investigators in the five separate governmental and private investigations.
• Representation of numerous companies in FDA/US Department of Justice investigations, product recalls, inspections, import detentions, and other compliance and enforcement matters.
• Counsel to major pharmaceutical company in negotiating settlement after termination of multiyear collaboration agreement with a biotech company.
• Represent leading medical device Internet retailer in FDA, US Federal Trade Commission (FTC) and state regulatory matters.
• Counsel to major specialty chemical company in seeking inclusion of an active ingredient in a developing over-the-counter drug monograph.
• Counsel to major pharmaceutical company in achieving US Department of Defense policy on procurement of terrorism countermeasure, and in efforts to secure stockpiling of a pandemic countermeasure product.
• Represented a range of companies in advertising investigations brought by the FTC and State Attorneys General.
• Advisor to major over-the-counter (OTC) drug/dietary supplement/cosmetic company in setting up European regulatory operations.