FDA and Healthcare

Vernessa Pollard is a partner in Arnold & Porter LLP's FDA and Healthcare group, principally focusing on regulatory matters involving the US Food and Drug Administration and US Department of Justice (DOJ). She advises companies on regulatory, compliance, enforcement, and legislative matters involving pharmaceuticals, medical devices, cosmetics, food, and medical technology and software. She regularly counsels companies on product approvals, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event reporting, FDA Warning Letters, FDA inspections, recalls, import detentions, and corporate compliance programs. She has represented companies and executives in FDA and DOJ investigations and enforcement matters. The National Law Journal named her one of the 2011 Minority 40 under 40.

Prior to joining Arnold & Porter LLP, Ms. Pollard spent six years as Associate Chief Counsel for Enforcement in the Office of Chief Counsel at the FDA, where she handled a range of enforcement and regulatory matters. Among the highlights of her tenure at the FDA, Ms. Pollard, in conjunction with the DOJ, handled an enforcement action that resulted in a consent decree of permanent injunction against a leading medical device company and its executives; obtained the FDA's first administrative civil money penalty (CMP) judgment for violations of the medical device report (MDR) requirements (the judgment was later affirmed by the US Court of Appeals for the Tenth Circuit in 2010); and handled First Amendment and Administrative Procedure Act challenges involving issues such as pharmacy compounding, dietary supplement and food health claims, and misbranding based on the "intended use" doctrine. Ms. Pollard received several recognitions and awards during her tenure at FDA including, the FDA's Commissioner's Award of Excellence (2008).

FDA and Healthcare Representative Matters

• Advises FORTUNE 500 technology, telecommunications, and device manufacturers on integrated healthcare IT devices, wireless-enabled medical devices, medical mobile apps, and disease management software.
• Advises medical device manufacturers on 510(k) submissions, manufacturing, and safety issues involving lasers, life-saving cardiopulmonary resuscitation devices, and ophthalmic devices.
• Represented pharmaceutical company executives in consent decree negotiations with FDA and DOJ; successfully negotiated removal of executives as named defendants in complaints and consent decrees entered against companies and other named individual defendants.
• Advises FORTUNE 500 company and emerging manufacturers on cosmetic packaging, labeling, and regulatory issues, including "anti-aging" claims and cosmetic ingredients.
• Reviews global clinical research, safety, and medical compliance functions of leading pharmaceutical company.
• Advises global retailer/marketer on nationwide medical device recalls, FDA inspections, and MDR issues.
• Advises national and international food producers, retailers, and leading marketer of shipping products on regulatory and legislative strategies related to food additives, food contact surfaces, and supply chain safety issues.
• Represented device manufacturer in an FDA investigation concerning marketing and promotional practices, executive and board member liability, and social media marketing.
• Advises food manufacturers and US retailers on product recalls and detention without physical examination (DWPE) under FDA Import Alerts.
• Advised a university medical system on FDA-regulated laboratory software systems, clinical trial risk assessment policies, and Institutional Review Board (IRB) requirements.
• Conducts due diligence evaluations and analyses of FDA regulatory issues relating to mergers and acquisitions.