Vernessa T. Pollard advises companies on regulatory, compliance, enforcement and policy matters involving pharmaceuticals, medical devices, health information technology (HIT) and digital health solutions, services and software. She advises companies and investors on regulatory and compliance issues arising from mergers, acquisitions and other transactions involving Food and Drug Administration (FDA)-regulated products. She also counsels manufacturers, distributors and retailers on regulatory and compliance issues related to food and cosmetic marketing and safety.
Vernessa regularly counsels companies on product development and premarket strategy, Good Manufacturing Practice (GMP) and Quality System (QS) requirements, advertising and promotion, adverse event report FDA warning letters, FDA inspections, recalls, import detentions and corporate compliance programs. She has represented companies and executives in FDA and Department of Justice (DOJ) investigations and enforcement matters. She also conducts due diligence evaluations and analyses of FDA regulatory issues relating to mergers and acquisitions.
Previously, Vernessa spent six years as an associate chief counsel for enforcement in the Office of Chief Counsel at the FDA, where she represented the FDA in a variety of litigation, compliance and regulatory matters. In conjunction with the DOJ, she handled civil injunction and consent decree actions involving pharmaceutical, medical device, food and cosmetic manufacturers. She obtained the FDA’s first administrative civil money penalty (CMP) judgment for violations of the Medical Device Report (MDR) requirements. She also handled defensive matters involving FDA regulations and policies for product labeling, advertising and product approval issues arising under the Administrative Procedure Act (APA), the First Amendment, and the Federal Food Drug and Cosmetic Act (FDCA).
While in law school, Vernessa was the managing editor for the Temple Political and Civil Rights Law Review.
Pharmaceutical, Biotechnology and Medical Device Regulatory
Advised manufacturers on device classification issues, adverse event reporting, premarket strategy and cGMP/QSR requirements for medical devices including, prosthetic and orthotic devices, cardiac monitors, lasers and glucometers
Advises biologics and pharmaceutical manufacturers on FDA inspections, cGMP requirements, 483 responses and remediation and compliance matters
Represents pharmaceutical and medical device companies and individual executives in FDA/DOJ injunction actions and consent decree negotiations
Counsels medical device and technology developers on FDA premarket strategy and post-market compliance issues related to innovative digital health, combination products and mobile applications
Advising pharmaceutical, cosmetic and food manufacturers, distributors and retailers on FDA labeling and advertising issues, post-market labeling changes and import and export of FDA-regulated products
Advising a pharmaceutical manufacturer on FDA Good Clinical Practice (GCP) requirements related to global clinical trials
FDA and Health Care Due Diligence
Counseled a private equity company on regulatory due diligence matters involving acquisition of pharmaceutical contract manufacturer and contract research organization (CRO)
Advised a Fortune 500 pharmaceutical company on acquisition of physician and patient-directed health care media and multi-channel marketing platform, including health IT solutions, mobile apps designed to assist HCPs with management of daily workflow at the point-of-care when they make diagnosis, treatment and prescribing decisions
Represented a private equity company on regulatory due diligence for transaction involving the acquisition of Institutional Review Board (IRB) that oversees drug and medical device clinical trials
Advised a private equity company on due diligence purchase of medical device and health IT solutions for patient diagnosis, electronic health care records and financial and operational systems for emergency departments in hospitals
Represented a private equity company on regulatory due diligence matters involving separate acquisitions of manufacturers of urinary catheter devices marketed globally
Counseled a manufacturer on regulatory due diligence matters involving the acquisition of cosmetic company and adult consumer products