Julie Tibbets is a partner in the firm’s Food, Drug & Device/FDA Group. Julie focuses her practice on advising clients on compliance with the laws and regulations affecting FDA-regulated products and assessing regulatory risks. She counsels developers, manufacturers and distributors of drugs, biologics, medical devices, in vitro diagnostics, foods, dietary supplements and cosmetics in addition to counseling marketers and retailers of these products. Her experience includes advising clients on corporate communications, labeling, advertising and marketing materials, employee training, company interactions with health care professionals, medical affairs activities, Physician Payments Sunshine Act compliance, product development strategies, interactions with FDA and dispute resolution, product formulations/ingredients product recalls and adverse event reporting. Since 2013, Julie has appeared on the Washington, D.C., Super Lawyers list of “Rising Stars” in the area of food and drug practice. In addition, Julie was recently selected by her peers for inclusion in The Best Lawyers in America 2016 for FDA law.
- Counsels the promotional review committees of biologic, drug, device, IVD and laboratory companies on managing regulatory risks and ensuring compliant marketing materials and activities across an array of products and uses.
- Counsels the promotional review committees of biologic, drug, device, IVD and laboratory companies on managing regulatory risks and ensuring compliant marketing materials and activities across a broad portfolio of products and uses.
- Advises biologic, drug, device and IVD companies on the application of Physician Payments Sunshine Act reporting requirements to their businesses.
- Conducts FDA regulatory due diligence reviews of food, drug, device, clinical laboratory and dietary supplement companies and advises clients on the regulatory risk profiles of target companies and business units subject to pending mergers and acquisitions.
- Advises clinical-stage biopharmaceutical companies on regulatory submissions, clinical development meetings with the FDA and related corporate communications.
- Represents food manufacturers and retailers on compliance with and implementation of the requirements of the FDA Food Safety Modernization Act and menu labeling requirements.
- Advises health care providers and distributors on DEA and state reporting requirements for the diversion or loss of controlled substances.
- Assists food, dietary supplement and cosmetic manufacturers with new product launches, including review of product labeling and marketing claims.