Julie Tibbets

Julie Tibbets chairs Goodwin’s Life Sciences Regulatory & Compliance practice at the firm. In addition, she co-chairs Goodwin’s firmwide Attorney Review Committee.

Julie focuses her practice on FDA-regulated product development, crisis resolution, product marketing and corporate communications as well as the intersection of each of those with corporate strategy and securities disclosure obligations. Her product areas of focus include biologics, drugs, medical devices, in vitro diagnostics, as well as digital therapeutics, tools and apps. Julie advises clients on product development strategy, interactions with the FDA, clinical trial conduct and documentation, adverse event reporting, commercial strategy, product labeling and advertising, and FDA inspections. She also leads the regulatory due diligence reviews of FDA-regulated M&A or investment targets, potential collaborators and licensees, and guides the regulatory disclosures of FDA-regulated entities in their initial public offerings and follow-on offerings. Julie also works closely with the Food & Healthy Living practice team at Goodwin on the intersection of food, supplement, and cosmetic regulation with FDA’s drug and device authorities.

• Advises early- to late-stage developers in the drug, device, digital health, and diagnostic areas on product development pathway strategies, regulatory submissions, meetings with the FDA, data disclosures, expedited program designations, patient engagement, disease awareness programs, and corporate communications
• Counsels numerous public biopharmaceutical companies on the resolution of clinical holds, including those issued following unexpected patient deaths or serious adverse events
• Counsels the medical affairs and promotional review committees of biologic, drug, medical device, diagnostic, and laboratory companies on managing regulatory risks and ensuring compliant promotional materials and activities across a broad portfolio of products and uses
• Advises on clinical trial agreements, patient informed consents, and expanded access and right to try policies and programs
• Conducts internal investigations on regulatory compliance matters, including investigations relating to good clinical practices, product promotion, and drug sampling
• Counsels on the resolution of Form FDA-483 observations and warning letters
• Negotiates the regulatory terms of commercial agreements, including pharmacovigilance agreements, clinical collaboration and development agreements, distribution agreements and supply and quality agreements
• Provides BridgeBio Pharma and its subsidiaries with regulatory counseling in connection with data releases, clinical operations, medical and corporate communications and regulatory disclosures
• Represented AMAG Pharmaceuticals in the sale of its rights to Intrarosa® to Millicent Pharma for up to $125 million
• Represented Amylyx Pharmaceuticals in its $190 million IPO and $246 million underwritten public offering
• Represented Cerevel Therapeutics on its $350 million underwritten public offering of common stock
• Represented Valo Health on its $2.8 billion business combination with Khosla Ventures Acquisition Co., a special purpose acquisition company (SPAC) founded by affiliates of Khosla Ventures
• Represented SpringWorks Therapeutics on regulatory matters in conjunction with its $186.3 million IPO
• Represented Fresenius Medical Care in regulatory due diligence for its $150 million equity investment in Humacyte, Inc. and exclusive distribution rights for Humacyte’s investigational human acellular vessel, a regenerative medicine product, to dialysis patients worldwide
• Represented Nautic Partners on its acquisition of Mikart, Inc., a contract development and manufacturing organization

PRO BONO

Julie represents The Fed Is Best Foundation in its national pursuit of regulatory, legislative, and policy changes to set minimum newborn nutritional requirements and to increase parent and health care provider education regarding newborn nutrition and safe feeding practices.

In 2020, Julie began representing VoteRiders, a nonpartisan, nonprofit organization founded in 2012 with a mission to ensure that all citizens are able to exercise their right to vote.

Julie is a member of the Food and Drug Law Institute and the Society of Clinical Research Associates.

Julie has been ranked in Washington, DC for Pharmaceuticals / Medical Products Regulatory by Chambers USA since 2018. In 2022, LMG Life Sciences recognized Julie as its Regulatory Attorney of the Year: FDA Pharmaceutical. She has appeared on the Washington, DC, Super Lawyers list of “Rising Stars” in the FDA area and has been selected by her peers for inclusion in The Best Lawyers in America every year since 2016 for FDA law.

• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2023-2024 ed.,” published by Thomson Reuters, January 2024
• Quoted, “FDA Increasingly Halting Human Trials as Companies Pursue Risky, Cutting-Edge Drugs,” The Wall Street Journal, January 10, 2023
• Quoted, “Data Integrity Fallout: Sponsors Risk Reputational Damage, Negative Impacts On Other Research,” The Pink Sheet, January 5, 2023
• Contributor, “Guide to Biosimilars Litigation and Regulation in the U.S., 2022-2023 ed.,” published by Thomson Reuters, December 2022
• Co-Author, "U.S. CARES Act Supply Shortage Provisions: What Drug and Device Manufacturers Need to Know," Goodwin Alert, April 3, 2020
• Co-Author, “Public Health Crises and FDA Scrutiny,” PM360, March 7, 2020
• Co-Author, “Developing Medical Products for Public Health Emergencies,” Goodwin Insight, February 27, 2020
• Quoted, "ParaGard TV Spot Misrepresents Contraceptive’s Risks, US FDA Says," Pink Sheet, July 31, 2019
• Author, “Words & Functionalities Matter: FDA Regulation of Consumer Software and Apps,” PM360, April 15, 2019
• Author, “Talking About Your Pipeline,” PM360, January 17, 2019
• Author, “Patient Experience Data and R&D,” PM360, November 19, 2018
• Quoted, “First Amendment takes center stage in DTC price fight,” BiopharmaDive, October 22, 2018
• Quoted, “FDA could set record low for drug marketing warning letters — again,” BiopharmaDive, October 3, 2018
• Author, “Office of Prescription Drug Promotion Enforcement Letters: 2018 Year in Review,” Goodwin Insight, September 19, 2018
• Author, “Pitfalls of Generic Drug Marketing,” PM360, June 21, 2018
• Presenter, “Reviewing OPDP Enforcement Actions and Best Practices for Compliant Drug Promotion”, Q1 Productions Webcast, June 21, 2018
• Author, “Exhibit Displays: Beware the FDA,” PM360, April 20, 2018
• Author, “The FDA, Clinical Decision Support Tools, and the Medical Device Industry,” PM360, February 21, 2018
• Author, “Is Pharma Leading the Pack with Compliant Endorser Disclosures?,” PM360, November 15, 2017
• “FDA Enforcement Trends for Broadcast Advertisements,” RAPS, September 28, 2017
• Author, “Disclosing Connections With Advertisers on Social Networking Sites,” PM360, September 22, 2017
• Author, “Promoting Products Right: FDA’s Latest Recommendations,” PM360, April 10, 2017