Steven J. Gonzalez
Steven Gonzalez focuses his practice on FDA regulatory matters and advises life sciences and health care clients on a broad range of issues under the Food, Drug and Cosmetics Act and related laws. Steven routinely conducts regulatory due diligence in connection with corporate transactions involving drug, device, food and dietary supplement companies. Steven has also provided legal and strategic advice to FDA-regulated companies in government enforcement and litigation, advertising and promotion, and general regulatory compliance matters.
While in law school, Steven was the President of the Harvard Food Law Society and worked on pro bono matters through Harvard’s Food Law and Policy Clinic.
- Routinely perform FDA regulatory diligence for private equity funds’ acquisition of or investment in drug, medical device, and food companies.
- Performed regulatory diligence and drafted contract terms for a manufacturing and supply agreement on behalf of a private label distributor of human tissue products.*
- Routinely assess regulatory compliance of advertising and promotional materials, including product labeling and website content for pharmaceutical, medical device, food/beverage, and dietary supplement companies.*
- Developed a detailed drug promotion training presentation for internal use by a pharmaceutical company’s marketing and sales team and advised the company on a variety of specific promotional issues related to its products.*
- Advised a pharmaceutical company on the use of Key Opinion Leaders (KOLs) in promotional and educational contexts.*
General Regulatory and Enforcement
- Provided strategic counsel and drafted public comments related to FDA rulemaking on behalf of multiple food and beverage trade associations.*
- Advised drug, medical device, and food companies during FDA inspections, responses to FDA Form 483, responses to Warning Letters, and product recalls.*
- Regularly advised medical device and consumer product companies on FDA regulatory approval pathways and product classification for products in development.*
- Advised banking, private equity, food/beverage, and dietary supplement clients on the legal and regulatory implications of the 2018 Farm Bill on the manufacture and sale of FDA-regulated products containing hemp-derived ingredients like cannabidiol (CBD).*
- Advised health care providers on compliance matters associated with both 503A and 503B drug compounding according to the Drug Quality and Security Act (DQSA) and implementing FDA regulations and guidance.*
- Advised health care providers on compliance matters associated with the use of human cells, tissues, or cellular or tissue-based products (HCT/Ps).*
- Engaged with the FDA to advocate and negotiate on behalf of a trade association’s members after the agency changed its interpretation of existing law through enforcement rather than guidance.*
*Experience prior to joining Ropes & Gray
- Co-author, “Incentives And Risks From OTC Drug Monograph Revamp” Law360 (May 29, 2020)
- JD, Harvard Law School, 2017; Executive Editor, Harvard Law and Policy Review
- BA (Philosophy: Ethics and Public Policy), cum laude, University of California, Santa Barbara, 2012