We Help Solve FDA
Legal Challenges

Successfully Navigate The Maze Of FDA Legal
And Regulatory Requirements

Mr. Johnson has represented Pharma companies before hearings at the Federal Trade Commission (FTC), the Food and Drug Administration (FDA) and defended OTC drug client’s advertising from competitor’s challenges before the
National Advertising Division (NAD) of the Better Business Bureau. He has also successfully defended companies in litigation before the US District Court.

Steven A. Johnson

Steven A. Johnson is the principal at FDACOUNSELS.COM a full service legal, regulatory and compliance consulting firm located in Southern California. Steve has led the Global Legal and Compliance functions at pharmaceutical and device firms advising specifically on FDA legal and regulatory matters. Additionally, Steve was with FDA where he served as an Associate Chief Counsel for Enforcement in FDA’s Office of Chief Counsel trying OCI criminal and civil cases against the Food, Drug and Device regulated industry around the United States. He was a recipient of the Office of Chief Counsel’s Special Recognition Award and received his BA from Boston College and his JD from Suffolk University School of Law. He is a regular guest lecturer at industry groups such as the Food & Drug Law Institute and the Pharmaceutical Compliance Forum.


In-House FDA Counsel

Mr. Johnson has substantial experience advising and representing firms as an in-house counsel with FDA work and related matters.

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Many legal challenges relate to where you are in the company's life cycle.


Mr. Steven Johnson has been addressing FDA legal issues for over 30+ years.


See the events that Mr. Johnson is and has been involved in.

Our Focus Areas

Rx-OTC Switch

Secured FDA reversal of agency’s initial denial of 3-year exclusivity under Hatch-Waxman.

Unique Topical Drug

Spearheaded strategy to fight FDA’s proposed withdrawal of client’s.

Cancer Pain

Developed overall strategy leading to filing and approval of New Drug Application (NDA)


FDA counsel to major compounding pharmacy; led strategy to establish separate subsidiary to obtain formal FDA

Analgesic Products

Penned waiver requests under Pediatric Research Equity Act (PREA) as applicable to NDAs being filed by clients.

Health Assessment

Coordinated all aspects of recall of pharmaceutical, including securing health assessment, drafting recall letters and press releases.

Transactions FDA Enforcement
And Crisis Management

No matter when or why an FDA-related issue confronts you or what it relates to, you need
experienced counsel. More information on the services I provide can be found below.

FDA Legal Services For The Life Of A Life Sciences Company

Product and Issue Specific Services


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