Faraz Rahim Siddiqui Associate
Faraz Rahim Siddiqui

Overview

Faraz Siddiqui advises clients in the food and life sciences industries on a wide range of FDA-regulatory matters. He has helped drug and device manufacturers at various stages of product development, from advice on regulatory and expedited pathways and reviewing labeling and promotion materials, to advising clients on pharmacovigilance issues and safety reporting. Mr. Siddiqui has drafted white papers to the agency and helped clients prepare for FDA meetings.

Mr. Siddiqui has led FDA-regulatory diligence on several large mergers and acquisitions on behalf of buyers. He has provided post-transaction support on registration and listing, state licensure, and transfer of proprietary information. Mr. Siddiqui also participated as a subject-matter expert in M&A litigations, including in a landmark case which saw the Delaware Chancery Court’s only termination of a merger agreement based on a “material adverse effect” theory.

Prior to joining Hyman Phelps & McNamara, Mr. Siddiqui worked at an AmLaw 100 firm, advising drug, device, and tobacco clients on regulatory questions. While in law school, Mr. Siddiqui interned with an administrative appeals judge at the U.S. Department of Health & Human Services and won the 2016 ABA Health Law Section Law Student Writing Competition for his paper entitled, Balancing Health Privacy Law with Emerging Healthcare Innovation. Prior to his legal career, Mr. Siddiqui led Global Inroad Consulting, a Canadian management consulting firm, advising international clients on organizational strategy and operational management. He has also worked as a public health researcher at Georgetown Law School and as an epidemiologist for the Baltimore City Health Department.

Mr. Siddiqui holds a Masters in Public Health from Johns Hopkins Bloomberg School of Public Health. He has published several articles in the intersection of FDA-law, policy, and public health, including a paper in the Lancet. He uses his public health background to better advise clients on the FDA approval practices and provide a multidisciplinary approach to client advocacy.

Education & Admissions

Education

J.D., Howard University School of Law, magna cum laude
M.P.H, Johns Hopkins Bloomberg School of Public Health
B.S., University of Toronto, with Honours

Admissions

American Bar Association
District of Columbia
U.S. District Court of District of Columbia

Experience

  • Provided practical and strategic FDA regulatory advice to a broad spectrum of corporate clients on initiatives or activities involving FDA-regulated products and options and strategies to navigate regulatory hurdles to advance their business needs while addressing their legal risks and protecting the company’s integrity;
  • Focused on drugs, biologics, medical devices, food, and tobacco products in all phases of the product lifecycle; experience in pharmacovigilance, state licensure, data integrity, cell and gene therapies, expedited pathways, packaging and labeling, regulatory submission standards, promotion, establishment registration and listing, and DSCSA
  • Supported litigation counsel in Delaware Chancery Court lawsuits challenging mergers for issues related to data integrity, GxP compliance, Application Integrity Policy and fraud; supported e-discovery and creating legal strategy including in the landmark Fresenius v. Akorn case; helped draft a cease & desist letter on claims made by client’s competitor that were not supported by scientific evidence
  • Conducted due diligence of transactions in the life sciences industry by characterizing legal and business risk, negotiating key regulatory terms to manage such risks, and supporting post-transaction integration activities; led diligence calls and drafted diligence memoranda summarizing risks related to clinical trials, manufacturing, company policies, promotional materials and product authorizations; also summarized legal risks in SEC filings
  • Drafted comments and white papers to advocate for client interests; often used FDA approval and enforcement databases to understand FDA practice and leverage that for client’s arguments; interpret statutes, regulations, and FDA guidance to better characterize client needs and answer client questions
  • Non-FDA matters include reviewing a value-based employer health plan contract; drafting a comment on CMS pricing regulation; filing a FOIA complaint in Federal District Court of DC to compel production; representing a central American family in affirmative and defensive asylum proceedings

Honors & Awards

Vincent F. Prada Pro Bono Award 2018, 2019

Education

J.D., Howard University School of Law, magna cum laude
M.P.H, Johns Hopkins Bloomberg School of Public Health
B.S., University of Toronto, with Honours

Admissions

American Bar Association
District of Columbia
U.S. District Court of District of Columbia

Practice Areas
Industries
FDA Regulatory Categories