Faraz R. Siddiqui

Faraz Siddiqui, JD MPH, provides drug and biologicals manufacturers with strategic regulatory counsel and advice to navigate the FDA review and regulatory process in all phases of the development lifecycle.

Faraz focuses on government pricing and reimbursement, counseling life sciences companies that market or distribute FDA-regulated products with HHS, CMS, and OIG regulatory and compliance issues as they relate to the Medicaid Drug Rebate Program, Veterans Health Care Act, and the 340B Drug Pricing Program.

He advises companies on False Claims Act and fraud and abuse issues, including the federal antikickback statute, PhRMA/AdvaMed Code, HIPAA, and complementary state statutes and regulations.

Faraz also helps sponsors draft and review services and quality agreements with clinical sites, contract research organizations, suppliers, and licensees. Drug, biopharmaceutical, life science, medical device and food and tobacco companies—both brand and generic—rely on him for support with new and existing products and come to him for experienced advice on navigating changing laws and other cutting-edge issues.

Faraz regularly uses his subject matter expertise to support internal investigations, litigation, and complex buyer-side transactions and public offerings for clients manufacturing all types of FDA-regulated products. He has supported client as brand attorney, providing legal and regulatory advice on promotion, sales, training, and market access.

He also advises clients on pre-approval issues, clinical trial agreements and expedited drug reviews, and helped clients navigate FDA regulations on orphan drugs and pipeline products.

Faraz uses his public health background to provide a multidisciplinary approach to client support and advocacy.

Prior to law school, Faraz worked as a public health researcher at Georgetown Law School and as an epidemiologist at the Baltimore City Health Department. He was also involved in management consulting with health service research organizations. He completed his J.D. at Howard University School of Law and his Masters in Public Health at the Johns Hopkins Bloomberg School of Public Health.

Faraz regularly blogs on drug pricing reform legislation and regulations and has published several peer-reviewed articles in the intersection of FDA law, policy and public health, including papers in the Lancet and BMJ. He has also contributed articles to PLI’s FDA Deskbook, and is on the editorial advisory board of the American Health Law Association.

Finally, Faraz maintains an active pro bono practice and has fought for rights for the homeless and for asylum seekers in the United States, and is a board member of the American Muslim Health Professionals.