Guillaume Julian guides pharmaceutical manufacturers and other innovative life sciences companies through complex regulatory regimes related to drug approval, market access, pricing, and reimbursement.

A member of the firm’s leading Food, Drug, and Device and Health Care practice groups, Guillaume specializes in the challenging legal and regulatory issues facing manufacturers of drugs and biological products. Guillaume frequently assists FDA-regulated entities with the following kinds of activities:

Preparing and submitting drug applications;
Navigating complex pre- and post-marketing legal and regulatory questions;
Developing innovative legal and policy strategies related to the regulation of drug and biological products;
Advising on FDA disclosure laws and regulations including the Freedom of Information Act; and
Counseling on matters related to FDA user fee programs including PDFUA and BsUFA.

Guillaume also assists clients with key market access, pricing, and reimbursement issues including:

Advising on government price reporting, payor communications, Pharmacy Benefit Manager (PBM) matters, most favored nation pricing, and other coverage, coding, and reimbursement matters.
Counseling pharmaceutical manufacturers on the drug pricing provisions of the Inflation Reduction Act (IRA) and the 340B Drug Pricing Program.

In particular, Guillaume has advised multiple manufacturers of drugs selected for the IRA’s Medicare “Drug Price Negotiation Program” on all aspects of the program—including preparing for selection, meeting with the Centers for Medicare and Medicaid Services (CMS), and implementing processes to effectuate the “Maximum Fair Price.” Guillaume also routinely advises pharmaceutical manufacturers on the 340B Drug Pricing Program including general compliance questions, state and federal contract pharmacy laws and regulations, the administrative dispute resolution process, and the intersection of the 340B program with the IRA and Medicaid Drug Rebate Program.

Guillaume maintains an active pro bono practice where he assists veterans and victims of violent crimes with immigration matters and advises non-profit health organizations on government advocacy and regulatory questions related to FDA and congressional matters.