Eli Lilly
International pharmaceutical websites under FDA regulatory constraints
The Problem
Designing pharmaceutical websites under FDA regulatory constraints is a different discipline than most digital product design. The restrictions aren't arbitrary. They exist because the stakes of misleading a patient about a drug (its efficacy, its risks, its contraindications) are serious enough that the federal government mandates how the information is presented.
Fair balance requirements mean that any promotional claim about a drug's benefits must be accompanied by a statement of risks with equal prominence. Important Safety Information, the dense paragraph of contraindications and warnings that appears on every pharmaceutical product page, is not optional and cannot be buried. Medical, Legal, and Regulatory review (the MLR process) means that design changes don't ship until they've passed a multi-stakeholder review cycle that can take weeks. In practice, this means designing under constraints where a layout decision that shifts ISI below the fold can kill a review, and where the instinct to optimize for visual hierarchy often runs directly against regulatory requirement.
The Work
As Principal Designer at Eli Lilly, I worked across international pharmaceutical website properties, designing product and brand pages that had to operate simultaneously as marketing communications and FDA-compliant medical information.
The primary design challenge was hierarchy: how do you create a page that a patient will actually read and find useful, while meeting fair balance requirements that exist precisely to limit how you shape attention? The answer lives in the structural system. You can't promote one thing without attending to another, but you can design the system in which both exist to be coherent, legible, and navigable rather than adversarial. Type scale, component structure, and spatial relationships can make required disclosures feel integrated rather than appended, which is better for compliance and better for the user who actually needs the information.
The international dimension added another layer. Different markets have different regulatory environments. The component system had to expose variables that could be adjusted per-market without requiring a full redesign for each territory, a localization and compliance challenge that lived entirely in how the design system was architected.
The MLR review process itself shaped how I worked: more upfront documentation, more explicit annotation of design decisions and their regulatory rationale, and closer collaboration with legal and medical reviewers to understand where the constraints had flexibility and where they were fixed.
The Outcome
Pharmaceutical websites that balanced genuine usability with FDA compliance across multiple international markets, operating within one of the most heavily constrained design environments in the industry.