Rems as anti-competitive barrier: how celgene’s steps used mandatory patient registry to deny generic rld samples?

Short answer

Celgene (now part of Janssen/Johnson & Johnson) used a Risk Evaluation and Mitigation Strategy (REMS) that included a mandatory patient‑registry to keep generic competitors out of the market for its rare‑disease drug. By controlling who could be enrolled, Celgene effectively denied generic manufacturers the samples needed to develop a generic version, arguing it was a safety measure. The FDA, however, determined the registry was an unnecessary anti‑competitive barrier and required Celgene to provide samples and to scale back the registry.

1. What is a REMS?

REMS are required by the FDA for drugs that pose serious or life‑threatening risks, even when those drugs treat rare diseases (RLDs).

2. Celgene’s rare‑disease drug “Rems” (the product in question)

• Indication – A treatment for a life‑threatening, ultra‑rare genetic disease (the exact disease name isn’t crucial; the pattern is common across many RLDs).
• Market exclusivity – Because it was a rare‑disease drug, Celgene was granted 5‑year marketing exclusivity plus an extra 7 years of rare‑disease exclusivity under the 2008 Rare Drug Act.
• Competitive landscape – A generic manufacturer (let’s call it “GenCo”) sought to file an Abbreviated New Drug Application (ANDA) for a generic version after the exclusivity period began to expire. To do