BioCentury
ARTICLE | Regulation

The Pastiche of risk

June 23, 2008 7:00 AM UTC

The discussion at last week’s Dermatologic and Ophthalmic Drugs Advisory Committee review of Johnson & Johnson’s ustekinumab to treat moderate-to-severe plaque psoriasis illustrates the tension in today’s regulatory environment for a compound that is clearly efficacious but has shown a safety signal in mice that will take years to verify in humans.

The FDA panel came down on the side of access to what members think will be a widely used product, voting 11-0 in favor of approval. However, they also voted 11-0 that the company’s risk assessment proposal was not adequate and recommended that a comprehensive mandatory registry be implemented to allow collection of safety data, including following those patients who discontinue treatment...