From development to withdrawal of Raptiva: A case study examining conflicts of interest in pharma-FDA relationships, inadequate safety studies, and circumvention of the physician intermediary

The FDA's drug review process is intended to be rigorous, thorough, and balanced in its evaluation of a drug's safety profile, benefits, and efficacy before, and sometimes after, it is approved to go to market. An agency-approved label is meant to communicate all of a drug's risks and relevant information which a prescribing physician can consider and accordingly relay to his patient. However, a pharmaceutical maker can increase the likelihood of its drug's approval and a consumer's continued use by taking steps to marginalize these regulatory mechanisms. This talk will explore psoriasis biologic Raptiva's road to market withdrawal with regards to Genentech's discussion of a bribe with a FDA official; the inadequacy of pre-approval and post-marketing studies evaluating the biologic's safety; and the corporate practice of medicine in Genentech's direct communications with patients.