Multiple Sclerosis Research Repository

Dear FDA,

I am writing to inquire why the FDA did not convene an Advisory Committee Meeting for the approval of Ocrevus for PPMS (per Cross Discipline Team Leader Review, Recommended Comments to the Applicant: “8. Advisory Committee Meeting.  There are no plans for an advisory committee meeting.”)

Per research, The FDA may convene an advisory committee meeting when:

-data interpretation or benefit-risk analysis doesn’t support a clear decision (this was the case with the Ocrevus for PPMS application)

-there are concerns about data presentation (there were numerous concerns about data presentation, accuracy, and validity in the Ocrevus for PPMS clinical trial)

-Safety or efficacy concerns are raised during development (both safety and efficacy concerns were raised in the Ocrevus for PPMS clinical trial and application)

Per research, the FDA advisory committees help the FDA make informed decisions by providing independent scientific advice.  The committees benefit the FDA by:

-improving regulatory decision-making: the committees’ advice helps the FDA make sound decisions based on the best science

-Increasing credibility: The committees’ advice lends credibility to the product review process

-Encouraging open and transparent governance: The committees encourage stakeholders to share their opinions

-Protecting public health: The committees help the FDA evaluate the safety, effectiveness, and appropriate use of products

Why did the FDA not want to gain the aforementioned benefits for Ocrevus for PPMS?  I suspect it is because they felt an Advisory Committee would not recommend FDA approval of Ocrevus for PPMS due to the many issues found in the sole clinical trial (WA25046) that the FDA was going to make an approval decision based upon.  Therefore, the FDA didn’t want “open and transparent governance,” for example.  

I look forward to the FDA’s thorough, complete, and satisfactory response to this inquiry.