Former FDA staffer - “I recently left FDA due to the political pressure I was receiving to withhold my recommendation for approval for a drug that was intended for a rare disease. I was part of a review division that was constantly under pressure. Specifically for this recent example, we met frequently with Prasad and other FDA leadership who emphasized the drug should not be approved. However, from the review document and my experience, it would have been approved had it not been for the political pressure.”