At present, when a drug candidate differs from FDA-approved drugs only in that existing drugs can cause serious medical conditions whereas the new drug candidate has a superior safety profile, the FDA does not consistently deem the superior safety profile as fulfilling the relevant conditions for granting accelerated approval. Accelerated approval exists “to allow for earlier approval of drugs that treat serious conditions, and fill an unmet medical need based on a surrogate endpoint” (Accelerated Approval Program | FDA).
An internal FDA rule, and subsequently Congressional legislation, should establish that such a superior safety profile is consistent with the requirements for accelerated approval. In other words, it should be made clear that accelerated approval is not only for drugs for serious medical conditions, but also for drugs for diseases currently treated with drugs that can cause serious medical conditions.
The status quo is ethically unacceptable because it selectively neglects patients’ safety.