Delaying approval of a critical drug: safety, efficacy, economics, compassion.

Biotechnological advance is speeding the development of drugs. The approval processes for new drugs will inevitably involve a regulatory agency in making political-economic and scientific choices. Interests of specific patients and the public in general are to be considered, and enormous stakes are involved for companies concerned. A medical regulatory authority must be at once insulated from and responsive to many different mixes of singular and general interests and pressures. Access to new drugs can be spurred by the press of patient advocacy groups, but if there are well organized groups to monitor the testing and approval process for such as AIDS or cancer drugs there is often no similar group to represent patient needs. If there is no organized advocacy group, compassionate responsibility by a medical regulatory authority is indeed called for. Delay in the approval of new drugs for fighting severe blood infections raises the question of how to insure the compassionate responsibility of a regulatory authority.