Drug Prices, Dying Patients, and the Pharmaceutical Marketplace: A New Conditional Approval Pathway for Critical Unmet Medical Needs

Abstract

Prescription drugs are much in the news these days. There are two topics which appear very often; first, the very high prices of new drugs, particularly the “specialty�? drugs developed for serious diseases; and second, the time required for FDA approval in relation to the perceived need for earlier access to new therapies for critically ill patients. Much less in the news, but lurking behind both problems, is the need for better information for physicians and patients to use in making decisions about prescribing and taking drugs and for insurance companies and the government to use to structure their pharmaceutical benefits plans. This article proposes an approach to both accelerated access and drug prices that would generate the information doctors and patients need to make decisions about drugs and the information the government and private insurers need to provide appropriate access and coverage for those drugs. The new form of conditional approval proposed here would be similar to the parallel track program developed by the FDA in the 1990s, during the HIV crisis. I argue that, like parallel track, the conditional approval proposed here could be implemented by the FDA under its existing authority, allow wide access to desperately needed drugs, and would control prices while providing better information about the real safety and efficacy of new drugs for critically ill patients.