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


Prescription drugs have been a major topic in the news for much of the past year. There are two issues which appear 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 issues, 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 accelerated access and drug prices that would generate this much-needed information for doctors, patients, the government, and private insurers. 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 FDA could implement the conditional approval proposed here under its existing authority, that this approach would allow critically ill patients wide access to desperately needed drugs, and would also control prices for drugs that have not demonstrated clinical benefit until sufficient information is available about their real safety and efficacy.