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Controversy over stretching expanded access to off-label uses

FDA, patient advocates divided over whether to apply expanded access to off-label uses

Compassionate use is no exception to the axiom that sooner or later, someone will find an unexpected and controversial way to bend any law or regulation for unanticipated purposes.

FDA’s expanded access, or compassionate use, pathway was created to help patients who have run out of options receive access to unapproved drugs. Although drug companies are permitted to recover their manufacturing costs, they almost always provide drugs under expanded access at no charge.

However, patients and physicians are requesting expanded access for unapproved indications of marketed drugs if they anticipate that payers will decline to cover an unapproved use.

There is a lively debate within FDA and disagreements among patient advocates, bioethicists and drug companies about the merits of stretching expanded access to include unapproved uses of approved

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