Summary: H.R.4475 — 113th Congress (2013-2014)All Information (Except Text)

There is one summary for H.R.4475. Bill summaries are authored by CRS.

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Introduced in House (04/10/2014)

Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Declares that, except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device shall not be liable in any action under state or federal law for loss, damage, or injury arising out of, relating to, or resulting from: (1) the design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of such drugs or devices; or (2) their safety or effectiveness.