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Access to Life-Savings Therapies Act

Introduced: July 11, 1991 See on congress.gov
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
Jul 26, 1991
Referred to the Subcommittee on Health and the Environment.
Jul 11, 1991
Referred to the House Committee on Energy and Commerce.
Jul 11, 1991
Introduced in House
 Plain-English summary Congressional Research Service

Access to Life-Saving Therapies Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services, through the Food and Drug Administration, to approve, at the request of the sponsor and on an expedited basis, a drug or biologic needed to treat or prevent a life threatening disease or seriously debilitating illness if the drug or biologic meets certain conditions, including some indications of effectiveness and safety and a lack of alternative satisfactory therapy. Deems an application under the amendments made by this Act approved unless other action is taken within 120 days.

Prohibits any health insurance policy or plan from distinguishing, for the purpose of determining whether a drug is eligible for coverage or reimbursement, between a drug approved under the amendments made by this Act and one approved under specified other provisions of the Public Health Service Act.

Mandates suspension of approval under the amendments made by this Act if at least two subsequent studies fail to confirm the initial safety and efficacy conclusions.

Requires written informed consent for administration of a drug approved under amendments made by this Act.

What's happening now July 26, 1991

Referred to the Subcommittee on Health and the Environment.

 Committees of jurisdiction 2