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May 8, 2007, 12:00 am ET - Amendment SA 1019 proposed by Senator Brown for Senator Casey.
May 8, 2007, 12:00 am ET - Amendment SA 1019 agreed to in Senate by Unanimous Consent.
Full Text of this Amendment
SA 1019. Mr. CASEY (for himself and Mr. Specter) submitted an amendment intended to be proposed by him to the bill S. 1082, to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes; which was ordered to lie on the table; as follows:
At the appropriate place, insert the following:
SEC. __. ORPHAN DISEASE TREATMENT IN CHILDREN.
(a) Finding.--The Senate finds that parents of children suffering from rare genetic diseases known as orphan diseases face multiple obstacles in obtaining safe and effective treatment for their children due mainly to the fact that many Food and Drug Administration-approved drugs used in the treatment of orphan diseases in children may not be approved for pediatric indications.
(b) Sense of the Senate.--It is the sense of the Senate that the Food and Drug Administration should enter into a contract with the Institute of Medicine for the conduct of a study concerning measures that may be taken to improve the likelihood that Food and Drug Administration-approved drugs that are safe and effective in treating children with orphan diseases are made available and affordable for pediatric indications.
(As printed in the Congressional Record for the Senate on May 2, 2007.)
At the appropriate place, insert the following:
SEC. __. ORPHAN DISEASE TREATMENT IN CHILDREN.
(a) Finding.--The Senate finds that parents of children suffering from rare genetic diseases known as orphan diseases face multiple obstacles in obtaining safe and effective treatment for their children due mainly to the fact that many Food and Drug Administration-approved drugs used in the treatment of orphan diseases in children may not be approved for pediatric indications.
(b) Sense of the Senate.--It is the sense of the Senate that the Food and Drug Administration should enter into a contract with the Institute of Medicine for the conduct of a study concerning measures that may be taken to improve the likelihood that Food and Drug Administration-approved drugs that are safe and effective in treating children with orphan diseases are made available and affordable for pediatric indications.
(As printed in the Congressional Record for the Senate on May 2, 2007.)
