An amendment in the nature of a substitute
by Mr. Bilirakis, #1, was adopted, amended,
by a voice vote;
A substitute amendment by Mr.
Waxman, for the amendment in the nature of a substitute, #1A,
was not adopted by a yea-nay vote: 9 - 20;
An amendment to the amendment in the nature
of a substitute by Mr. Green, #1B, re: exclusion from
eligibility for extension of period of market exclusivity for a drug for which a pediatric
study has been requested if the Secretary of Health and Human Services determines that the
aggregate amount of Federal funds from grants, cooperative agreements, and contracts from
the National Institutes of Health or other Federal agencies for research on the
development of the drug exceeds the costs of conducting the pediatric study, was not
adopted by a yea-nay vote: 9 - 19;
An amendment to the amendment in the nature
of a substitute by Mr. Pallone, #1C, re: exclusion from
eligibility for extension of period of market exclusivity for a drug for which a pediatric
study has been requested if the gross sales of the drug to individuals who received the
drug through participation in covered Federal programs exceeds an amount equal to the cost
of the proposed study (or as estimated by the Secretary of Health and Human Services, as
applicable) multiplied by 100, was not adopted by a yea-nay
vote: 9 - 20;
An amendment to the amendment in the nature
of a substitute by Mr. Waxman, #1D, re: exclusion from
eligibility for extension of period of market exclusivity for a drug for which a pediatric
study has been requested if the drug manufacturer has reported to a covered health-program
data system an average wholesale price for any drug it manufactures that is greater than
the average manufacturers price it reports to the Department of Health and Human Services,
was not adopted by a yea-nay vote: 9 - 20;
An amendment to the amendment in the nature
of a substitute by Mr. Deutsch, #1E, re: shortening the
extension of the period of market exclusivity by three months, was not adopted
by a yea-nay vote: 9 - 17;
An amendment to the amendment in the nature
of a substitute by Mr. Deutsch, #1F, re: reduces six-month exclusivity period to three months
if sales of the drug being studied exceeded $400,000,000 in the prior six-month period.
All other drugs retain the six-month exclusivity period, was not
adopted by a yea-nay vote: 9 - 20;
An amendment to the amendment in the nature
of a substitute by Mr. Green, #1G, re: General
Accounting Office study of the cost of conducting requested pediatric studies, was not
adopted by a voice vote;
An amendment to the amendment in the nature
of a substitute by Mr. Pallone, #1H, re: research
fund/program for study of drugs lacking exclusivity ("off patent") - modify this
program to include the testing of "on patent" drugs where the FDA has requested
a pediatric study but the sponsor has declined to conduct the test, was withdrawn
by unanimous consent.
