The Best Pharmaceuticals for Children Act

[Guest guest]

I never heard of this before today but apparently since this passed

in 2002 Pharma gets paid with my tax dollars to conduct experimental

studies of their new drugs on children.

Someone please tell me I am wrong!!!!!!

THE BEST PHARMACEUTICALS FOR

CHILDREN ACT OF 2002:

THE RISE OF THE VOLUNTARY INCENTIVE

STRUCTURE AND CONGRESSIONAL REFUSAL

TO REQUIRE PEDIATRIC TESTING

Hammer Breslow & #8727;

On January 4, 2002, President Bush signed into law the Best

Pharmaceuticals

for Children Act, which is the government's most comprehensive

legislation

regarding pediatric research to date. The Act offers pharmaceutical

companies a six-month exclusivity term in return for their agreement

to conduct

pediatric tests on drugs. It also provides public funding and

organizes

private funding to help conduct pediatric research on those drugs

that pharmaceutical

companies opt not to test in children. This Note reviews the history

of pediatric research and traces the development of the Best

Pharmaceuticals

for Children Act's unique incentive and public funding structure. The

Note contends that, while the Act is comprehensive and promotes

important

pediatric studies, its incentive structure forces consumers and

taxpayers to

bear the costs of testing pharmaceuticals in children instead of the

manufacturers

who research, develop, and market those drugs. Congress should

consider

mandating pediatric studies in any future enactment of the

legislation.

In January of 2002, Congress passed the Best Pharmaceuticals for

Children Act ( " BPCA " ), which was its second major attempt to increase

the number of clinical tests performed on pediatric populations.1

Congress

passed the BPCA in response to the modest success of its earlier

effort to promote pediatric clinical testing,2 the pediatric

exclusivity provision

of the Food and Drug Administration Modernization Act of 1997

( " FDAMA " ).3 With both the 1997 and 2002 efforts, Congress has

attempted

to address the dearth of information about the safety and

effectiveness

of drugs that children commonly use.4 Indeed, before passage of

& #8727; Law Clerk to the Honorable Barbara S. , United States District

Judge for the

Southern District of New York; Harvard College, A.B., 1998; Harvard

Law School, J.D.,

2002.

1