Re: The Best Pharmaceuticals for Children Act

[Guest guest]

I never saw this before. Yikes. I'm assuming it was a precurser to

the New Freedom Initiative's (2004) Orwellian plan to screen and

drug the bejesus out of ever kid in the U.S..

>

> 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

>