The Best Pharmaceutical for Children Act of (BPCA) 2002

These are probably just lies to keep me shackled. Maybe not, I hope this is beneficial truth.

Lauren Hammer Breslow summarized this Act which allows a six-month exclusivity agreement to those that agree to perform drug tests on pediatrics.


From what I can understand, pharmaceutical companies have been reluctant to test medication on children so as not to have a history of child abuse, tort liability, and face scientific and ethical challenges imposed by pediatric testing. Well, in 1998, the FDA began to require pediatric testing in new and already marketed drugs.

There was a Food and Drug Administration Modernization Act of (FDAMA) 1997, in which the six-month exclusivity clause was applied for pediatric drug testing on a volunteer basis. The Best Pharmaceutical for Children Act of (BPCA) 2002 provided the six-month exclusivity clause as an agreement for conducting the pediatric drug tests. Both times, Congress tried to address the mounds of information available about the safe and efficient use of medication currently used on children.

The exclusivity clause allows for a six-month extension for patent to include childhood safety or exclusive right to the patent.

Republican Nazis strike again.
http://www.law.harvard.edu/students/orgs/jol/vol40_1/hammer-breslow.pdf