500th Label: Milestone for Children’s Health

The Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA) ensure that medication is safe and effective for children.


Imagine having to take medication with no information on dosage, frequency, or side effects. Now, imagine that you’re a child suffering from something as uncomplicated as a sinus infection or the flu or something as serious as cancer or HIV/AIDS, and if you’re lucky enough to get dosage information — it’s intended for an adult.

For many children this was the case up until the late 1990’s, but thanks to two pediatric drug laws, the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA), medication labels are now required to include information specifically for children.

Earlier this month, news of the 500th drug labeled with pediatric information was announced by the U.S. Food and Drug Administration (FDA).  The Elizabeth Glaser Pediatric AIDS Foundation (EGPAF) along with the American Academy of Pediatrics (AAP), and the FDA issued a joint news release celebrating this milestone for children’s health.

According to the FDA, prior to  BPCA and PREA becoming  law, more than 80 percent  of the drugs approved for adults were being used in children, despite a lack of  proven safety testing practices in children. Today that number has been reduced to about 50 percent.

U.S. Senators Tom Harkin (D-IA), Jack Reed (D-RI), Lamar Alexander (R-TN), Patty Murray (D-WA), and Pat Roberts (R-KS) also released a statement applauding the news.

The 500th drug is a nasal spray for rhinitis.

Racine Tucker-Hamilton is EGPAF’s  Associate Director of Media Communications & Editorial Services based in Washington, D.C.