Juvenile Toxicology Research
I am grateful for FDA-regulated juvenile toxicology research.
I find it rather shocking that prior to 1998, manufacturers of new drugs intended to treat the pediatric population were not required to conduct safety testing in juvenile animals. Animal testing concerns aside, it’s a necessary evil in our country because we can’t just go out and find enough human guinea pigs on which to evaluate the safety of new drugs.
Prior to 1998, physicians may have assumed that any given drug could be prescribed for children but at a much small dose. Smaller person = smaller dose. Well, when it comes to new FDA regulations, it generally takes a tragedy or two to suggest something is not safe. I completely disagree with this reactive logic because a proactive approach seems much more “safe,” don’t you think? Oh well, that’s just my opinion (for what it’s worth).
So here we are in 2011. It’s been 13 years since the Pediatric Rule went into effect which legally required manufacturers of pharmaceuticals intended for treating juveniles to go through a standard battery of safety testing. In 2002, barely 10 years ago, the Best Pharmaceuticals for Children Act improved safety and efficacy standards for pediatric drugs. This milestone laid the groundwork for pediatric guidelines on appropriate drug labels.
I found myself almost speechless when I realized what wasn’t regulated when I was a child. Thank God the FDA finally recognized the need for safety toxicology studies in juveniles. It leaves me wondering though, what else isn’t regulated properly even now in 2011? After all, it wasn’t until 2009 that the FDA finally outlawed flavored tobacco and candy cigarettes!
For the full list of FDA milestones, click here.
- Drug companies leave children at risk for dosing errors: CMAJ (parentcentral.ca)
- Kids prescribing info lacking: editorial (cbc.ca)
- Doctors lack drug data for kids: Editorial (canada.com)
Posted on June 17, 2011, in Gratitude: Giving Thanks for Scientific Discoveries and tagged Food and Drug Administration, Pediatrics, Regulation, safety, United States. Bookmark the permalink. Leave a comment.