FDA "bioethicist" Dr. Sara Bodkind, told the President’s Council on Bioethics ( December 2005) that under the 1997 law–FDA Modernization Act– "if the FDA issued a request for pediatric studies and if those studies were designed and approved by the FDA and they were completed, then the sponsor could get an additional six-month period of market protection, not only in the specific drug that they tested in children but in the entire moiety, in any preparation that used that particular chemical."

In other words, FDAMA opened the flood gates for drug testing to be done on children: the financial incentives were doubled: that is, a six month patent extension exclusivity, and the drug’s market was expanded to include children.

This "public gtood" was "accomplished" by encouraging manufacturers and their paid academic pharmacologists to exploit children’s vulnerability in mostly non-therapeutic risky drug experiments.

Dr. Bodkind stated:
"So sildenafil, for example, is now tested for pulmonary hypertension in children, but it’s the compound that’s known as Viagra.  So if that company were to get six months of exclusivity, then it would apply to all of the products and all the uses of that moiety.  So this was a very important incentive to encourage pediatric research.  And that was I guess commonly called "the carrot."  See: http://www.bioethics.gov/transcripts/dec05/session4.html

 
Contact: Vera Hassner Sharav
veracare@ahrp.org