BioCentury
ARTICLE | Politics & Policy

Senators challenge FDA's pediatric incentive

March 12, 2001 8:00 AM UTC

Sens. Orin Hatch (R-Utah), Chris Dodd (D-Conn.) and Mike DeWine (R-Ohio) called on HHS Secretary Tommy Thompson to intervene in a dispute between generic and branded drug companies over incentives for conducting pediatric research. An FDA official recently informed generic manufacturer Barr Laboratories (BRL) that a six-month exclusivity period granted to drug sponsors who conduct FDA-requested pediatric studies should run concurrently with the six-month exclusivity period granted to the first company to market a generic version of the drug. ...