FDA Approves Treatment for Rosa Nervosa

Rosa Nervosa and Full Speed Ahead

BioCentury reports that the Reagan-Udall Foundation received $900,000 from FDA to support FY12 operations and infrastructure. The funds are the first from FDA since Congress created the foundation in 2007 as a public-private partnership to oversee and fund precompetitive research to advance drug development and regulation. FDA funding was previously blocked by the U.S. House of Representatives, led by Rep. Rosa DeLauro (D-Conn.), who claimed that the foundation could prompt FDA to lower its approval standards.

The FDA Amendments Act of 2007 authorized $500,000-$1.3 million annually from FDA to support the foundation, and also gave Reagan-Udall authority to accept private sector funding. The specific amount from FDA is determined annually between the foundation and the agency, but the foundation's Executive Director Jane Reese-Coulbourne said she does not expect further funding roadblocks.

Reagan-Udall has received $1.3 million in grants and donations to fund research, including a $60,000 grant last year from Susan G. Komen for the Cure to support a project on cardiotoxicity associated with tyrosine kinase inhibitors. By year end, the foundation expects to have a publicly-accessible database of genes and pathways associated with cardiotoxicity. Last May, the foundation also received a $1 million grant from the Bill & Melinda Gates Foundation to serve as a facilitator among global tuberculosis stakeholders in the Critical Path to TB Multidrug Regimens Project (CPTR), an initiative to test and seek approval for combinations of individual investigational TB drug candidates.

Huzzah!