Congress passes bill giving $1.73 billion to FDA
WASHINGTON Congress last week passed a consolidated appropriations bill, giving, among other things, nearly $1.73 billion to the Food and Drug Administration, more than $79 million over the president’s budget request.
In addition, the bill also gives the Center for Drug Evaluation and Research more than $682 million, of which $41.9 million is available for the Office of Generic Drugs, while the Center for Biologics Evaluation and Research would receive more than $236 million.
On Dec. 17, the House passed H.R. 2764 by a vote of 214–189, and the following day, the Senate passed a revised version by a vote of 76–17, The House agreed to send the revised version to the president, increasing 2007’s FDA funding by $145 million.
In addition, the committees encouraged the FDA to limit “to the greatest extent possible” granting financial conflict-of-interest waivers to advisory committee members, which has been a hot topic recently. While the committees were encouraged by the FDA’s announcement earlier this year that it would limit the number of waivers, they said the agency should do more.
Stake in drug-testing contractor purchased in $3 billion-plus deal
NEW YORK In a deal worth a reported $3 billion-plus, One Equity Partners’ stake in drug trial manager Quintiles Translational is being sold to its chief executive and other buyout firms, including Bain Capital and TPG Capital, according to The New York Times.
Dennis Gillings, founder of Quintiles and its chief executive officer and chairman, has teamed up with Bain and TPG to take control of the stake from One Equity, the private equity arm of JPMorgan Chase, which also sponsored the company’s $1.7 billion buyout in 2003.
Gillings had previously offered to buy the company in 2002 for $1.3 billion, but that number was rejected as being too low.
Quintiles, based in Research Triangle Park, N.C., has more than 19,000 employees. At the time of its founding in 1982, Gillings was a professor of biostatistics at the University of North Carolina. The company went public in 1994.
Jazz, Solvay receive approvable letter from FDA regarding extended-release Luvox
PALO ALTO, Calif. The Food and Drug Administration issued an approvable letter for Jazz Pharmaceuticals’ Once-a-Day Luvox CR (fluvoxamine maleate), which the company is trying to market as an extended-release capsule indicated for the treatment of social anxiety disorder and obsessive compulsive disorder.
Jazz has teamed up with Solvay Pharmaceuticals to market the drug. The FDA earlier this month approved the regular formulation of Luvox for the treatment of OCD.
The companies are seeking clarification from the FDA and look forward to working with the FDA to resolve any issues as quickly as possible. They stressed that the approvable letter did not raise any questions related to the safety or efficacy of Luvox CR.