President’s FDA budget for 2009 includes 283 new CDER staff
WASHINGTON The president’s fiscal 2009 budget request for the Food and Drug Administration includes—out of 526 new full-time equivalent employees—an estimated 283 for the Center for Drug Evaluation and Research.
CDER requested an additional $5.6 million in user fees and 18 full-time equivalent employees for its human drug review program. Three of these would review direct-to-consumer television advertisements, a growing issue, highlighted recently by accusations of misleading ads for Pfizer’s Lipitor.
Among the new employees, 26 would be in the Center for Biologics Evaluation and Research, 161 would be in the Office of Regulatory Affairs and five would be in the FDA Headquarters and the Office of the Commissioner, according to the FDA.
The fiscal 2009 budget represents a 5.7 percent increase—approximately $2.26 million—more than the $2.27 billion the FDA received for fiscal 2008.
Among its other requestions, the FDA has asked for $15 million and 34 full-time equivalent employees for generic drug application reviews. In fiscal 2007, CDER approved 682 new generic drugs, and has said it expects to maintain this level of approval performance in FY 2009. In addition, CDER expects to increase its abbreviated new drug application actions.
Congressional committees have begun hearings to discuss the proposed budget. The House Energy and Commerce Committee has scheduled a hearing on HHS’ fiscal 2009 budget proposal for this week.
Cornelius elected to chairman of Bristol-Myers Squibb board
NEW YORK Bristol-Myers Squibb Wednesday announced that the company’s board of directors has elected chief executive officer James Cornelius as chairman of the board. He will continue serving in his previous role as well.
The board also named Textron’s chairman, president and chief executive officer Lewis Campbell, chairman, president as lead independent director. James Robinson III, co-founder and general partner of RRE Ventures, resigned as non- executive chairman of the Board, a position he has held since June 2005. He will remain a director of the company until May 6, 2008, the date of the company’s annual meeting of stockholders, when he will retire pursuant to the Board’s mandatory age retirement policy.
Cornelius was named chief executive officer of Bristol-Myers Squibb on April 30, 2007, after serving as interim chief executive officer since September 12, 2006. He joined the Board in January 2005. “I am excited by this tremendous opportunity to serve as chairman of the Board of this great company,” he stated. “Over the past 18 months as chief executive officer, I have been deeply impressed by the commitment and dedication of our employees to our mission and goals, and the strong belief they share with me in the promise of Bristol-Myers Squibb as a BioPharma leader for the future.”
Cornelius was previously a member of the board of directors of Eli Lilly, a member of its executive committee and chief financial officer from 1983 to 1995.
Duragesic pain patches getting recall
WASHINGTON Ortho-McNeil-Janssen, a unit of drug and consumer giant Johnson & Johnson on Tuesday said it was recalling certain strengths of its Duragesic pain patches, which have the potential to expose patients to a dangerous gel inside.
All lots of Ortho-McNeil’s 25 microgram-per-hour strength patch of Duragesic are being recalled, in coordination with the Food and Drug Administration.
The recalled patches may have an opening which could result in release of the gel—made of the drug fentanyl—inside, Reuters reported. Exposure to fentanyl directly can cause serious harm, including breathing problems and overdose, which can be fatal, the company said.
All the recalled patches have an expiration date on or before December 2009.