February FDA NDA/BLA Approvals

2/01 Cosopt PF, Merck Sharp Dohme; 2/03 Giazo, Salix Pharmaceuticals ; 2/07 Mitosol, Mobius Therapeutics;
2/07 Sklice, Sanofi-Topaz; 2/10 Zioptan, Merck Sharp Dohme

FDA nominee says agency confidence boost needed

As Reported on

By Lisa Richwine
WASHINGTON, May 7 (Reuters) - President Barack Obama's nominee to run the Food and Drug Administration pledged on Thursday to boost public confidence in the agency with a focus on improving the safety of medical products and foods.
"The American people place a huge amount of trust in the FDA. It is critical that we take steps to boost their confidence, particularly when it comes to the safety of drugs and foods," Dr. Margaret Hamburg told the Senate health committee.
If confirmed by the Senate, Hamburg will take over an agency battered in recent years by a string of often deadly food poisoning and drug safety issues.
Improvements in those areas will be a priority, she said.
For foods, Hamburg said: "Now is the time to shift to a food safety system that puts prevention first."
Close monitoring of medical products after approval would be key to identifying safety problems early and responding quickly, she said.
Hamburg also said fostering innovation was a priority and that she would "strive to lead an agency that appropriately balances innovation with regulation."
Democrats and Republicans alike praised Hamburg, a Harvard-trained doctor and former New York City health commissioner, as being well-qualified with expertise in public health and bioterrorism preparedness.
Senator Patty Murray, a Democrat who chaired the hearing, said she would push for speedy approval of Hamburg's nomination so she could get to work on the multitude of pressing issues facing the agency.
The FDA oversees prescription and over-the-counter drugs, medical devices, most foods and other products that account for about one-quarter of the U.S. economy.
Lawmakers urged Hamburg to look at a range of issues from the new H1N1 flu strain to the safety of imported foods and medicines and oversight of tobacco, which Congress may put in the FDA's hands.
Many asked Hamburg to fix low morale at the agency after complaints that politics has trumped science in some of the agency's decisions.
Hamburg said she would aim to "create an environment where scientists feel very free to raise issues and concerns without any fear of retaliation."
"I think science is best served by robust discussion," she said.
On the new flu strain seen in many countries, Hamburg said she would look into whether more could be done to make flu-related medical products and laboratory tests available. (Editing by Dave Zimmerman, Maureen Bavdek and Ted Kerr)