This article is a hoot. I am so comforted to know that the FDA may be able to provide guidance on development of my own stem cells before I have to submit them to the FDA for approval. I don't think Congress has a clue what is going on with the FDA declaring our own stem cells to be drugs. The rest of the article wasn't too encouraging either. Sounds like a lot of shuffling going on to me. All the more reason to get on board with ASCTA. www.safestemcells.org
By Lisa Richwine
WASHINGTON, May 21 (Reuters) - The acting head of the U.S. Food and Drug Administration defended the agency's request for more funding, including an increase in fees from industries the agency regulates.
Democrats debating the FDA's budget voiced concern annual increases in industry fees might compromise the agency's work.
"I understand the concern that people ... have expressed that user fees create a perception or a conflict of the agency's work," Acting FDA Commissioner Joshua Sharfstein told a U.S. House of Representatives appropriations subcommittee.
"I think these concerns reflect a broader lack of trust in the FDA."
To alleviate unease, the new FDA leadership under President Barack Obama must "renew the public's confidence by acting with integrity and transparency" and send "the signal inside and outside the agency that we will make decisions based on the best available scientific evidence and not on influence that's inappropriate."
For fiscal 2010, Obama has asked the Democratic-controlled Congress for an FDA budget of $3.2 billion, including $828 million in fees from manufacturers of medical and food products.
The fees include hundreds of millions of dollars drugmakers pay annually to help speed the review of new medicines.
Obama's budget plan also seeks new fees to help clear a backlog of generic drug applications and to reinspect food and medical product plants that fail to meet FDA standards.
Democratic Representative Maurice Hinchey said the growing percentage of fees from drugmakers "is something of great concern for a number of people on this committee."
Sharfstein, speaking to reporters, said he did not think the industry fees had risen too high.
Republicans, meanwhile, said it may be difficult to win authority from Congress to collect the new types of fees.
"Every administration rolls out user fees and yet rarely do user fees get beyond this (subcommittee) hearing," said Republican Representative Jack Kingston.
Sharfstein also said he wanted the FDA to be more proactive in encouraging development of new treatments.
"We want to help get drugs to people who need them. At the same time we want to reduce the safety concerns. Both parts of the equation are important to us," he said at a separate hearing before a Senate Appropriations subcommittee.
Stem cell research is one emerging field in which the FDA may be able to provide guidance on development before any products are submitted for approval, Sharfstein told reporters.
Sharfstein, the FDA's principal deputy commissioner, is serving as the agency's acting chief until Dr. Margaret Hamburg steps into the top job. Hamburg was confirmed by the Senate on Monday. Sharfstein expected her to be sworn in as FDA commissioner next week. (Reporting by Lisa Richwine; Editing by Andre Grenon)
By Lisa Richwine
WASHINGTON, May 21 (Reuters) - The acting head of the U.S. Food and Drug Administration defended the agency's request for more funding, including an increase in fees from industries the agency regulates.
Democrats debating the FDA's budget voiced concern annual increases in industry fees might compromise the agency's work.
"I understand the concern that people ... have expressed that user fees create a perception or a conflict of the agency's work," Acting FDA Commissioner Joshua Sharfstein told a U.S. House of Representatives appropriations subcommittee.
"I think these concerns reflect a broader lack of trust in the FDA."
To alleviate unease, the new FDA leadership under President Barack Obama must "renew the public's confidence by acting with integrity and transparency" and send "the signal inside and outside the agency that we will make decisions based on the best available scientific evidence and not on influence that's inappropriate."
For fiscal 2010, Obama has asked the Democratic-controlled Congress for an FDA budget of $3.2 billion, including $828 million in fees from manufacturers of medical and food products.
The fees include hundreds of millions of dollars drugmakers pay annually to help speed the review of new medicines.
Obama's budget plan also seeks new fees to help clear a backlog of generic drug applications and to reinspect food and medical product plants that fail to meet FDA standards.
Democratic Representative Maurice Hinchey said the growing percentage of fees from drugmakers "is something of great concern for a number of people on this committee."
Sharfstein, speaking to reporters, said he did not think the industry fees had risen too high.
Republicans, meanwhile, said it may be difficult to win authority from Congress to collect the new types of fees.
"Every administration rolls out user fees and yet rarely do user fees get beyond this (subcommittee) hearing," said Republican Representative Jack Kingston.
Sharfstein also said he wanted the FDA to be more proactive in encouraging development of new treatments.
"We want to help get drugs to people who need them. At the same time we want to reduce the safety concerns. Both parts of the equation are important to us," he said at a separate hearing before a Senate Appropriations subcommittee.
Stem cell research is one emerging field in which the FDA may be able to provide guidance on development before any products are submitted for approval, Sharfstein told reporters.
Sharfstein, the FDA's principal deputy commissioner, is serving as the agency's acting chief until Dr. Margaret Hamburg steps into the top job. Hamburg was confirmed by the Senate on Monday. Sharfstein expected her to be sworn in as FDA commissioner next week. (Reporting by Lisa Richwine; Editing by Andre Grenon)