Acting US FDA chief defends rise in industry fees

Thu May 21, 2009 4:15pm EDT
 
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* Democrats worry about increasing share of industry fees

* Sharfstein says science will drive FDA decisions

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.  Continued...

 

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