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Wall Street Journal- Obama Wants Additional $300 Million for FDA

Wall Street Journal- Obama Wants Additional $300 Million for FDA

By Jared A. Favole and Alicia Mundy, President Barack Obama wants Congress to give the Food and Drug Administration an additional $300 million in its budget, which the agency called the largest funding boost in its history.

Meanwhile, Mr. Obama’s pick to oversee food and drug safety said during her Senate confirmation hearing that she would revamp the FDA to better protect the nation’s food supply. Margaret Hamburg, a bioterrorism expert who once served as New York City health commissioner, also said she wants to restore public confidence in the FDA. Dr. Hamburg breezed through her committee hearing, the Associated Press reported, with no senators expressing opposition. The full Senate is expected to vote on her nomination before Memorial Day.

Mr. Obama’s budget request, released Thursday, calls for the FDA to get $2.35 billion for fiscal year 2010, compared with $2.06 billion in the previous fiscal year.

“This is good,” said William Hubbard, a former associate commissioner for policy and planning at the agency. “The FDA had been held down for so many years with very, very small increases.”

These figures don’t include user fees the agency collects from the drug, device and other industries to review product applications and inspect facilities. Including such fees, Mr. Obama’s budget request totals $3.04 billion compared with $2.7 billion in the prior year.

An FDA official said the agency plans to tell the public later Thursday the increase is the largest in the regulator’s history. About $1 billion of the budget is made up of user fees, including $300 million the agency doesn’t have the authority to collect yet, such as fees from generic drug manufacturers.

The FDA’s budget has shrunk or been held flat since the mid 1990s. Mr. Hubbard said this increase, along with an increase of about $172 million from the previous year, will help the agency hire more inspectors, more scientists, and “begin to solve some problems.”

The budget would bring the FDA’s staffing back to the same levels it had in 1994, the year before the agency’s budget began falling and getting held back.

Mr. Hubbard said the real increase would be about $200 million because the FDA’s 5.8% inflation rate will suck up about $100 million.

What is most promising, Mr. Hubbard said, is the bump in funding for FDA food oversight. Mr. Obama wants $783 million for food oversight compared with $649 million in the prior year.

The budget also factors in about $75 million in user fees from food companies to inspect food plants and $36 million from generic drug makers to review generic drug applications. The FDA doesn’t yet have the authority to collect these fees, and the budget notes these numbers are “contingent” on legislation passing in Congress.

Although new user fees and fee increases have tended to provoke opposition among brand name drug makers, generic drug manufacturers are prepared to support such fees this time, in order to speed their application process at the FDA.

Many generic applications get stalled at the agency because they require a referral from the generic division to the drug evaluation offices or the biologic drug centers for more detailed consultation reviews. The drug evaluation and biologic centers process brand name applications first because brand-name drug makers pay fees to get their medicines reviewed. That pushes reviews of generic copies of medicines to the back, said Kathleen Jaeger, CEO of the Generic Pharmaceutical Association, the Washington lobbyists for generic drug makers.

“We want to create a structure with the FDA for user fees that will get our products to consumers faster, and take that to Capitol Hill, where we are hopeful they will pass it,” she said. But user fees have to include FDA performance deadlines, as they do for brand name drugs, she added.

User fees could pop up in the health care reform package, she said, because generic drugs save billions of dollars, and Mr. Obama has made faster generic drug approvals a key issue in the budget when he announced it in February.