FDA chief defends budget, says agency is taxpayer 'bargain'
WASHINGTON (Reuters) - The head of the U.S. Food and Drug Administration asked Congress for more money on Thursday to improve food safety, police imports and develop countermeasures against chemical and biological threats.
FDA Commissioner Margaret Hamburg told a Senate appropriations subcommittee that the agency is doing its best to tighten its belt by cutting back on travel and training. She said mandatory federal spending cuts known as sequestration will cut funds to the agency by $209 million.
The FDA gets part of its funding from taxpayers, but most comes from user fees agreed to and paid by drug companies to speed the review and potential approval of new products.
The agency's proposed budget for 2014 would rise by $821 million to $4.7 billion over 2012, of which industry fees would account for $770 million, or 94 percent. The 2013 budget has not been finalized.
To the surprise of the pharmaceutical industry, the mandatory cuts to federal agencies include the withholding of $83 million in industry user fees. Hamburg said she would like to see those fees exempt from the sequester.
"We will not be able to use all those user fees to achieve the performance goals negotiated with industry," she said, adding that without them the agency will not always be able to complete its review of new drug applications on the agreed upon schedule.
Included in the FDA's proposed budget is $3 million to help oversee specialty pharmacies which compound specialized drugs that are generally not made by traditional pharmaceutical companies. The agency has come under withering criticism for its failure to prevent a deadly meningitis outbreak linked to one such pharmacy in Massachusetts.
Hamburg said that while she hopes Congress will give the agency greater authority to regulate big compounding pharmacies that make sterile injectible drugs, the FDA will more aggressively exercise the inspection authority it already has.
Under questioning from Missouri Republican Senator Roy Blunt, Hamburg also said the FDA is doubling the period for public comment on its sweeping new food safety regulations to 240 days from 120.
While the agency has requested more funds in certain areas, it has suggested cuts in others, including funding for drug and medical device programs.
"FDA is a true bargain among federal agencies," Hamburg said. "Americans each pay about $8 a year for FDA's appropriations." For about 2 cents a day, she said, "Americans get an extraordinary array of public health benefits."
Hamburg said one of the agency's greatest challenges is to respond to the globalization of the food and drug supply chain. She noted that over the past decade the number of imported shipments of FDA-regulated products has soared.
In 2012, she said, about 28 million shipments of imported food and medical products were imported, including 50 percent of the country's fresh fruits, 20 percent of fresh vegetables, 80 percent of seafood and 40 percent of drugs.
"The world has changed and our historical regulatory approaches and tools - such as hoping to intercept products at our borders - are outdated and often inadequate," she said.
"If we are to continue to promise Americans a safe food and drug supply, FDA must continue to transform itself, from a primarily domestic agency to one that uses innovative global strategies to secure a vast global supply chain."
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