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.
"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.
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.
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.
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