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Congress restores $85M to FDA program for reviewing new drugs

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Congress has agreed to spare from sequestration about $85 million in user fees paid by life science companies to the Food and Drug Administration, according to U.S. Rep. Leonard Lance.

Restoration of that money means the FDA can resume using the targeted fees toward advancing its drug and medical device review program.

"The release of these funds will benefit patients, public health and medical innovation," said Lance, R-Westfield, who lobbied for restoring the fees to the FDA's budget and introduced a bill last year to shield such funds from sequestration.

Under last year's sequester — a term for automatic spending cuts triggered by Congress — the FDA was prohibited by the federal Office of Management Budget from collecting the fees, Lance said. The funds were diverted for general budget purposes.

Lance said an agreement late Monday by House and Senate budget leaders means "the agency will have the tools and resources to ensure that millions of Americans will continue to benefit from medicines and medical devices that are safe and effective."

A full vote on the House and Senate omnibus spending bill for 2014 is expected Thursday.

The issue was followed by groups supporting New Jersey's life science and health care industry. Health Care Institute of New Jersey CEO Dean Paranicas said restoring the fees is critical to "ensure that the newest life-saving and medicines and technologies will reach those patients who need them as quickly, safely and efficiently as possible."

Pharmaceutical and medical device companies pay the fees directly to the FDA. The fees amount to about 35 percent of the agency's budget; the rest is supported by taxes.

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