House bill would spare FDA user fees from sequester

Rep. Anna Eshoo (D-CA)

A bipartisan congressional group has proposed a bill that would unlock millions in FDA user fees, industry-paid funds currently hamstrung by across-the-board sequester cuts.

The agency is set to collect about $1 billion from the industry in fiscal 2013, including roughly $100 million from medical device companies, but, thanks to sequestration, the FDA can't touch about $85 million of that, the bill's sponsors said.

The latest hike in user fees, passed by Congress last summer, is meant to fund a speedier approval process for drugs and devices, and federal budget cuts aren't reason enough to break a promise to private industry, California Democrat and bill sponsor Anna Eshoo said.

"If the intent of sequestration is to limit public spending, withholding private monies is counterintuitive," Eshoo said in a statement. "Whether one agrees or disagrees with sequestration, I don't believe private dollars should be held hostage by the policy. It discourages investment in medical innovation and denies patients access to timely therapies."

The FDA Safety Over Sequestration Act--or FDA SOS Act, in keeping with Congress' acronymical affinities--would exempt user fees from mandatory budget cuts, and it has the support of industry groups like AdvaMed and PhRMA.

J.C. Scott, AdvaMed senior executive vice president, has long advocated for sparing user fees from sequestration, saying his organization "believes that FDA should be properly funded and supports correcting the language in the sequester to prevent any further restriction on FDA's access to industry user fees."

Fellow House Energy and Commerce Committee members Leonard Lance (R-NJ), Doris Matsui (D-CA) and Mike Rogers (R-MI) joined Eshoo in sponsoring the bill.

- check out the representatives' statement
- read the bill (PDF)

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