Hamburg: FDA is a bargain for taxpayers

FDA Commissioner Margaret Hamburg

The FDA wants about $4.7 billion in the next fiscal year, a sum Commissioner Margaret Hamburg said is hardly burdensome considering all the agency does for taxpayers.

Speaking to a Senate appropriations subcommittee Thursday, Hamburg pointed out that 94% of the agency's $821 million requested increase over fiscal 2012 funding would be covered by user fees, paid by companies seeking FDA approval, Reuters reports.

"FDA is a true bargain among federal agencies," Hamburg said. "Americans each pay about $8 a year for FDA's appropriations."

The FDA wants an 11% increase for the Center for Devices and Radiological Health, asking for $870 million to follow through on its promise to speed up PMA and 510(k) turnaround times, planning to add 80 full-time-equivalent positions to meet its goals. If it gets the money it wants, the FDA says it will improve approval decision times by 20% and rule on clearances 3% faster.

But all of that hangs in limbo if Congress can't agree on a budget and halt automatic sequestration cuts, which bar the agency from touching $83 million in user fees Hamburg said it needs to implement its plan. President Barack Obama signed a bill that would effectively double user fees for devicemakers over 5 years, but the prolonged congressional squabble over a budget has put their use on hold, irking industry and agency alike.

Hamburg is urging Congress to exempt user fees from the sequester, warning that the FDA won't be able to keep its promises to drug and device companies without the added funds.

- read the Reuters news