Bipartisan Bill exempting FDA user fees from sequestration introduced in USA

A bipartisan group of US House of Representatives Members last week introduced the FDA Safety Over Sequestration Act, or FDA SOS Act, which exempts Food and Drug Administration user fees from sequestration. FDA user fees are 100% industry-financed and are used specifically for the approval of safe and effective drugs and devices. Under sequestration, the FDA is set to lose $85 million in user fees in fiscal year 2013 alone.

“Sequestration” is a term we have become all too familiar with in the USA. It refers to automatic spending cuts to the US federal budget that went into effect earlier this year as a result of the Budget Control Act of 2011 and the American Taxpayer Relief Act of 2012. The agency is set to collect about $1 billion from the pharmaceutical industry in fiscal 2013, however, thanks to sequestration, the FDA cannot touch about $85 million of that, the bill's sponsors said.

The authors of the bill, Representatives Anna Eshoo (Democrat, California), Leonard Lance (Republican, New Jersey), Doris Matsui (De, California) and Mike Rogers (Rep, Michigan) have grave concerns that the FDA will be unable to meet its Congressionally-mandated responsibilities unless its user fees are exempted from sequestration.