New powers and a budget increase, despite cuts to government spending, have been proposed to help the FDA monitor the global supply chain.
Spending cuts totalling $38bn (€26bn) are proposed in the last minute budget deal but the US Food and Drug Administration (FDA) has been spared. In fact, the FDA’s budget will increase compared to 2010 levels, a decision welcomed by advocates of a strong FDA.
“Congress heard our message that a robust well-funded FDA is essential for patients, consumers and industry”, said Nancy Bradish Myers, president of the Alliance for a Stronger FDA. Funding is needed to equip the FDA to cope with complex science and globalisation, said Myers.
The proposal sets the FDA budget at $3.66bn, with more than $1bn of this coming from user fees. In February 2010 the FDA requested $4.03bn for fiscal 2011, an increase of 23 per cent over the prior year.
A vote on the budget proposal is due to be held this week. If passed, the budget will allocate $957m to the Center for Drug Evaluation and Research and $325m to the Center for Biologics Evaluation and Research.
Additional FDA funding has been proposed by a group of House Democrats. In a bill due to be reintroduced the Democrats propose: generating increased funding for facility inspections; taking the same approach to foreign and domestic plants; and creating a registry of production sites.
Representative John Dingell said: “For too long, Americans have suffered from the challenges FDA and the industry face in ensuring the safety of the US drug supply. We must address the deficiencies uncovered by recent recalls.”
Dingell has been trying to strengthen the FDA for some time. He introduced the FDA Globalization Act in January 2009 and followed it up with the Drug Safety Enhancement Act, which built on the earlier proposal, in December 2010.
Neither was passed into law. Dingell now plans to reintroduce the Drug Safety Enhancement Act in an attempt to ensure drug quality despite an “increasingly global and complex drug supply”.