The Food and Drug Administration changes in how it approves the vast majority of medical devices (see story, page 16) aren’t going to come cheap. So the FDA has requested more money to do its job.
The agency requested more than $4 billion to promote and protect health as part of President Obama’s fiscal year 2011 budget, which would start Oct. 1.
If the request is granted, it would be a 23% hike over the agency’s current budget, which comes in at almost $3.3 billion.
That amount is inclusive of user fees that the FDA expects to collect from the drug, tobacco and food industries. The Obama administration has called for $2.5 billion in federal funds, up 6% from the previous year.
The FDA has requested funds for programs that could affect the medical device and drug industries.
• $101 million for a “protecting patients” initiative that will be used for supporting the safety of drugs, medical devices and vaccines, as well as blood supply.
• $25 million for what the administration refers to as “advancing regulatory science,” which will promote easier approvals for new devices and drugs.
• $325.7 million for the FDA’s Center for Devices and Radiological Health, which is 3% higher than the appropriations level for the 12 months ending Sept. 30.
It’s not just funds the FDA is looking for. It also could benefit from additional congressional resources, such as IT infrastructure improvements, additional reviewers and reviewer educational opportunities, and more opinion from outside experts, said James Mazzo, president of Abbott Medical Optics Inc., a Santa Ana-based maker of eye surgery devices and contact lens care products.
Earlier this month, four members of the House of Representatives sent a letter to Health and Human Services Secretary Kathleen Sebelius to boost the FDA’s fiscal 2012 budget.
But Mazzo, who also is chair of industry group AdvaMed, said that increased funding was only one half of the equation. He said the agency needed to be “run effectively and efficiently in meeting its dual mission of protecting the public health and promoting innovative healthcare.”
And the Alliance for a Stronger FDA, a Silver Spring, Md.-based advocacy group, told the Gray Sheet, an industry website, that the 6% budget increase requested by the Obama administration would not offset what it called “a decade of neglect” caused by underfunding of the FDA.
The alliance, which includes Abbott Laboratories and Corona-based Watson Pharmaceuticals Inc., said earlier this year that it wanted $349 million more in federal funds than the Obama administration proposed, including $59 million more for the Center for Devices and Radiological Health, which regulates companies that manufacture, repackage, re-label or import medical devices sold in the U.S., according to the Gray sheet.
—Vita Reed
