House Subcommittee Marks FDA for $2.571 Billion for FY 11

BREAKING NEWS

The House Agriculture/FDA appropriations subcommittee marked up its FY 11 bill this afternoon. The subcommittee mark for FDA is for $2.571 billion, an increase of $214 million above FY 10 and $55 million above the President’s request. The President’s number reflected about a 6.5% increase over FY 10. The House subcommittee mark is about 9%. Our position is as follows:

The Alliance is very pleased with this proposed increase. It demonstrates that Members of Congress recognize that FDA needs to be an exception to efforts to cut the federal budget. We applaud the leadership of Chairwoman De Lauro, Ranking Member Kingston and the members of the subcommittee.

Representative DeLauro’s opening statement provides these examples of where additional funds are to be used:

• A $15 million increase over the request for the office of generic drugs

• A $3 million increase for the review of direct consumer ads

• A $2 million increase for the review of communications to medical professionals in the Division of Drug Marketing and Communication

• A $7 million increase over the request for the Center for Devices and Radiological Health

• A $16 million increase over the request for the center and field activities in the Center for Food Safety and Applied nutrition related to imported food safety.

Chairwoman DeLauro's full statement can be found if you click here. You can also click here to see a summary table showing how different agencies (including FDA) fared

ANALYSIS AND COMMENTARY

FDA has a large mission — vital to public health and the economy. A strong FDA needs the resources to do it vast and complex work well.Much of the attention in the media and among lawmakers focuses on FDA’s big three: the Center for Food Safety and Applied Nutrition, the Center for Drug Evaluation and Research, and the Center for Devices and Radiation Health. Yet the core functions of these three centers plus activities in the commissioner’s office plus rent payments are only about half of the Agency’s appropriated funding in FY 2010. Surprised?Looking at where the rest of the money is going … strongly reinforces the Alliance’s major theme about the breadth and depth of the FDA’s responsibilities.The largest unit of the FDA — both in manpower and appropriated dollars — is the Office of Regulatory Affairs (ORA). This unit is responsible for inspections and enforcement across the entire spectrum of FDA’s jurisdiction. While its funding is “hidden” in the various centers’ budgets as “field activities,” ORA’s total budget is about $850 million. This is more than a third of the agency’s appropriation and is also about 40% of the appropriated workforce.The other, less visible parts of FDA are: the Center for Biologics Evaluation and Research, the Center for Veterinary Medicine, and the National Center for Toxicological Research. The non-field portions of these organizations are about 15% of the FDA’s appropriated funding.This week the Alliance met with Dr. Karen Midthun, acting director of CBER, and her staff. Over the last 9 months, we have also met with the heads of ORA, CVM and NCTR. I have come away from all four meetings thinking about the importance of the issues each deals with … and how little they are appreciated.In CBER’s case, I was struck by how much the Center’s mission is different and not parallel with CDER. Their responsibilities — cells, gene therapies, human tissues, vaccines, allergenics, blood and blood products — deal quite literally with what makes each of us alive and functional. They are the vanguard against pandemic flu, the protector of our blood supply, and the home to an increasing array of novel biological technologies.CVM is in the middle of public discussion about “the judicious use of medically important antimicrobial drugs in food-producing animals.” NCTR has a lead role in public discussion about the safety of bisphenol A (BPA). ORA is being asked to do more each day to insure food and drug safety.None of the four is usually in the headlines, but ORA, CBER, CVM and NCTR are a critical backbone of the FDA’s service to the American people.

Note: This analysis and commentary is written by Steven Grossman, Deputy Executive Director of the Alliance.