Congress has set the floor for FDA’s Office of Generic Drugs funding at $52.947 million in fiscal 2012, almost 5% less than the minimum of $55.5 million it directed FDA to spend on OGD in fiscal 2011.

FDA proposed a budget of $88.8 million for OGD in fiscal 2012. But $40 million of that was to have come from $40 million in generic drug user fees that are not yet authorized. Whether FDA chooses to supplement the $53 million in the conference report to the appropriations bill with other money from the Center for Drug Evaluation and Research remains to be seen.

Any inadequacies in OGD funding should be short-lived as leaders in both the House and Senate authorizing committees have pledged to complete action by the end of March on an FDA user fee reauthorization measure that is expected to include the generic user fee program negotiated by the agency and industry Also see "ANDA User Fee Negotiations Finished; Backlog To Be Mostly Cleared By Year Five" - Pink Sheet, 12 September, 2011..

The program is designed to generate $299 million per year, plus annual adjustment for inflation after the first year. The agreement has been going through clearance procedures at HHS and the White House Office of Management and Budget and FDA plans to release it shortly. FDA/industry user fee proposals are due on Capitol Hill in January.

The OGD funding is part of H.R. 2112, which originally was the Department of Agriculture/FDA funding measure, but House and Senate conferees converted the bill into a “mini-bus” that rolled in two other appropriations measures – Commerce/Justice/Science and Transportation/Housing and Urban Development – and includes a continuing resolution to keep other government programs operating until Dec. 16. President Obama signed the legislation into law Nov. 18, the day after it was passed by the House and Senate.

The FDA portion of the bill provides the agency with $3.8 billion for salaries and expenses in fiscal 2012, which began Oct. 1, plus a separate account of $8.8 million for buildings and facilities. User fees account for $1.3 billion in agency funding, including $702 million in prescription drug user fees.

The Center for Drug Evaluation and Research and related field activities are to be funded at $978.7 million and the Center for Biologics Evaluation and Research at $329.1 million.

Conferees accepted the $50 million increase in budget authority (non-user fee money) over fiscal 2011 levels provided in the Senate bill, including $20 million for advancing medical countermeasures Also see "FDA's Medical Countermeasure Program Among Senate Funding Priorities" - Pink Sheet, 12 September, 2011..

And while that funding boost is welcome news for FDA and its advocates, the funding picture for the agency looks bleaker next year, as all domestic discretionary programs face an automatic 7.8% spending cut as part of the sequestration process that was triggered after the congressional “supercommittee” failed to reach a deficit reduction deal ([A#14111121005]).

Another Chance For FDA To Show Its Approval Record

The appropriations conferees entered the debate about whether FDA takes too long to approve drugs with a directive in the conference report for FDA to report by Feb. 15 on the speed of its approvals. The agency is to report on the average number of calendar days that elapse from the date that drug applications (including any supplements) and biological license applications (including any supplements) are submitted to the agency until the date the drugs are approved.

Industry has complained that FDA’s quest for more certainty about a medical product’s benefit/risk equation delays market entry and Congress should make some legislative changes to address this as part of the Prescription Drug User Fee Act reauthorization Also see "FDA Approval Standards Need To Be Relaxed, Venture Capitalists Say" - Pink Sheet, 11 July, 2011..

During House hearings in the summer, however, CDER Director Janet Woodcock said the agency’s first-cycle drug approvals are the highest they’ve been in 20 years Also see "Woodcock Defends Speed Of FDA Reviews, Cites 20 Approvals In First Half Of 2011" - Pink Sheet, 7 July, 2011.. That claim is based on approvals of 20 new medications during the first half of 2011. The conferees did not specify a time frame for FDA to calculate the average approval times for its report to Congress.

Sen. Richard Burr, R-N.C., indicated at Senate hearings that regulatory efficiency will be an important criteria for him in judging whether user fees should be renewed Also see "Burr Warns User Fee Renewal Could Be Difficult Without Performance Measure Improvements" - Pink Sheet, 28 July, 2011..

The conferees also use the report to “urge FDA to be responsive, timely and transparent throughout the approval process for all human and veterinary drugs, biological products, medical devices, and medical countermeasures.” FDA and industry have addressed this issue in their prescription drug user fee agreement, which calls for more communications between sponsors and FDA during the review process Also see "PDUFA V: Emerging Sponsor Communication Issue Resolved And Expanded" - Pink Sheet, 6 June, 2011..

FDA’s Generic Drug Office Goes On Diet Before Swallowing User Fees

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