The Senate Appropriations Committee has approved a $2.524 billion budget in fiscal year (FY) 2013 for the FDA. The budget will be used to implement the Food Safety and Modernization Act, carry out the medical countermeasures program, and conduct safety inspections in China.
The FY 2013 funding increases the FDA’s budget by $27.47 million over FY 2012. However, when industry user fees are included, the FDA’s total program spending would be $3.91 billion, which is nearly $571 million below the President’s proposed level by trimming the total user fees by 30 percent. The committee did so by limiting user fees to the current-year budget request. The resulting cutbacks were approved as a precaution, because prescription drug and medical device user fees are still pending reauthorization for FY 2013. The spending plan for FDA also does not include new generic drug and biosimilar fees, as these programs have yet to be authorized by Congress.
The FDA would rely upon on $299 million in first-time revenue from new user fees to be imposed on developers of generic drugs, allowing for hiring 450 full-time equivalent employees in the agency and $20.242 million in first-time biosimilar user fees to pay for staff. Those charges account for more than half the $563.125 million in new user fees projected by FDA. The committee noted that final numbers for those first-time user fees and adjusted drug and device user fees will be added to FDA’s budget later. Those user fees are expected in increase, as the agency has stated that it expects user fees to account for a substantial portion of its budget. Of the remainder, the largest new fee would be the $220.2 million in “food establishment registration” fees FDA plans to collect to help pay for personnel to implement an initiative regarding food safety.
In addition, the committe approved as proposed by President Obama the FDA’s China Initiative. In turn, the FDA would set aside $10 million to advise Chinese biopharmaceuticals on manufacturing products to FDA standards as well as inspect products produced at the companies’ manufacturing plants by having FDA staff and inspectors in China. The committee also gave endorsement to the FDA’s desire to communicate with medical practitioners of drug shortages through specialty-specific lists and other means of targeted communications to address growing concern on the matter.