A US House Committee has strongly criticised the Food and Drug Administration (FDA) for carrying "in excess of $1,000,000,000 in unobligated [industry] user fees" halfway through the current financial year.
The criticism comes in a draft report published by the House of Representatives Committee on Appropriations to accompany the proposed Agriculture, Rural Development, FDA and Related Agencies Appropriations bill covering fiscal 2014.
The Committee is proposing an appropriation of $2,485,399,000 in new budget authority for the FDA for the year, plus $760,000,000 in user fee amounts for human-use prescription drugs, $305,996,000 for human-use generics and $20,716,000 for biosimilars.
However, the members also note their concern about the "large unobligated balances that continue to occur in FDA's user programmes."
"While Congress did allow for some exemptions from fiscal year limitations and for some amounts to be carried forward into subsequent fiscal years, it could not have been anticipated that FDA would be carrying in excess of $1,000,000,000 in unobligated user fees halfway into any fiscal year," they say.
Therefore, "the Committee directs that, not later than November 1, 2013, and each month thereafter through the months covered by this Appropriations Act, the [FDA] Commissioner to submit to the Committee on Appropriations of the House and the Senate a report on user fees collected for each user fee programme included in the bill," they say.
"The report shall also include monthly obligations incurred against such fee collections. The first report shall include a distinct categorisation of the user fee balances that are being carried forward into fiscal year 2014 for each user fee account, as well as a detail explanation of what accounts for the balance and what the balance will be used for,” they add.
The members are also worried about unintended consequences for smaller generics makers of the Generic Drug User Fee Act (GDUFA) fee structure. They direct FDA to study its impact on their ability to pay at the same level as large manufacturers, and to report its findings to the panel within 180 days of the Appropriations Act's enactment.
The legislators also express concern about subjecting FDA user fees to sequestration - the $85.3 billion automatic federal spending cuts that took effect on March 1. These fees are not normal tax revenues, they point out, adding: "it is important to maintain the integrity and industry support for user fee programmes."
The report makes a number of other criticisms of the FDA, not least in the area of transparency. The Committee says it is "concerned about the unpredictable nature and pace at which FDA moves guidance, rules and regulations through the process,” and emphasises that: “the Agency must understand that FDA is often viewed as a primary source of information for consumer decisions that impact their health and well-being."
Another concern for the legislators is the shortages of critical drugs which still persist following the enactment of the Food and Drug Safety and Innovation Act. Shortages continue primarily because of problems in manufacturing, they say, and point out that these impair patients' access to care and their experiences in the healthcare system, delay surgical procedures and possibly increase overall healthcare costs. Therefore, their report directs the FDA Commissioner to continue to prioritise the public reporting of manufacturing shortages and to work with industry to prevent conditions that might lead to drug shortages.