As I write this article, the Animal Drug User Fee Act (ADUFA) is beginning its move for congressional renewal. ADUFA has been fairly successful at providing additional funding through user fees to the Food and Drug Administration (FDA). These fees are used to promote a more rapid transit through the drug approval process to bring new drugs to market. It is relatively non-controversial and is expected to ultimately be renewed if it can remain unburdened with extraneous amendments.
Our experience with the process of getting ADUFA renewed is a good example of the kind of challenges we face as legislation progresses through congressional committees and onto the floor for a final vote. The atmosphere in Washington today seems to be one of little activity, so any time a bill actually appears to be moving forward, it becomes a tantalizing vehicle on which to try to load various bits of legislation in the hopes that those amendments will ride the bill’s coattails through the approval process.
Efforts have been made recently to attach other antimicrobial-related legislation onto ADUFA, including, for instance, legislation calling for the collection of additional antimicrobial-use data. These amendments are often more controversial than the parent bill and would likely not pass, or even be considered, on their own. The addition of these amendments often results in many supporters withdrawing their support, thus potentially slowing the passage or derailing it altogether, or worse yet, passage of a bill containing provisions we find onerous.
There are various stages during the legislative process where amendments might be added, such as in committee or even on the congressional floor during debate. For this reason, it is important that groups like the National Pork Producers Council (NPPC) and the American Veterinary Medical Association’s (AVMA’s) Government Relations Division monitor the passage of these bills and be ready to provide supporters with information and stakeholder opinions at the spur of the moment. The AASV has been supportive of a “clean” ADUFA, meaning a bill without superfluous amendments. It will be interesting to watch as the bill moves closer to a vote.
In other activities of interest, FDA is teaming up with United States Department of Agriculture (USDA) to conduct five listening sessions to consider the impact on rural producers and veterinarians of enhancing veterinary oversight of antimicrobials and the proposed expansion of the veterinary feed directive. The objective of these sessions is to provide an opportunity for public dialogue and feedback on challenges faced by the animal-agriculture industry and practicing veterinarians, as FDA implements its initiative for the judicious use of medically important antimicrobials in medicated feed or drinking water of food-producing animals. Particular emphasis will be placed on challenges faced by animal producers in areas that may lack access to adequate veterinary services.
These sessions will be held in April-June, and AASV and the pork producers will have members at each session to speak to the potential challenges this legislation may cause. As a source for potential participants from AASV, we were able to call on members who had participated in the Swine Veterinarian Public Policy Advocacy Program facilitated by NPPC. Currently, over 40 AASV members have completed the program. These folks are a handy resource that we can access on short notice if needed. If you are interested in participating in the program, contact either me or Dr Liz Wagstrom at NPPC.
In other news, AVMA continues to work with Congress to develop legislative language to address the issue of veterinarians transporting controlled substances, which is currently illegal. The Drug Enforcement Administration (DEA) has been unwilling to interpret the existing regulations in a manner that would exempt veterinarians, thus requiring a legislative fix. Response from congressional offices thus far has been favorable. Just keep in mind, however, that until the regulation is changed, it is illegal to transport controlled substances away from the premises registered with the DEA.
Finally, USDA is proposing changes to the swine brucellosis and pseudorabies surveillance programs. Swine brucellosis and pseudorabies have been eliminated from commercial swine herds within the United States, but potential sources of introduction of these diseases exist and USDA believes program modifications are necessary to address these risks. The proposed changes are significant and place a lot of the responsibility for the program design on the states and tribes. The proposal can be viewed in the federal register (http://www.gpo.gov/fdsys/pkg/FR-2013-02-07/html/2013-02772.htm), and USDA is currently accepting comments.