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U.S. Department of Health and Human Services

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The Comments of Food Animal Concerns Trust at the Animal Drug User Fee Act of 2003 (ADUFA) Public Meeting

April 24, 2007

Comments presented by Steven Roach,
Director, Public Health Program
Food Animal Concerns Trust

Introduction

Food Animal Concerns Trust (FACT) appreciates this opportunity to provide comments on the Animal Drug User Fees Act of 2003 (ADUFA). Food Animal Concerns Trust (FACT) is a non-profit that addresses public health problems related to the production of poultry, meat, milk, and eggs. FACT had originally decided not to comment on ADUFA because we believed it to be primarily relevant to the regulated industry, but then as we learned more about the program we came to realize that it has had significant impacts on the FDA’s public health mission.

FACT clearly recognizes the importance of veterinary drugs in protecting the health and welfare of animals, whether they are companions or raised for profit. We also strongly support providing adequate funding for FDA work that promotes animal health and see the benefits in having an efficient animal drug approval process. At the same time, FACT has serious questions as to whether ADUFA is an appropriate tool to meet this goal.

The Food and Drug Administration’s mission is to protect consumers and promote public health. FACT believes that ADUFA has harmed FDA’s ability to fulfill its public health mission in three ways. First, FACT is concerned that the implementation of user fees has contributed to “regulatory capture” where the regulated industry, in this case the animal drug industry, “strongly influence(s) the regulatory agency’s decision making,” to quote the Institute of Medicine’s, 2007 report. Second, because the fees collected have not been adequate to meet the resource requirements for fulfilling ADUFA goals, it is our understanding that other important programs within the FDA’s Center for Veterinary Medicine (CVM) have had their budgets cut and positions have been eliminated. Finally, ADUFA has created an imbalance in the Center for Veterinary Medicine between its public health mission and its mission to provide access to animal drugs, because ADUFA requires FDA to make progress on animal drug approvals while not placing any similar requirement that progress be made on other important aspects of its mission, including monitoring the public health impacts of drug approvals.

Regulatory Capture

In the recent Institute of Medicine Report, “The Future of Drug Safety: Promoting and Protecting the Health of the Public” (IOM, 2007), the experts examined the U.S. drug safety system and recommended that more resources be provided to FDA through general appropriations instead of through user fees. They favored general appropriations in part because of concerns about the perception that fees contribute to “regulatory capture.” Regulatory capture occurs when a regulated industry is able to strongly influence regulatory agency decision making.

While the IOM report refers to human drug approvals, FACT is concerned that IOM observations regarding regulatory capture are equally valid for animal drug approvals. FACT believes that the FDA currently gives too much deference to drug sponsors and agricultural veterinary drug users and we feel that ADUFA contributes to this problem.

While FDA bears part of the responsibility and needs to do a better job of resisting industry pressure, part of the problem also rests with Congress, which recently passed a series of statutes aimed at speeding drug approvals and increasing access to veterinary drugs. The Animal Medicinal Drug Use Clarification Act of 1994 (AMDUCA) greatly extended the way that animal drugs could be used off label and made it difficult for FDA to restrict this use. The 1996 Animal Drug Availability Act made it easier for new drugs to be approved. ADUFA in 2003 was followed by the Minor Use and Minor Species Animal Health Act of 2004. The clear message from this series of laws is that FDA has to approve more animal drugs. However, Congress did not simultaneously mandate the FDA to improve its efforts to protect public health as related to animal feed and animal drugs.

As I stated above, FACT believes that the FDA currently gives too much deference to drug sponsors and agricultural veterinary drug users. We believe this undue deference has impacted the drug approval process. Because of confidentiality requirements and the associated lack of transparency around the drug approval process, public information on drug safety evaluations by the FDA is very limited. However, since ADUFA was passed there have been two public meetings before the FDA’s Veterinary Medicine Advisory Committee (VMAC) which provided information about FDA’s approach to evaluating the human health impacts of animal drugs. FACT believes that in both cases there is evidence of regulatory capture.

When VMAC met in 2004 to consider a drug sponsor’s risk assessment for the new veterinary antibiotic drug, tulathromycin, FDA did not acknowledge that the sponsor’s risk recommendations were inconsistent with FDA’s guidance on risk assessment until a committee member pointed this out. In 2006 when VMAC met to consider the public health implications of cefquinome, another new antibiotic drug for use in livestock, FDA allowed the sponsor to present a risk assessment to the committee that left out significant information relating to the drugs potential impact on human health and that made scientifically questionable assertions minimizing the potential human health impacts of the drug in question.

FACT attended both VMAC meetings and believes that FDA did not give either of the drugs adequate scrutiny before bringing them before VMAC. In the case of cefquinome, VMAC agreed with this opinion and voted that the sponsor had failed to show safety. attributes this lack of scrutiny on the pressure to approve.

ADUFA’s Financial Impact on FDA’s Public Health Mission

As I stated above FACT originally had decided not to comment on ADUFA, but later as we learned more we felt that comment was necessary. A large part of our decision to comment is based on discussions we had with FDA staff in the Center for Veterinary Medicine (CVM). We were repeatedly told that resources were being shifted from other programs at CVM to the Office of New Animal Drug Evaluation (ONADE) in order to meet ADUFA goals. This concern is consistent with our findings when we examined FDA budget reports.

Table 1 included in my written comments clearly shows how funding for research at CVM has been drastically cut back and how all postmarket activities have had reduced funding over time since ADUFA was initiated. Table 1 is compiled from FDA functional activity tables. The net result has been that funds for premarket review have increased from 38% of CVM’s total budget before ADUFA to 53% in 2006. At the same time, all post market activities at CVM have dropped from 53% of the total before ADUFA to 43% in 2006.

Table 1. Impact of ADUFA on CVM Research and PostMarket Activities

 PremarketPostmarketCVM
YearReviewResearchTotalResearchTotalTotal
20022137738%43278%2661548%789614%2911252%55727
20032178238%43658%2710047%807214%3001553%57115
20042233940%40867%2724349%763314%2827051%55513
20052865946%40917%3357553%761512%2932347%62898
20063350753%17293%3576257%53188%2732643%63088
2005 Postmarket Research from Budget Request

These cuts in funding for CVM activities other than drug review have occurred despite new threats such as the detection of Bovine Spongiform Encephalopathy (BSE) in North America and the need to address the pandemic potential of avian influenza.

FACT believes that, at best, this indicates that ADUFA fees are not high enough to meet the requirements of the program. If it is so important that drugs be approved quickly then sponsors should pay higher fees so that other parts of CVM do not need to be cannibalized to meet this goal. FACT believes a better approach is that all parts of CVM be adequately funded and that if this is not possible then funding be targeted to areas of CVM that are necessary for its public health mission.

Imbalance between CVM’s public health mission and CVM drug approvals.

ADUFA has harmed FDA’s public health mission by removing resources for FDA activities related to animal drugs and feed and by tying funding only to goals related to drug approvals. This runs counter to FDA’s primary mission to protect consumers and promote public health. The efficient review of new animal drugs is a worthy goal, but it is secondary to protecting public health. ADUFA has led to a CVM with priorities as expressed in funding and in actions that places efficient drug approval above protecting public health.

While ADUFA has created incentives to quickly improve new animal drugs, it does not include any incentives related to improving post marketing drug safety monitoring. This situation is directly analogous to human drugs where the Prescription Drug User Fee Act (PDUFA) has contributed to an imbalance between new drug approvals and post marketing safety as described in the IOM report mentioned above.

For example, antibiotic resistance is a recognized public health crisis and there is a strong consensus among public health experts that more needs to be done to address the role of agriculture in this crisis. Despite this, funding for the National Antimicrobial Resistance Monitoring System (NARMS) has been drastically cut since ADUFA was implemented. In this case, NARMS is a primary tool for monitoring the post market safety of veterinary antimicrobial drugs, but its funding has been cut while ADUFA speeds that rate at which new drugs are approved.

Another example related to antimicrobial resistance is FDA’s failure to put in place a system to monitor quantities of antimicrobial drugs used in livestock production. This has been a top priority item in the Public Health Action Plan to Combat Antimicrobial Resistance (Action Plan) that was developed by an interagency Task Force on Antimicrobial Resistance organized in 1999. The collection of antimicrobial drug use data has been recommended by the World Health Organization, the World Organization for Animal Health (OIE), the Institute of Medicine, and the GAO. Despite the well recognized need for drug use data, the FDA has delayed taking action to put a system in place to collect this data for years.

This imbalance between priorities related to new drug approvals and protecting public health is also apparent in the FDA’s inability to complete antimicrobial resistance safety assessments on drugs approved before CVM understood the risk from antimicrobial resistance. In 2003, FDA published a guidance document, Guidance Document #152, describing its preferred method for evaluating the human health impact of antimicrobial resistance arising from the food-animal use of veterinary drugs. During public meetings discussing this new guidance, FDA stated that the agency intended this guidance to be used for both new and existing approvals. At that time FDA also described the order in which it intended to examine existing approvals. Since then, FDA has at most completed the review of only one class of drugs outside of new drug approvals. I say at most because CVM has announced each year since 2004 that it has completed the review of the penicillin class of drugs. The last year reported is 2006 but if the trend holds CVM will complete the penicillin assessment once again in 2007. This is in contrast with FDA’s use of Guidance #152 in the context of new drug approvals where FDA applied the guidance to at least four different classes of drugs in 2005 and 2006 alone. This lack of action on existing approvals shows that FDA is able to act efficiently in completing safety evaluations only in the context of new approvals. This lack of balance occurs even though bulk of antibiotics used and therefore the likely public health impact is from the existing approvals not from new drugs yet to enter the market.

FDA has shown itself incapable of acting in an efficient manner to address other important health problems related to animal feeds and drugs. Despite the detection of Bovine Spongiform Encephalopathy (BSE), or mad cow disease, in North America in 2003 followed by two native born U.S. cases and several Canadian cases that were born after ruminant feeding bans were put in place, the FDA has failed to address recognized gaps in the ruminant feed ban. FDA announced, but never put in place, improvements in the feed ban in early 2004. In 2005, FDA published a proposed rule, but has failed to act to publish a final rule in a timely manner.

In addition to addressing feed issues around mad cow disease, FDA has failed to move forward to efficiently address feed safety in general. The recent problems with contaminated pet food highlight the need for more action in this important area.

CVM enforcement activities have also been drastically reduced since the implementation of ADUFA.

FACT believes that the combination of resource shortages related to FDA’s overall funding combined with Congressionally set goals focusing only on new drug approvals has resulted in FDA failing to act in a timely manner to address significant public health problems.

Conclusion

FACT believes that ADUFA has harmed FDA’s public health mission. In conclusion, FACT would like to make a few suggestions as to how these problems could be addressed at least in part.

First, FACT recommends that general funds be used for all FDA activities. If this is not possible, then Congress should not limit the use of these funds to new drug approvals, but instead should direct them to be used to address public health concerns related to animal feeds and drugs. Approving drugs efficiently is not the highest priority of FDA when it comes to animal drugs and feed; instead, FDA’s priority must be on protecting public health.

Second, if fees are directed solely to new animal drug approvals, the fees should be high enough so that other program areas are not negatively impacted by resource shifts to ONADE.

Third, in order to reduce the perception that regulatory capture overly influences FDA decision making, Congress should direct FDA to make public complete drug safety information, not just the very limited information currently available in freedom of information summaries on new drug approvals. Greater transparency will increase confidence in the system.

Finally, FACT recommends that Congress require FDA to take steps to control antibiotic resistance by phasing out the non-therapeutic use of medically important antibiotics in livestock feeds. FACT also recommends that Congress direct FDA to close the gaps in the ruminant feed ban.

I thank you for your attention and hope that you will consider our recommendations for strengthening FDA’s public health protection activities related to animal feeds and drugs.

References

IOM, 2007. The Future of Drug Safety: Promoting and Protecting the Health of the Public (2007)disclaimer icon Board on Population Health and Public Health Practice.