The FDA’s Center for Veterinary Medicine’s Eroding Focus on Protecting Consumers

By Steve Roach and Madeleine Kleven, FACT’s Safe and Healthy Food Team

The Food and Drug Administration (FDA) and its Center of Veterinary Medicine (CVM) were created as public health agencies with the regulatory goal of making sure that drugs for humans or animals cannot be sold unless they are safe and effective. Under pressure from the regulated industry and elected officials, this original public health mission has been eroded. Now the Center for Veterinary Medicine whose primary reason for existence is to make sure animal drugs are safe both for animals and people prioritizes “spur[ring] the development of new technologies” over making sure people are not harmed by existing technologies. The CVM is becoming more and more like the U.S. Department of Agriculture (USDA) with dual roles of both regulating and promoting U.S. agriculture. Like the USDA, this means the CVM too often prioritizes the regulated industry over protecting public health.

This is clearly illustrated in the CVM’s recently announced “Innovation agenda,” in its reliance on collecting fees from animal drug makers, and in its glacially slow and ineffective approach to addressing antibiotic resistance. The CVM’s Innovation agenda document sings the praises of the new technologies that are going to solve all the world’s problems while completely ignoring the potential for new technologies to create unforeseen problems. It also ignores huge, ongoing problems such as antibiotic resistance, harm to animal welfare, pandemic risk, environmental pollution, and injustice created by the current set of technologies.

The CVM has become completely reliant on fees collected from the regulated industry - the animal drug makers. These fees come with serious strings which establish clear deadlines that the agency must meet when evaluating animal drugs. The CVM commits to acting on drug applications in months and to some part of the applications in days in exchange for the industry’s money. In contrast, even voluntary actions aimed at protecting public health will take at a minimum over five years to go anywhere. The drug industry gets the added bonus that every five years the fees must be renegotiated giving the drug makers the opportunity to ask for more concessions from the CVM such as it did in 2018 when it successfully lobbied the agency to support expanding conditional approvals - a drug approval pathway that allows drugs to be approved without having to provide complete data showing they work.

Congress requires the CVM to get feedback from consumer advocates during this process but does not require the CVM to listen. FACT regularly provides this input but drug makers have vetoed any suggestions we have made in the last ten years. The head of the CVM division that approves new drugs previously told us that the CVM cannot listen to consumer advocates because the industry would not like it and then the CVM would have to lay off workers when the funds fail to be reauthorized. Job security for CVM employees was more important than protecting public health to this now-retired CVM leader.

Where we are most aware of the erosion of the public health mission of the CVM is when it comes to combatting the public health threat from antibiotic resistance. The CVM, like all federal health agencies, acknowledges the seriousness of the threat to public health from antibiotic resistance. The CVM’s most significant current planned action to address resistance is an effort started in 2016 to get drug makers to voluntarily prohibit the continuous use of medically important antibiotics in food animals. Continuous use is bad because the more an antibiotic is used, in this case, used for a long period of time, the more resistance will develop and spread. This effort has resulted in a draft guidance (GFI#273) that asks drug makers to set duration limits (a set maximum number of days a drug can be used without another order from a veterinarian) for the 30% of feed antibiotics that currently have no limits on how long they can be used.  

FACT and KAW have argued that the CVM should adopt the maximum duration recommended by an existing CVM guideline (GFI #152) which tells drug makers how to assess the safety of new animal drugs with respect to antibiotic resistance. GFI #152 which was first finalized in 2003 states that drugs at risk for antibiotic resistance not be used for more than 21 days in groups of animals. FACT and KAW asked the CVM to adopt the 21-day maximum duration which is already part of these earlier CVM recommendations as it moves forward with setting duration limits for the antibiotics that do not currently have them. These drugs without duration limits were approved before GFI#152 was implemented. The CVM has not done this. The CVM’s latest plan despite the goal to minimize antibiotic resistance, states drug makers do not need to consider resistance in setting durations but should instead set maximum durations based solely on animal health concerns. The FDA plan recommends a maximum long enough to cover any situation that “might sometimes be encountered in the United States.” In order to address the inconsistency between this recommendation (as long as the drug maker decides a drug might someday be needed) and the 21-days in GFI#152, the CVM is rewriting GFI#152 as well, asking drug makers to now consider animal health needs as part of the safety assessment of a drug.  

So, when we asked them to apply their recommendations consistently across these guidelines in a way that protects public health, the CVM instead weakened the existing guideline - putting public health at risk while supporting the drug and livestock industries. Of course, even this is not enough and the pork industry has complained that putting any limits on how long an antibiotic can be fed to animals is too much.

Beyond weakening these two sets of recommendations, this sets a terrible precedent for the FDA. Longstanding FDA not just CVM policy is that human safety assessments are done independent of efficacy assessments because it is dangerous to balance protecting human health against animal health. Drugs need to be safe and if they are safe then they can be approved for use in food animals. By mixing safety concerns and animal health needs, like the CVM is doing with its recommendations on duration limits (GFI#273) and its rewrite of the earlier microbiological safety guidelines (GFI#152), the CVM is blurring the separation between safety and efficacy assessment.

The CVM has stated that it chooses to use voluntary guidance to address antibiotic resistance because of the difficulty and resources needed for a contested withdrawal once a human health concern has been identified in an animal drug. By creating guidance that requires balancing animal and human health needs (draft GFI#152 and draft GFI#273) in the context of improving drug safety, the CVM undermines its own authority to withdraw drugs based on human health concerns because the regulated industry will always argue that any drug is needed for animal health, welfare, and food safety.

The drug maker and livestock industry argued that a ban on the use of the antibiotic enrofloxacin in poultry would lead to an animal welfare disaster, food safety problems, and increased food prices. None of this occurred, though animal welfare was bad for chickens before and after the ban. In the future, when the CVM argues that it is inappropriate to consider animal health concerns in a hearing on the human safety of an animal drug, the drug maker and allied industries can point to these guidances as evidence that the CVM’s own policies require balancing human and animal health when making decisions related to drug safety. This makes us all less safe.