Posted: April 20th, 2012 - 5:42pm
Source: Leavitt Partners

This week’s newsletter examines how two unrelated issues: FDA moving forward with reinspection fees, and the recent announcement around changes in the use of antibiotics on farms—illustrate how FDA is using its available tools to send some strong signals to the food industry. The issuance of the guidance on antibiotic use calls into question the effective difference between regulation and guidance, the impact of each on the industry and the repercussions if not followed.
In one action, FDA began adding a section to Warning Letters declaring its authority to assess and collect fees to cover its costs for re-inspections and detailing the conditions under which it could assess those fees. As found in Warning Letters as far back as February 14, in a letter to Ginsberg’s Institutional Foods, and as recent as April 2, in a letter to Lucky Taco, FDA wrote:
“Section 743 of the Act (21 U.S.C. § 379j-31) authorizes FDA to assess and collect fees to cover FDA’s costs for certain activities, including costs related to re-inspection. A re-inspection is one or more inspections conducted subsequent to an inspection that identified non-compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA’s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees, 21 U.S.C. § 379j-31(a)(2)(B). For a domestic facility, FDA will assess and collect fees for re-inspection-related costs from the responsible party for the domestic facility. The inspection noted in this letter identified non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.”
As I stated in a previous newsletter, “Get Ready to Pay New Registration Fees,” this is an authority that FDA already has but so far has not used. At that time, I also stated that it was currently unclear exactly when this would start and how it would be implemented. It seems that FDA has decided to start and is finding a way to implement it. As a reminder this could cost some serious cash with an hourly rate of $224 for domestic reinspection and $335 for foreign reinspection. So if you find yourself in this situation following a 483, focus on making sure you address the issues in a way that will enable any reinspection to be targeted and swift.
In another action, FDA issued a guidance document and proposed regulation on the Judicious Use of Medically Important Antimicrobial Drugs in Food-Producing Animals. The new strategy was announced by Deputy Commissioner for Foods Michael Taylor, as a strategy to “phase out production uses [e.g., to promote growth or improve feed efficiency] of medically important antimicrobials and provide that they be used only for targeted, FDA-approved animal health purposes under the supervision of a veterinarian.”
The guidance focused on two principles which, on the surface, seem innocent enough, but in reality will have massive impact on the food industry and subsequently likely on the cost of certain food products.
Principle 1: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that are considered necessary for assuring animal health.
Because they pose a public health risk, FDA believes the use of the antimicrobial drugs for production purposes represents an injudicious use. Thus, veterinary involvement in the decision-making process is important to assuring appropriate use.
My interpretation of this first principle is that very few antibiotics will be allowed to be used for food production unless there is a health benefit to the animal. This will likely rule out their use as pure growth promoters and it will be up to some smart people to demonstrate that there are health benefits associated with the use of some of the current antibiotics in food production.
Principle 2: The use of medically important antimicrobial drugs in food-producing animals should be limited to those uses that include veterinary oversight or consultation. Most feed-use antimicrobial drugs are currently approved for over-the-counter (OTC) use. In this new guidance, FDA is recommending that drug sponsors voluntarily change the status of the drugs from OTC to Veterinary Feed Directive (VFD) status for medicated feed products and to prescription status for medicated drinking water products.
My view of the second principle is that it will effectively remove the ability of a farmer to buy antibiotics for feed over the counter and will place a veterinarian between the farmer and the drugs.
InTaylor’s announcement explaining the strategy to limit rather than ban the use of the antimicrobials, he said:
“I know there will be those who question why we have not taken mandatory action to ban production uses of antimicrobials. The answer is that, with the willingness of drug companies and others in the animal production industry to collaborate in implementing our strategy, we can make changes more quickly than if we had to rely solely on a cumbersome regulatory process that would require us to seek change drug by drug, and labeled use by labeled use. Working together is how we will get good results in a timely manner.”
Taylor’s perspective is correct: it is much easier and faster for FDA to publish guidance than to work through the regulatory process. While guidance is just that and not a regulatory requirement, industry that ignores guidance does so at their peril. In a previous newsletter, “BPA Passes FDA Safety Check,” I also noted thatTaylor seemed to be (rightly) passing on some of the onus for the delayed publication of FSMA rulings to the OMB on whose desk the pile is pending. Perhaps rather than simply accepting the inherent governmental lags, FDA has decided to work around the regulatory process to move forward its initiatives.
In the case of the antimicrobials, FDA is giving the animal and veterinary communities the opportunity to “voluntarily” limit the use of the drugs to targeted, FDA-approved animal health uses under the supervision of a veterinarian rather than the general production uses for which the drugs had been being used.
While giving the industries some free rein, however, Taylor backs it up with consequences should the phase out not occur within a three-year time frame: “If progress is not what we expected, we will consider further action as warranted in accordance with existing provisions of the FD&C for addressing matters related to the safety of approved new animal drugs.”
As someone who spent time treating patients with a variety of infectious diseases, I am well aware of the dangers of antibiotic-resistant microbes and believe we have to do all we can to limit the growing threat of antibiotic resistance. Certainly some studies have indicated that limiting the use of antibiotics in food production will temper the development of antibiotic resistance but so will better control of the use of antibiotics in human medicine. But the key message here is around the fact that the guidance should not be seen as a light tap but as a major game changer for the food industry.
What do these actions tell us?
FDA may issue its industry declarations in a variety of ways for a variety of reasons. But whether published in a guidance document, warning letter or regulation, you should take all rulings and “recommendations” to heart, and know that there could be long-term repercussions should you choose to ignore them.
In fact, it seems that FDA is beginning to take matters into its own hands, seeking ways to move food safety actions forward despite the standard “cumbersome regulatory process.” The fact that we are seeing FSMA stalled will force FDA to move forward in other ways, and while the “bar” for the publication of guidance is certainly present, that bar is not nearly as high as it is for a regulation. But the impact on the food industry may be minimally different. So should we expect more impactful guidance in the coming months? Probably!