August 27, 2013
Last Thursday, The Washington Post ran an op-ed by Dr. Donald Kennedy, a former commissioner of the Food and Drug Administration (FDA), who called on the agency to finalize a voluntary policy to limit antibiotic use in food animal production. Dr. Kennedy sought to counter “public health advocates” who have criticized the agency for its approach to this issue. Ironically, he detailed its fatal flaw instead.
Antibiotics are fed to food animals at low doses and for extended durations, both for “production purposes” like growth promotion and to compensate for the overcrowded and unsanitary conditions in which many of these animals are produced, a practice known euphemistically as “disease prevention.” This misuse erodes the effectiveness of these drugs for treating human infections. For decades, scientists and advocates have called for mandatory restrictions. While other countries have heeded these calls, the FDA has focused on voluntary reform.
The Logic of Voluntarism
The FDA released a draft of Guidance 213, as the voluntary policy is known, in April of last year. The draft recommends that drug companies voluntarily withdraw approvals to market antibiotics for production purposes over a three-year period. Dr. Kennedy wants the agency to finalize this document, formally initiating the voluntary process and timeframe.
The obvious question to ask about Guidance 213 is this: Why would drug companies voluntarily surrender approvals and reduce their sales? An analysis of FDA data, which Dr. Kennedy cites, revealed that 80 percent of antibiotics sold in the United States are approved for use in food animals, not humans. Ninety percent of antibiotics sold for use in food animals are formulated for use in feed and water, the means by which many antibiotics are administered for production and prevention. If drug companies voluntarily relinquished approvals to market antibiotics for these purposes, profits would drop. These companies are not charities, so the question remains: Why would they agree to voluntary changes that, on their face, would be terrible business decisions?
The answer lies in what Guidance 213 leaves out. While the document recommends voluntarily withdrawing approvals to market antibiotics for production purposes, it also endorses their continued use for disease prevention. (The agency claims that prevention uses are “necessary for assuring animal health” but it ignores the production practices that make them “necessary.” The success of more comprehensive and mandatory restrictions in other countries demonstrates that, when these practices are modified, such restrictions may be adopted without serious consequences for animal health.)
Most antibiotics are approved for multiple purposes; many are approved for both production and prevention. When FDA approves a drug, it specifies the dose and duration at which the drug should be used for each approved purpose. The dose and duration specified for prevention are often similar to, if the not the same as, the dose and duration specified for production. They are lower and longer, respectively, than when antibiotics are administered to treat sick animals. Low doses and long durations promote the development of antibiotic-resistant bacteria.
Dose and duration also shape the quantity of antibiotics consumed by animals—and therefore the quantity purchased from drug companies. By agreeing to withdraw production approvals while leaving prevention approvals untouched, drug companies can comply fully with Guidance 213 while sidestepping a decline in sales. The guidance even allows companies to replace production approvals with prevention approvals more efficiently than before, just in case there was not sufficient overlap already. The food animal industry, for its part, can continue to use antibiotics as it does now by calling the use “disease prevention,” which certainly sounds better to the uninitiated. Unfortunately, bacteria do not care what you call it; dose and duration are what matter and Guidance 213 will not change them.
Disconnecting the Dots
Dr. Kennedy clearly understands the disingenuity of “disease prevention.” He writes, “Many animals are raised in conditions that pose a constant threat to their health. …[T]he FDA should not allow extensive uses of antibiotics in confined animals for prophylactic protection.” The op-ed does not, however, call on the agency to amend Guidance 213 so that drug companies can only comply by voluntarily withdrawing prevention approvals, too. The closest it comes is this: “Action by the FDA would be the initial step to encourage companies to make such changes and stop relying on massive overuse of antibiotics.” The omission is no surprise: if Guidance 213 sought to end prevention uses, voluntary compliance would be a fantasy. The guidance would be ignored.
The FDA has asked us to “trust but verify” that the voluntary approach will work. As the op-ed explains, however, the agency does not even have needed authority to collect data to evaluate its plan. The agency also withholds most of what it collects. How, then, is anyone supposed to verify anything? The FDA has solicited public comments on how more data may be collected, as Dr. Kennedy notes, but the agency has ignored repeated recommendations that it seek new authorities from Congress.
The op-ed verges on absurdity by the end of the second paragraph: because Guidance 213 has not been finalized, it states, “[d]rugmakers have been left awaiting further instruction.” The implication of this sentence is that drug companies want to do the right thing and simply need someone to explain what that is. It completely elides the fact that these companies seek to maximize profits, not to protect public health. That is precisely why we have regulatory agencies like the FDA, and why these agencies should act forcefully to do what companies will not.
The FDA need not rely on voluntarism; indeed, the law requires it to withdraw approvals when it finds that they are unsafe. Last year, a federal court ordered the FDA to complete the 1977 withdrawals mentioned by Dr. Kennedy in his opening paragraph. As he tells it, “Congress halted [this] effort before it started.” In reality, Congress made an implicit threat and the agency backed down, suspending the withdrawal proceedings for 35 years. The court ordered the agency to begin anew, stating explicitly that voluntary guidance is not an acceptable alternative. Rather than comply, the agency appealed. A decision is expected soon. Unsurprisingly, the op-ed does not acknowledge the litigation or sharp judicial criticism of the voluntary approach.
Dr. Kennedy insists that while “[s]ome public health advocates want the agency to make the restrictions mandatory…voluntary guidance can work — if it is finalized.” This depends on what it means for voluntary guidance to work. Will production approvals be withdrawn? Possibly, perhaps probably. Will these withdrawals, by themselves, change how antibiotics are used in food animals and protect public health? Probably not.
Photo: Out to Pasture: The Future of Farming? (2010)