The Food and Drug Administration (FDA) recently recommitted itself to its lame proposal to address the profligate use of antibiotics in livestock by enlisting the voluntary participation of the drug companies that make the antibiotics. Two documents issued last month reveal the details of the agency’s current plans. The first is a final guidance document describing the FDA’s process for handling drug sponsors’ voluntary efforts to phase out “production uses” of antibiotics in animal feed and water and to bring the remaining uses under the oversight of a veterinarian. The second is a draft rule relaxing the requirements for veterinarians in exercising this oversight. Production uses are aimed at promoting growth and improving feed efficiency, not at treating active infections. The FDA will continue to allow mass medication of whole herds and flocks of livestock for purposes of preventing infection.
The FDA has, in internal documents, conceded that “all” of the relevant drug companies must participate in order to make its approach work. But there is no guarantee that even a significant number of these companies will voluntarily give up production uses simply because the FDA asks them to. Even if some do – Zoetis and Elanco have said they intend to – there is no guarantee that other companies will not step in to capture the market share given up by the volunteers. And even if they do not – note the piling of hope upon hope required to believe the FDA’s policy might succeed – these companies will, under the FDA’s approach, still be allowed to feed antibiotics to whole herds and flocks of food-producing animals so long as they call it “disease prevention” rather than “growth promotion” or “feed efficiency.” Not surprisingly, criticisms of the FDA’s proposal have been withering.
Previous critiques of the FDA’s approach have, however, missed a key aspect of the agency’s approach, one that is both troubling and fixable: the near-complete opacity of the FDA’s program. In its recent guidance document explaining its policy on livestock antibiotics, the FDA promises just three measures to keep the public apprised of its work. First, the agency promises to post on its website a list of the drug products initially affected by its guidance document; the agency has already done this. Second, the agency says that it will, after the three-month period in which drug sponsors are to inform the agency if they will take part in the agency’s voluntary initiative, “publish summary information to provide an indicator of the level of engagement of affected drug sponsors in the voluntary process.” Third, the FDA will notify the public “of completed changes to affected products through publication of approval of supplemental new drug applications” – or, in other words, it will tell the public when it has approved any drug companies’ requests to remove production uses from the list of indicated uses for their products.
This is very meager transparency. It is nice to have the list of drug products affected by the FDA’s guidance document, but the list means little without a sense of the market share, and potential market share, captured by these products. It means next to nothing without a sense of whether the companies making these products will actually participate in the FDA’s program. And the FDA’s promise to tell the public of completed changes to affected products adds nothing to what the public already would expect; the FDA’s own regulations require it to notify the public of approval of drug applications.
Moreover, the “summary information” the FDA promises to provide appears to include only “the level of engagement” of drug sponsors – not the identities of the sponsors who are and who are not participating in the FDA’s voluntary program, nor even, perhaps, the total market share represented by any participating sponsors. It is not clear that, by pledging to let the public know the “level of engagement” of drug sponsors, the agency has promised anything more than a meaningless qualitative assessment, such as, say: “The FDA believes that the level of engagement in this program is very promising.”
In addition, once the FDA has, three months from December, disclosed to the public the “level of engagement” of drug sponsors in its program, the FDA will essentially go to ground for three years while it works things out privately with the drug sponsors. The FDA does not, as a general rule, tell the public when it has received an application to alter a drug’s intended uses, and it does not disclose the status of any application it has received until the application is finally approved. Even once the application is approved, the agency does not typically make available the documents that have been exchanged between the agency and drug sponsor during the application process or let the public know what the agency-sponsor interactions involved. The process is private, not public, and the FDA appears to intend to keep it that way in this case.
In a situation rife with potential for coziness between the government and the regulated industry, this extreme level of secrecy does not augur well for the success of the “judicious use” program.
To give its voluntary program even the slimmest chance of succeeding, the FDA should promise to report not just the “level of engagement” of drug companies in its voluntary program, but also the identity of the drug companies that have indicated they will volunteer. In December, the agency asked the companies that sell the relevant antibiotics to let it know within three months whether they would volunteer for the judicious use program. In March of this year, therefore, the FDA should give the public a list of the companies that have stepped forward to participate. The FDA should at the same time provide a list of the companies that have not stepped forward.
Voluntary programs work, if at all, when volunteers are rewarded and laggards are called out. The public deserves to know what the FDA will know in March: whether drug companies are heeding the agency’s call to withdraw production uses for antibiotics used in livestock.
This improved transparency will not fix the FDA’s program, as the program suffers from defects that go beyond secrecy. But, with this change, at least we would know sooner rather than later whether this initiative is hopelessly doomed to fail because too few companies have volunteered for the FDA’s voluntary program.
Lisa Heinzerling, CPR Member Scholar; Professor, Georgetown Law. Bio.
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