By Diana R. H. Winters
[Cross-posted at HealthLawProf Blog.]
On Thursday, October 2, 2014, FDA released its “Summary Report on Antimicrobials Sold or Distributed in Food-Producing Animals” for 2012. The Report contains the depressing news that “domestic sales and distribution of medically important antimicrobials approved for use in food-producing animals increased by 16%,” between 2009 and 2012, though the percentage of those labeled solely for therapeutic use rose from 28% to 32%. The other 68% are labeled for just production (growth promotion) or production and therapeutic uses.
But why is that depressing, you may ask. Isn’t this exactly why FDA issued a final-guidance document and a draft rule in December 2013, both addressing its voluntary program with drug sponsors to decrease, and eventually end, the use of medically important antimicrobials for growth promotion in animal feed? Problem identified, solution initiated—right? If only it were that simple.
FDA has a long history of delay and intransigence on this issue. I have written about that history in the past, and do so again in this forthcoming article. In 2011, FDA was sued by a group of public interest organizations for its unwarranted delay, and a federal district court ordered the agency to begin proceedings to hold withdrawal of approval hearings for certain medically important antibiotics, hearings that it had originally called for in 1977. The Second Circuit reversed this decision in July of this year (NRDC v. FDA, 760 F.3d 151).
FDA argued, during the course of these proceedings, that its pursuit of voluntary compliance should relieve it of its duty to hold withdrawal hearings. The district court rejected this argument, but the Second Circuit found that this was a judgment properly made by the agency. The point is that FDA argued that it was seeking voluntary compliance in 2011 and 2012, pursuant to a draft version of the 2013 Guidance issued in 2010. But during these years, the sale of medically important antimicrobials went up, and not by a little bit.
Also troubling is that in the 2012 Report, FDA shows that sales of cephalosporins rose by 37% from 2009 to 2012. Cephalosporins are medically important drugs, and FDA restricted their use in animal feed early in 2012. As Food Safety News and the New York Times have pointed out, advocates are concerned that this rise demonstrates that FDA’s policies do not have the desired effect.
Moreover, the voluntary policy itself, even if it was not in full effect before December 2013, is riddled with loopholes. Lisa Heinzerling has identified four weak areas in FDA’s voluntary initiatives: (1) the reliance on drug companies and the absence of a backup plan in case of recalcitrance; (2) the continued permission given to give antibiotics to entire herds of uninfected animals to prevent sickness; (3) the simultaneous weakening of veterinary oversight; and (4) the lack of transparency as FDA works with drug companies.
And now, the administration’s new big push against antibiotic resistance, which I wrote about here, relies on FDA’s voluntary initiatives to address the use of medically important antimicrobials in animal feed, a use that accounts for as much as 80% of the sale of all antibiotics in the United States. Voluntary initiatives are not enough.