From the Porcine to the Ridiculous: Veterinary Drugmaker Sues FDA for Alleged APA Violations

A new lawsuit against FDA is the latest happening in the veterinary drugs space and, by extension, FDA’s Center for Veterinary Medicine (CVM). We blogged about CVM last week and explained the increasing attention to animal health products due to the expansion of the animal and pet product market. Phibro Animal Health Corp. has filed suit in the D.C. District Court challenging FDA’s plan to remove their products from the market.

Specifically, FDA is looking to remove a drug called carbadox from the market. Used for over 50 years, carbadox is an antimicrobial drug used to treat gastrointestinal disease in pigs. Last November, FDA published a notice of a proposal to withdraw approval of the three carbadox New Animal Drug Applications (“NADAs”) under 21 U.S.C. 360b(d)(1)(I). That section of the FDCA allows the Agency to issue an order refusing to approve a drug if substantial evidence shows it to be carcinogenic. But did FDA pig out?

FDA says that since the approval of carbadox, new evidence about residue from the drug remaining in pork products has come to light. That evidence now leads FDA to believe that old testing methods used for approval are inadequate to measure the cancer risk that the drug poses. According to FDA, the more recent evidence shows that carbadox residues stick around in processed pork longer than was previously understood. In light of this new data and improved science, FDA has determined that carbadox must come off the market.

Phibro holds the three NADAs at issue here, and the company, unsurprisingly, vehemently disagrees with FDA. In its whopping 70-page complaint. Phibro is asking for judicial review of FDA’s decision, claiming that the Agency skirted its responsibilities under the Administrative Procedures Act (“APA”). Phibro alleges that once FDA determined internally that carbadox was a danger to the pork-eating public, it “took shortcuts by issuing its orders without conducting an evidentiary hearing mandated by statute.”

Indeed, according to the company, FDA’s revocation of the regulatory method of testing that landed the carbadox approval is all a pretext to remove the drug from the market without an evidentiary hearing that Phibro claims would reinforce the drug’s safety. The company asserts that carbadox residues fall below dangerous levels before the products hit consumers’ plates, and that the Agency’s anti-carbadox bias and failure to follow the mandated regulatory procedures violated the “the FDCA, FDA’s regulations, the APA, and due process.”

Carbadox has had a tortured approval history. FDA has expressed concerns about risks to consumers since the drug was approved. At that time, the Agency allowed it to stay on the market under a program that tested edible portions of pigs, a method FDA now claims is not sufficient. The EU prohibited it in 1999, almost immediately after FDA approved the testing methods at issue here, and Canada banned it in 2006. In 2016, FDA again threatened to remove it, but ultimately took no action for reasons that remain unclear.

FDA now says that this long prologue put Phibro on notice that its bacon was close to the fire. In its public website message about carbadox, FDA notes that “[b]ecause the FDA first made public its concern regarding the adequacy of the 1998-approved [testing] method with regard to carbadox in 2016, the swine industry has had the opportunity to consider and mitigate potential impacts of this action for several years.”

We will see how FDA responds to the suit, but we also note that Phibro’s complaint prominently uses internal communications from FDA, obtained via FOIA, to make its case that the Agency’s bias prompted the alleged shortcuts in administrative procedure. Included in those messages are staff assertions that further consideration of this issue is a “waste of time” given the current state of the evidence, as well as an unfortunate allegation that during a public meeting, Agency officials “exchanged Internet memes lampooning Phibro’s representative while she presented the company’s evidence and legal arguments.” One image was of a small violin with the caption “Aww, you poor thing” sarcastically emblazoned below it.

While these may be distractions from the real question—whether the Agency followed APA requirements in withdrawing Phibro’s NADAs—they certainly aren’t a good look for the Agency. FDA has not responded to the suit yet, but its litigators from the Department of Justice are going to need to figure out if they want to respond to the allegations of bias as viewed through this window into how the FDA policy sausage is made.