Lanham Act covers ads that drug is FDA-approved/has ANDA

Arbor Pharmaceuticals, LLC v. ANI Pharmaceuticals,
Inc., 2018 WL 3677923, No. 17-4910 (D. Minn. Aug. 2, 2018)
Arbor sells prescription erythromycin ethylsuccinate
for oral suspension, allegedly the only FDA-approved products of their kind on
the market. ANI announced the launch of its own erythromycin ethylsuccinate for
oral suspension, allegedly claiming to be a generic version of Arbor’s products
and falsely claiming FDA approval/AB-rating pursuant to an approved Abbreviated
New Drug Application (ANDA). A product similar to an NDA-approved drug may be
approved and marketed based on an ANDA, which requires a showing of therapeutic
equivalence; the resulting AB-rating communicates that the product is a true
Arbor alleged that ANI acquired an ANDA from another
pharmaceutical company for a discontinued product that had been manufactured
using a process that differs from that used by ANI, and that the FDA has
notified ANI that its application wasn’t approvable. ANI stated that the
relevant ANDA was originally approved in 1978 for Barr Pharmaceuticals, that
Barr stopped marketing the approved product in 2003, and that the ANDA was
discontinued. ANI said that it filed a supplement to the ANDA with the FDA,
detailing changes it made to the manufacturing process, and indicated its
intent to market the product if the FDA did not advise otherwise within 30
days. The FDA allegedly didn’t object, so it must know and be ok with it.  [Nice work if you can get it.]
ANI argued that Arbor’s claims were precluded under
the FDCA. Despite Pom, courts have
continued to find preclusion where a plaintiff’s claims would require a court
to interpret and apply the FDCA.  This
wasn’t such a case.  Arbor asserted
competitive injury and sought to enforce the Lanham Act’s prohibition on false
advertising, here false representations of FDA approval.  ANI stated that it owned an ANDA that couldn’t
be circumvented by Arbor’s pleadings, and that the FDA tacitly approved of ANI’s
actions, but those were just statements in a brief, whereas Arbor alleged that
the FDA considered the ANDA discontinued and had so notified ANI.  Also, the FDA has a list of approved
generics, and ANI’s product isn’t on the latest printing.  Because the allegations were that ANI falsely
promoted its product as a generic equivalent, no interpretation of the FDCA was

For the same reason, the primary jurisdiction doctrine didn’t justify declining
to decide the case.  Likewise, state and
common-law claims weren’t preempted, though the unfair competition claim under
Minnesota law was dismissed as merely duplicative of the false advertising

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