Preventing Antibiotic Resistance Act of 2015

“(q) Ensuring judicious use in animals of medically important antimicrobials

“(1) Applicability—This subsection applies to medically important antimicrobials approved for use in a food-producing animal—

“(A)

“(i) for which there is in effect an approval of an application or an exemption under subsection (b), (i), or (j) of section 505; or

“(ii) that is otherwise marketed for human use;

“(B) for which the Food and Drug Administration has initiated or completed withdrawal or modification of an approved label for growth promotion, feed efficiency, or other production use or over-the-counter use, in accordance with the Guidance for Industry entitled, “New Animal Drugs and New Animal Drug Combination Products, Administered in or on Medicated Feed or Drinking Water of Food-Producing Animals: Recommendations for Drug Sponsors for Voluntarily Aligning Product Use Conditions with GFI #209”, published in December 2013; and

“(C) for which the Food and Drug Administration has approved a label—

“(i) for disease control or prevention at the same or similar dosage level as applicable for the approved production use described in subparagraph (B);

“(ii) that does not specify an explicitly defined duration of therapy; or

“(iii) specifying a dosage that is not expected to treat a specific bacterial pathogen.

“(2) Review of disease prevention and control approvals

“(A) In general—Not later than January 1, 2017, the Secretary shall initiate a process whereby—

“(i) not later than January 1, 2018, a sponsor of an antimicrobial drug described in paragraph (1) shall submit to the Secretary evidence demonstrating that, with respect to such drug—

“(I) there is evidence of effectiveness in controlling or preventing bacterial disease;

“(II) an approved use is consistent with accepted veterinary practice;

“(III) an approved use is linked to a specific etiologic agent;

“(IV) an approved use is appropriately targeted to animals at risk of developing a specific bacterial disease;

“(V) an approved use has an explicitly defined duration of therapy; and

“(VI) there is reasonable certainty of no harm to human health due to the development of antimicrobial resistance; and

“(ii)

“(I) if the Secretary determines that the evidence submitted under clause (i) is sufficient to demonstrate that the drug meets the requirements described in subclauses (I) through (VI) of such clause, not later than December 31, 2018, the Secretary shall issue a revised label approval for the antimicrobial drug, as necessary; or

“(II) if the Secretary determines that the evidence submitted under clause (i) is insufficient to demonstrate that the drug meets the requirements described in subclauses (I) through (VI) of such clause, not later than December 31, 2018, the Secretary shall withdraw approval of any indication claims described in paragraph (1)(C) for which the Secretary determines the evidence is insufficient and, as necessary, issue a revised label approval.

“(B) Withdrawal of claims—On or before January 1, 2018, the sponsor of a drug described in paragraph (1) may request the approval of the Secretary to remove any label claim described in paragraph (1)(C), and the Secretary shall approve any such request and, as necessary, issue a revised label. The sponsor shall not be required to submit the evidence required under subparagraph (A)(i) with respect to any claim so withdrawn.

“(3) Exemptions—In the case of a drug that is a medically important antimicrobial for which the Secretary grants an exemption under section 505(i), the withdrawal of indication claims in a food-producing animal in accordance with paragraph (2)(B) shall be effective on the date that is 2 years after the date on which the Secretary grants the exemption, unless, not later than 2 years after the date on which the Secretary grants the exemption, the Secretary provides a written determination of intent to extend the exemption.

“(4) Definition—In this subsection, the term medically important antimicrobial means a drug that—

“(A) is intended for use in food-producing animals; and

“(B) is composed wholly or partly of—

“(i) any kind of penicillin, tet­ra­cy­cline, mac­ro­lide, lin­cos­amide, strep­to­gram­in, aminoglycoside, sul­fon­amide, ceph­a­lo­spo­rin, or flu­o­ro­quin­o­lone; or

“(ii) a drug from an antimicrobial class that is listed as “highly important”, “critically important”, or “important” by the World Health Organization in the latest edition of its publication entitled “Critically Important Antimicrobials for Human Medicine” (or a successor publication).”