Preventing Antibiotic Resistance Act of 2017

“(r) 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 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 applies; 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, 2019, the Secretary shall initiate a process of reviewing medically important antimicrobials described in paragraph (1), in accordance with subparagraph (B).

“(B) Review of approval

“(i) In general—If, not later than January 1, 2020, a sponsor of an antimicrobial drug described in paragraph (1) submits to the Secretary sufficient evidence to 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 targets a specific bacterial pathogen;

“(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 not a reasonable probability of risk to the public health due to the development of antimicrobial resistance,

“(ii) Insufficient evidence—If the sponsor of an antimicrobial drug described in paragraph (1) does not submit sufficient evidence as described in clause (i) by December 31, 2020, the Secretary shall withdraw approval of any indication claims described in paragraph (1)(B) for which the sponsor does not submit evidence or for which the Secretary determines the evidence submitted is insufficient and, as necessary, issue a revised label approval.

“(C) Withdrawal of claims—On or before January 1, 2020, 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)(B), 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 (B)(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

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

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

“(ii) is composed wholly or partly of—

“(I) any kind of penicillin, tetracycline, macrolide, lincosamide, streptogramin, aminoglycoside, sulfonamide, cephalosporin, or fluoroquinolone, or any drug included in the list pursuant to updates under subparagraph (B); or

“(II) a drug from an antimicrobial class that is listed as “highly important”, “critically important”, or “important” in Appendix A of the Guidance for Industry entitled, “Evaluating the Safety of Antimicrobial New Animal Drugs with Regard to Their Microbiological Effects on Bacteria of Human Health Concern” (or any successor guidance).

“(B) Review and updates—The Secretary shall conduct periodic reviews of the drugs included in the list described in subparagraph (A)(ii)(I), and add to or remove from such list any drugs that the Secretary determines appropriate. A review shall be undertaken at the Secretary’s discretion, but not less than once every five years.”