S.Amdt. 3329

SA 3329. Mr. DURBIN submitted an amendment intended to be proposed by
him to the bill S. 524, to authorize the Attorney General to award
grants to address the national epidemics of prescription opioid abuse
and heroin use; which was ordered to lie on the table; as follows:

At the end of title I, add the following:

SEC. 104. OPIOID ACTION PLAN.

(a) Advisory Committee.--
(1) New drug application.--Except as provided in paragraph
(4), prior to the approval of a new drug that is an opioid
under section 505 of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355), the Commissioner of Food and Drugs shall
refer such drug to an advisory committee of the Food and Drug
Administration to seek recommendations from such Committee.
(2) Pediatric opioid labeling.--The Commissioner of Food
and Drugs shall convene the Pediatric Advisory Committee of
the Food and Drug Administration to seek recommendations from
such Committee regarding a framework for the inclusion of
information in the labeling of drugs that are opioids
relating to the use of such drugs in pediatric populations
before such Commissioner approves any labeling changes for
drugs that are opioids intended for use in pediatric
populations.
(3) Public health exemption.--If the Commissioner of Food
and Drugs finds that referring a new opioid drug or drugs to
an advisory committee of the Food and Drug Administration as
required under paragraph (1) is not in the interest of
protecting and promoting public health, and has submitted a
notice containing the rationale for such a finding to the
Committee on Health, Education, Labor, and Pensions of the
Senate and the Committee on Energy and Commerce of the House
of Representatives, or if the matter that would be considered
by such advisory committee with respect to any such drug or
drugs concerns bioequivalence or sameness of active
ingredients, the Commissioner shall not be required to refer
such drug or drugs to an advisory committee as required under
paragraph (1).
(4) Sunset.--Unless Congress reauthorizes paragraphs (1)
and (2), the requirements of such paragraphs shall cease to
be effective on October 1, 2022.
(b) Continuing Medical Education for Prescribers of
Opioids.--Not later than 1 year after the date of enactment
of this Act, the Secretary of Health and Human Services,
acting through the Commissioner of Food and Drugs, in
consultation with the Director of the Centers for Disease
Control and Prevention, the Director of the National
Institutes of Health, the Administrator of the Agency for
Healthcare Research and Quality, the Administrator of the
Drug Enforcement Administration, and relevant stakeholders,
shall develop recommendations regarding continuing medical
education programs for prescribers of opioids required to be
disseminated under section 505-1 of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355-1), including recommendations
for which prescribers should participate in such programs and
how often participation in such programs is necessary.
(c) Guidance.--Not later than 1 year after the date of
enactment of this Act, the Commissioner of Food and Drugs
shall issue guidance on if and how the approved labeling of a
drug that is an opioid and is the subject of an application
under section 505(j) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 355(j)) may include statements that such drug
deters abuse.
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