H. R. 6—40 
(B) considers the risk of addiction of controlled sub-
stances approved to treat pain when establishing unmet 
medical need; and 
(C) considers pain, pain control, or pain management 
in assessing whether a disease or condition is a serious 
or life-threatening disease or condition; 
(2) the methods by which sponsors may evaluate acute 
and chronic pain, endpoints for non-addictive medical products 
intended to treat pain, the manner in which endpoints and 
evaluations of efficacy will be applied across and within review 
divisions, taking into consideration the etiology of the under-
lying disease, and the manner in which sponsors may use 
surrogate endpoints, intermediate endpoints, and real world 
evidence; 
(3) the manner in which the Food and Drug Administration 
will assess evidence to support the inclusion of opioid-sparing 
data in the labeling of non-addictive medical products intended 
to treat acute or chronic pain, including— 
(A) alternative data collection methodologies, including 
the use of novel clinical trial designs (consistent with sec-
tion 3021 of the 21st Century Cures Act (Public Law 114– 
255)) and real world evidence (consistent with section 505F 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355g)), including patient registries and patient reported 
outcomes, as appropriate, to support product labeling; 
(B) ethical considerations of exposing subjects to con-
trolled substances in clinical trials to develop opioid-sparing 
data and considerations on data collection methods that 
reduce harm, which may include the reduction of opioid 
use as a clinical benefit; 
(C) endpoints, including primary, secondary, and surro-
gate endpoints, to evaluate the reduction of opioid use; 
(D) best practices for communication between sponsors 
and the agency on the development of data collection 
methods, including the initiation of data collection; and 
(E) the appropriate format in which to submit such 
data results to the Secretary; and 
(4) the circumstances under which the Food and Drug 
Administration considers misuse and abuse of a controlled sub-
stance (as defined in section 102 of the Controlled Substances 
Act (21 U.S.C. 802)) in making the risk benefit assessment 
under paragraphs (2) and (4) of subsection (d) of section 505 
of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355) 
and in finding that a drug is unsafe under paragraph (1) 
or (2) of subsection (e) of such section. 
(c) DEFINITIONS.—In this section— 
(1) the term ‘‘medical product’’ means a drug (as defined 
in section 201(g)(1) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 321(g)(1))), biological product (as defined in 
section 351(i) of the Public Health Service Act (42 U.S.C. 
262(i))), or device (as defined in section 201(h) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 321(h))); and 
(2) the term ‘‘opioid-sparing’’ means reducing, replacing, 
or avoiding the use of opioids or other controlled substances 
intended to treat acute or chronic pain.
H. R. 6—41 
SEC. 3002. EVIDENCE-BASED OPIOID ANALGESIC PRESCRIBING GUIDE-
LINES AND REPORT. 
(a) GUIDELINES.—The Commissioner of Food and Drugs shall 
develop evidence-based opioid analgesic prescribing guidelines for 
the indication-specific treatment of acute pain only for the relevant 
therapeutic areas where such guidelines do not exist. 
(b) PUBLIC INPUT.—In developing the guidelines under sub-
section (a), the Commissioner of Food and Drugs shall— 
(1) consult with stakeholders, which may include con-
ducting a public meeting of medical professional societies 
(including any State-based societies), health care providers, 
State medical boards, medical specialties including pain medi-
cine specialty societies, patient groups, pharmacists, academic 
or medical research entities, and other entities with experience 
in health care, as appropriate; 
(2) collaborate with the Director of the Centers for Disease 
Control and Prevention, as applicable and appropriate, and 
other Federal agencies with relevant expertise as appropriate; 
and 
(3) provide for a notice and comment period consistent 
with section 701(h) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 371(h)) for the submission of comments by the 
public. 
(c) REPORT.—Not later than 1 year after the date of enactment 
of this Act, or, if earlier, at the time the guidelines under subsection 
(a) are finalized, the Commissioner of Food and Drugs shall submit 
to the Committee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, Labor, and 
Pensions of the Senate, and post on the public website of the 
Food and Drug Administration, a report on how the Food and 
Drug Administration will utilize the guidelines under subsection 
(a) to protect the public health and a description of the public 
health need with respect to each such indication-specific treatment 
guideline. 
(d) UPDATES.—The Commissioner of Food and Drugs shall 
periodically— 
(1) update the guidelines under subsection (a), informed 
by public input described in subsection (b); and 
(2) submit to the committees specified in subsection (c) 
and post on the public website of the Food and Drug Adminis-
tration an updated report under such subsection. 
(e) STATEMENT TO ACCOMPANY GUIDELINES AND RECOMMENDA-
TIONS.—The Commissioner of Food and Drugs shall ensure that 
opioid analgesic prescribing guidelines and other recommendations 
developed under this section are accompanied by a clear statement 
that such guidelines or recommendations, as applicable— 
(1) are intended to help inform clinical decisionmaking 
by prescribers and patients; and 
(2) are not intended to be used for the purposes of 
restricting, limiting, delaying, or denying coverage for, or access 
to, a prescription issued for a legitimate medical purpose by 
an individual practitioner acting in the usual course of profes-
sional practice.
H. R. 6—42 
CHAPTER 2—STOP COUNTERFEIT DRUGS BY 
REGULATING AND ENHANCING ENFORCEMENT NOW 
SEC. 3011. SHORT TITLE. 
This chapter may be cited as the ‘‘Stop Counterfeit Drugs 
by Regulating and Enhancing Enforcement Now Act’’ or the 
‘‘SCREEN Act’’. 
SEC. 3012. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CON-
TROLLED SUBSTANCES. 
(a) PROHIBITED ACTS.—Section 301 of the Federal Food, Drug, 
and Cosmetic Act (21 U.S.C. 331) is amended by adding at the 
end the following: 
‘‘(eee) The failure to comply with any order issued under section 
569D.’’. 
(b) NOTIFICATION, NONDISTRIBUTION, AND RECALL
OF CON-
TROLLED SUBSTANCES.—Subchapter E of chapter V of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360bbb et seq.) is amended 
by adding at the end the following: 
‘‘SEC. 569D. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF CON-
TROLLED SUBSTANCES. 
‘‘(a) ORDER TO CEASE DISTRIBUTION AND RECALL.— 
‘‘(1) IN GENERAL.—If the Secretary determines there is a 
reasonable probability that a controlled substance would cause 
serious adverse health consequences or death, the Secretary 
may, after providing the appropriate person with an opportunity 
to consult with the agency, issue an order requiring manufac-
turers, importers, distributors, or pharmacists, who distribute 
such controlled substance to immediately cease distribution 
of such controlled substance. 
‘‘(2) HEARING.—An order under paragraph (1) shall provide 
the person subject to the order with an opportunity for an 
informal hearing, to be held not later than 10 days after the 
date of issuance of the order, on whether adequate evidence 
exists to justify an amendment to the order, and what actions 
are required by such amended order pursuant to subparagraph 
(3). 
‘‘(3) ORDER RESOLUTION.—After an order is issued according 
to the process under paragraphs (1) and (2), the Secretary 
shall, except as provided in paragraph (4)— 
‘‘(A) vacate the order, if the Secretary determines that 
inadequate grounds exist to support the actions required 
by the order; 
‘‘(B) continue the order ceasing distribution of the con-
trolled substance until a date specified in such order; or 
‘‘(C) amend the order to require a recall of the con-
trolled substance, including any requirements to notify 
appropriate persons, a timetable for the recall to occur, 
and a schedule for updates to be provided to the Secretary 
regarding such recall. 
‘‘(4) RISK ASSESSMENT.—If the Secretary determines that 
the risk of recalling a controlled substance presents a greater 
health risk than the health risk of not recalling such controlled 
substance from use, an amended order under subparagraph 
(B) or (C) of paragraph (3) shall not include either a recall
H. R. 6—43 
order for, or an order to cease distribution of, such controlled 
substance, as applicable. 
‘‘(5) ACTION FOLLOWING ORDER.—Any person who is subject 
to an order pursuant to subparagraph (B) or (C) of paragraph 
(3) shall immediately cease distribution of or recall, as 
applicable, the controlled substance and provide notification 
as required by such order. 
‘‘(b) NOTICE TO PERSONS AFFECTED.—If the Secretary deter-
mines necessary, the Secretary may require the person subject 
to an order pursuant to paragraph (1) or an amended order pursuant 
to subparagraph (B) or (C) of paragraph (3) to provide either a 
notice of a recall order for, or an order to cease distribution of, 
such controlled substance, as applicable, under this section to appro-
priate persons, including persons who manufacture, distribute, 
import, or offer for sale such product that is the subject of an 
order and to the public. In providing such notice, the Secretary 
may use the assistance of health professionals who prescribed or 
dispensed such controlled substances. 
‘‘(c) NONDELEGATION.—An order described in subsection (a)(3) 
shall be ordered by the Secretary or an official designated by 
the Secretary. An official may not be so designated under this 
section unless the official is the Director of the Center for Drug 
Evaluation and Research or an official senior to such Director. 
‘‘(d) SAVINGS CLAUSE.—Nothing contained in this section shall 
be construed as limiting— 
‘‘(1) the authority of the Secretary to issue an order to 
cease distribution of, or to recall, any drug under any other 
provision of this Act or the Public Health Service Act; or 
‘‘(2) the ability of the Secretary to request any person 
to perform a voluntary activity related to any drug subject 
to this Act or the Public Health Service Act.’’. 
(c) CONTROLLED SUBSTANCES SUBJECT TO REFUSAL.—The third 
sentence of section 801(a) of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 381(a)) is amended by inserting ‘‘, or is a controlled 
substance subject to an order under section 569D’’ before ‘‘, or 
(4)’’. 
(d) EFFECTIVE DATE.—Sections 301(eee) and 569D of the Fed-
eral Food, Drug, and Cosmetic Act, as added by subsections (a) 
and (b), shall be effective beginning on the date of enactment 
of this Act. 
SEC. 3013. SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL DRUGS. 
Section 801 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381), as amended by section 3012, is further amended by 
adding at the end the following: 
‘‘(t) SINGLE SOURCE PATTERN OF IMPORTED ILLEGAL DRUGS.— 
If the Secretary determines that a person subject to debarment 
as a result of engaging in a pattern of importing or offering for 
import controlled substances or drugs as described in section 
306(b)(3)(D), and such pattern is identified by the Secretary as 
being offered for import from the same manufacturer, distributor, 
or importer, the Secretary may by order determine all drugs being 
offered for import from such person as adulterated or misbranded, 
unless such person can provide evidence otherwise.’’.