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[Congressional Bills 115th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5228 Engrossed in House (EH)]

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115th CONGRESS
  2d Session
                                H. R. 5228

_______________________________________________________________________

                                 AN ACT

 
 To strengthen the authorities of the Food and Drug Administration to 
 address counterfeit drugs, illegal and synthetic opioids, and opioid-
                like substances, and for other purposes.

    Be it enacted by the Senate and House of Representatives of the 
United States of America in Congress assembled,

SECTION 1. SHORT TITLE; TABLE OF CONTENTS.

    (a) Short Title.--This Act may be cited as the ``Stop Counterfeit 
Drugs by Regulating and Enhancing Enforcement Now Act'' or the ``SCREEN 
Act''.
    (b) Table of Contents.--The table of contents of this Act is as 
follows:

Sec. 1. Short title; table of contents.
Sec. 2. Detention, refusal, and destruction of drugs offered for 
                            importation.
Sec. 3. Notification, nondistribution, and recall of adulterated or 
                            misbranded drug products.
Sec. 4. Single source pattern of shipments of adulterated or misbranded 
                            drugs.
Sec. 5. Fund to strengthen efforts of FDA to combat the opioid and 
                            substance use epidemic.
Sec. 6. Consideration of potential for misuse and abuse required for 
                            drug approval.

SEC. 2. DETENTION, REFUSAL, AND DESTRUCTION OF DRUGS OFFERED FOR 
              IMPORTATION.

    (a) Increasing the Maximum Dollar Amount of Drugs Subject to 
Destruction.--The sixth sentence in section 801(a) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking 
``except that the Secretary'' and all that follows through the two 
periods at the end and inserting ``except that the Secretary of Health 
and Human Services may destroy, without the opportunity for export, any 
drug refused admission under this section, if such drug is declared to 
be valued at an amount that is $2,500 or less (or such higher amount as 
the Secretary of the Treasury may set by regulation pursuant to section 
498(a)(1) of the Tariff Act of 1930 or such higher amount as the 
Commissioner of Food and Drugs may set based on a finding by the 
Commissioner that the higher amount is in the interest of public 
health), or if such drug is entering the United States by mail, and was 
not brought into compliance as described under subsection (b).''.
    (b) Destruction of Articles of Concern.--The sixth sentence of 
section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381(a)), as amended by subsection (a), is further amended by inserting 
before the period at the end the following: ``; and the Secretary of 
Health and Human Services may destroy, without the opportunity for 
export, any article refused admission under clause (6) of the third 
sentence of this subsection''.
    (c) Technical Amendments.--The seventh, eighth, and ninth sentences 
of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 381(a)) are amended--
            (1) by striking ``a drug'' each place it appears and 
        inserting ``an article''; and
            (2) by striking ``the drug'' each place it appears and 
        inserting ``the article''.
    (d) Rule of Construction.--The last sentence in section 801(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended 
to read as follows: ``Clauses (2), (5), and (6) of the third sentence 
of this subsection shall not be construed to prohibit the admission of 
narcotic or nonnarcotic drugs or other substances, the importation of 
which is permitted under the Controlled Substances Import and Export 
Act.''.

SEC. 3. NOTIFICATION, NONDISTRIBUTION, AND RECALL OF ADULTERATED OR 
              MISBRANDED DRUG PRODUCTS.

    (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 Adulterated or 
Misbranded Drugs.--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 ADULTERATED 
              OR MISBRANDED DRUGS.

    ``(a) Order To Cease Distribution and Recall.--
            ``(1) In general.--Upon a determination that the use or 
        consumption of, or exposure to, a drug may present an imminent 
        or substantial hazard to the public health, the Secretary shall 
        issue an order requiring any person who distributes the drug to 
        immediately cease distribution of the drug.
            ``(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--
                    ``(A) the actions required by the order; and
                    ``(B) whether the order should be amended to 
                require a recall of the drug.
            ``(3) Inadequate grounds.--If, after providing an 
        opportunity for a hearing under paragraph (2), the Secretary 
        determines that inadequate grounds exist to support the actions 
        required by the order, the Secretary shall vacate the order.
            ``(4) Amendment to order to require recall.--If, after 
        providing an opportunity for an informal hearing under 
        paragraph (2), the Secretary determines that the order should 
        be amended to include a recall of the drug with respect to 
        which the order was issued, the Secretary shall--
                    ``(A) amend the order to require a recall; and
                    ``(B) after consultation with the drug sponsor, 
                specify a timetable in which the recall will occur.
            ``(5) Notice to persons affected.--An order under this 
        subsection shall require any person who distributes the drug to 
        provide for notice, including to individuals as appropriate, to 
        persons who may be affected by the order to cease distribution 
        of or recall the drug, as applicable.
            ``(6) Action following order.--Any person who is subject to 
        an order under paragraph (1) or (4) shall immediately cease 
        distribution of or recall, as applicable, the drug and provide 
        notification as required by such order.
    ``(b) Notice to Consumers and Health Officials.--The Secretary 
shall, as the Secretary determines to be necessary, provide notice of a 
recall order under this section to--
            ``(1) consumers to whom the drug was, or may have been, 
        distributed; and
            ``(2) appropriate State and local health officials.
    ``(c) Order To Recall.--
            ``(1) Contents.--An order to recall a drug under subsection 
        (a) shall--
                    ``(A) require periodic reports to the Secretary 
                describing the progress of the recall; and
                    ``(B) provide for notice, including to individuals 
                as appropriate, to persons who may be affected by the 
                recall.
            ``(2) Assistance allowed.--In providing for notice under 
        paragraph (1)(B), the Secretary may allow for the assistance of 
        health professionals, State or local officials, or other 
        individuals designated by the Secretary.
            ``(3) Nondelegation.--An order under this section 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, is an official senior to such 
        Director, or is so designated by 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, an 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) Drugs Subject to Refusal.--The third sentence of subsection (a) 
of section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
381) is amended by inserting ``or (5) in the case of a drug, such drug 
is subject to an order under section 568 to cease distribution of or 
recall the drug,'' before ``then such article shall be refused 
admission''.
    (d) Application.--Sections 301(eee) and 569D of the Federal Food, 
Drug, and Cosmetic Act, as added by subsections (a) and (b), shall 
apply with respect to a drug as of such date, not later than 1 year 
after the date of the enactment of this Act, as the Secretary of Health 
and Human Services shall specify.

SEC. 4. SINGLE SOURCE PATTERN OF SHIPMENTS OF ADULTERATED OR MISBRANDED 
              DRUGS.

    Section 801 of the Federal Food, Drug, and Cosmetic Act is amended 
by adding at the end the following:
    ``(t) Single Source Pattern of Shipments of Adulterated or 
Misbranded Drugs.--If the Secretary identifies a pattern of adulterated 
or misbranded drugs being offered for import from the same 
manufacturer, distributor, or importer, the Secretary may by order 
choose to treat all drugs being offered for import from such 
manufacturer, distributor, or importer as adulterated or misbranded 
unless otherwise demonstrated.''.

SEC. 5. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE OPIOID AND 
              SUBSTANCE USE EPIDEMIC.

    Chapter X of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
391 et seq.) is amended by adding at the end the following:

``SEC. 1015. FUND TO STRENGTHEN EFFORTS OF FDA TO COMBAT THE OPIOID AND 
              SUBSTANCE USE EPIDEMIC.

    ``(a) In General.--The Commissioner of Food and Drugs shall use any 
funds appropriated pursuant to the authorization of appropriations 
under subsection (c) to carry out the programs and activities described 
in subsection (d) to strengthen and facilitate the Food and Drug 
Administration's efforts to address the opioid and substance use 
epidemic. Such funds shall be in addition to any funds which are 
otherwise available to carry out such programs and activities.
    ``(b) FDA Opioid and Substance Use Epidemic Response Fund.--
            ``(1) Establishment of fund.--There is established in the 
        Treasury a fund, to be known as the FDA Opioid and Substance 
        Use Epidemic Response Fund (referred to in this subsection as 
        the `Fund'), for purposes of funding the programs and 
        activities described in subsection (d).
            ``(2) Transfer.--For the period of fiscal years 2019 
        through 2023, $110,000,000 shall be transferred to the Fund 
        from the general fund of the Treasury.
            ``(3) Amounts deposited.--Any amounts transferred under 
        paragraph (2) shall remain unavailable in the Fund until such 
        amounts are appropriated pursuant to subsection (c).
    ``(c) Appropriations.--
            ``(1) Authorization of appropriations.--For the period of 
        fiscal years 2019 through 2023, there is authorized to be 
        appropriated from the Fund to the Food and Drug Administration, 
        for the purpose of carrying out the programs and activities 
        described in subsection (d), an amount not to exceed the total 
        amount transferred to the Fund under subsection (b)(2). 
        Notwithstanding subsection (g), such funds shall remain 
        available until expended.
            ``(2) Offsetting future appropriations.--For any of fiscal 
        years 2019 through 2023, for any discretionary appropriation 
        out of the Fund to the Food and Drug Administration pursuant to 
        the authorization of appropriations under paragraph (1) for the 
        purpose of carrying out the programs and activities described 
        in subsection (d), the total amount of such appropriations for 
        the applicable fiscal year (not to exceed the total amount 
        remaining in the Fund) shall be subtracted from the estimate of 
        discretionary budget authority and the resulting outlays for 
        any estimate under the Congressional Budget and Impoundment 
        Control Act of 1974 or the Balanced Budget and Emergency 
        Deficit Control Act of 1985, and the amount transferred to the 
        Fund shall be reduced by the same amount.
    ``(d) Food and Drug Administration.--The entirety of the funds made 
available pursuant to subsection (c)(1) shall be for the Commissioner 
of Food and Drugs, pursuant to applicable authorities in the Public 
Health Service Act (42 U.S.C. 201 et seq.) or this Act and other 
applicable Federal law, to support widespread innovation in non-opioid 
and non-addictive medical products for pain treatment, access to opioid 
addiction treatments, appropriate use of approved opioids, and efforts 
to reduce illicit importation of opioids. Such support may include the 
following programs and activities:
            ``(1) Obligating contract funds beginning in fiscal year 
        2019 for an educational campaign that will--
                    ``(A) educate patients and their families to 
                differentiate opioid medications;
                    ``(B) raise awareness about preferred storage and 
                disposal methods; and
                    ``(C) inform patients, families, and communities 
                about medication-assisted treatment options.
            ``(2) Building the Food and Drug Administration's presence 
        in international mail facilities, including through--
                    ``(A) improvements in equipment and information 
                technology enhancements to identify unapproved, 
                counterfeit, or other unlawful pharmaceuticals for 
                destruction;
                    ``(B) increased and improved surveillance;
                    ``(C) renovations at international mail facility 
                locations; and
                    ``(D) the purchase of laboratory equipment.
            ``(3) Enhancing the identification and targeting of 
        entities offering products and products being offered by such 
        entities for import into the United States through review and 
        analysis of Internet websites, import data, and other sources 
        of intelligence for purposes of making the best use of the Food 
        and Drug Administration's inspection and analytical resources.
            ``(4) Increasing the number of staff of the Food and Drug 
        Administration to increase the number of packages being 
        examined, ensuring the safety of the staff undertaking such 
        examinations, and ensuring that packages identified as illegal, 
        counterfeit, misbranded, or adulterated are removed from 
        commerce through available authorities, including 
        administrative destruction.
            ``(5) Enhancing the Food and Drug Administration's criminal 
        investigations resources (including full-time equivalent 
        employees and equipment), imports surveillance, and 
        international work.
            ``(6) Obtaining for the Food and Drug Administration 
        equipment and full-time equivalent employees needed to 
        efficiently screen and analyze products offered for import, 
        including by building data libraries of new substances and 
        analogues to facilitate identification and evaluation of 
        pharmaceutical-based agents and by purchasing screening 
        technologies for use at international mail facilities.
            ``(7) Operating the Food and Drug Administration's forensic 
        laboratory facility to ensure adequate laboratory space and 
        functionality for additional work and full-time equivalent 
        employees.
    ``(e) Accountability and Oversight.--
            ``(1) Work plan.--
                    ``(A) In general.--Not later than 180 days after 
                the date of enactment of this Act, the Commissioner of 
                Food and Drugs shall submit to the Committee on Health, 
                Education, Labor and Pensions of the Senate and the 
                Committee on Energy and Commerce of the House of 
                Representatives, a work plan including the proposed 
                allocation of funds appropriated pursuant to the 
                authorization of appropriations under subsection (c) 
                for each of fiscal years 2019 through 2023 and the 
                contents described in subparagraph (B).
                    ``(B) Contents.--The work plan submitted under 
                subparagraph (A) shall include--
                            ``(i) the amount of money to be obligated 
                        or expended out of the Fund in each fiscal year 
                        for each program and activity described in 
                        subsection (d); and
                            ``(ii) a description and justification of 
                        each such program and activity.
            ``(2) Reports.--
                    ``(A) Annual reports.--Not later than October 1 of 
                each of fiscal years 2020 through 2024, the Secretary 
                of Health and Human Services shall submit to the 
                Committee on Health, Education, Labor and Pensions of 
                the Senate and the Committee on Energy and Commerce of 
                the House of Representatives a report that includes--
                            ``(i) the amount of money obligated or 
                        expended out of the Fund in the prior fiscal 
                        year for each program and activity described in 
                        subsection (d);
                            ``(ii) a description of all programs and 
                        activities using funds provided pursuant to the 
                        authorization of appropriations under 
                        subsection (c); and
                            ``(iii) how the programs and activities are 
                        advancing public health.
                    ``(B) Additional reports.--At the request of the 
                Committee on Health, Education, Labor and Pensions of 
                the Senate or the Committee on Energy and Commerce of 
                the House of Representatives, the Commissioner shall 
                provide an update in the form of testimony and any 
                additional reports to the respective congressional 
                committee regarding the allocation of funding under 
                this section or the description of the programs and 
                activities undertaken with such funding.
    ``(f) Limitations.--Notwithstanding any transfer authority 
authorized by this section or any appropriations Act, any funds made 
available pursuant to the authorization of appropriations under 
subsection (c) may not be used for any purpose other than the programs 
and activities described in subsection (d) to strengthen and facilitate 
the Food and Drug Administration's efforts to address the opioid and 
substance use epidemic.
    ``(g) Sunset.--This section shall expire on September 30, 2022, 
except that--
            ``(1) this subsection does not apply to reporting under 
        subsection (e)(2); and
            ``(2) this section shall remain in effect until such time, 
        and to such extent, as may be necessary for the funds 
        transferred by subsection (b)(2) to be fully expended.''.

SEC. 6. CONSIDERATION OF POTENTIAL FOR MISUSE AND ABUSE REQUIRED FOR 
              DRUG APPROVAL.

    (a) In General.--Section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) is amended--
            (1) in the first sentence--
                    (A) by striking ``or (7)'' and inserting ``(7)''; 
                and
                    (B) by inserting ``or (8) if the drug is or 
                contains a controlled substance for which a listing in 
                any schedule is in effect under the Controlled 
                Substances Act or that is permanently scheduled 
                pursuant to section 201 of such Act, on the basis of 
                information submitted to him as part of the 
                application, or upon the basis of any other information 
                before him with respect to such drug, the drug is 
                unsafe for use due to the risks of abuse or misuse or 
                there is insufficient information to show that the drug 
                is safe for use considering such risks;'' before ``he 
                shall issue an order refusing to approve the 
                application''; and
            (2) in the second sentence, by striking ``(6)'' and 
        inserting ``(8)''. 
    (b) Withdrawal Authority.--Section 505(e) of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 355(e)) is amended in the first 
sentence--
            (1) by striking ``or (5)'' and inserting ``(5)''; and
            (2) by inserting the following: ``; or (6) that, in the 
        case of a drug that is or contains a controlled substance for 
        which a listing in any schedule is in effect under the 
        Controlled Substances Act or that is permanently scheduled 
        pursuant to section 201 of such Act, on the basis of new 
        information before him with respect to such drug, evaluated 
        together with the information available to him when the 
        application was approved, that the drug is unsafe for use due 
        to the risks of abuse or misuse'' after ``of a material fact''.
    (c) Rule of Construction.--Nothing in the amendments made by this 
section shall be construed to limit or narrow, in any manner, the 
meaning or application of the provisions of paragraphs (1), (2), (3), 
(4), (5), and (7) of section 505(d) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 355(d)) or paragraphs (1) and (2) of section 
505(e) of such Act (21 U.S.C. 355(e)). 

            Passed the House of Representatives June 12, 2018.

            Attest:

                                                                 Clerk.
115th CONGRESS

  2d Session

                               H. R. 5228

_______________________________________________________________________

                                 AN ACT

 To strengthen the authorities of the Food and Drug Administration to 
 address counterfeit drugs, illegal and synthetic opioids, and opioid-
                like substances, and for other purposes.
```