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Bill
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H.R. 5228 — what changed

Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now Act

From Introduced in House to Engrossed in House. 5 sections amended and 1 removed between Introduced in House and Engrossed in House.

Sec. 2 Detention, refusal, and destruction of drugs offered for importation

(a)
changed Certain imported products deemed To be drugs—Increasing the maximum dollar amount of drugs subject to destruction— Section 201(g) The sixth sentence in section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321(g)) 381(a)) is amended by adding striking “except that the Secretary” and all that follows through the two periods at the end and inserting “except that the following: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)
added 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”.

removed “(3) An article being imported or offered for import is deemed to be a drug if it—

removed “(A) is or contains an active ingredient that is contained within—

removed “(i) a drug for which an approval is in effect under section 505 of this Act; or

removed “(ii) biological product for which a license is in effect under section 351 of the Public Health Service Act;

removed “(B) is or contains an active ingredient that is contained within a drug or biological product for which an investigational use exemption is in effect under section 505(i) of this Act or section 351(a) of the Public Health Service Act, for which substantial clinical investigations have been instituted, and for which the existence of such investigations has been made public; or

removed “(C) is a chemical analog of a drug or biological product described in clause (A) or (B).”

(b)
removed Articles of concern—
(1)
removed Delivery by Treasury to HHS— The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking “and cosmetics” and inserting “cosmetics, and potential articles of concern (as defined in subsection (t)), and controlled substances described paragraph (6) in the third sentence of this subsection”.
(2)
removed Repeal of antiquated review process—
(A)
removed Repeal— The second sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is repealed.
(B)
removed Technical change to keep numbering of sentences the same— The first sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended by striking “the owner or consignee, who may appear” and inserting “the owner or consignee. The owner or consignee may appear”.
(3)
removed Refused admission—
(A)
removed In general— The third sentence of section 801(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381(a)) is amended—
(i)
removed by striking “If it appears from the examination” and inserting “Subject to subsection (b), if it appears from the examination”; and
(ii)
removed by striking “then such article shall be refused admission, except as provided in subsection (b) of this section” and inserting “or (5) such article is an article of concern (as defined in subsection (t)), or (6) such article is a controlled substance (as defined in section 102 of the Controlled Substances Act) for which a listing in any schedule is in effect (on a temporary or permanent basis) under section 201 of the Controlled Substances Act, or (7) such article is being imported or offered for import in violation of section 301(cc), then such article may be refused admission, and if it appears such article may not be imported into the United States pursuant to subsection (d) or it appears that the article is a counterfeit drug, then such article shall be refused admission”.
(B)
removed Definition of article of concern— Section 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 381) is amended by adding at the end the following:

removed “(t) Article of concern defined—For purposes of subsection (a), the term article of concern means an article that is or contains a drug or other substance—

removed “(1) for which, during the 24-month period prior to the article being imported or offered for import, the Secretary of Health and Human Services—

removed “(A) has requested that, based on a determination that the drug or other substance appears to meet the requirements for temporary or permanent scheduling pursuant to section 201 of the Controlled Substances Act, the Attorney General initiate the process to control the drug or other substance in accordance with such Act; or

removed “(B) has made a determination, following the publication by the Attorney General of a notice in the Federal Register of the intention to issue an order temporarily or permanently scheduling such drug or substance in schedule I of section 202 of the Controlled Substances Act, that such article presents an imminent risk to the public health; and

removed “(2) with respect to which the Attorney General has not—

removed “(A) scheduled the drug or other substance under section 201 of such Act; or

removed “(B) notified the Secretary of Health and Human Services that the Attorney General has made a determination not to schedule the drug or other substance under such section.”

(c)
removed 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 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) and was not brought into compliance as described under subsection (b).”.
(d)
removed 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 (c), 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)
renumbered was (6) 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)
renumbered was (6)(3) by striking “a drug” each place it appears and inserting “an article”; and
(2)
renumbered was (6)(4) by striking “the drug” each place it appears and inserting “the article”.
(d)
renumbered was (7) 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:

“569D. Notification, Nondistribution, And Recall Of Adulterated Or Misbranded Drugs

changed “(a) Order To cease distributiondistribution and recall

changed “(1) In general—If the Secretary has reason to believe general—Upon a determination that the use or consumption of, or exposure to, a drug may cause serious adverse health consequences present an imminent or death substantial hazard to humans, the public health, the Secretary may shall issue an order requiring any person who distributes such the drug to immediately cease distribution of such the drug.

changed “(2) Action following order—Any person who is subject to an Hearing—An order under paragraph (1) shall immediately cease distribution of such drug and provide notification as required by such order, and may appeal to the Secretary within 24 hours of person subject to the issuance of such order. Such appeal may include a request order with an opportunity for an informal hearing and a description of any efforts hearing, to recall such drug undertaken voluntarily by the person, including after a request under subsection (b). Except as provided in subsection (c), an informal hearing shall be held as soon as practicable, but not later than 5 calendar days, or less as determined by the Secretary, 10 days after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether the order should be amended to require a recall date of such drug. If, after providing an opportunity for such a hearing, the Secretary determines that inadequate grounds exist to support the actions required by issuance of the order, the Secretary shall vacate the order.on—

changed “(b) Emergency recall order“(A) the actions required by the order; and

changed “(1) In general—If “(B) whether the Secretary has credible evidence or information that a drug subject to an order under subsection (a) presents an imminent threat of serious adverse health consequences or death should be amended to humans, require a recall of the Secretary may issue an order requiring any person who distributes such drug—drug.

changed “(A) “(3) Inadequate grounds—If, after providing an opportunity for a hearing under paragraph (2), the Secretary determines that inadequate grounds exist to immediately recall such drug; andsupport the actions required by the order, the Secretary shall vacate the order.

changed “(B) “(4) Amendment to provide order to require recall—If, after providing an opportunity for notice, including an informal hearing under paragraph (2), the Secretary determines that the order should be amended to individuals as appropriate, include a recall of the drug with respect to persons who may be affected by which the recall.order was issued, the Secretary shall—

changed “(2) Action following order—Any person who is subject to an emergency recall order under this subsection shall immediately recall such drug and provide notification as required by such order, and may appeal to the Secretary within 24 hours after issuance of such order. The person subject to an emergency recall order shall conduct the recall notwithstanding the pendency of any such appeal. An informal hearing shall be held as soon as practicable but not later than 5 calendar days, or less as determined by the Secretary, after such an appeal is filed, unless the parties jointly agree to an extension. After affording an opportunity for an informal hearing, the Secretary shall determine whether “(A) amend the order should be amended pursuant to subsection (d)(1). If, after providing an opportunity for such require a hearing, the Secretary determines that inadequate grounds exist to support the actions required by the order, the Secretary shall vacate the order.recall; and

changed “(c) Notice to consumers and health officials—The Secretary shall, as “(B) after consultation with the Secretary determines to be necessary, provide notice of drug sponsor, specify a timetable in which the recall order under this section to—will occur.

added “(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.

added “(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.

added “(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.

removed “(d) Order To recall

removed “(1) Amendment—Except as provided under subsection (e), if after providing an opportunity for an informal hearing under subsection (a) or (b), the Secretary determines that an order issued under subsection (a) or (b) should be amended to include a recall of the drug with respect to which the order was issued, the Secretary shall amend the order to require a recall.

removed “(2) Contents—An amended order under paragraph (1) shall—

changed “(A) specify a timetable in which the recall will occur;“(c) Order To recall

changed “(B) require periodic reports “(1) Contents—An order to the Secretary describing the progress of the recall; andrecall a drug under subsection (a) shall—

changed “(C) provide for notice, including to individuals as appropriate, “(A) require periodic reports to persons who may be affected by the recall.Secretary describing the progress of the recall; and

changed “(3) Assistance allowed—In providing for notice under paragraph (2)(C), the Secretary may allow “(B) provide for the assistance of health professionals, State or local officials, or other notice, including to individuals designated as appropriate, to persons who may be affected by the Secretary.recall.

changed “(4) Nondelegation—An amended order “(2) Assistance allowed—In providing for notice under this subsection shall be ordered by paragraph (1)(B), the Secretary or an official designated by the Secretary. An official may not be so designated under this section unless the official is allow for the director assistance of the district in which the drug involved is located, health professionals, State or is an official senior to such director.local officials, or other individuals designated by the Secretary.

changed “(e) Savings clause—Nothing contained in “(3) Nondelegation—An order under this section shall be construed as limiting—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.

added “(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)
changed 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), as amended by section 2(b)(C), 381) is further amended by inserting “or (8) (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

changed Section 304(b) 801 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 334(b)) is amended by striking the first sentence and inserting the following: “The article, equipment, or other thing proceeded against shall be liable to seizure by process pursuant to the libel, and the procedure in cases under this section shall conform, as nearly as may be, to the procedure in admiralty rather than the procedure used for civil asset forfeiture proceedings set forth in section 983 of title 18, United States Code. On demand of either party any issue of fact joined in any such a case brought under this section shall be tried by jury. A seizure brought under this section is not governed by Rule G of the Supplemental Rules of Admiralty or Maritime Claims and Asset Forfeiture Actions. Exigent circumstances shall be deemed to exist for all seizures brought under this section, and in such cases, the summons and arrest warrant shall be issued by adding at the clerk of end the court without court review. ”.following:

added “(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

changed Section 801 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:

changed “(u) Single source pattern of shipments of adulterated or misbranded drugs—If the Secretary identifies a pattern “1015. Fund to strengthen efforts of adulterated or misbranded drugs being offered for import from the same manufacturer, distributor, or importer, the Secretary may by order choose FDA to treat all drugs being offered for import from such manufacturer, distributor, or importer as adulterated or misbranded unless otherwise demonstrated.”combat the opioid and substance use epidemic

added “(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.

added “(b) FDA Opioid and Substance Use Epidemic Response Fund

added “(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).

added “(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.

added “(3) Amounts deposited—Any amounts transferred under paragraph (2) shall remain unavailable in the Fund until such amounts are appropriated pursuant to subsection (c).

added “(c) Appropriations

added “(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.

added “(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.

added “(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:

added “(1) Obligating contract funds beginning in fiscal year 2019 for an educational campaign that will—

added “(A) educate patients and their families to differentiate opioid medications;

added “(B) raise awareness about preferred storage and disposal methods; and

added “(C) inform patients, families, and communities about medication-assisted treatment options.

added “(2) Building the Food and Drug Administration’s presence in international mail facilities, including through—

added “(A) improvements in equipment and information technology enhancements to identify unapproved, counterfeit, or other unlawful pharmaceuticals for destruction;

added “(B) increased and improved surveillance;

added “(C) renovations at international mail facility locations; and

added “(D) the purchase of laboratory equipment.

added “(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.

added “(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.

added “(5) Enhancing the Food and Drug Administration’s criminal investigations resources (including full-time equivalent employees and equipment), imports surveillance, and international work.

added “(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.

added “(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.

added “(e) Accountability and oversight

added “(1) Work plan

added “(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).

added “(B) Contents—The work plan submitted under subparagraph (A) shall include—

added “(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

added “(ii) a description and justification of each such program and activity.

added “(2) Reports

added “(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—

added “(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);

added “(ii) a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection (c); and

added “(iii) how the programs and activities are advancing public health.

added “(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.

added “(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.

added “(g) Sunset—This section shall expire on September 30, 2022, except that—

added “(1) this subsection does not apply to reporting under subsection (e)(2); and

added “(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)
changed Prohibited Act—In general— Section 301(cc) 505(d) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(cc)) 355(d)) is amended to read as follows:amended—
(1)
added in the first sentence—
(A)
added by striking “or (7)” and inserting “(7)”; and
(B)
added 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)
added in the second sentence, by striking “(6)” and inserting “(8)”.

removed “(cc) The importing or offering for import into the United States of an article by, with the assistance of, or at the direction of, a person debarred from such activity under section 306(b)(3).”

(b)
changed Debarment—Withdrawal authority— Section 306(b) 505(e) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 335a(b)) 355(e)) is amended—amended in the first sentence—
(1)
changed in paragraph (1)—by striking “or (5)” and inserting “(5)”; and
(A)
removed in the matter preceding subparagraph (A), by striking “paragraph (2)” and inserting “paragraph (2) or (3)”;
(B)
removed in subparagraph (B), by striking “or” at the end;
(C)
removed in subparagraph (C), by striking the period at the end and inserting “, or”; and
(D)
removed by adding at the end the following:

removed “(D) a person from importing or offering to import into the United States—

removed “(i) a controlled substance as defined in section 102(6) of the Controlled Substances Act; or

removed “(ii) any article that is regulated by the Food and Drug Administration that is valued at $2500 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).”

(2)
changed by striking paragraph (3) and inserting the following: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)
added 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)).

removed “(3) Persons subject to permissive debarment; importation

removed “(A) Food—A person is subject to debarment under paragraph (1)(C) if—

removed “(i) the person has been convicted of a felony for conduct relating to the importation into the United States of any food; or

removed “(ii) the person has engaged in a pattern of importing or offering for import adulterated food that presents a threat of serious adverse health consequences or death to humans or animals.

removed “(B) Importation of drugs—A person is subject to debarment under paragraph (1)(D) if—

removed “(i) the person has been convicted of a felony for conduct relating to the importation into the United States of any drug or controlled substance (as defined in section 102 of the Controlled Substances Act); or

removed “(ii) the person has engaged in a pattern of importing or offering for import drugs that are—

removed “(I) adulterated, misbranded, or in violation of section 505; or

removed “(II) controlled substances whose importation is prohibited pursuant to section 401(m) of the Tariff Act of 1930.”

Sec. 7 Account to strengthen efforts of FDA to combat the opioid and substance use epidemic

removed
(a)
removed In general— The Commissioner of Food and Drugs (referred to in this section as the “Commissioner”) 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)
removed FDA Opioid and Substance Use Epidemic Response Fund—
(1)
removed Establishment of fund— There is established in the Treasury an account, 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)
removed 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)
removed Amounts deposited— Any amounts transferred under paragraph (2) shall remain unavailable in the Fund until such amounts are appropriated pursuant to subsection (c).
(c)
removed Appropriations—
(1)
removed Authorization of appropriations— For the period of fiscal years 2019 through 2023, there is authorized to be appropriated from the Account 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 Account under subsection (b)(2). Notwithstanding subsection (g), such funds shall remain available until expended.
(2)
removed Offsetting future appropriations— For any of fiscal years 2019 through 2023, for any discretionary appropriation out of the Account 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 Account) 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 Account shall be reduced by the same amount.
(d)
removed 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 the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and other applicable 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)
removed Obligating contract funds beginning in fiscal year 2019 for an educational campaign that will—
(A)
removed educate patients and their families to differentiate opioid medications;
(B)
removed raise awareness about preferred storage and disposal methods; and
(C)
removed inform patients, families, and communities about medication-assisted treatment options.
(2)
removed Building the Food and Drug Administration’s presence in international mail facilities, including through—
(A)
removed improvements in equipment and information technology enhancements to identify unapproved, counterfeit, or other unlawful phar­ma­ceu­ti­cals for destruction;
(B)
removed increased and improved surveillance;
(C)
removed renovations at international mail facility locations; and
(D)
removed the purchase of laboratory equipment.
(3)
removed Enhancing the identification and targeting of firms and products being offered for import into the United States through review and analysis of websites, imports data, and other sources of intelligence thereby making best use of the Food and Drug Administration’s inspectional and analytical resources.
(4)
removed Increasing the number of staff to increase the number of packages being examined, ensuring the safety of the staff undertaking this work, and ensuring that packages identified as illegal, counterfeit, misbranded, or adulterated are removed from commerce through available authorities, including administrative destruction.
(5)
removed Enhancing criminal investigations resources (including full-time equivalent employees and equipment), imports surveillance, and international work.
(6)
removed Obtaining 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)
removed 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)
removed Accountability and oversight—
(1)
removed Work plan—
(A)
removed 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)
removed Contents— The work plan submitted under subparagraph (A) shall include—
(i)
removed the amount of money to be obligated or expended out of the Account in each fiscal year for each program and activity described in subsection (d); and
(ii)
removed a description and justification of each such program and activity.
(2)
removed Reports—
(A)
removed 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 including—
(i)
removed the amount of money obligated or expended out of the Account in the prior fiscal year for each program and activity described in subsection (d);
(ii)
removed a description of all programs and activities using funds provided pursuant to the authorization of appropriations under subsection (c); and
(iii)
removed how the programs and activities are advancing public health.
(B)
removed 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)
removed Limitations— Notwithstanding any transfer authority authorized by this Act 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) strengthen and facilitate the Food and Drug Administration’s efforts to address the opioid and substance use epidemic.
(g)
removed Sunset— This section shall expire on September 30, 2022, except that—
(1)
removed this subsection does not apply to reporting under subsection (e)(2); and
(2)
removed 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.