[Congressional Bills 116th Congress]
[From the U.S. Government Publishing Office]
[H.R. 6660 Introduced in House (IH)]

<DOC>






116th CONGRESS
  2d Session
                                H. R. 6660

   To amend the Federal Food, Drug, and Cosmetic Act to require the 
holders of approved applications for drugs to conduct a risk assessment 
   to identify and evaluate risks to their supply chain and develop, 
 maintain, and implement risk mitigation plans to address such risks, 
                        and for other purposes.


_______________________________________________________________________


                    IN THE HOUSE OF REPRESENTATIVES

                              May 1, 2020

Ms. Blunt Rochester (for herself and Mr. Carter of Georgia) introduced 
 the following bill; which was referred to the Committee on Energy and 
                                Commerce

_______________________________________________________________________

                                 A BILL


 
   To amend the Federal Food, Drug, and Cosmetic Act to require the 
holders of approved applications for drugs to conduct a risk assessment 
   to identify and evaluate risks to their supply chain and develop, 
 maintain, and implement risk mitigation plans to address such risks, 
                        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.

    This Act may be cited as the ``Limit Ongoing Shortages and 
Stabilize Supply Act of 2020'' or the ``LOSS Act of 2020''.

SEC. 2. RISK ASSESSMENTS AND RISK MITIGATION PLANS FOR DRUGS.

    (a) In General.--The Federal Food, Drug, and Cosmetic Act is 
amended by inserting after section 506C-1 of such Act (21 U.S.C. 356c-
1) the following new section:

``SEC. 506C-2. RISK ASSESSMENTS AND RISK MITIGATION PLANS FOR DRUGS.

    ``(a) Covered Drug Defined.--In this section, the term `covered 
drug'--
            ``(1) means a drug that--
                    ``(A) is described in section 506C(a); or
                    ``(B) is included, or was included at any point 
                during the preceding 5 years, in the drug shortage list 
                in effect under section 506E; and
            ``(2) includes any such drug that is not required to be 
        approved pursuant to an application under subsection (b) or (j) 
        of section 505 of this Act or subsection (a) or (k) of section 
        351 of the Public Health Service Act to be lawfully marketed.
    ``(b) Requirement.--The manufacturer of a covered drug shall--
            ``(1) conduct a risk assessment that identifies and 
        evaluates risks to the supply of the drug, including 
        vulnerabilities that would likely lead to a meaningful 
        disruption in the supply of the drug in the United States;
            ``(2) develop and maintain a risk mitigation plan to ensure 
        the supply of the drug during such a shortage; and
            ``(3) implement such plan during such a shortage.
    ``(c) Confidentiality.--The Secretary shall--
            ``(1) maintain the confidentiality of any risk assessment, 
        and any risk mitigation plan, under this section; and
            ``(2) limit the use by the Secretary of information in such 
        an assessment or plan to preventing, mitigating, or responding 
        to a drug shortage.
    ``(d) Guidance.--The Secretary shall publish guidance on--
            ``(1) how manufacturers should work with their supply chain 
        partners in developing the required risk assessments and risk 
        mitigation plans;
            ``(2) the elements of a risk mitigation plan under this 
        section; and
            ``(3) the form and manner of developing and maintaining 
        such plan.
    ``(e) Inspection.--A risk mitigation plan under this section shall 
be subject to inspection and copying by the Secretary under section 
704.
    ``(f) Expedited Inspections and Reviews.--The Secretary may conduct 
an expedited inspection or review as described in section 506C(g) for 
the purpose of facilitating the implementation of a risk management 
plan developed pursuant to this section.''.
    (b) Prohibited Act.--Section 301 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 331) is amended by adding at the end the 
following:
    ``(fff) The failure to conduct a risk assessment, or to develop, 
maintain, and implement a risk mitigation plan, in accordance with 
section 506C-2.''.
    (c) Applicability.--The amendments made by this section apply 
beginning on the date that is 24 months after the date of enactment of 
this Act, except that the Secretary of Health and Human Services, 
acting through the Commissioner of Food and Drugs, shall have 
discretion to allow persons subject to such amendments additional time 
to comply with such amendments as the Secretary determines necessary.

SEC. 3. DISCONTINUANCE OR INTERRUPTION IN PRODUCTION.

    (a) Active Pharmaceutical Ingredients.--
            (1) Active pharmaceutical ingredients.--Section 506C of the 
        Federal Food, Drug, and Cosmetic Act (21 U.S.C. 356c) is 
        amended by adding at the end the following:
    ``(j) Applicability With Respect to Active Pharmaceutical 
Ingredients.--This section shall apply with respect to an active 
pharmaceutical ingredient in a drug described in subsection (a) in the 
same manner and to the same extent as this section applies with respect 
to a drug described in subsection (a), except that subsection (i) shall 
not apply with respect to active pharmaceutical ingredients.''.
            (2) Guidance.--
                    (A) Issuance.--Not later than 24 months after the 
                date of enactment of this Act, the Secretary of Health 
                and Human Services, acting through the Commissioner of 
                Food and Drugs, shall issue final guidance on 
                implementing the amendment made by paragraph (1).
                    (B) Contents.--The guidance required by 
                subparagraph (A) shall specify--
                            (i) the form and manner of the disclosures 
                        required by the amendment made by paragraph 
                        (1); and
                            (ii) the details that need to be included 
                        in such disclosures.
    (b) Prohibited Acts With Respect to Drugs and Active Pharmaceutical 
Ingredients.--Section 301 of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 331), as amended by section 2(b), is further amended by 
adding at the end the following:
    ``(ggg) The failure of a manufacturer of a drug described in 
section 506C(a) or an active pharmaceutical ingredient of such a drug, 
without a reasonable basis as determined by the Secretary, to notify 
the Secretary of a permanent discontinuance or an interruption, and the 
reasons for such discontinuance or interruption, as required by section 
506C.''.
    (c) Applicability.--The amendments made by subsections (a) and (b) 
apply beginning on the date that is 180 days after the date of 
enactment of this Act.
                                 <all>