Promoting Readiness and Ensuring Proper Active pharmaceutical ingredient Reserves of Essential medicines Act of 2021 or the PREPARE Act of 2021
This bill establishes the Strategic Active Pharmaceutical Ingredient Reserve.
The Department of Health and Human Services (HHS) must annually publish a public list of essential generic medicines that are medically necessary to have available at all times.
HHS must report and implement a plan to establish the reserve, which must be designed to minimize the impact of an interruption or reduction in imports of (1) key starting materials (including active pharmaceutical ingredients) for essential generic medicines, and (2) finished dosage forms of essential generic medicines for which key starting materials are not imported. The plan must also contain provisions to strengthen domestic capacity for active pharmaceutical ingredient production, storage, and conversion.
Within one year of this bill's enactment, the plan must include at least 25 of the essential generic medicines on the required list. The plan must add at least 25 medicines each year until the full list is covered.
HHS must prioritize domestically manufactured key starting materials for the reserve to the maximum extent possible.
A manufacturer of an essential generic medicine that switches to an active pharmaceutical ingredient sourced through the reserve shall not have to update the approved application for that medicine.
The Government Accountability Office must report to Congress on active pharmaceutical ingredient manufacturing, including the time and costs needed to develop domestic manufacturing capabilities.
[Congressional Bills 117th Congress]
[From the U.S. Government Publishing Office]
[H.R. 5388 Introduced in House (IH)]
<DOC>
117th CONGRESS
1st Session
H. R. 5388
To establish a strategic active pharmaceutical ingredient reserve to
maintain a domestic supply of active pharmaceutical ingredients and key
starting materials needed for the manufacturing of essential generic
medicines, and to build a pipeline for domestic active pharmaceutical
ingredient production.
_______________________________________________________________________
IN THE HOUSE OF REPRESENTATIVES
September 27, 2021
Ms. Spanberger (for herself and Mr. McKinley) introduced the following
bill; which was referred to the Committee on Energy and Commerce
_______________________________________________________________________
A BILL
To establish a strategic active pharmaceutical ingredient reserve to
maintain a domestic supply of active pharmaceutical ingredients and key
starting materials needed for the manufacturing of essential generic
medicines, and to build a pipeline for domestic active pharmaceutical
ingredient production.
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 ``Promoting Readiness and Ensuring
Proper Active Pharmaceutical Ingredient Reserves of Essential Medicines
Act of 2021'' or the ``PREPARE ACT of 2021''.
SEC. 2. LISTING OF ESSENTIAL GENERIC MEDICINES.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.) is amended by inserting after section 319M the following:
``SEC. 319N. LISTING OF ESSENTIAL GENERIC MEDICINES.
``(a) In General.--The Secretary, in consultation with the
Commissioner of Food and Drugs, the Assistant Secretary for
Preparedness and Response, the Secretary of Defense, Secretary of
Homeland Security, and other heads of agencies, as appropriate, shall
establish and make public a list of essential generic medicines
determined, in accordance with subsection (b), to be medically
necessary to have available at all times.
``(b) Requirements.--
``(1) Initial list.--The initial list of essential generic
medicines under subsection (a) shall be the generic medicines
included on the list of essential medicines, medical
countermeasures, and critical inputs identified by the
Commissioner of Food and Drugs as published on October 30,
2020, in accordance with section 3(c) of Executive Order 13944.
``(c) Updates.--
``(1) Annual review.--Not less than once each year, the
Secretary, after consultation with the Commissioner of Food and
Drugs, the Assistant Secretary for Preparedness and Response,
the Secretary of Defense, Secretary of Homeland Security, and
other heads of agencies, as appropriate, shall review and
update the list of essential generic medicines required under
subsection (a).
``(2) Rationale.--In carrying out the annual review and
update under paragraph (1), the Secretary shall provide a
rationale for each essential generic medicine added to, or
removed from, the list under subsection (a).
``(3) Specific populations.--The Secretary shall consider
including on the list under subsection (a), and, where
appropriate, include on such list, essential generic medicines
that are essential to specific subpopulations, including
pediatric populations, in developing the list under such
subsection.
``(4) Threat assessments.--
``(A) In general.--The Secretary, after
consultation with the Public Health Emergency Medical
Countermeasures Enterprise established under section
2811-1, shall conduct regular threat assessments, and
take such assessments into consideration in updating
the list in accordance with paragraph (1).
``(B) Threat assessments considerations.--Each
threat assessment under this paragraph shall include
consideration of--
``(i) the lack of existing domestic
capacity of essential generic medicines;
``(ii) the concentration of current supply
of the essential generic medicine or active
pharmaceutical ingredients of the essential
generic medicine in one geographical region;
``(iii) whether there are less than 2
manufacturers of the essential generic medicine
or active pharmaceutical ingredients of the
essential generic medicine; and
``(iv) the potential for increased demand
in a public health emergency.
``(5) Director of the strategic active pharmaceutical
ingredients reserve.--The Secretary shall appoint a Director of
the Strategic Active Pharmaceutical Ingredients Reserve who has
experience in one or more of the following areas: supply chain
management, disaster response, pharmaceutical or active
pharmaceutical ingredient development, or logistics. Such
Director shall ensure a sufficient supply of the active
pharmaceutical ingredients and critical components necessary to
manufacture the essential generic medicines included on the
list under subsection (a) in an amount adequate to serve the
needs of patients living in the United States and in the
appropriate dosage forms.
``(d) Appeal Process.--The Secretary shall establish a process by
which stakeholders may appeal a determination by the Secretary not to
include an essential generic medicine on the list under subsection (a).
``(e) Definitions.--In this section:
``(1) Drug.--The term `drug' has the meaning given such
term in section 201(g) of the Federal Food, Drug, and Cosmetic
Act, and includes a biological product (as defined in section
351(i) of this Act). Such term includes prescription and
nonprescription drugs, or active pharmaceutical ingredients of
drugs.
``(2) Essential generic medicine.--The term `essential
generic medicine' means a drug for which a generic is approved,
that is medically necessary to have available at all times
because the drug is--
``(A) commonly used to prevent, mitigate, or treat
a common disease or condition, or used in a common
procedure;
``(B) an antibiotic or antifungal used to treat an
infectious diseases;
``(C) necessary to prevent or mitigate a public
health emergency; or
``(D) life-supporting, life-sustaining, or intended
for use in the prevention or treatment of a
debilitating disease or condition.''.
SEC. 3. ESTABLISHMENT OF THE STRATEGIC ACTIVE PHARMACEUTICAL INGREDIENT
RESERVE.
Part B of title III of the Public Health Service Act (42 U.S.C. 243
et seq.), as amended by section 2, is further amended by inserting
after section 319N the following:
``SEC. 319N-1. STRATEGIC ACTIVE PHARMACEUTICAL INGREDIENT RESERVE.
``(a) Strategic Active Pharmaceutical Ingredient Reserve Plan.--
``(1) In general.--Not later than 90 days after the date of
enactment of the Promoting Readiness and Ensuring Proper Active
Pharmaceutical Ingredient Reserves of Essential Medicines Act
of 2021, the Secretary, in consultation with the Assistant
Secretary for Preparedness and Response, the Director of the
Centers for Disease Control and Prevention, the Commissioner of
Food and Drugs, and the Director of the Biomedical Advanced
Research and Development Authority, shall prepare and submit to
Congress a Strategic Active Pharmaceutical Ingredient Reserve
Plan (referred to in this section as the `Plan') in accordance
with subsection (b), which shall be used by the Secretary in
establishing and maintaining the Strategic Active
Pharmaceutical Ingredient Reserve described in subsection (c).
``(2) Annual updates.--The Secretary shall update the plan
annually and, by not later than June 1 of each year, submit the
updated plan to the applicable committees of Congress.
``(3) National security considerations.--
``(A) Submissions.--The Secretary shall ensure that
any submission of the plan (including any update to the
plan) to the applicable committees of Congress is in a
manner that does not compromise national security.
``(B) Exemption from disclosure.--Information in
the plan that, in the judgment of the Secretary, would
reveal public health vulnerabilities shall be exempt
from disclosure under section 552(b)(3) of title 5,
United States Code.
``(b) Plan Requirements.--
``(1) In general.--The Plan required under subsection (a)
shall--
``(A) detail the design, construction, and filling
of the storage and related facilities comprising the
Strategic Active Pharmaceutical Ingredient Reserve
described in subsection (c) (referred to in this
section as the `Reserve');
``(B) detail the requirements for maintaining the
Reserve described in subsection (c), including--
``(i) storage and testing requirements,
consistent with parts 210 and 211 of title 21,
Code of Federal Regulations, or any successor
regulation; and
``(ii) any specific criteria agreed to by
the Secretary and the manufacturer of the
essential generic medicine using the active
pharmaceutical ingredient or key starting
material;
``(C) be designed to minimize the impact of any
interruption or reduction in imports of--
``(i) active pharmaceutical ingredients and
other key starting materials that the Secretary
determines are, or are likely to become,
dependent upon such imports for a substantial
portion of finished essential generic
medicines; and
``(ii) finished dosage forms of essential
generic medicines for which active
pharmaceutical ingredients and other key
starting materials are not imported;
``(D) include provisions to strengthen domestic
capacity for active pharmaceutical ingredient
production, storage, and conversion; and
``(E) outline plans and processes for coordinating
and consulting, as appropriate, with the Assistant
Secretary for Preparedness and Response regarding
relevant issues of interest pertaining to the
maintenance and stocking of the strategic national
stockpile.
``(2) Required components.--
``(A) In general.--The Plan shall include the
following:
``(i) Identification and prioritization of
the essential generic medicines included on the
most recent list under section 319N(a)--
``(I) that the Secretary determines
are essential for health care needs in
the United States; and
``(II) for which the Secretary
determines that there is the greatest
need to maintain a reserve of the
active pharmaceutical ingredients and
key starting materials for the
essential generic medicines--
``(aa) taking into account
factors including the extent to
which the United States is, or
is at risk of becoming,
dependent on foreign sources
for a substantial portion of
the domestic need; and
``(bb) giving special
consideration to the essential
generic medicines at risk of
supply interruption as a result
of the factors described in
section 319N(c)(4)(B).
``(ii) An evaluation of the utilization
levels of the essential generic medicines
identified under clause (i) to inform how much
of the active pharmaceutical ingredients of
such medicines is required to cover the
projected health care needs for one year of the
United States population.
``(iii) A comprehensive assessment of the
essential generic medicines identified under
clause (i), including the existing
manufacturing bases for each such medicine
(including identification and location of
ownership of such facilities) and whether the
active pharmaceutical ingredients of such
ingredients are manufactured domestically or
abroad, and whether finished dosage conversion
steps for such essential generic medicines are
performed domestically or abroad.
``(iv) The types of facilities, equipment,
and technology required to appropriately store,
track, test, and convert all forms of active
pharmaceutical ingredients that are critical
inputs of drugs that are essential generic
medicines, preliminary proposed locations for
such public and privately owned facilities in
multiple locations in the United States, the
capacity required of the facilities used, and
the estimated cost of acquisition and storage
of the active pharmaceutical ingredients and
management and operation of the facilities.
``(v) An evaluation of the impact that the
establishment and ongoing maintenance of the
Reserve may have, including on availability and
pricing of active pharmaceutical ingredients
and finished drug dosages.
``(vi) A distribution plan for the active
pharmaceutical ingredients held in the Reserve,
which shall include--
``(I) protocols for the method of
conversion of active pharmaceutical
ingredients into finished drugs,
including conversion of key starting
materials into active pharmaceutical
ingredients and distribution from the
Reserve into the strategic national
stockpile and other government and
commercial pharmaceutical distribution
networks; and
``(II) benchmarks for the Secretary
to initiate conversion of drug products
that are essential generic medicines
using the active pharmaceutical
ingredients stored in the Reserve for
transfer to the strategic national
stockpile or other government or
commercial pharmaceutical distribution
networks, based on changes in the
supply chain for the top essential
generic medicines or a determination by
the Secretary regarding a threat to
public health.
``(vii) A mechanism through which private
sector manufacturers of active pharmaceutical
ingredients or finished dosage forms may,
through contracts with existing Reserve
facilities, store and withdraw such ingredients
in the Reserve to enhance resilience and reduce
shortages and disruptions in the supply chain.
``(viii) A mechanism through which the
Federal Government may purchase, via
manufacturing partners, reserve capacity for
finished drug manufacturing to convert active
pharmaceutical ingredients into finished drugs
for essential generic medicines.
``(B) Number of drugs.--
``(i) In general.--Pursuant to subparagraph
(A)(i), the Secretary shall ensure that for the
first year after the date of enactment of the
Promoting Readiness and Ensuring Proper Active
Pharmaceutical Ingredient Reserves of Essential
Medicines Act of 2021, the Plan includes not
less than 25 essential generic medicines, and
that 25 additional essential generic medicines
are included in such Plan for each year
thereafter until the active pharmaceutical
ingredients necessary to support the full list
of essential generic medicines identified under
section 319N(a) are covered.
``(ii) Prioritization.--The Secretary shall
prioritize essential generic medicines needed
immediately in the event of an emergency.
``(3) Quantities of apis and key starting materials.--
``(A) In general.--To the maximum extent
practicable, the Plan should include a plan to ensure
that, for each essential generic medicine included in
the Plan, the active pharmaceutical ingredients used in
the production of such medicine that are stored in the
Reserve are available in the minimum quantities as
follows:
``(i) By the date that is 18 months after
the date of enactment of the Promoting
Readiness and Ensuring Proper Active
Pharmaceutical Ingredient Reserves of Essential
Medicines Act of 2021, not less than 10 percent
of the total amount of such ingredients needed
to produce sufficient quantities of the
essential generic medicines for the treatment
of individuals living in the United States.
``(ii) By the date that is 3 years after
such date of enactment, not less than 25
percent of the total amount of such ingredients
needed to produce sufficient quantities of the
essential generic medicines for the treatment
of individuals living in the United States.
``(iii) By the date that is 5 years after
such date of enactment, not less than 50
percent of the total amount of such ingredients
needed to produce sufficient quantities of the
essential generic medicines for the treatment
of individuals living in the United States.
``(iv) By the date that is 10 years after
such date of enactment, not less than 90
percent of the total amount of such ingredients
needed to produce sufficient quantities of the
essential generic medicines for the treatment
of individuals living in the United States.
``(B) Calculation of quantity of api.--In
calculating the quantities of active pharmaceutical
ingredients needed for purposes of subparagraph (A),
the Secretary shall determine the quantity of each
essential generic medicine required to cover the
projected health care needs, over a 1-year period, of
people living in the United States, based on average
annual demand during the 3-year period preceding the
date of enactment of the Promoting Readiness and
Ensuring Proper Active Pharmaceutical Ingredient
Reserves of Essential Medicines Act of 2021.
``(c) Administering the Strategic Active Pharmaceutical Ingredient
Reserve.--
``(1) In general.--With respect to each active
pharmaceutical ingredient and key starting material that is
included in the Plan, the Secretary shall place in storage,
transport, track, and exchange quantities of the substance that
are--
``(A) produced in conformance with all quality
requirements under this Act and the Federal Food, Drug,
and Cosmetic Act, including the associated regulations
of such Acts;
``(B) stored in compliance with--
``(i) the requirements of parts 210 and 211
of title 21, Code of Federal Regulations, or
any successor regulation; and
``(C) any specific criteria agreed to by the
Secretary and the manufacturer of the essential generic
medicine using the active pharmaceutical ingredient or
key starting material.
``(2) Requirements.--To the greatest extent practicable, in
carrying out paragraph (1), the Secretary shall acquire active
pharmaceutical ingredients and key starting materials in a
manner that minimizes cost, minimizes vulnerability of the
United States to severe shortages or disruptions for essential
generic medicines, minimizes the impact of acquisition of such
ingredients and materials to the marketplace, gives preference
to domestic manufacturers, and encourages competition in the
marketplace.
``(3) Drawdown of the reserve.--
``(A) In general.--The Secretary may distribute
active pharmaceutical ingredients and key starting
materials in the Reserve in order to initiate
conversion of active pharmaceutical ingredients and
finished dosage form, in accordance with the Plan
developed under subsection (b).
``(B) Deviations from plan.--In distributing active
pharmaceutical ingredients and key starting materials
under subparagraph (A), the Secretary, in consultation
with the Commissioner of Food and Drugs and the
Assistant Secretary for Preparedness and Response, may
deviate from the Plan developed under subsection (b)
only after certifying that the distribution from the
Reserve is required in response to a significant drug
supply interruption.
``(d) Consultation.--
``(1) In general.--In carrying out this section, the
Secretary shall consult with--
``(A) the Commissioner of Food and Drugs, with
respect to identifying essential generic medicines;
``(B) the Administrator of the Centers for Medicare
& Medicaid Services, with respect to determining the
volume of essential generic medicines needed
domestically; and
``(C) the Assistant Secretary for Preparedness and
Response, and, as appropriate, the Director of the
Centers for Disease Control and Prevention, regarding
coordination with the strategic national stockpile.
``(2) Reporting by fda.--The Commissioner of Food and Drugs
shall provide to the Secretary the information collected under
section 510(j)(3) of the Federal Food, Drug, and Cosmetic Act,
for purposes of carrying out this section.
``(e) Contracting.--
``(1) In general.--In carrying out this section, the
Secretary shall--
``(A) prioritize the purchase of active
pharmaceutical ingredients and other key starting
materials manufactured in the United States by domestic
manufacturers to the maximum extent possible;
``(B) contract with domestic entities for the--
``(i) distribution of active pharmaceutical
ingredients and finished drug products;
``(ii) storage, withdrawal, testing, and
conversion of active pharmaceutical ingredients
and other key starting materials;
``(iii) tracking and coordinating the
storage, testing, and sale of active
pharmaceutical ingredients and other key
starting materials;
``(iv) sale of active pharmaceutical
ingredients in advance of their expiration
dates; and
``(v) manufacturing, including continuous
manufacturing as appropriate, of an active
pharmaceutical ingredient or other key starting
material of an essential generic medicine that
is anticipated to be in shortage, as defined by
the Secretary for purposes of this section;
``(C) give preference to domestic nonprofit and
public-private partnerships, as appropriate;
``(D) ensure geographic diversity of the physical
storage of active pharmaceutical ingredients and other
key starting materials;
``(E) support domestic manufacturers of active
pharmaceuticals and other key starting materials and
facilitate long-term domestic capacity for essential
generic medicines in the United States; and
``(F) prioritize contracts that facilitate the
conversation of active pharmaceutical ingredients and
other key starting materials into finished dosage form.
``(2) Rule of construction.--Nothing in this subsection
shall be construed to limit the Secretary's ability to enter
into other types of contracts to facilitate the implementation
of this section.
``(f) Reports to Congress.--The Secretary shall report to the
applicable committees of Congress on supply chain resiliency with
respect to active pharmaceutical ingredients for essential generic
medicines, the status of the Reserve, and other relevant information in
a manner that does not compromise national security.
``(g) Definitions.--In this section:
``(1) Applicable committees of congress.--The term
`applicable committees of Congress' means--
``(A) the Committee on Health, Education, Labor,
and Pensions and the Committee on Intelligence of the
Senate; and
``(B) the Committee on Energy and Commerce of the
House of Representatives.
``(2) Essential generic medicine.--The term `essential
generic medicine' means a drug included on the most current
list under section 319N(a).
``(3) Key starting material.--The term `key starting
material' means an active pharmaceutical ingredient or critical
input used in the manufacturing of an essential generic
medicine, as well as ingredients or components that possess
unique attributes essential in assessing the safety and
effectiveness of such essential generic medicines, including
excipients and inactive ingredients.
``(h) Authorization of Appropriations.--There are authorized to be
appropriated to carry out this section such sums as may be
necessary.''.
SEC. 4. WAIVER OF CERTAIN FDA ANDA REQUIREMENTS.
Section 505(j) of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 355(j)) is amended by adding at the end the following:
``(14) Notwithstanding any other provision of this section,
the holder of an approved application under this subsection
that changes the source of an active pharmaceutical ingredient
of the drug that is the subject of such application to a source
available through the Strategic Active Pharmaceutical
Ingredient Reserve established under section 319N-1 of the
Public Health Service Act--
``(A) shall not be required to update the approved
application with respect to such change before changing
the source; and
``(B) shall inform the Secretary of the change,
through an update to the approved application or other
manner determined appropriate by the Secretary, prior
to commercial distribution of the drug.''.
SEC. 5. GAO REPORT.
By not later than 18 months after the date of enactment of this
Act, the Comptroller General of the United States shall prepare and
submit a report to Congress that includes--
(1) an assessment of what is known about active
pharmaceutical ingredient manufacturing, including--
(A) the time needed to develop and implement
domestic manufacturing capabilities;
(B) projected costs of developing new manufacturing
capabilities for active pharmaceutical ingredients not
currently available domestically, as of the date of the
report; and
(C) projected costs of expanding existing domestic
capabilities and policies, as of the date of the
report, that may help establish or strengthen domestic
manufacturing capacity for active pharmaceutical
ingredients, excipients, key starting materials,
components, functional ingredients, and finished dosage
manufacturing facilities; and
(2) an assessment of incentives already offered or being
considered for the development or improvement of domestic
capacity to manufacture active pharmaceutical ingredients,
their intermediates, and their excipients, including--
(A) contractual arrangements for existing domestic
storage and manufacturing of active pharmaceutical
ingredients;
(B) guaranteed contracts for initial purchase and
replenishment of essential generic medicines; and
(C) other policies designed to help incentivize the
relocation of manufacturing facilities to the United
States or provide economic incentives for domestic
production.
<all>
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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