[House Document 119-150]
[From the U.S. Government Publishing Office]
119th Congress, 2d Session - - - - - - - - - - - - House Document 119-150
ADJUSTING IMPORTS OF PHARMACEUTICALS AND PHARMACEUTICAL INGREDIENTS
INTO THE UNITED STATES
__________
MESSAGE
from
THE PRESIDENT OF THE UNITED STATES
transmitting
A NOTIFICATION OF ACTION TO ADJUST IMPORTS OF PHARMACEUTICALS AND
PHARMACEUTICAL INGREDIENTS SO THAT SUCH IMPORTS WILL NOT THREATEN TO
IMPAIR THE NATIONAL SECURITY OF THE UNITED STATES, PURSUANT TO 19
U.S.C. 1862(c)(2); PUBLIC LAW 87-794, SEC. 232 (AS AMENDED BY PUBLIC
LAW 100-418, SEC. 1501(a)(3)); (102 STAT. 1258)
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April 21, 2026.--Message and accompanying papers referred to the
Committee on Ways and Means and ordered to be printed
______
U.S. GOVERNMENT PUBLISHING OFFICE
69-011 WASHINGTON : 2026
To the Congress of the United States:
Consistent with applicable law, including section 232(c)(2)
of the Trade Expansion Act of 1962, as amended (19 U.S.C.
1862(c)(2)) (section 232), I am submitting to the Congress this
written statement of the reasons why I have decided to take
action to adjust imports of pharmaceuticals and pharmaceutical
ingredients so that such imports will not threaten to impair
the national security of the United States.
On January 5, 2026, the Secretary of Commerce (Secretary),
in accordance with section 232, transmitted to me a report on
his investigation into the effects of imports of
pharmaceuticals and pharmaceutical ingredients on the national
security of the United States. Based on the facts considered in
that investigation, the Secretary found and advised me of his
opinion that pharmaceuticals and associated active
pharmaceutical ingredients, including key starting materials,
are being imported into the United States in such quantities
and under such circumstances as to threaten to impair the
national security of the United States.
In Proclamation 11020 of April 2, 2026 (Adjusting Imports
of Pharmaceuticals and Pharmaceutical Ingredients Into The
United States) (Proclamation), after considering the
Secretary's report, the factors in section 232(d) (19 U.S.C.
1862(d)), and other relevant factors and information, among
other things, I concurred with the Secretary's finding that
pharmaceuticals and associated pharmaceutical ingredients are
being imported into the United States in such quantities and
under such circumstances as to threaten to impair the national
security of the United States. In my judgment, and in light of
the Secretary's report, the factors in section 232(d) (19
U.S.C. 1862(d)), and other relevant factors and information, I
determined that it is necessary and appropriate to adopt a plan
of action to adjust such imports of pharmaceuticals and
associated pharmaceutical ingredients so that such imports will
not threaten to impair the national security of the United
States. In particular, I determined that it is necessary and
appropriate for the Secretary and the Secretary of Health and
Human Services, and any senior official they deem appropriate,
to pursue or continue pursuing negotiations of agreements to
address the threatened impairment of the national security with
respect to imported pharmaceuticals and pharmaceutical
ingredients. In the Proclamation, I noted that depending on the
status or outcome of those negotiations, I may take other
measures to adjust the imports of pharmaceuticals and
pharmaceutical ingredients to address the threat to the
national security found in the Proclamation. I also determined
that it is necessary and appropriate to impose an immediate ad
valorem duty rate on the import of certain patented
pharmaceuticals and associated pharmaceutical ingredients to
address the national security threat found in the Proclamation.
I am enclosing a copy of the Proclamation that I have
issued. The Proclamation further explains the circumstances
underlying the threat to impair the national security of the
United States posed by imports of pharmaceuticals and
pharmaceutical ingredients and the actions taken in the
Proclamation to eliminate that threat.
Donald J. Trump.
The White House, April 16, 2026.
Adjusting Imports of Pharmaceuticals and Pharmaceutical Ingredients
Into the United States
----------
By the President of the United States of America
A Proclamation
1. The Secretary of Commerce (Secretary) recently
transmitted to me a report on his investigation into the
effects of imports of pharmaceuticals and pharmaceutical
ingredients on the national security of the United States under
section 232 of the Trade Expansion Act of 1962, as amended, 19
U.S.C. 1862 (section 232). Based on the facts considered in
that investigation, and taking into account the close relation
of the economic welfare of the Nation to our national security
and other relevant factors, see 19 U.S.C. 1862(d), the
Secretary found and advised me of his opinion that
pharmaceuticals and associated active pharmaceutical
ingredients (APIs), including key starting materials, are being
imported into the United States in such quantities and under
such circumstances as to threaten to impair the national
security of the United States.
2. The Secretary found that the present quantities and
circumstances of imports of pharmaceuticals and pharmaceutical
ingredients threaten to impair the national security and
economy. Despite being the world leader in research and
development (R&D) for most innovative pharmaceuticals (those
that are typically patented and branded, as compared to generic
pharmaceuticals or pharmaceuticals approved pursuant to section
505(j) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C.
355(j)), the United States is heavily reliant on imports,
threatening to limit United States access to life-saving
medications in the event of global supply chain disruption due
to geopolitical or economic disruption. According to the Food
and Drug Administration, as of 2025, approximately 53 percent
of patented pharmaceutical products distributed domestically
are produced outside the country. The degree of import reliance
is significant at the API level with only 15 percent of
patented APIs by volume domestically produced for the United
States market.
3. The Secretary found that patented pharmaceuticals and
associated pharmaceutical ingredients are essential to the
United States' military and civilian healthcare. A self
sufficient domestic manufacturing and industrial base for
pharmaceutical products is vital for the ability to support
national defense requirements and maintain public health
security during a national emergency or wartime. Patented
pharmaceuticals are pivotal for treating cancer, rare diseases,
autoimmune disorders, infectious diseases, and other critical
health challenges. The Secretary further found that foreign
government intervention has undermined the competitiveness of
the United States patented pharmaceutical industry. This
intervention has led to further dependence on foreign
production of patented pharmaceuticals that have fragile supply
chains.
4. In light of these findings, the Secretary recommended
actions to adjust imports of patented pharmaceuticals and
associated pharmaceutical ingredients, including continuing to
negotiate onshoring agreements related to Most-Favored-Nation
(MFN) pharmaceutical pricing agreements; imposing significant
tariffs on pharmaceuticals and pharmaceutical ingredients, so
that such imports will not threaten to impair the national
security of the United States; and granting preferential
treatment to those companies that commit to onshore production
of pharmaceuticals and pharmaceutical ingredients.
5. After considering the Secretary's report, the factors in
section 232(d) (19 U.S.C. 1862(d)), and other relevant factors
and information, among other things, I concur with the
Secretary's finding that pharmaceuticals and associated
pharmaceutical ingredients are being imported into the United
States in such quantities and under such circumstances as to
threaten to impair the national security of the United States.
In my judgment, and in light of the Secretary's report, the
factors in section 232(d) (19 U.S.C. 1862(d)), and other
relevant factors and information, I have also determined that
it is necessary and appropriate to adopt a plan of action, as
described below, to adjust such imports of pharmaceuticals and
associated pharmaceutical ingredients so that such imports will
not threaten to impair the national security of the United
States.
6. I have decided to direct the Secretary and the Secretary
of Health and Human Services to pursue negotiations of
agreements or continue any current negotiations of agreements,
such as agreements contemplated in section 232(c)(3)(A)(i) (19
U.S.C. 1862(c)(3)(A)(i)), to address the threatened impairment
of the national security with respect to imported patented
pharmaceuticals and associated pharmaceutical ingredients, with
any party the Secretary and the Secretary of Health and Human
Services deem appropriate, and to update me on the progress of
such negotiations within 90 days of the date of this
proclamation. Under current circumstances and in light of
future requirements of the United States, this action is
necessary and appropriate to address the threatened impairment
of the national security.
7. I have determined that it is necessary and appropriate
to impose a 100 percent ad valorem duty rate on the import of
patented pharmaceuticals and associated pharmaceutical
ingredients, as identified in Annex I to this proclamation, and
except as otherwise provided in this proclamation.
Pharmaceutical products and ingredients that are subject to the
section 232 zero tariff at this time are listed in Annex IV to
this proclamation.
8. I have determined that it is necessary and appropriate
that the ad valorem duty rate be 20 percent on imports of
patented pharmaceuticals and associated pharmaceutical
ingredients produced by companies that have plans, approved by
the Secretary, to onshore production of such pharmaceuticals
and pharmaceutical ingredients. The aforementioned 20 percent
rate shall increase to 100 percent 4 years after the date of
this proclamation.
9. I have further determined that it is necessary to
implement pharmaceutical-related commitments in existing trade
deals with the European Union, Japan, the Republic of Korea,
and Switzerland and Liechtenstein jointly, as well as a future
pharmaceutical-related deal with the United Kingdom (on which
the United States and the United Kingdom have reached an
agreement in principle as of December 1, 2025). These deals
further United States economic and national security interests.
10. I further find that it is necessary and appropriate to
impose no tariffs on imports of patented pharmaceuticals and
associated pharmaceutical ingredients produced by companies
that have fully executed agreements or are negotiating
agreements with the Secretary and the Secretary of Health and
Human Services regarding MFN pricing and onshoring of
production and R&D of patented pharmaceuticals and
pharmaceutical ingredients. Such agreements further United
States economic and national security interests by making
pharmaceuticals more accessible and affordable in the United
States and by strengthening the domestic manufacturing base.
11. I have further determined not to adjust imports of
generic pharmaceuticals and their associated ingredients,
including biosimilar products, at this time. This determination
includes purchases of generic pharmaceuticals and ingredients
for the Strategic API Reserve. I find that such products should
not be subject to section 232 tariffs at this time.
12. In my judgment, based on current circumstances as well
as the future needs of the United States, the actions in this
proclamation are necessary and appropriate to address the
threatened impairment of the national security posed by imports
of pharmaceuticals and pharmaceutical ingredients.
13. Section 232 authorizes the President to take action to
adjust the imports of an article and its derivatives that are
being imported into the United States in such quantities or
under such circumstances as to threaten to impair the national
security. Section 232 includes the authority to adopt and carry
out a plan of action, with adjustments over time, to address
the national security threat. This plan of action may include
negotiations of agreements along with other actions to adjust
imports to address the national security threat, including
tariffs. If action under section 232 includes the negotiation
of an agreement, such as one contemplated in section
232(c)(3)(A)(i) (19 U.S.C. 1862(c)(3)(A)(i)), the President may
also take other actions he deems necessary to adjust imports to
eliminate the threat that the imported article poses to the
national security, including if such an agreement is not
entered into within 180 days of the date of this proclamation,
is not being carried out, or is ineffective. See 19 U.S.C.
1862(c)(3)(A).
14. Section 604 of the Trade Act of 1974, as amended (19
U.S.C. 2483) (section 604), authorizes the President to embody
in the Harmonized Tariff Schedule of the United States (HTSUS)
the substance of statutes affecting import treatment, and
actions thereunder, including the removal, modification,
continuance, or imposition of any rate of duty or other import
restriction.
NOW, THEREFORE, I, DONALD J. TRUMP, President of the United
States of America, by the authority vested in me by the
Constitution and the laws of the United States, including
section 232, 19 U.S.C. 1862; section 604, 19 U.S.C. 2483; and
section 301 of title 3, United States Code, do hereby proclaim
as follows:
(1) The Secretary and the Secretary of Health and Human
Services, and any senior official they deem appropriate, shall
pursue or continue pursuing negotiations of agreements, as
contemplated in section 232(c)(3)(A)(i) (19 U.S.C.
1862(c)(3)(A)(i)), to address the threatened impairment of the
national security with respect to imported pharmaceuticals and
pharmaceutical ingredients.
(2) I hereby ratify, and delegate to the Secretary the
authority necessary to enter into, the company-specific tariff
agreements listed in Annex II to this proclamation that the
Secretary entered into prior to this proclamation. I also
hereby delegate to the Secretary the authority to enter into
and implement similar agreements in the future, as referenced
in clause (1) of this proclamation. The Secretary is authorized
to monitor and enforce these agreements as he deems
appropriate, consistent with clause (6) of this proclamation
and applicable law.
(3)(a) Imports of patented pharmaceuticals and associated
pharmaceutical ingredients, as listed in Annex I to this
proclamation, will be subject to a 100 percent ad valorem duty
rate.
(b) The ad valorem duty rate for patented pharmaceuticals
and associated pharmaceutical ingredients, as listed in Annex I
to this proclamation, shall be 20 percent for products of
companies that have, or that the Secretary assesses are likely
soon to have (e.g., based on agreements in principle),
onshoring plans approved by the Secretary. The aforementioned
20 percent rate shall increase to 100 percent on April 2, 2030.
(c) The ad valorem duty rate for patented pharmaceuticals
and associated pharmaceutical ingredients, as listed in Annex I
to this proclamation, shall be 15 percent for products of
Japan, the European Union, the Republic of Korea, and
Switzerland and Liechtenstein jointly, unless a lower rate
applies under clause (3) of this proclamation. The tariff rate
on patented pharmaceuticals and associated pharmaceutical
ingredients for products of the United Kingdom shall be 10
percent and then reduce to zero to the extent required by any
future agreement between the United States and the United
Kingdom on pharmaceutical pricing. The Secretary shall publish
a Federal Register notice should the rate for the United
Kingdom be reduced to zero.
(d) The ad valorem tariff rate shall be zero for drugs and
associated ingredients, where all approved indications are
designated as orphan pursuant to the Orphan Drug Act, 21 U.S.C.
360aa et seq., and its implementing regulations; nuclear
medicines; plasma derived therapies; fertility treatments; cell
and gene therapies; antibody drug conjugates; medical
countermeasures related to chemical, biological, radiological,
and nuclear threats; or other specialty pharmaceutical products
to be identified by the Secretary, as well as pharmaceutical
products for animal health, provided that the Secretary, in
consultation with the United States Trade Representative (Trade
Representative) and the Secretary of Health and Human Services,
determines that: (1) they are products of a jurisdiction that
has a current or forthcoming trade and security framework
agreement as referenced in Executive Order 14346 of September
5, 2025 (Modifying the Scope of Reciprocal Tariffs and
Establishing Procedures for Implementing Trade and Security
Agreements), or (2) they meet an urgent United States health
need. The Secretary shall publish a Federal Register notice
whenever he makes such a determination.
(e) For companies that are eligible for the tariff
treatment outlined in clause (3)(b) of this proclamation, and
that have entered into MFN pharmaceutical pricing agreements
with the Secretary of Health and Human Services, the applicable
ad valorem tariff rate for pharmaceuticals and associated
pharmaceutical ingredients shall be zero until January 20,
2029. The Secretary shall apply this zero tariff rate to
companies that he determines are likely to be eligible soon
(e.g., because they have agreements in principle with the
Secretary and the Secretary of Health and Human Services). For
avoidance of doubt, this zero tariff rate shall also apply per
the terms of the agreements listed in Annex II to this
proclamation.
(f) The Secretary may increase the tariff rates referenced
in clause (2) of this proclamation, and in clauses (3)(b) and
(3)(e) of this proclamation, to address companies' failure to
fulfill commitments under the relevant plans and agreements.
The Secretary, in consultation with the Trade Representative,
may increase the tariff rates referenced in clause (3)(c) of
this proclamation to address foreign jurisdictions' failure to
fulfill commitments under agreements with the United States.
The Secretary shall publish a Federal Register notice when
tariff rates are increased.
(4) The tariffs and tariff treatment imposed by this
proclamation shall be effective with respect to goods entered
for consumption, or withdrawn from warehouse for consumption,
on or after 12:01 a.m. eastern daylight time on July 31, 2026,
for the companies listed in Annex III to this proclamation and
September 29, 2026, for other companies and shall continue in
effect, unless such actions are expressly reduced, modified, or
terminated.
(5) Generic pharmaceuticals and their associated
ingredients shall not be subject to tariffs pursuant to section
232 at this time. Within 1 year of the date of this
proclamation, the Secretary shall, in consultation with any
senior executive branch officials the Secretary deems
appropriate, inform the President of any circumstances that, in
the Secretary's opinion, might indicate the need to take action
to adjust the imports of generic pharmaceuticals and their
associated ingredients.
(6) The Secretary, in consultation with the Secretary of
Health and Human Services, shall establish criteria for
onshoring plans referenced in clause (3)(b) of this
proclamation, to be published in the Federal Register. All
onshoring plans shall be subject to approval, monitoring, and
enforcement by the Secretary. The Secretary shall require
companies with qualifying onshoring plans to submit periodic
reports to the Secretary regarding progress towards fulfilling
onshoring milestones. The Secretary may require that such
reports be audited by an external auditing firm. In cases where
the executive branch assesses that a company engaged in fraud
or deliberately misled the United States Government with
respect to onshoring commitments, the Secretary may reimpose
tariffs discussed in this proclamation both prospectively and
retroactively on imports from relevant companies, and he may
impose other tariffs and penalties to the extent consistent
with applicable law.
(7) If a product is subject to tariffs under this
proclamation and Column 1 of the HTSUS (Column 1 Duty Rate),
then the sum of the additional section 232 tariff imposed
pursuant to this proclamation and the applicable Column 1 Duty
Rate shall be equal to the applicable rate listed in clause (3)
of this proclamation, unless the Column 1 Duty Rate is greater
than the applicable rate listed in clause (3) of this
proclamation, in which case only the Column 1 Duty Rate shall
apply. This clause does not apply to the tariff treatment for
products of the United Kingdom described in clause (3)(c) of
this proclamation.
(8) If a product is subject to more than one rate of duty
under this proclamation, then the lowest applicable rate shall
apply.
(9) The Secretary, in consultation with the Chair of the
United States International Trade Commission and the
Commissioner of U.S. Customs and Border Protection (CBP), shall
determine whether any modifications to the HTSUS or other
administrative measures are necessary to effectuate or
implement this proclamation or any actions taken pursuant to
this proclamation. Any changes shall be published in a notice
in the Federal Register.
(10) Drawback shall be available with respect to the duties
imposed pursuant to this proclamation.
(11) Imports of United States-origin pharmaceutical
products shall not be subject to the tariffs imposed by this
proclamation at this time.
(12) To the extent permitted by applicable law, CBP may
take any necessary or appropriate measure to administer the
tariffs imposed or altered by this proclamation. Importers
shall provide to CBP information necessary to carry out this
proclamation.
(13) Any product described in clause (4) of this
proclamation, except those eligible for admission as ``domestic
status'' as described in 19 CFR 146.43, that is subject to a
duty imposed by this proclamation and that is admitted into a
United States foreign trade zone on or after the effective date
of this proclamation, must be admitted as ``privileged foreign
status'' as described in 19 CFR 146.41 and will be subject upon
entry for consumption to any ad valorem rates of duty related
to the classification under the applicable HTSUS subheading.
(14) The Secretary shall continue to monitor imports of
patented and generic pharmaceuticals and pharmaceutical
ingredients. The Secretary also shall, from time to time, in
consultation with any senior executive branch officials the
Secretary deems appropriate, review the status of such imports
with respect to the national security. The Secretary shall
inform me of any circumstances that, in the Secretary's
opinion, might indicate the need for further action by the
President under section 232. The Secretary shall also inform me
of any circumstance that, in the Secretary's opinion, might
indicate that the tariff imposed in this proclamation is no
longer necessary.
(15) To the extent consistent with applicable law and the
purpose of this proclamation, the Secretary, the Secretary of
Health and Human Services, and the Secretary of Homeland
Security are directed and authorized to take all actions that
are appropriate to implement and effectuate this proclamation
and any actions contemplated by this proclamation, including,
consistent with applicable law, the issuance of regulations,
rules, guidance, and procedures and the temporary suspension or
amendment of regulations, within their respective
jurisdictions, and to employ all powers granted to me under
section 232.
(16) The Secretary, the Trade Representative, and the
Secretary of Homeland Security may, consistent with applicable
law, including section 301 of title 3, United States Code,
redelegate any of these functions within their respective
executive departments or agencies.
(17) Any provision of previous proclamations and Executive
Orders that is inconsistent with this proclamation is
superseded to the extent of such inconsistency. If any
provision of this proclamation or the application of any
provision of this proclamation to any individual or
circumstance is held to be invalid, the remainder of this
proclamation and the application of its provisions to any other
individual or circumstance shall not be affected.
IN WITNESS WHEREOF, I have hereunto set my hand this second
day of April, in the year of our Lord two thousand twenty-six,
and of the Independence of the United States of America the two
hundred and fiftieth.
Donald J. Trump.
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