I 
118TH CONGRESS 
2D SESSION 
H. R. 9938 
To amend the Federal Food, Drug, and Cosmetic Act to establish a time- 
limited conditional approval pathway, subject to specific obligations, for 
certain drugs and biological products, and for other purposes. 
IN THE HOUSE OF REPRESENTATIVES 
OCTOBER 4, 2024 
Mr. WESTERMAN (for himself and Mr. MIKE GARCIA of California) 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 
establish a time-limited conditional approval pathway, 
subject to specific obligations, for certain drugs and bio-
logical products, and for other purposes. 
Be it enacted by the Senate and House of Representa-
tives of the United States of America in Congress assembled, 
SECTION 1. SHORT TITLE. 
This Act may be cited as the ‘‘Promising Pathway 
Act 2.0’’. 
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SEC. 2. CONDITIONAL APPROVAL OF NEW HUMAN DRUGS 
FOR INDIVIDUALS WITH RARE, PROGRES-
SIVE, AND SERIOUS DISEASES. 
(a) IN GENERAL.—Subchapter A of chapter V of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 351 
et seq.) is amended by adding at the end of the following: 
‘‘SEC. 524C. CONDITIONAL APPROVAL OF HUMAN DRUGS 
FOR INDIVIDUALS WITH RARE, PROGRES-
SIVE, AND SERIOUS DISEASES. 
‘‘(a) CONDITIONAL APPROVAL; PRIORITY REVIEW; 
OTHER DESIGNATIONS.— 
‘‘(1) IN GENERAL.—The sponsor of a drug may 
file with the Secretary an application for conditional 
approval of an eligible drug described in subsection 
(b). The Secretary shall approve or deny such appli-
cation in accordance with subsection (c). 
‘‘(2) PRIORITY REVIEW.—The Secretary shall 
give priority review to an application for conditional 
approval of an eligible drug described in subsection 
(b). 
‘‘(3) OTHER DESIGNATIONS.—If a drug that is 
granted conditional approval under this section is el-
igible for a special designation by the Secretary 
under this Act, including as a drug for a rare dis-
ease or condition under section 526, all applicable 
benefits of such other designation shall be available 
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for use under such conditional approval, including 
any tax credits and waiving of fees under chapter 
VII. 
‘‘(4) OTHER PROGRAMS.—A sponsor of a drug 
seeking conditional approval of such drug under this 
section may also seek designation, exclusivity, or ap-
proval, as applicable, of such drug under other appli-
cable provisions of this Act or the Public Health 
Service Act, subject to the requirements of such pro-
visions. 
‘‘(b) ELIGIBILITY.— 
‘‘(1) IN GENERAL.—A drug may be eligible for 
conditional approval under this section if such drug 
is intended to treat a disease or condition that is— 
‘‘(A) rapidly progressive, terminal, and has 
substantial unmet medical need, as determined 
by the Secretary; or 
‘‘(B) a rare disease or condition (as de-
fined in section 526(a)(2)) that results in a 
substantially shortened lifespan, substantial re-
duction in quality of life, or other substantial 
adverse health effects, as determined by the 
Secretary. 
‘‘(2) EXCLUSION FROM ELIGIBILITY.—A drug 
that is intended to treat or respond to a material 
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threat identified by the Secretary of Homeland Secu-
rity under section 319F–2(c)(2)(A)(ii) shall not be 
eligible for conditional approval under this section. 
‘‘(c) STANDARD OF REVIEW FOR CONDITIONAL AP-
PROVAL.— 
‘‘(1) REQUIREMENTS.—The Secretary shall 
only approve an application for conditional approval 
of a drug under this section if— 
‘‘(A) the Secretary determines that— 
‘‘(i)(I) evidence of safety for the drug 
has been established by— 
‘‘(aa) the completion of a phase 1 
clinical investigation of the drug (as 
described in section 312.21 of title 21, 
Code of Federal Regulations (or suc-
cessor regulations)); or 
‘‘(bb) another demonstration of 
safety, as determined appropriate by 
the Secretary; and 
‘‘(II) evidence of effectiveness in 
treating a given indication (which indica-
tion is congruent with the eligibility re-
quirements of subsection (b)), as estab-
lished by an ongoing or completed phase 2 
clinical investigation of the drug (as de-
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scribed in section 312.21 of title 21, Code 
of Federal Regulations (or successor regu-
lations)); or 
‘‘(ii) in the case of a drug that is in-
tended to treat a terminal pediatric rare 
disease or condition (as defined in section 
526(a)(2)) that does not predominately af-
fect adults— 
‘‘(I) evidence of safety for the 
drug has been established in accord-
ance with clause (i)(I); and 
‘‘(II) the drug shows preliminary 
evidence of clinical effectiveness based 
upon studies in animal models; and 
‘‘(B) the sponsor has provided a written 
affirmation of the sponsor’s intent to pursue 
under section 505 of this Act or section 351 of 
the Public Health Service Act approval of the 
drug, which affirmation shall include a justifica-
tion and a plan for pursuing such approval. 
‘‘(2) ROLLING, REAL-TIME REVIEW.— 
‘‘(A) IN GENERAL.—If the Secretary deter-
mines, after preliminary evaluation of data sub-
mitted by the sponsor, that a drug may meet 
the standard for conditional approval, the spon-
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sor may submit portions of an application for 
conditional approval of a drug under this sec-
tion for evaluation by the Secretary before the 
sponsor submits a complete application, which 
submission shall include— 
‘‘(i) a schedule for submission of in-
formation necessary to make the applica-
tion complete; and 
‘‘(ii) a payment of any fee that may 
be required under section 736. 
‘‘(B) REVIEW.—The Secretary— 
‘‘(i) shall evaluate each application 
submitted under subparagraph (A) to as-
sess whether such application is complete 
or ready to be filed; and 
‘‘(ii) may commence review of portions 
of such application for approval. 
‘‘(3) USE OF REAL-WORLD EVIDENCE.— 
‘‘(A) IN
GENERAL.—The Secretary shall 
allow the use of real world evidence (as defined 
in section 505F(b)), including real world data 
used to generate real world evidence, and of ex-
ternal sources of data, including prospective or 
retrospective natural history data, to support an 
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application for conditional approval under this 
section. 
‘‘(B) DATA INTEGRITY REQUIREMENTS.— 
In using evidence described in subparagraph 
(A) to support an application for conditional 
approval under this section, the sponsor shall 
consider the guidance of the Food and Drug 
Administration entitled ‘Data Standards for 
Drug and Biological Product Submissions Con-
taining Real-World Data’ and dated December 
2023 (or successor guidance). 
‘‘(d) FDA AUTHORITY TO WITHDRAW CONDITIONAL 
APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary may with-
draw the conditional approval of a drug under this 
section if— 
‘‘(A) after adequate review of appropriate 
safety data, including data from an observa-
tional registry established under subsection (g), 
the Secretary determines that such data no 
longer supports conditional approval; 
‘‘(B) the Secretary determines that the ap-
plication for conditional approval submitted 
under subsection (a)(1) contained an untrue 
statement of material fact; or 
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‘‘(C) the Secretary determines that the 
drug is no longer eligible under subsection (b). 
‘‘(2) FDA EXAMINATION AUTHORITY.— 
‘‘(A) IN GENERAL.—For purposes deter-
mining whether to withdraw the conditional ap-
proval of a drug under paragraph (1), the Sec-
retary may— 
‘‘(i) review any available clinical data 
made available through clinical trials or an 
observational registry under subsection (g), 
applicable to such drug; and 
‘‘(ii) determine whether the sponsor of 
such drug is in violation of a requirement 
established under paragraph (3) or (4) of 
section 505(o) or section 505–1 with re-
spect to the drug. 
‘‘(B) TRANSPARENCY.— 
‘‘(i) IN
GENERAL.—The Secretary 
may require drug sponsors and observa-
tional registries under subsection (g) to 
submit the data described in subparagraph 
(A) for the purposes of the review under 
that subparagraph. 
‘‘(ii) FINES.—The Secretary may levy 
fines on sponsors and observational reg-
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istries that do not comply with a request 
for data under clause (i) within such rea-
sonable timeframe as is established by the 
Secretary. 
‘‘(3) EFFECT OF WITHDRAWAL.— 
‘‘(A) AVAILABILITY TO NEW PATIENTS.— 
‘‘(i) IN
GENERAL.—If a conditional 
approval is withdrawn under this sub-
section, the sponsor may not make the 
drug available to any new patients, but 
may continue to make such drug available 
to patients who started taking the drug 
prior to the date of withdrawal. 
‘‘(ii) EFFECT.—Nothing in this sub-
paragraph shall be construed to require— 
‘‘(I) a patient to continue taking 
a conditionally approved drug if such 
patient decides to stop taking such 
drug; or 
‘‘(II) the sponsor to ensure such 
drug continues to be manufactured 
after the date of withdrawal. 
‘‘(B) CIVIL
MONETARY
PENALTY.—Any 
sponsor who makes available to new patients a 
drug for which conditional approval has been 
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withdrawn under this subsection shall be sub-
ject to such civil monetary penalty as is deter-
mined by the Secretary. 
‘‘(4) 
WITHDRAWAL
NOTICE.—Upon 
deter-
mining to withdraw the conditional approval of a 
drug under paragraph (1), the Secretary shall sub-
mit written notice to the sponsor of such drug and 
such withdrawal shall be effective on the date that 
is 14 days after the date of such submission of no-
tice. 
‘‘(5) APPEALS.—Not later than 180 days after 
the date of enactment of the Promising Pathway Act 
2.0, the Secretary, by rule, shall establish a process 
by which a sponsor of a drug for which conditional 
approval was withdrawn under paragraph (1) may 
appeal such withdrawal. 
‘‘(6) AUTOMATIC WITHDRAWAL.— 
‘‘(A) IN GENERAL.—If the sponsor of a 
drug that receives conditional approval under 
this section does not submit an application for 
renewal of such conditional approval under sub-
section (f)(2) by the deadline under that sub-
section, such conditional approval shall auto-
matically be withdrawn in accordance with 
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paragraph (3) on the date on which such condi-
tional approval expires. 
‘‘(B) MARKETING REQUIREMENT.—If any 
drug that receives conditional approval under 
this section is not brought to market within 1 
year of the date on which the conditional ap-
proval is granted, such conditional approval, 
along with any benefits described in subsection 
(a)(3), shall automatically be withdrawn in ac-
cordance with paragraph (3) on such date. 
‘‘(C) NO RIGHT TO APPEAL; EFFECT OF 
AUTOMATIC WITHDRAWAL.— 
‘‘(i) IN
GENERAL.—A sponsor shall 
not have the right to appeal an automatic 
withdrawal under this paragraph. 
‘‘(ii) EFFECT.—The Secretary shall 
have no means or power to prevent an 
automatic withdrawal under this para-
graph from occurring. 
‘‘(e) LABELING; REVIEW OF MATERIALS.— 
‘‘(1) IN
GENERAL.—Sponsors may not make 
available to patients a drug conditionally approved 
under this section, unless— 
‘‘(A) all labeling and advertising of such 
drug contains the statement ‘conditionally ap-
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proved for a limited population’ in a prominent 
manner and adjacent to, and not more promi-
nent than— 
‘‘(i) the proprietary name of such 
drug, if any; or 
‘‘(ii) if there is no proprietary name, 
the established name of such drug, if any, 
as defined in section 502(e)(3), or, in the 
case of a drug that is a biological product, 
the proper name, as defined by regulation; 
and 
‘‘(B) the prescribing information for the 
drug required by section 201.57 of title 21, 
Code of Federal Regulations (or any successor 
regulation) includes the following statement: 
‘This drug is conditionally approved for use in 
a limited and specific population. This drug has 
not received full approval by the Food and 
Drug Administration. Conditional approval of 
this drug may be withdrawn at short notice.’. 
‘‘(2) SUBMISSION.—Not later than 45 days be-
fore such materials are distributed, all promotional, 
educational, and marketing materials for such drug 
shall be submitted to the Secretary for review. 
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‘‘(3) PUBLIC LIST.—The Secretary shall main-
tain a list of all drugs conditionally approved under 
this section on a publicly accessible website. Such 
website shall briefly describe what each conditionally 
approved drugs is and list the 1 or more diseases or 
conditions for which the drug is indicated. 
‘‘(f) RENEWAL
OF CONDITIONAL APPROVAL; RE-
QUIREMENT TO BRING DRUG TO MARKET.— 
‘‘(1) DURATION; RENEWALS.—The conditional 
approval for a drug under this section is effective for 
a 2-year period. The sponsor may request renewal of 
such conditional approval for up to 3 subsequent 2- 
year periods. Conditional approval with respect to a 
drug shall not exceed a total of 8 years from the ini-
tial date the drug was granted conditional approval. 
‘‘(2) APPLICATIONS FOR RENEWAL OF CONDI-
TIONAL APPROVAL.— 
‘‘(A) IN GENERAL.—Except as provided in 
subparagraph (C), the sponsor of a drug seek-
ing a renewal of conditional approval for such 
drug under this subsection shall submit to the 
Secretary, not later than 180 days before the 
date on which such conditional approval expires, 
an application that contains the applicable in-
formation described in paragraph (3) in a 
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standardized format determined by the Sec-
retary. 
‘‘(B) PROCESS
FOR
GRANTING
RENEW-
ALS.—Not later than 180 days after the date of 
enactment of the Promising Pathway Act 2.0, 
the Secretary, by rule, shall establish the proc-
ess for granting a renewal under this sub-
section. 
‘‘(C) EXEMPTION FOR SMALL POPULATION 
DISEASES.— 
‘‘(i) IN
GENERAL.—The Secretary 
shall exempt from the requirements of sub-
paragraph (A) and paragraph (3) an appli-
cation for a renewal of conditional approval 
for a drug under this subsection if the Sec-
retary determines that the population af-
fected by the disease or condition that the 
drug is intended to treat does not support 
additional preliminary evidence of effective-
ness (as defined in paragraph (3)(D)). 
‘‘(ii) 
APPLICATION
FOR
EXEMP-
TION.—Sponsors may submit an applica-
tion for exemption under this subpara-
graph not later than 180 days before the 
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date on which the conditional approval ex-
pires. 
‘‘(iii) APPLICATION
PROCESS.—Not 
later than 180 days after the date of en-
actment of the Promising Pathway Act 
2.0, the Secretary shall establish a stand-
ardized application process for purposes of 
this subparagraph. 
‘‘(iv) DEADLINE.—The Secretary shall 
approve or deny an application under this 
subparagraph before the date on which the 
conditional approval expires. 
‘‘(v) APPEALS.—Not later than 180 
days after the date of enactment of the 
Promising Pathway Act 2.0, the Secretary 
shall establish a process under which a 
sponsor my appeal a denial of an applica-
tion under this subparagraph. 
‘‘(3) ADDITIONAL PRELIMINARY EVIDENCE OF 
EFFECTIVENESS.—The information described in this 
paragraph is the following: 
‘‘(A) FOR
THE
FIRST
APPROVAL
RE-
NEWAL.—With respect to an application under 
paragraph (2) for the first renewal of condi-
tional approval for a drug under this sub-
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section, additional preliminary evidence of effec-
tiveness of the drug, as compared to the evi-
dence provided in the initial application for con-
ditional approval for the drug under subsection 
(c). 
‘‘(B) FOR
THE
SECOND
APPROVAL
RE-
NEWAL.—With respect to an application under 
paragraph (2) for the second renewal of condi-
tional approval for a drug under this sub-
section, additional preliminary evidence of effec-
tiveness of the drug, as compared to the evi-
dence provided in the renewal application de-
scribed in subparagraph (A). 
‘‘(C) FOR
THE
FINAL
APPROVAL
RE-
NEWAL.—With respect to an application under 
paragraph (2) for the third renewal of condi-
tional approval for a drug under this sub-
section, a written affirmation from the head of 
the drug’s review division of the Office of New 
Drugs or the Office of Therapeutic Products 
asserting that a third renewal is necessary— 
‘‘(i) for patients who have benefitted 
from such drug to retain access to such 
drug; and 
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‘‘(ii) to generate additional prelimi-
nary evidence of effectiveness for the pur-
poses of attaining approval under section 
505 of this Act or section 351 of the Pub-
lic Health Service Act. 
‘‘(D) DEFINITION.—In this paragraph, the 
term ‘preliminary evidence of effectiveness’ 
means— 
‘‘(i) clinical evidence generated by an 
ongoing or completed clinical trial con-
ducted in accordance with section 11.22 of 
title 42, Code of Federal Regulations (or 
successor regulations); 
‘‘(ii) real-world evidence (as defined in 
section 505F(b)); or 
‘‘(iii) evidence from an observational 
registry under subsection (g). 
‘‘(4) DENIAL OF RENEWAL ON THE BASIS OF 
DATA FRAUD.—The Secretary may deny the applica-
tion for renewal of conditional approval for a drug 
under this subsection if the Secretary, in conducting 
a review under subsection (d)(2), finds that the evi-
dence provided in such application under subpara-
graph (A) or (B) of paragraph (3) was fraudulently 
manipulated by the applicable observational registry 
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and that such application substantially relies on 
such data. 
‘‘(g) OBSERVATIONAL REGISTRIES.— 
‘‘(1) ESTABLISHMENT.— 
‘‘(A) IN
GENERAL.—Subject to subpara-
graph (C), the sponsor of a drug conditionally 
approved under this section shall establish an 
observational registry, for patients who are or 
will be treated with such drug, that pertains to 
the disease or condition that the drug is in-
tended to treat. 
‘‘(B) REGISTRIES.—In establishing an ob-
servational registry for a drug under subpara-
graph (A), the sponsor may— 
‘‘(i) establish a new observational reg-
istry; 
‘‘(ii) use an existing observational reg-
istry that pertains to the disease or condi-
tion such drug is intended to treat; 
‘‘(iii) combine 1 or more existing ob-
servational registries that pertain to the 
disease or condition such drug is intended 
to treat with a new observational registry; 
or 
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‘‘(iv) combine 2 or more existing ob-
servational registries that pertain to the 
disease or condition such drug is intended 
to treat. 
‘‘(C) APPROVAL OF REGISTRY AND RIGHT 
TO APPEAL.—Not later than 180 days after the 
date of enactment of the Promising Pathway 
Act 2.0, the Secretary shall establish— 
‘‘(i) a process to approve or deny the 
establishment of an observational registry 
under subparagraph (A); and 
‘‘(ii) a process for sponsors that re-
ceived such a denial to appeal the denial. 
‘‘(2) REQUIREMENT FOR PATIENTS TO ENROLL 
IN OBSERVATIONAL REGISTRY.— 
‘‘(A) IN GENERAL.—A drug conditionally 
approved under this section shall not be made 
available to a patient unless such patient is en-
rolled in the applicable observational registry 
described in paragraph (1). 
‘‘(B) INFORMED CONSENT.— 
‘‘(i) IN GENERAL.—Prior to enrolling 
in an observational registry under subpara-
graph (A), a patient shall provide informed 
consent in accordance with clause (ii). 
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‘‘(ii) APPLICATION
OF
CERTAIN
RE-
QUIREMENTS.—The requirements for in-
formed consent under part 50 of sub-
chapter A of chapter I of title 21, Code of 
Federal Regulations (or successor regula-
tions), shall apply to enrollment an obser-
vational registry under this paragraph. 
‘‘(3) SUBMISSION OF PATIENT DATA.— 
‘‘(A) IN GENERAL.—The sponsor of a drug 
conditionally approved under this section shall 
be responsible for obtaining and submitting pa-
tient data to the applicable observational reg-
istry described in paragraph (1). 
‘‘(B) SUBMISSION STANDARDS.—Not later 
than 180 days after date of enactment of the 
Promising Pathway Act 2.0, the Secretary shall 
establish data submission standards for spon-
sors to comply with for purposes of subpara-
graph (A) to ensure that registry data is con-
sistent and clinically informed. 
‘‘(4) REQUIREMENTS FOR REGISTRIES.—An ob-
servational registry described in paragraph (1) for a 
drug conditionally approved under this section may 
be operated by the sponsor of such drug or, at the 
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sponsor’s discretion, a third party, for-profit organi-
zation, or nonprofit organization. 
‘‘(5) RISK AND BENEFIT DATA.— 
‘‘(A) IN GENERAL.—The sponsor of a drug 
conditionally approved under this section shall 
submit relevant risk and benefit data to the ap-
plicable observational registry described in 
paragraph (1). 
‘‘(B) ONLINE
PORTAL.—The Secretary 
shall operate an online portal on an existing 
website of the Secretary for sponsors to submit 
data described in subparagraph (A). 
‘‘(6) ACCESSIBILITY.— 
‘‘(A) IN GENERAL.—An observational reg-
istry described in paragraph (1) shall— 
‘‘(i) not later than 30 days after re-
ceipt of a request, provide patients (or 
their designated representatives) with ac-
cess to such patient’s personal registry in-
formation; and 
‘‘(ii) provide approved researchers and 
medical professionals access to de-identi-
fied and aggregated data from the registry 
for the purposes of indication- and disease- 
specific and translational research into 
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conditions and diseases relating to the dis-
ease or condition that the drug tracked by 
the observational registry is intended to 
treat. 
‘‘(B) APPROVED RESEARCHERS AND MED-
ICAL
PROFESSIONALS.—Not later than 180 
days after the date of enactment of the Prom-
ising Pathway Act 2.0, the Secretary, by rule, 
shall establish a process for approving research-
ers and medical professionals for purposes of 
subparagraph (A)(ii). 
‘‘(7) EFFECT.—Nothing in this section shall be 
construed to modify or limit the Secretary’s author-
ity to require for a drug conditionally approved 
under this section any type of postapproval study 
under any other provision of law, including sections 
505(o)(3), 505B, and 506. 
‘‘(h) PURSUIT OF A DIFFERENT INDICATION.— 
‘‘(1) IN GENERAL.—In the case of a drug con-
ditionally approved under this section for which such 
approval was withdrawn under subsection (d), ex-
pired under subsection (f)(1), or was denied for re-
newal under subsection (f)(4), not later than 2 years 
after the date of withdrawal, expiration, or denial, as 
applicable, the sponsor of such drug shall have the 
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opportunity to petition the Secretary to receive con-
ditional approval of such drug, in accordance with 
this section, for a different indication. 
‘‘(2) PROCESS.—Not later than 180 days after 
the date of enactment of the Promising Pathway Act 
2.0, the Secretary shall establish a process for peti-
tions under paragraph (1). 
‘‘(i) TRANSITION TO OTHER FORMS OF APPROVAL.— 
‘‘(1) IN GENERAL.—A drug that receives condi-
tional approval under this section may be granted 
approval under section 505 of this Act or section 
351 of the Public Health Service Act during the pe-
riod in which such conditional approval is in effect. 
Effective on the date on which approval for such 
drug is granted under section 505 of this Act or sec-
tion 351 of the Public Health Service Act, such con-
ditional approval shall be automatically withdrawn in 
accordance with subsection (d)(3). 
‘‘(2) 
CONSIDERATION
OF
CERTAIN
EVI-
DENCE.—In determining whether to approve under 
section 505 of this Act or section 351 of the Public 
Health Service Act a drug that has received condi-
tional approval under this section, the Secretary may 
consider evidence from the observational registry for 
the drug under subsection (g). 
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‘‘(j) INFORMED CONSENT.— 
‘‘(1) IN GENERAL.—Prior to being prescribed a 
drug conditionally approved under this section, a pa-
tient shall provide informed consent in accordance 
with paragraph (2). 
‘‘(2) APPLICATION
OF
CERTAIN
REQUIRE-
MENTS.—The requirements for informed consent 
under part 50 of subchapter A of chapter I of title 
21, Code of Federal Regulations (or successor regu-
lations), shall apply to drugs conditionally approved 
under this section. 
‘‘(3) OBSERVATIONAL REGISTRIES.—An obser-
vational registry established for a drug in accord-
ance with subsection (g) may obtain, and maintain 
records of, informed consent of a patient on behalf 
of the drug sponsor, in accordance with paragraph 
(2). 
‘‘(4) COMMON RULE.—Drugs conditionally ap-
proved under this section shall comply with subpart 
A of part 46 of title 45, Code of Federal Regulations 
(commonly known as the ‘Common Rule’) (or suc-
cessor regulations), if applicable. 
‘‘(k) LIMITATION ON LIABILITY.—With respect to 
any claim under State law relating to a drug made avail-
able pursuant to a grant of conditional approval under this 
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section, no liability shall lie against a sponsor or manufac-
turer of the drug, or any health care provider who pre-
scribes or administers the drug, absent intentional wrong-
doing. 
‘‘(l) REPORT TO CONGRESS.— 
‘‘(1) IN
GENERAL.—Not later than 2 years 
after the date of enactment of the Promising Path-
way Act 2.0, and once every 2 years thereafter, the 
Secretary, in collaboration with drug sponsors, shall 
submit a report to Congress on all drugs granted 
conditional approval under this section. Such report 
shall include— 
‘‘(A) an estimated number of patients 
treated with each such drug, and the number of 
patients tracked in an observational registry 
under subsection (g) with respect to each such 
drug, if applicable; 
‘‘(B) a discussion, at an aggregate level , 
of the types and amounts of data obtained 
through observational registries under sub-
section (g), such as patient treatments and 
uses, length of use, side effects encountered, 
relevant biomarkers, scan results, cause of 
death and how long the patient lived, and ad-
verse drug effects; 
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‘‘(C) a list of all such drugs for which an 
application for approval under this section, or 
an application for an extension of conditional 
approval under this section, has been sub-
mitted; and 
‘‘(D) the number of all applications grant-
ed and denied conditional approval under this 
section. 
‘‘(2) SPONSOR PARTICIPATION.—Not later than 
180 days before the date on which the Secretary 
submits a report under paragraph (1), the sponsor 
of a drug conditionally approved under this section 
shall provide to the Secretary the information de-
scribed in subparagraphs (A) and (B) of paragraph 
(1), as applicable. 
‘‘(3) NOTICE AUTHORITY.—The Secretary may 
notify sponsors of drugs conditionally approved 
under this section and observational registries under 
subsection (g) as necessary to complete a report 
under paragraph (1).’’. 
(b) CONFORMING AMENDMENT.—Section 505(a) of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
355(a)) is amended by inserting ‘‘, or there is in effect 
a conditional approval under section 524C with respect to 
such drug’’ before the period. 
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(c) REIMBURSEMENT.— 
(1) 
PRIVATE
HEALTH
INSURERS.—Section 
2719A of the Public Health Service Act (42 U.S.C. 
300gg–19a) is amended by adding at the end the 
following: 
‘‘(f) COVERAGE
OF CERTAIN DRUGS.—A group 
health plan or health insurance issuer offering group or 
individual health insurance coverage shall provide coverage 
for, and shall not impose any cost sharing requirements 
for, drugs conditionally approved under section 524C of 
the Federal Food, Drug, and Cosmetic Act for patients 
who have the disease or condition the drug is intended 
to treat.’’. 
(2) FEDERAL HEALTH CARE PROGRAMS.—The 
requirement under subsection (f) of section 2719A 
of the Public Health Service Act (as added by para-
graph (1)) shall apply with respect to coverage de-
terminations under a Federal health care program 
(as defined in section 1128B(f) of the Social Secu-
rity Act (42 U.S.C. 1320a–7b(f))) in the same man-
ner such requirement applies under such subsection 
(f). 
(3) 
CONFORMING
AMENDMENT.—Section 
1927(k)(2)(A)(i) of the Social Security Act (42 
U.S.C. 1396r–8(k)(2)(A)(i)) is amended— 
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(A) by striking ‘‘or which’’ and inserting ‘‘, 
which’’; and 
(B) by inserting ‘‘, or which is condi-
tionally approved under section 524C of such 
Act’’ before the semicolon. 
Æ 
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