172 
(b) GAO REPORT.—Not later than December 31, 
2026, the Comptroller General of the United States shall 
submit to the Committee on Energy and Commerce of the 
House of Representatives and the Committee on Health, 
Education, Labor, and Pensions of the Senate a report 
on— 
(1) the number of proposed modifications to an 
approved risk evaluation and mitigation strategy the 
Secretary has granted under section 505–1(h) of the 
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 
255–1(h)); 
(2) any issues affecting patient access to the 
drug that is subject to the strategy or considerations 
with respect to the administration or prescribing of 
such drug by health care providers that arose as a 
result of such modifications; and 
(3) how such issues were resolved, as applica-
ble. 
SEC. 809. FACILITATING EXCHANGE OF PRODUCT INFOR-
MATION PRIOR TO APPROVAL. 
(a) IN GENERAL.—Section 502 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 352) is amended 
(1) in paragraph (a), by striking ‘‘drug’’ each 
place it appears and inserting ‘‘drug or device’’; 
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(2) in paragraph (a)(2)(B), by striking ‘‘under 
section 505 or under section 351 of the Public 
Health Service Act for such drug’’ and inserting 
‘‘under section 505, 510(k), 513, or 515 of this Act 
or section 351 of the Public Health Service Act’’; 
and 
(3) by adding at the end the following: 
‘‘(gg)(1) Unless its labeling bears adequate directions 
for use in accordance with paragraph (f), except that (in 
addition to drugs or devices that conform with exemptions 
pursuant to such paragraph) no drug or device shall be 
considered misbranded under such paragraph through the 
provision of product information to a payor, formulary 
committee, or other similar entity with knowledge and ex-
pertise in the area of health care economic analysis car-
rying out its responsibilities for the selection of drugs or 
devices for coverage or reimbursement if the product infor-
mation relates to an investigational drug or device or in-
vestigational use of a drug or device that is approved, 
cleared, granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of this Act 
or section 351 of the Public Health Service Act (as appli-
cable), provided— 
‘‘(A) the product information includes— 
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‘‘(i) a clear statement that the investiga-
tional drug or device or investigational use of a 
drug or device has not been approved, cleared, 
granted marketing authorization, or licensed 
under section 505, 510(k), 513(f)(2), or 515 of 
this Act or section 351 of the Public Health 
Service Act (as applicable) and that the safety 
and effectiveness of the drug or device or use 
has not been established; 
‘‘(ii) information related to the stage of de-
velopment of the drug or device involved, such 
as— 
‘‘(I) the status of any study or studies 
in which the investigational drug or device 
or investigational use is being investigated; 
‘‘(II) how the study or studies relate 
to the overall plan for the development of 
the drug or device; and 
‘‘(III) whether a premarket applica-
tion, premarket notification, or request for 
classification for the investigational drug 
or device or investigational use has been 
submitted to the Secretary and when such 
a submission is planned; 
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175 
‘‘(iii) in the case of information that in-
cludes factual presentations of results from 
studies, which shall not be selectively presented, 
a description of— 
‘‘(I) all material aspects of study de-
sign, methodology, and results; and 
‘‘(II) all material limitations related 
to the study design, methodology, and re-
sults; 
‘‘(iv) where applicable, a prominent state-
ment disclosing the indication or indications for 
which the Food and Drug Administration has 
approved, granted marketing authorization, 
cleared, or licensed the product pursuant to sec-
tion 505, 510(k), 513(f)(2), or 515 of this Act 
or section 351 of the Public Health Service Act, 
and a copy of the most current approved label-
ing; and 
‘‘(v) updated information, if previously 
communicated information becomes materially 
outdated as a result of significant changes or as 
a result of new information regarding the prod-
uct or its review status; and 
‘‘(B) the product information does not in-
clude— 
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176 
‘‘(i) information that represents that an 
unapproved product— 
‘‘(I) has been approved, cleared, 
granted marketing authorization, or li-
censed 
under 
section 
505, 
510(k), 
513(f)(2), or 515 of this Act or section 
351 of the Public Health Service Act (as 
applicable); or 
‘‘(II) has otherwise been determined 
to be safe or effective for the purpose or 
purposes for which the drug or device is 
being studied; or 
‘‘(ii) information that represents that an 
unapproved use of a drug or device that has 
been so approved, granted marketing authoriza-
tion, cleared, or licensed— 
‘‘(I) is so approved, granted mar-
keting authorization, cleared, or licensed; 
or 
‘‘(II) that the product is safe or effec-
tive for the use or uses for which the drug 
or device is being studied. 
‘‘(2) For purposes of this subsection, the term ‘prod-
uct information’ includes— 
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177 
‘‘(A) information describing the drug or device 
(such as drug class, device description, and fea-
tures); 
‘‘(B) information about the indication or indica-
tions being investigated; 
‘‘(C) the anticipated timeline for a possible ap-
proval, clearance, marketing authorization, or licen-
sure pursuant to section 505, 510(k), 513, or 515 
of this Act or section 351 of the Public Health Serv-
ice Act; 
‘‘(D) drug or device pricing information; 
‘‘(E) patient utilization projections; 
‘‘(F) product-related programs or services; and 
‘‘(G) factual presentations of results from stud-
ies that do not characterize or make conclusions re-
garding safety or efficacy.’’. 
(b) GAO STUDY AND REPORT.—Beginning on the 
date that is 5 years and 6 months after the date of enact-
ment of this Act, the Comptroller General of the United 
States shall conduct a study on the provision and use of 
information pursuant to section 502(gg) of the Federal 
Food, Drug, and Cosmetic Act, as added by this sub-
section (a), between manufacturers of drugs and devices 
(as defined in section 201 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 321)) and entities described in 
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179 
SEC. 810. BANS OF DEVICES FOR ONE OR MORE INTENDED 
USES. 
(a) IN GENERAL.—Section 516(a) of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 360f(a)) is 
amended— 
(1) in paragraph (1), by inserting ‘‘for one or 
more intended use’’ before the semicolon at the end; 
and 
(2) in the matter following paragraph (2), by 
inserting ‘‘for any such intended use or uses. A de-
vice that is banned for one or more intended uses is 
not a legally marketed device under section 1006 
when intended for such use or uses’’ after ‘‘banned 
device’’. 
(b) SPECIFIC DEVICES DEEMED BANNED.—Section 
516 of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360f) is further amended by adding at the end the 
following: 
‘‘(c) SPECIFIC DEVICE BANNED.—Electrical stimula-
tion devices that apply a noxious electrical stimulus to a 
person’s skin intended to reduce or cease self-injurious be-
havior or aggressive behavior are deemed to be banned de-
vices, as described in subsection (a). Such devices are 
banned unless or until the Secretary promulgates a regula-
tion to make such devices no longer banned based on a 
finding that such devices do not present an unreasonable 
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180 
and substantial risk of illness or injury, or that such risk 
can be corrected or eliminated by labeling.’’. 
SEC. 811. CLARIFYING APPLICATION OF EXCLUSIVE AP-
PROVAL, 
CERTIFICATION, 
OR 
LICENSURE 
FOR DRUGS DESIGNATED FOR RARE DIS-
EASES OR CONDITIONS. 
Section 527 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360cc) is amended— 
(1) in subsection (a), in the matter following 
paragraph (2), by striking ‘‘same disease or condi-
tion’’ and inserting ‘‘same indication or use for 
which the Secretary has approved or licensed such 
drug’’; 
(2) in subsection (b)— 
(A) in the matter preceding paragraph (1), 
by striking ‘‘same rare disease or condition’’ 
and inserting ‘‘same indication or use for which 
the Secretary has approved or licensed such 
drug’’; and 
(B) in paragraph (1), by striking ‘‘with the 
disease or condition for which the drug was des-
ignated’’ and inserting ‘‘for whom the drug is 
indicated’’; and 
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181 
(3) in subsection (c), by striking ‘‘same rare 
disease or condition’’ and inserting ‘‘same indication 
or use’’. 
SEC. 812. GAO REPORT ON THIRD-PARTY REVIEW. 
Not later than September 30, 2026, the Comptroller 
General of the United States shall submit to the Com-
mittee on Energy and Commerce of the House of Rep-
resentatives and the Committee on Health, Education, 
Labor, and Pensions of the Senate a report on the third- 
party review program described in section 523 of the Fed-
eral Food, Drug, and Cosmetic Act (21 U.S.C. 360m). 
Such report shall include— 
(1) a description of the financial and staffing 
resources used to carry out such program; 
(2) a description of actions taken by the Sec-
retary pursuant section 523(b)(2)(C) of the Federal 
Food, 
Drug, 
and 
Cosmetic 
Act 
(21 
U.S.C. 
360m(b)(2)(C)); and 
(3) the results of an audit of the performance 
of select persons accredited under such program. 
SEC. 813. REAUTHORIZATION OF DEVICE PILOT PROJECTS. 
Section 519(i)(10) of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360i(i)(10)) is amended by strik-
ing ‘‘2022’’ and inserting ‘‘2027’’. 
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SEC. 814. REPORTING ON PENDING GENERIC DRUG APPLI-
CATIONS AND PRIORITY REVIEW APPLICA-
TIONS. 
Section 807 of the FDA Reauthorization Act of 2017 
(Public Law 115–52) is amended, in the matter preceding 
paragraph (1), by striking ‘‘2022’’ and inserting ‘‘2027’’. 
Æ 
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