$10,000 for each day of the violation after such 
period until the violation is corrected. If appli-
cation patient participation in an observational 
registry is not at or above 90 percent within 6 
months of issuance of such penalty, the provi-
sional approval shall be withdrawn. 
‘‘(4) ANNUAL
REPORT
TO
CONGRESS.—The 
Secretary shall submit an annual report to Congress 
on all drugs granted provisional approval under this 
section. Such report shall include— 
‘‘(A) the number of patients treated with 
each such drug, and the number of patients 
tracked in an observational registry with re-
spect to each such drug; 
‘‘(B) a discussion of the minimum amount 
of data required in the registries, including pa-
tient treatments and uses, length of use, side 
effects encountered, relevant biomarkers or sci-
entifically substantiated surrogates, scan re-
sults, cause of death and how long the patient 
lived, and adverse drug effects; 
‘‘(C) a list of all such drugs for which an 
application for approval under section 505 of 
this Act or section 351 of the Public Health 
Service Act, or an application for an extension 
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of provisional approval under this section, has 
been submitted; and 
‘‘(D) a list of all applications denied provi-
sional approval under this section, together with 
an explanation for the decisions to deny each 
such application. 
‘‘(e) WITHDRAWAL OF PROVISIONAL APPROVAL.— 
‘‘(1) IN GENERAL.—The Secretary shall with-
draw provisional approval under this section if there 
are a significant numbers of patients who experience 
serious adverse effects, compared to the other cur-
rently marketed on-label therapies that are available 
for the applicable disease or condition. 
‘‘(2) EFFECT
OF
WITHDRAWAL.—If a provi-
sional approval is withdrawn under this subsection, 
the sponsor may not make the drug available to any 
new patients, but may be allowed to continue to 
make such drug available to patients who started 
taking the drug prior to the date of withdrawal, for 
as long a period as dictated by patient need, as de-
termined by the Secretary. 
‘‘(f) TRANSPARENCY.—Any scientific, medical, aca-
demic, or health care journal publishing an article explain-
ing, releasing, conveying, or announcing research findings 
which were funded by the Department of Health and 
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Human Services shall be prohibited from publishing such 
research unless— 
‘‘(1) such article conveying research findings is 
made publicly available on the journal’s internet 
website without a paywall or charge not later than 
3 months after the date on which such article was 
first provided to subscribers of such journal (or first 
made available for purchase); and 
‘‘(2) the article’s author or researcher or au-
thor’s institution (or, in the case of multiple authors, 
researchers, or institutions, all such authors, re-
searchers, or institutions) received less than 30 per-
cent of funding for such research from the Depart-
ment of Health and Human Services throughout the 
period of time the research was conducted. 
‘‘(g) INFORMED CONSENT.—Prior to receiving a drug 
provisionally approved under this section, the sponsor of 
the drug shall receive from each patient, or the patient’s 
representative, informed consent, through a signed in-
formed consent form, acknowledging that such patient un-
derstands that the drug did not undergo the usual process 
for approval of a drug by the Food and Drug Administra-
tion, and that such patient is willing to accept the risks 
involved in taking such drug. 
‘‘(h) POSTMARKET CONTROLS AND LABELING.— 
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‘‘(1) FDA 
ANNUAL
REVIEW
OF
REGISTRY 
DATA.—The Secretary shall annually review the data 
made available through the observational registries 
under subsection (d) and make a determination re-
garding whether the side effect profile of any drug 
provisionally approved under this section does not 
support the benefit provided, or the data shows the 
benefit is less than the benefits offered through 
other, fully approved drugs. 
‘‘(2) LABELING.—The sponsor of the provision-
ally approved drug shall ensure that all labeling and 
promotional materials for the drug bear the state-
ment ‘provisionally approved by the FDA pending a 
full demonstration of effectiveness under application 
number llllll’ (specifying the application 
number assigned by the Secretary in place of the 
blank). All promotional, educational and marketing 
materials for provisionally approved products shall 
be reviewed and approved by the Secretary before 
such materials are distributed. 
‘‘(3) 
RESCISSION
OF
PROVISIONAL
AP-
PROVAL.—If the Secretary determines that the side 
effect profile of any drug included in such observa-
tional registries does not support the benefit pro-
vided by such drug, or that the data shows that the 
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benefit is less than the benefits offered through 
other drugs approved under section 505 of this Act 
or section 351 of the Public Health Service Act, the 
Secretary shall rescind such provisional approval. 
‘‘(i) DURATION
OF PROVISIONAL APPROVAL; RE-
QUIREMENT TO BRING DRUG TO MARKET.— 
‘‘(1) DURATION; RENEWALS.—The provisional 
approval for a drug under this section is effective for 
a 2-year period. The sponsor may request renewal 
for provisional approval status for up to 3 subse-
quent 2-year periods. Provisional approval status 
with respect to a drug shall not exceed a total of 8 
years from the initial date the sponsor was awarded 
provisional approval status. 
‘‘(2) MARKETING REQUIREMENT.—If any drug 
that receives provisional approval under this section 
is not brought to market within 180 days of the pro-
visional approval, such provisional approval shall be 
rescinded. 
‘‘(j) LIMITATION ON LIABILITY.—With respect to any 
claim under State law alleging that a drug sold or other-
wise made available pursuant to a grant of provisional ap-
proval under this section is unsafe or ineffective, no liabil-
ity in a cause of action shall lie against a sponsor or manu-
facturer, unless the relevant conduct constitutes reckless 
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or willful misconduct, gross negligence, or an intentional 
tort under any applicable State law. 
‘‘(k) RIGHT TO PETITION AN ADVISORY COMMITTEE 
FOR APPROVAL.— 
‘‘(1) IN
GENERAL.—The sponsor of a drug 
granted provisional approval pursuant to this section 
may request, at any time after provisional approval 
is granted under this section, a meeting with the ap-
propriate advisory committee (or advisory commit-
tees) to present safety and efficacy data for the pur-
poses of receiving a recommendation from such an 
advisory committee for approval under section 505 
of this Act or section 351 of the Public Health Serv-
ice Act of the provisionally approved drug. Such a 
requested meeting shall be granted not later than 90 
days after a request is made. Nothing in this para-
graph shall be construed to alter the processes and 
timeframes for recommendation for approval by such 
an advisory committee of the provisionally approved 
drug or for approval of the provisionally approved 
drug under section 505 of this Act or section 351 
of the Public Health Service Act. 
‘‘(2) WAIVER OF ADEQUATE AND WELL-CON-
TROLLED STUDY REQUIREMENTS.— 
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‘‘(A) IN GENERAL.—In considering wheth-
er to recommend a drug that was provisionally 
approved under this section for approval under 
section 505, the Director of the Center for 
Drug Evaluation and Research shall consider 
the option to waive requirements for adequate 
and well-controlled studies in accordance with 
the process described in section 314.126(c) of 
title 21, Code of Federal Regulations (or suc-
cessor regulations). 
‘‘(B) BIOLOGICAL PRODUCTS.—In consid-
ering whether to recommend a biological prod-
uct that was provisionally approved under this 
section for licensure under section 351 of the 
Public Health Service Act, the Director of the 
Center for Biologics Evaluation and Research 
may, and shall consider the option to, waive re-
quirements, as applicable, for adequate and 
well-controlled studies for such biological prod-
uct in accordance with the process described in 
section 314.126(c) of title 21, Code of Federal 
Regulations (or successor regulations).’’. 
(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 
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a provisional approval under section 524C with respect to 
such drug’’ before the period. 
(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) TREATMENT
OF CERTAIN DRUGS.—A group 
health plan or health insurance issuer of group or indi-
vidual health insurance coverage shall not deny coverage 
of any drug provisionally approved under section 524C of 
the Federal Food, Drug, and Cosmetic Act on the basis 
of such drug being experimental. In determining coverage 
under the applicable plan or coverage, a group health plan 
or health insurance issuer shall treat a drug provisionally 
approved under such section in the same manner as such 
plan or coverage would treat a drug approved under sec-
tion 505 of the Federal Food, Drug, and Cosmetic Act 
or section 351 of this Act. Nothing in this subsection shall 
be construed to require a group health plan or health in-
surance issuer to cover any specific drug provisionally ap-
proved under such section 524C.’’. 
(2) FEDERAL HEALTH CARE PROGRAMS.—The 
requirement under subsection (f) of section 2719A 
of the Public Health Service Act (as added by para-
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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— 
(A) by striking ‘‘or which’’ and inserting ‘‘, 
which’’; and 
(B) by inserting ‘‘, or which is provision-
ally approved under section 524C of such Act’’ 
before the semicolon. 
Æ 
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