effect on the date that is 180 days after the date of the 
enactment of this Act. 
(c) REGULATIONS.—Not later than the date that is 
180 days after the date of the enactment of this Act, the 
Secretary of Health and Human Services shall promulgate 
final regulations to implement such requirements. 
SEC. 5. LIABILITY UNDER STATE AND LOCAL REQUIRE-
MENTS RESPECTING DEVICES. 
(a) AMENDMENT.—Section 521 of the Federal Food, 
Drug, and Cosmetic Act (21 U.S.C. 360k) is amended by 
adding at the end the following: 
‘‘(c) NO EFFECT
ON LIABILITY UNDER STATE 
LAW.—Nothing in this section shall be construed to mod-
ify or otherwise affect any action for damages or the liabil-
ity of any person under the law of any State.’’. 
(b) EFFECTIVE DATE; APPLICABILITY.—The amend-
ment made by subsection (a) shall— 
(1) take effect as if included in the enactment 
of the Medical Device Amendments of 1976 (Public 
Law 94–295); and 
(2) apply to any civil action pending or filed on 
or after the date of enactment of this Act. 
SEC. 6. CLARITY IN DRUG LABELING. 
(a) IN GENERAL.—Not later than 1 year after the 
date of the enactment of this Act, the Secretary of Health 
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and Human Services (in this section referred to as the 
‘‘Secretary’’), acting through the Commissioner of Food 
and Drugs, shall— 
(1) complete a review of the Food and Drug 
Administration’s regulations and guidance per-
taining to the labeling of drugs and biological prod-
ucts; and 
(2) revise such regulations and guidance as ap-
propriate to improve the clarity and readability of 
such labeling. 
(b) APPLICABILITY.— 
(1) NEW PRODUCTS.—With respect to the label-
ing of any drug or biological product that is ap-
proved or licensed under section 505 of the Federal 
Food, Drug, and Cosmetic Act (21 U.S.C. 355) or 
section 351 of the Public Health Service Act (42 
U.S.C. 262) on or after the day that is 1 year after 
the date of the enactment of this Act, the revised 
regulations and guidance under subsection (a)(2) 
shall apply as of the date of such approval or licen-
sure. 
(2) EXISTING PRODUCTS.—With respect to any 
drug or biological product that was so approved or 
licensed before such day, the revised regulations and 
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guidance under subsection (a)(2) shall apply as soon 
as the Secretary determines practicable. 
SEC. 7. DISCLOSURE OF CLINICAL TRIAL ADVERSE EVENTS 
ON FDA WEB SITE. 
(a) IN GENERAL.—The Secretary of Health and 
Human Services, acting through the Commissioner of 
Food and Drugs, shall make all clinical trial adverse 
events included in the registry and results data bank of 
the National Institutes of Health publicly available on the 
Web site of the Food and Drug Administration. 
(b) DEFINITION.—In this section, the term ‘‘registry 
and results data bank’’ has the meaning given to such 
term in section 402(j)(3)(B)(i) of the Public Health Serv-
ice Act (42 U.S.C. 282(j)(3)(B)(i)). 
SEC. 8. PROHIBITION AGAINST PARTICIPATION BY ADVI-
SORY 
COMMITTEE 
MEMBERS 
WITH 
CON-
FLICTS OF INTEREST. 
Section 712 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 379d–1) is amended— 
(1) in paragraph (2) of subsection (b), by strik-
ing ‘‘, so as to reduce’’ and all that follows through 
the end of the paragraph and inserting a period; 
(2) in subsection (c)— 
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(A) by amending the subsection heading to 
read as follows: ‘‘PROHIBITION; INAPPLICA-
BILITY OF WAIVERS’’; 
(B) in subparagraph (A) of paragraph (2), 
by striking ‘‘Except as provided under subpara-
graph (B), a member’’ and inserting ‘‘A mem-
ber’’; 
(C) by striking subparagraphs (B) and (C) 
of paragraph (2) and inserting the following: 
‘‘(B) INAPPLICABILITY
OF
WAIVERS.—A 
member of an advisory committee under this 
Act may not, with respect to service on such 
committee, be granted a written determination 
as referred to in section 208(b)(1) of title 18, 
United States Code, or a written certification as 
referred to in section 208(b)(3) of title 18, 
United States Code.’’; and 
(D) by striking paragraph (3); 
(3) in subsection (e)— 
(A) in paragraph (1), by inserting ‘‘and’’ 
at the end; 
(B) by striking paragraphs (2) and (3); 
and 
(C) by redesignating paragraph (4) as 
paragraph (2); and 
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(4) by striking subsection (f). 
SEC. 9. FEES RELATING TO ADVERTISEMENTS FOR DRUGS 
AND DEVICES. 
Part 2 of subchapter C of chapter VII (21 U.S.C. 
379g et seq.) is amended by inserting after section 736A 
the following: 
‘‘SEC. 736A–1. FEES RELATING TO ADVERTISEMENTS FOR 
DRUGS AND DEVICES. 
‘‘(a) IN GENERAL.—Beginning with respect to fiscal 
year 2011, each person intending to publish or dissemi-
nate an advertisement for a drug or device during a fiscal 
year shall, prior to the advertisement’s initial publication 
or dissemination during such fiscal year, pay a fee to the 
Secretary in the amount established under subsection (b). 
‘‘(b) FEE AMOUNTS.— 
‘‘(1) TOTAL REVENUE AMOUNTS.—For each of 
fiscal years 2011 through 2015, the Secretary shall 
establish fees under subsection (a) to generate a 
total revenue amount equal to $4,000,000, except 
that such amount shall be adjusted for each of fiscal 
years 2012 through 2015 to reflect inflation. 
‘‘(2) FEE SETTING.—The Secretary shall— 
‘‘(A) set the amount of fees to be assessed 
and collected under this section before the start 
of the relevant fiscal year; 
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‘‘(B) make such fees payable with respect 
to each distinct advertisement for a drug or de-
vice to be published or disseminated during the 
fiscal year; and 
‘‘(C) set the amount of such fees without 
regard to the number of times on which the ad-
vertisement is so published or disseminated. 
‘‘(3) LIMIT.—Notwithstanding paragraph (1), 
the fees under this section shall be retained in each 
fiscal year in an amount not to exceed the total costs 
for such fiscal year for the regulation of advertise-
ments for drugs and devices. 
‘‘(c) DEFINITION.—In this section: 
‘‘(1) The term ‘advertisement’ shall be defined 
by the Secretary. 
‘‘(2) The term ‘regulation of advertisements for 
drugs and devices’— 
‘‘(A) means any regulation of advertise-
ments for drugs and devices by the Food and 
Drug Administration under this Act; and 
‘‘(B) notwithstanding subparagraph (A), 
excludes activities for which fees are assessed 
and collected under section 736A (relating to 
the process for the advisory review of prescrip-
tion drug advertising). 
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