298 
SEC. 907. STATEMENT FOR INCLUSION IN DIRECT-TO-CON-
SUMER ADVERTISEMENTS OF DRUGS. 
Section 502(n) of the Federal Food, Drug, and Cos-
metic Act (21 U.S.C. 352), as amended by section 
901(d)(3), is further amended by striking ‘‘of this Act, 
except that’’ and inserting ‘‘of this Act, and in the case 
of any direct-to-consumer advertisement the following 
statement: ‘You are encouraged to report adverse effects 
of prescription drug medication to the FDA. Log onto 
www.fda.gov/medwatch or call 1–800-FDA-1088.’, except 
that’’. 
SEC. 908. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 510 the following: 
‘‘SEC. 511. CLINICAL TRIAL GUIDANCE FOR ANTIBIOTIC 
DRUGS. 
‘‘(a) IN GENERAL.—Not later than 1 year after the 
date of enactment of this section, the Secretary, acting 
through the Commissioner of Food and Drugs, shall issue 
guidance for the conduct of clinical trials with respect to 
antibiotic drugs, including antimicrobials to treat acute 
bacterial sinusitis, acute bacterial otitis media, and acute 
bacterial exacerbation of chronic bronchitis. Such guide-
lines shall indicate the appropriate animal models of infec-
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tion, in vitro techniques, and valid microbiologic surrogate 
markers. 
‘‘(b) REVIEW.—Not later than 5 years after the date 
of enactment of this section, the Secretary, acting through 
the Commissioner of Food and Drugs, shall review and 
update the guidance described under subsection (a) to re-
flect developments in scientific and medical information 
and technology.’’. 
SEC. 909. PROHIBITION AGAINST FOOD TO WHICH DRUGS 
OR 
BIOLOGICAL 
PRODUCTS 
HAVE 
BEEN 
ADDED. 
Section 301 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 331), as amended by section 901(d)(2)(A), 
is amended by adding at the end the following: 
‘‘(kk) The introduction or delivery for introduction 
into interstate commerce of any food to which has been 
added— 
‘‘(1) a drug approved under section 505, 
‘‘(2) a biological product licensed under section 
351 of the Public Health Service Act, or 
‘‘(3) a drug or biological product for which sub-
stantial clinical investigations have been instituted 
and for which the existence of such investigations 
has been made public, 
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unless such drug or biological product was marketed in 
food before any approval of the drug under section 505 
of this Act, before licensure of the biological product under 
section 351 of the Public Health Service Act, and before 
any substantial clinical investigations involving the drug 
or biological product have been instituted, or unless the 
Secretary, in the Secretary’s discretion, has issued a regu-
lation, after notice and comment, approving the addition 
of such drug or biological product to the food.’’. 
SEC. 910. ASSURING PHARMACEUTICAL SAFETY. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505B the following: 
‘‘SEC. 505C. PHARMACEUTICAL SECURITY. 
‘‘(a) IN GENERAL.—The Secretary shall develop 
standards and identify and validate effective technologies 
for the purpose of securing the prescription drug distribu-
tion system against counterfeit, diverted, subpotent, sub-
standard, adulterated, misbranded, or expired drugs. 
‘‘(b) STANDARDS DEVELOPMENT.— 
‘‘(1) IN GENERAL.—The Secretary shall, in con-
sultation with the agencies specified in paragraph 
(3), prioritize and develop standards for the identi-
fication, validation, authentication, and tracking of 
prescription drugs. 
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