SEC. 2. PATIENT MEDICATION INFORMATION FOR PRE-
SCRIPTION DRUGS. 
Chapter V of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 351 et seq.) is amended by inserting after 
section 505D the following: 
‘‘SEC. 505E. PATIENT MEDICATION INFORMATION FOR PRE-
SCRIPTION DRUGS. 
‘‘(a) IN GENERAL.—Not later than 2 years after the 
date of enactment of this section, the Secretary shall issue 
regulations regarding the authorship, content, format, and 
dissemination requirements for patient medication infor-
mation (referred to in this section as ‘PMI’) for drugs sub-
ject to section 503(b)(1). 
‘‘(b) CONTENT.—The regulations promulgated under 
subsection (a) shall require that the PMI with respect to 
a drug— 
‘‘(1) be scientifically accurate and based on the 
professional labeling approved by the Secretary and 
authoritative, peer-reviewed literature; and 
‘‘(2) includes nontechnical, understandable, 
plain language that is not promotional in tone or 
content, and contains at least— 
‘‘(A) the established name of drug, includ-
ing the established name of such drug as a list-
ed drug (as described in section 505(j)(2)(A)) 
and as a drug that is the subject of an ap-
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proved abbreviated new drug application under 
section 505(j) or of an approved license for a 
biological product submitted under section 
351(k) of the Public Health Service Act, if ap-
plicable; 
‘‘(B) drug uses and clinical benefits; 
‘‘(C) general directions for proper use; 
‘‘(D) contraindications, common side ef-
fects, and most serious risks of the drug, espe-
cially with respect to certain groups such as 
children, pregnant women, and the elderly; 
‘‘(E) measures patients may be able to 
take, if any, to reduce the side effects and risks 
of the drug; 
‘‘(F) when a patient should contact his or 
her health care professional; 
‘‘(G) instructions not to share medications, 
and, if any exist, key storage requirements, and 
recommendations relating to proper disposal of 
any unused portion of the drug; and 
‘‘(H) known clinically important inter-
actions with other drugs and substances. 
‘‘(c) TIMELINESS, CONSISTENCY, AND ACCURACY.— 
The regulations promulgated under subsection (a) shall in-
clude standards related to— 
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‘‘(1) performing timely updates of drug infor-
mation as new drugs and new information becomes 
available; 
‘‘(2) ensuring that common information is ap-
plied consistently and simultaneously across similar 
drug products and for drugs within classes of medi-
cations in order to avoid patient confusion and 
harm; and 
‘‘(3) developing a process, including consumer 
testing, to assess the quality and effectiveness of 
PMI in ensuring that PMI promotes patient under-
standing and safe and effective medication use. 
‘‘(d) SUBMISSION OF PMI.— 
‘‘(1) SUBMISSION OF PMI FOR APPROVAL.—The 
regulations 
promulgated 
under 
subsection 
(a) 
shall— 
‘‘(A) with respect to any drug for which an 
application is submitted under subsection (b) or 
(j) of section 505 of this Act, or under sub-
section (a) or (k) of section 351 of the Public 
Health Service Act, on or after the date that is 
18 months after the date of the enactment of 
the Cody Miller initiative for Safer Prescrip-
tions Act— 
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‘‘(i) require the sponsor of the drug to 
submit PMI for the drug as part of such 
application; and 
‘‘(ii) provide for approval or dis-
approval of the PMI as part of the process 
for approving or disapproving the applica-
tion; and 
‘‘(B) with respect to any other drug law-
fully marketed in the United States— 
‘‘(i) require the sponsor of the drug to 
submit PMI for the drug to the Secretary; 
and 
‘‘(ii) provide for approval or dis-
approval of the PMI. 
‘‘(2) IDENTICAL PMI FOR GENERIC DRUGS.— 
The regulations promulgated under subsection (a) 
shall require the PMI for a drug subject to an ab-
breviated new drug application under section 505(j) 
to be identical to the PMI for the listed drug (as 
such term is used in section 505(j)), except for ex-
cluding any portion of the PMI for the listed drug 
that is protected by patent or by an exclusivity pe-
riod under this Act. 
‘‘(e) ELECTRONIC REPOSITORY.— 
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‘‘(1) IN
GENERAL.—The regulations promul-
gated under subsection (a) shall provide for the de-
velopment of a publicly accessible electronic reposi-
tory for all PMI documents and content to facilitate 
the availability of PMI. 
‘‘(2) EFFECT OF SUBMISSION.—If the sponsor 
of a drug submits PMI to such electronic registry, 
the sponsor is deemed, subject to the deadlines spec-
ified in subsection (d)(1), to have submitted the 
PMI for purposes of subsection (d)(1).’’. 
SEC. 3. PUBLICATION ON INTERNET WEB SITE. 
The Secretary of Health and Human Services shall 
publish on the Internet Web site of the Food and Drug 
Administration a link to the Daily Med Web site (http:// 
dailymed.nlm.nih.gov/dailymed) (or any successor Web 
site). 
Æ 
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