II 

112TH CONGRESS 

2D SESSION S. 3212 

To require the Secretary of Health and Human Services to promulgate 

regulations regarding the authorship, content, format, and dissemination 

of Patient Medication Information to ensure patients receive consistent 

and high-quality information about their prescription medications and 

are aware of the potential risks and benefits of prescription medications. 

IN THE SENATE OF THE UNITED STATES 

MAY 22, 2012 

Mrs. GILLIBRAND introduced the following bill; which was read twice and 

referred to the Committee on Health, Education, Labor, and Pensions 

A BILL 

To require the Secretary of Health and Human Services 

to promulgate regulations regarding the authorship, content, format, and dissemination of Patient Medication 

Information to ensure patients receive consistent and 

high-quality information about their prescription medications and are aware of the potential risks and benefits 

of prescription medications. 

1 Be it enacted by the Senate and House of Representa2 tives of the United States of America in Congress assembled, 

3 SECTION 1. SHORT TITLE. 

4 This Act may be cited as the ‘‘Cody Miller Initiative 

5 for Safer Prescriptions Act’’. 


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•S 3212 IS

1 SEC. 2. PATIENT MEDICATION INFORMATION FOR PRE2 SCRIPTION DRUGS. 

3 Chapter V of the Federal Food, Drug, and Cosmetic 

4 Act (21 U.S.C. 351 et seq.) is amended by inserting after 

5 section 505D the following: 

6 ‘‘SEC. 505E. PATIENT MEDICATION INFORMATION FOR PRE7 SCRIPTION DRUGS. 

8 ‘‘(a) IN GENERAL.—Not later than 2 years after the 

9 date of enactment of this section, the Secretary shall issue 

10 regulations regarding the authorship, content, format, and 

11 dissemination requirements for patient medication infor12 mation (referred to in this section as ‘PMI’) for drugs sub13 ject to section 503(b)(1). 

14 ‘‘(b) CONTENT.—The regulations promulgated under 

15 subsection (a) shall require that the PMI with respect to 

16 a drug— 

17 ‘‘(1) be scientifically accurate and based on the 

18 professional labeling approved by the Secretary and 

19 authoritative, peer-reviewed literature; and 

20 ‘‘(2) includes nontechnical, understandable, 

21 plain language that is not promotional in tone or 

22 content, and contains at least— 

23 ‘‘(A) the established name of drug, includ24 ing the established name of such drug as a list25 ed drug (as described in section 505(j)(2)(A)) 

26 and as a drug that is the subject of an apVerDate Mar 15 2010 02:55 May 23, 2012 Jkt 019200 PO 00000 Frm 00002 Fmt 6652 Sfmt 6201 E:\BILLS\S3212.IS S3212

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1 proved abbreviated new drug application under 

2 section 505(j) or of an approved license for a 

3 biological product submitted under section 

4 351(k) of the Public Health Service Act, if ap5 plicable; 

6 ‘‘(B) drug uses and clinical benefits; 

7 ‘‘(C) general directions for proper use; 

8 ‘‘(D) contraindications, common side ef9 fects, and most serious risks of the drug, espe10 cially with respect to certain groups such as 

11 children, pregnant women, and the elderly; 

12 ‘‘(E) measures patients may be able to 

13 take, if any, to reduce the side effects and risks 

14 of the drug; 

15 ‘‘(F) when a patient should contact his or 

16 her health care professional; 

17 ‘‘(G) instructions not to share medications, 

18 and, if any exist, key storage requirements, and 

19 recommendations relating to proper disposal of 

20 any unused portion of the drug; and 

21 ‘‘(H) known clinically important inter22 actions with other drugs and substances. 

23 ‘‘(c) TIMELINESS, CONSISTENCY, AND ACCURACY.— 

24 The regulations promulgated under subsection (a) shall in25 clude standards related to— 


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1 ‘‘(1) performing timely updates of drug infor2 mation as new drugs and new information becomes 

3 available; 

4 ‘‘(2) ensuring that common information is ap5 plied consistently and simultaneously across similar 

6 drug products and for drugs within classes of medi7 cations in order to avoid patient confusion and 

8 harm; and 

9 ‘‘(3) developing a process, including consumer 

10 testing, to assess the quality and effectiveness of 

11 PMI in ensuring that PMI promotes patient under12 standing and safe and effective medication use. 

13 ‘‘(d) ELECTRONIC REPOSITORY.—The regulations 

14 promulgated under subsection (a) shall provide for the de15 velopment of a publicly accessible electronic repository for 

16 all PMI documents and content to facilitate the avail17 ability of PMI.’’. 

18 SEC. 3. PUBLICATION ON INTERNET WEBSITE. 

19 The Secretary of Health and Human Services shall 

20 publish on the Internet website of the Food and Drug Ad21 ministration a link to the Daily Med website (http:// 

22 dailymed.nlm.nih.gov/dailymed) (or any successor 

23 website). 

Æ 


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