II 

110TH CONGRESS 

1ST SESSION S. 1024 

To improve the underlying science of drug safety decisionmaking and 

strengthen the ability of the Food and Drug Administration to assess, 

manage, and communicate drug safety information to patients and providers. 

IN THE SENATE OF THE UNITED STATES 

MARCH 29, 2007 

Mr. GREGG (for himself, Mr. BURR, and Mr. COBURN) introduced the following bill; which was read twice and referred to the Committee on 

Health, Education, Labor, and Pensions 

A BILL 

To improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug 

Administration to assess, manage, and communicate drug 

safety information to patients and providers. 

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 ‘‘Safer Drug Assess5 ment Technology Advancement Act’’ or the ‘‘Safer DATA 

6 Act’’. 


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1 SEC. 2. POSTMARKET RISK IDENTIFICATION AND ANAL2 YSIS; DISSEMINATION OF POSTMARKET 

3 DRUG SAFETY INFORMATION. 

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

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

6 section 505B the following: 

7 ‘‘SEC. 505C. POSTMARKET RISK IDENTIFICATION AND 

8 ANALYSIS; DISSEMINATION OF POSTMARKET 

9 DRUG SAFETY INFORMATION. 

10 ‘‘(a) POSTMARKET RISK IDENTIFICATION AND ANAL11 YSIS.— 

12 ‘‘(1) DEVELOPMENT OF THE POSTMARKET RISK

13 IDENTIFICATION AND ANALYSIS SYSTEM.—The Sec14 retary shall, not later than 2 years after the date of 

15 enactment of the Safer DATA Act, act in collabora16 tion with academic institutions and private entities 

17 to— 

18 ‘‘(A) establish minimum standards for col19 lection and transmission of postmarketing data 

20 elements from electronic health data systems; 

21 and 

22 ‘‘(B) establish, through partnerships, a 

23 validated and integrated postmarket risk identi24 fication and analysis system to integrate and 

25 analyze safety data from multiple sources. 

26 ‘‘(2) DATA COLLECTION ACTIVITIES.— 


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1 ‘‘(A) IN GENERAL.—The Secretary shall, 

2 not later than 1 year after the establishment of 

3 the minimum standards and the identification 

4 and analysis system under paragraph (1), es5 tablish and maintain an active surveillance in6 frastructure— 

7 ‘‘(i) to collect and report data for 

8 pharmaceutical postmarket risk identifica9 tion and analysis, in compliance with the 

10 regulations promulgated under section 

11 264(c) of the Health Insurance Portability 

12 and Accountability Act of 1996; and 

13 ‘‘(ii) that includes, in addition to the 

14 current collection and monitoring (in a 

15 standardized form) of data on all pharma16 ceutical serious adverse events (as defined 

17 in section 760) required to be submitted to 

18 the Secretary, and those events voluntarily 

19 submitted from patients, providers, and 

20 drug, when appropriate, procedures to— 

21 ‘‘(I) provide for adverse event 

22 surveillance by collecting and moni23 toring Federal health-related elec24 tronic data (such as data from the 

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1 tems of the Department of Veterans 

2 Affairs); 

3 ‘‘(II) provide for adverse event 

4 surveillance by collecting and moni5 toring private sector health-related 

6 electronic data (such as pharma7 ceutical purchase data and health in8 surance claims data); 

9 ‘‘(III) provide for adverse event 

10 surveillance by monitoring standard11 ized electronic health records, as 

12 available; 

13 ‘‘(IV) provide for adverse event 

14 surveillance by collecting and moni15 toring other information as the Sec16 retary deems necessary to create a ro17 bust system to identify adverse events 

18 and potential drug safety signals; 

19 ‘‘(V) enable the program to iden20 tify certain trends and patterns with 

21 respect to data reported to the pro22 gram; 

23 ‘‘(VI) enable the program to pro24 vide regular reports to the Secretary 

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1 verse event patterns, incidence and 

2 prevalence of adverse events, labora3 tory data, and other information de4 termined appropriate, which may in5 clude data on comparative national 

6 adverse event trends; and 

7 ‘‘(VII) enable the program to ex8 port data in a form appropriate for 

9 further aggregation, statistical anal10 ysis, and reporting. 

11 ‘‘(B) TIMELINESS OF REPORTING.—The 

12 procedures developed under subparagraph (A) 

13 shall ensure that such data are collected, mon14 itored, and reported in a timely, routine, and 

15 automatic manner, taking into consideration the 

16 need for data completeness, coding, cleansing, 

17 and transmission. 

18 ‘‘(C) PRIVATE SECTOR RESOURCES.—To 

19 ensure the establishment of the active surveil20 lance infrastructure by the date described under 

21 subparagraph (A), the Secretary may, on a 

22 temporary or permanent basis, implement sys23 tems or products developed by private entities. 

24 ‘‘(D) AUTHORITY FOR CONTRACTS.—The 

25 Secretary may enter into contracts with public 


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1 and private entities to fulfill the requirements 

2 of this paragraph. 

3 ‘‘(3) RISK IDENTIFICATION AND ANALYSIS.— 

4 ‘‘(A) PURPOSE.—To carry out this sub5 section, the Secretary shall establish collabora6 tions with other Government, academic, and 

7 private entities to provide for the risk identi8 fication and analysis of the data collected under 

9 paragraph (2) and data that is publicly avail10 able or is provided by the Secretary, in order 

11 to— 

12 ‘‘(i) improve the quality and efficiency 

13 of postmarket drug safety risk-benefit 

14 analysis; 

15 ‘‘(ii) provide the Secretary with rou16 tine access to expertise to study advanced 

17 drug safety data; and 

18 ‘‘(iii) enhance the ability of the Sec19 retary to make timely assessments based 

20 on drug safety data. 

21 ‘‘(B) PROCEDURES FOR THE DEVELOP22 MENT OF DRUG SAFETY COLLABORATIONS.— 

23 ‘‘(i) IN GENERAL.—Not later than 

24 180 days after the date of establishment of 

25 the active surveillance infrastructure under 


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1 paragraph (2), the Secretary shall estab2 lish and implement procedures under which 

3 the Secretary may routinely collaborate 

4 with a qualified entity to— 

5 ‘‘(I) clean, classify, or aggregate 

6 data collected under paragraph (2) 

7 and data that is publicly available or 

8 is provided by the Secretary; 

9 ‘‘(II) perform advanced research 

10 on identified drug safety risks; 

11 ‘‘(III) identify safety questions 

12 that require further clinical study; 

13 ‘‘(IV) convene an expert advisory 

14 committee to oversee the establish15 ment of standards for the ethical and 

16 scientific uses for, and communication 

17 of, postmarketing data collected under 

18 paragraph (2), including advising on 

19 the development of effective research 

20 methods for the study of drug safety 

21 questions; and 

22 ‘‘(V) carry out other activities as 

23 the Secretary deems necessary to 

24 carry out the purpose of this para25 graph. 


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1 ‘‘(ii) REQUEST FOR SPECIFIC METH2 ODOLOGY.—The procedures described in 

3 clause (i) shall permit the Secretary to re4 quest that a specific methodology be used 

5 by the qualified entity. The qualified entity 

6 shall work with the Secretary to finalize 

7 the methodology to be used. 

8 ‘‘(C) QUALIFIED ENTITIES.— 

9 ‘‘(i) IN GENERAL.—The Secretary 

10 shall enter into contracts with a sufficient 

11 number of qualified entities to develop and 

12 provide information to the Secretary in a 

13 timely manner. 

14 ‘‘(ii) QUALIFICATIONS.—The Sec15 retary shall enter into a contract with an 

16 entity under clause (i) only if the Secretary 

17 determines that the entity— 

18 ‘‘(I) has the research capability 

19 and expertise to conduct and complete 

20 the activities under this subsection; 

21 ‘‘(II) has in place an information 

22 technology infrastructure to support 

23 adverse event surveillance data and 

24 operational standards to provide secu25 rity for such data; 


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1 ‘‘(III) has experience with, and 

2 expertise on, the development of drug 

3 safety and effectiveness research using 

4 electronic population data; 

5 ‘‘(IV) has an understanding of 

6 drug development and risk/benefit bal7 ancing in a clinical setting; and 

8 ‘‘(V) has a significant business 

9 presence in the United States. 

10 ‘‘(D) CONTRACT REQUIREMENTS.—Each 

11 contract with a qualified entity shall contain the 

12 following requirements: 

13 ‘‘(i) ENSURING PRIVACY.—The quali14 fied entity shall provide assurances that 

15 the entity will not use the data provided by 

16 the Secretary in a manner that violates— 

17 ‘‘(I) the Federal regulations pro18 mulgated under section 264(c) of the 

19 Health Insurance Portability and Ac20 countability Act of 1996 (concerning 

21 the privacy of individually-identifiable 

22 beneficiary health information); or 

23 ‘‘(II) sections 552 or 552a of 

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1 identifiable beneficiary health infor2 mation. 

3 ‘‘(ii) COMPONENT OF ANOTHER ORGA4 NIZATION.—If a qualified entity is a com5 ponent of another organization— 

6 ‘‘(I) the qualified entity shall 

7 maintain the data related to the ac8 tivities carried out under this sub9 section separate from the other com10 ponents of the organization and estab11 lish appropriate security measures to 

12 maintain the confidentiality and pri13 vacy of such data; and 

14 ‘‘(II) the entity shall not make 

15 an unauthorized disclosure of such 

16 data to the other components of the 

17 organization in breach of such con18 fidentiality and privacy requirement. 

19 ‘‘(iii) TERMINATION OR NON20 RENEWAL.—If a contract under this sub21 section is terminated or not renewed, the 

22 following requirements shall apply: 

23 ‘‘(I) CONFIDENTIALITY AND PRI24 VACY PROTECTIONS.—The entity shall 

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1 tiality and privacy requirements under 

2 this subsection with respect to all data 

3 disclosed to the entity. 

4 ‘‘(II) DISPOSITION OF DATA.— 

5 The entity shall return to the Sec6 retary all data disclosed to the entity 

7 or, if returning the data is not prac8 ticable, destroy the data. 

9 ‘‘(E) COMPETITIVE PROCEDURES.—The 

10 Secretary shall use competitive procedures (as 

11 defined in section 4(5) of the Federal Procure12 ment Policy Act) to enter into contracts under 

13 subparagraph (C). 

14 ‘‘(F) REVIEW OF CONTRACT IN THE

15 EVENT OF A MERGER OR ACQUISITION.—The 

16 Secretary shall review the contract with a quali17 fied entity under this subsection in the event of 

18 a merger or acquisition of the entity in order to 

19 ensure that the requirements under this sub20 section will continue to be met. 

21 ‘‘(4) COORDINATION.—In carrying out this sub22 section, the Secretary shall provide for appropriate 

23 communications to the public, scientific, public 

24 health, and medical communities, and other key 

25 stakeholders, and provide for the coordination of the 


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1 activities of private entities, professional associa2 tions, or other entities that may have sources of sur3 veillance data. 

4 ‘‘(b) POSTMARKET DRUG SAFETY INFORMATION FOR

5 PATIENTS AND PROVIDERS.— 

6 ‘‘(1) ESTABLISHMENT.—Not later than 1 year 

7 after the date of enactment of the Safer DATA Act, 

8 the Secretary shall improve the transparency of 

9 pharmaceutical data and allow patients and health 

10 care providers better access to pharmaceutical data 

11 by developing and maintaining an Internet site 

12 that— 

13 ‘‘(A) provides comprehensive drug safety 

14 information for prescription drugs that are ap15 proved by the Secretary under this Act and on 

16 the market; and 

17 ‘‘(B) improves communication of drug 

18 safety information to patients and providers. 

19 ‘‘(2) INTERNET SITE.—Not later than 1 year 

20 after the date of enactment of the Safer DATA Act, 

21 the Secretary shall carry out paragraph (1) by— 

22 ‘‘(A) developing and maintaining an acces23 sible, consolidated Internet site with easily 

24 searchable drug safety information, including 

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1 ment Internet sites, such as the United States 

2 National Library of Medicine’s Daily Med and 

3 Medline Plus sites, in addition to other such 

4 sites maintained by the Secretary; 

5 ‘‘(B) ensuring that the information pro6 vided on the Internet site is comprehensive and 

7 includes, when available and appropriate— 

8 ‘‘(i) patient labeling, including medi9 cation guides and patient packaging in10 serts; 

11 ‘‘(ii) the most recent safety informa12 tion and alerts issued by the Food and 

13 Drug Administration for drugs approved 

14 by the Secretary under this Act, such as 

15 product recalls, warning letters, and im16 port alerts; 

17 ‘‘(iii) publicly available information 

18 about implemented RiskMAPs; 

19 ‘‘(iv) guidance documents and regula20 tions related to drug safety; and 

21 ‘‘(v) other material determined appro22 priate by the Secretary; 

23 ‘‘(C) including links to non-Food and Drug 

24 Administration Internet resources that provide 


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1 access to relevant drug safety information, such 

2 as medical journals and studies; 

3 ‘‘(D) providing access to summaries of the 

4 assessed and aggregated data collected from the 

5 active surveillance infrastructure under sub6 section (a)(2) to provide information of known 

7 and serious side-effects for drugs approved by 

8 the Secretary under this Act; 

9 ‘‘(E) enabling patients, providers, and 

10 drug sponsors to submit adverse event reports 

11 through the Internet site; 

12 ‘‘(F) providing educational materials for 

13 patients and providers about the appropriate 

14 means of disposing of expired, damaged, or un15 usable medications; and 

16 ‘‘(G) supporting initiatives that the Sec17 retary determines to be useful to fulfill the pur18 poses of the Internet site. 

19 ‘‘(3) PRIVATE SECTOR RESOURCES.—To ensure 

20 development of the Internet site by the date de21 scribed under paragraph (2), the Secretary may, on 

22 a temporary or permanent basis, implement systems 

23 or products developed by private entities. 

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1 vate entities to fulfill the requirements of this sub2 section. 

3 ‘‘(5) REVIEW.—The Advisory Committee on 

4 Communication of the Food and Drug Administra5 tion shall, on a regular basis, perform a comprehen6 sive review and evaluation of the types of risk com7 munication information provided on the Internet site 

8 described in paragraph (1) and, through other 

9 means, shall identify, clarify, and define the pur10 poses and types of information available to facilitate 

11 the efficient flow of information to patients and pro12 viders, and shall recommend ways for such Adminis13 tration to work with outside entities to help facilitate 

14 the dispensing of risk communication information to 

15 patients and providers. 

16 ‘‘(c) AUTHORIZATION OF APPROPRIATIONS.— 

17 ‘‘(1) ACTIVITIES COVERED BY PRESCRIPTION

18 DRUG USER FEES.—To carry out activities under 

19 this section for which funds are made available 

20 under section 736, there are authorized to be appro21 priated, in addition to such funds, such sums as may 

22 be necessary for fiscal year 2008 and each subse23 quent fiscal year. 

24 ‘‘(2) OTHER ACTIVITIES.—To carry out the ac25 tivities under this section not described in paragraph 


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1 (1), there are authorized to be appropriated 

2 $20,000,000 for fiscal year 2008 and such sums as 

3 may be necessary for each subsequent fiscal year.’’. 

Æ 


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