[Congressional Bills 110th Congress]
[From the U.S. Government Publishing Office]
[S. 1024 Introduced in Senate (IS)]







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.

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

SECTION 1. SHORT TITLE.

    This Act may be cited as the ``Safer Drug Assessment Technology 
Advancement Act'' or the ``Safer DATA Act''.

SEC. 2. POSTMARKET RISK IDENTIFICATION AND ANALYSIS; DISSEMINATION OF 
              POSTMARKET DRUG SAFETY INFORMATION.

    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. POSTMARKET RISK IDENTIFICATION AND ANALYSIS; DISSEMINATION 
              OF POSTMARKET DRUG SAFETY INFORMATION.

    ``(a) Postmarket Risk Identification and Analysis.--
            ``(1) Development of the postmarket risk identification and 
        analysis system.--The Secretary shall, not later than 2 years 
        after the date of enactment of the Safer DATA Act, act in 
        collaboration with academic institutions and private entities 
        to--
                    ``(A) establish minimum standards for collection 
                and transmission of postmarketing data elements from 
                electronic health data systems; and
                    ``(B) establish, through partnerships, a validated 
                and integrated postmarket risk identification and 
                analysis system to integrate and analyze safety data 
                from multiple sources.
            ``(2) Data collection activities.--
                    ``(A) In general.--The Secretary shall, not later 
                than 1 year after the establishment of the minimum 
                standards and the identification and analysis system 
                under paragraph (1), establish and maintain an active 
                surveillance infrastructure--
                            ``(i) to collect and report data for 
                        pharmaceutical postmarket risk identification 
                        and analysis, in compliance with the 
                        regulations promulgated under section 264(c) of 
                        the Health Insurance Portability and 
                        Accountability Act of 1996; and
                            ``(ii) that includes, in addition to the 
                        current collection and monitoring (in a 
                        standardized form) of data on all 
                        pharmaceutical serious adverse events (as 
                        defined in section 760) required to be 
                        submitted to the Secretary, and those events 
                        voluntarily submitted from patients, providers, 
                        and drug, when appropriate, procedures to--
                                    ``(I) provide for adverse event 
                                surveillance by collecting and 
                                monitoring Federal health-related 
                                electronic data (such as data from the 
                                Medicare program and the health systems 
                                of the Department of Veterans Affairs);
                                    ``(II) provide for adverse event 
                                surveillance by collecting and 
                                monitoring private sector health-
                                related electronic data (such as 
                                pharmaceutical purchase data and health 
                                insurance claims data);
                                    ``(III) provide for adverse event 
                                surveillance by monitoring standardized 
                                electronic health records, as 
                                available;
                                    ``(IV) provide for adverse event 
                                surveillance by collecting and 
                                monitoring other information as the 
                                Secretary deems necessary to create a 
                                robust system to identify adverse 
                                events and potential drug safety 
                                signals;
                                    ``(V) enable the program to 
                                identify certain trends and patterns 
                                with respect to data reported to the 
                                program;
                                    ``(VI) enable the program to 
                                provide regular reports to the 
                                Secretary concerning adverse event 
                                trends, adverse event patterns, 
                                incidence and prevalence of adverse 
                                events, laboratory data, and other 
                                information determined appropriate, 
                                which may include data on comparative 
                                national adverse event trends; and
                                    ``(VII) enable the program to 
                                export data in a form appropriate for 
                                further aggregation, statistical 
                                analysis, and reporting.
                    ``(B) Timeliness of reporting.--The procedures 
                developed under subparagraph (A) shall ensure that such 
                data are collected, monitored, and reported in a 
                timely, routine, and automatic manner, taking into 
                consideration the need for data completeness, coding, 
                cleansing, and transmission.
                    ``(C) Private sector resources.--To ensure the 
                establishment of the active surveillance infrastructure 
                by the date described under subparagraph (A), the 
                Secretary may, on a temporary or permanent basis, 
                implement systems or products developed by private 
                entities.
                    ``(D) Authority for contracts.--The Secretary may 
                enter into contracts with public and private entities 
                to fulfill the requirements of this paragraph.
            ``(3) Risk identification and analysis.--
                    ``(A) Purpose.--To carry out this subsection, the 
                Secretary shall establish collaborations with other 
                Government, academic, and private entities to provide 
                for the risk identification and analysis of the data 
                collected under paragraph (2) and data that is publicly 
                available or is provided by the Secretary, in order 
                to--
                            ``(i) improve the quality and efficiency of 
                        postmarket drug safety risk-benefit analysis;
                            ``(ii) provide the Secretary with routine 
                        access to expertise to study advanced drug 
                        safety data; and
                            ``(iii) enhance the ability of the 
                        Secretary to make timely assessments based on 
                        drug safety data.
                    ``(B) Procedures for the development of drug safety 
                collaborations.--
                            ``(i) In general.--Not later than 180 days 
                        after the date of establishment of the active 
                        surveillance infrastructure under paragraph 
                        (2), the Secretary shall establish and 
                        implement procedures under which the Secretary 
                        may routinely collaborate with a qualified 
                        entity to--
                                    ``(I) clean, classify, or aggregate 
                                data collected under paragraph (2) and 
                                data that is publicly available or is 
                                provided by the Secretary;
                                    ``(II) perform advanced research on 
                                identified drug safety risks;
                                    ``(III) identify safety questions 
                                that require further clinical study;
                                    ``(IV) convene an expert advisory 
                                committee to oversee the establishment 
                                of standards for the ethical and 
                                scientific uses for, and communication 
                                of, postmarketing data collected under 
                                paragraph (2), including advising on 
                                the development of effective research 
                                methods for the study of drug safety 
                                questions; and
                                    ``(V) carry out other activities as 
                                the Secretary deems necessary to carry 
                                out the purpose of this paragraph.
                            ``(ii) Request for specific methodology.--
                        The procedures described in clause (i) shall 
                        permit the Secretary to request that a specific 
                        methodology be used by the qualified entity. 
                        The qualified entity shall work with the 
                        Secretary to finalize the methodology to be 
                        used.
                    ``(C) Qualified entities.--
                            ``(i) In general.--The Secretary shall 
                        enter into contracts with a sufficient number 
                        of qualified entities to develop and provide 
                        information to the Secretary in a timely 
                        manner.
                            ``(ii) Qualifications.--The Secretary shall 
                        enter into a contract with an entity under 
                        clause (i) only if the Secretary determines 
                        that the entity--
                                    ``(I) has the research capability 
                                and expertise to conduct and complete 
                                the activities under this subsection;
                                    ``(II) has in place an information 
                                technology infrastructure to support 
                                adverse event surveillance data and 
                                operational standards to provide 
                                security for such data;
                                    ``(III) has experience with, and 
                                expertise on, the development of drug 
                                safety and effectiveness research using 
                                electronic population data;
                                    ``(IV) has an understanding of drug 
                                development and risk/benefit balancing 
                                in a clinical setting; and
                                    ``(V) has a significant business 
                                presence in the United States.
                    ``(D) Contract requirements.--Each contract with a 
                qualified entity shall contain the following 
                requirements:
                            ``(i) Ensuring privacy.--The qualified 
                        entity shall provide assurances that the entity 
                        will not use the data provided by the Secretary 
                        in a manner that violates--
                                    ``(I) the Federal regulations 
                                promulgated under section 264(c) of the 
                                Health Insurance Portability and 
                                Accountability Act of 1996 (concerning 
                                the privacy of individually-
                                identifiable beneficiary health 
                                information); or
                                    ``(II) sections 552 or 552a of 
                                title 5, United States Code, with 
                                regard to the privacy of individually-
                                identifiable beneficiary health 
                                information.
                            ``(ii) Component of another organization.--
                        If a qualified entity is a component of another 
                        organization--
                                    ``(I) the qualified entity shall 
                                maintain the data related to the 
                                activities carried out under this 
                                subsection separate from the other 
                                components of the organization and 
                                establish appropriate security measures 
                                to maintain the confidentiality and 
                                privacy of such data; and
                                    ``(II) the entity shall not make an 
                                unauthorized disclosure of such data to 
                                the other components of the 
                                organization in breach of such 
                                confidentiality and privacy 
                                requirement.
                            ``(iii) Termination or nonrenewal.--If a 
                        contract under this subsection is terminated or 
                        not renewed, the following requirements shall 
                        apply:
                                    ``(I) Confidentiality and privacy 
                                protections.--The entity shall continue 
                                to comply with the confidentiality and 
                                privacy requirements under this 
                                subsection with respect to all data 
                                disclosed to the entity.
                                    ``(II) Disposition of data.--The 
                                entity shall return to the Secretary 
                                all data disclosed to the entity or, if 
                                returning the data is not practicable, 
                                destroy the data.
                    ``(E) Competitive procedures.--The Secretary shall 
                use competitive procedures (as defined in section 4(5) 
                of the Federal Procurement Policy Act) to enter into 
                contracts under subparagraph (C).
                    ``(F) Review of contract in the event of a merger 
                or acquisition.--The Secretary shall review the 
                contract with a qualified entity under this subsection 
                in the event of a merger or acquisition of the entity 
                in order to ensure that the requirements under this 
                subsection will continue to be met.
            ``(4) Coordination.--In carrying out this subsection, the 
        Secretary shall provide for appropriate communications to the 
        public, scientific, public health, and medical communities, and 
        other key stakeholders, and provide for the coordination of the 
        activities of private entities, professional associations, or 
        other entities that may have sources of surveillance data.
    ``(b) Postmarket Drug Safety Information for Patients and 
Providers.--
            ``(1) Establishment.--Not later than 1 year after the date 
        of enactment of the Safer DATA Act, the Secretary shall improve 
        the transparency of pharmaceutical data and allow patients and 
        health care providers better access to pharmaceutical data by 
        developing and maintaining an Internet site that--
                    ``(A) provides comprehensive drug safety 
                information for prescription drugs that are approved by 
                the Secretary under this Act and on the market; and
                    ``(B) improves communication of drug safety 
                information to patients and providers.
            ``(2) Internet site.--Not later than 1 year after the date 
        of enactment of the Safer DATA Act, the Secretary shall carry 
        out paragraph (1) by--
                    ``(A) developing and maintaining an accessible, 
                consolidated Internet site with easily searchable drug 
                safety information, including the information found on 
                United States Government Internet sites, such as the 
                United States National Library of Medicine's Daily Med 
                and Medline Plus sites, in addition to other such sites 
                maintained by the Secretary;
                    ``(B) ensuring that the information provided on the 
                Internet site is comprehensive and includes, when 
                available and appropriate--
                            ``(i) patient labeling, including 
                        medication guides and patient packaging 
                        inserts;
                            ``(ii) the most recent safety information 
                        and alerts issued by the Food and Drug 
                        Administration for drugs approved by the 
                        Secretary under this Act, such as product 
                        recalls, warning letters, and import alerts;
                            ``(iii) publicly available information 
                        about implemented RiskMAPs;
                            ``(iv) guidance documents and regulations 
                        related to drug safety; and
                            ``(v) other material determined appropriate 
                        by the Secretary;
                    ``(C) including links to non-Food and Drug 
                Administration Internet resources that provide access 
                to relevant drug safety information, such as medical 
                journals and studies;
                    ``(D) providing access to summaries of the assessed 
                and aggregated data collected from the active 
                surveillance infrastructure under subsection (a)(2) to 
                provide information of known and serious side-effects 
                for drugs approved by the Secretary under this Act;
                    ``(E) enabling patients, providers, and drug 
                sponsors to submit adverse event reports through the 
                Internet site;
                    ``(F) providing educational materials for patients 
                and providers about the appropriate means of disposing 
                of expired, damaged, or unusable medications; and
                    ``(G) supporting initiatives that the Secretary 
                determines to be useful to fulfill the purposes of the 
                Internet site.
            ``(3) Private sector resources.--To ensure development of 
        the Internet site by the date described under paragraph (2), 
        the Secretary may, on a temporary or permanent basis, implement 
        systems or products developed by private entities.
            ``(4) Authority for contracts.--The Secretary may enter 
        into contracts with public and private entities to fulfill the 
        requirements of this subsection.
            ``(5) Review.--The Advisory Committee on Communication of 
        the Food and Drug Administration shall, on a regular basis, 
        perform a comprehensive review and evaluation of the types of 
        risk communication information provided on the Internet site 
        described in paragraph (1) and, through other means, shall 
        identify, clarify, and define the purposes and types of 
        information available to facilitate the efficient flow of 
        information to patients and providers, and shall recommend ways 
        for such Administration to work with outside entities to help 
        facilitate the dispensing of risk communication information to 
        patients and providers.
    ``(c) Authorization of Appropriations.--
            ``(1) Activities covered by prescription drug user fees.--
        To carry out activities under this section for which funds are 
        made available under section 736, there are authorized to be 
        appropriated, in addition to such funds, such sums as may be 
        necessary for fiscal year 2008 and each subsequent fiscal year.
            ``(2) Other activities.--To carry out the activities under 
        this section not described in paragraph (1), there are 
        authorized to be appropriated $20,000,000 for fiscal year 2008 
        and such sums as may be necessary for each subsequent fiscal 
        year.''.
                                 <all>