| Also tagged in: Access to health care, Administrative procedure, Affordable housing, Afghanistan, Aged, Agricultural subsidies, Agriculture, Aid to dependent children, AIDS (Disease), Alternative energy sources, Animals, Appropriations, Armed forces, Armed forces abroad, Armed forces reserves, Auditing Latest Action: 03/14/2008 - S.AMDT.4380 Amendment SA 4380 agreed to in Senate by Yea-Nay Vote. 41 - 57. Record Vote Number: 79.
Bill TextAn original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2009 and including the appropriate budgetary levels for fiscal years 2008 and 2010 through 2013. 3/14/2008--Passed Senate amended. (There are 2 other summaries) Sets forth the congressional budget for the federal government for FY2009, including the appropriate budgetary levels for FY2008 and FY2010-FY2013. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2008-FY2013, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) public debt; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security, U.S. Postal Service discretionary administrative expenses, and specified major functional categories for FY2008-FY2013.[...] show full description | | Also tagged in: Agricultural chemicals, Agricultural conservation, Agricultural credit, Agricultural industries, Agricultural machinery, Agricultural subsidies, Agriculture, Air pollution, Alcohol as fuel, Alternative energy sources, Animals, Biomass energy, Bonds, Broadband, Brownfields, Budgets Latest Action: 10/25/2007 - Placed on Senate Legislative Calendar under General Orders. Calendar No. 446.
Bill TextAn original bill to amend the Trade Act of 1974 to establish supplemental agricultural disaster assistance and to amend the Internal Revenue Code of 1986 to provide tax incentives for conservation and alternative energy sources and to provide tax relief for farmers, and for other purposes. 10/25/2007--Reported to Senate without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Heartland, Habitat, Harvest, and Horticulture Act of 2007 - Title I: Supplemental Agricultural Disaster Assistance from the Agricultural Disaster Relief Trust Fund - (Sec. 101) Amends the Trade Act of 1974 to establish a program of supplemental agricultural disaster assistance. Establishes an Agriculture Disaster Relief Trust Fund to provide payments to farmers and ranchers who suffer losses in areas declared as disaster areas by the [...] show full description | | Also tagged in: Auditing, Awards, medals, prizes, Budgets, Business, Commemorations, Communicable diseases, Congress, Congressional investigations, Cost effectiveness, Drug industry, Finance, Intellectual property, Marketing, Medical care, Medical innovations, Medicine Latest Action: 10/19/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to provide incentives for investment in research and development for new medicines, to enhance access to new medicines, and for other purposes. 10/19/2007--Introduced. Medical Innovation Prize Act of 2007 - Prohibits any person from having the right to exclusively manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents under the Federal Food, Drug, and Cosmetic Act, notwithstanding provisions of that Act and other specified laws. Establishes the Fund for Medical Innovation Prizes. Requires the Board of Trustees for the Fund to award prize payments for medical innovations relating to a drug, biological product, or manufacturing process. Requires an eligible award recipient to be either the first person to receive market clearance or the holder [...] show full description | | Also tagged in: Administrative remedies, Clinical trials, Congress, Data banks, Department of Health and Human Services, Executive departments, Food and Drug Administration (FDA), Health information systems, House rules and procedure, Law, Legislation, Medical care, Medical instruments and apparatus, Medicine, Technology Latest Action: 11/08/2007 - Referred to the Subcommittee on Health.
Bill TextTo correct technical errors in the enrollment of the bill H.R. 3580. 9/25/2007--Passed House without amendment. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary of that version is repeated here.) Makes corrections in the enrollment of H.R. 3580 (Food and Drug Administration Amendments Act of 2007): (1) to include devices as well as drugs within the scope of provisions regarding an expanded clinical trial registry data bank; and (2) to require that consideration of a citizen petition or a petition for stay of agency action be made separately from review and approval of any application. | | Also tagged in: Access to health care, Administrative fees, Administrative procedure, Administrative remedies, Agriculture, Animals, Antibiotics, Aquaculture, Authorization, Authors and authorship, Budgets, Business, Child health, Children, Civil liberties, Clinical trials Latest Action: 09/27/2007 - Signed by President.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 9/27/2007--Public Law. (There is 1 other summary) (This measure has not been amended since it was introduced. The summary has been expanded because action occurred on the measure.)Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential [...] show full description | | Also tagged in: Administrative procedure, Budgets, Child health, Children, Chronically ill, Department of Health and Human Services, Elementary and secondary education, Employee health benefits, Executive departments, Federal advisory bodies, Federal aid to child health services, Federal employees, Finance, Fines (Penalties), Fringe benefits, Government employees Latest Action: 09/19/2007 - Referred to the Subcommittee on Health, Employment, Labor, and Pensions.
Bill TextTo provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away. 7/24/2007--Introduced. Healthy Americans Act - Requires each adult individual to have the opportunity to purchase a Healthy Americans Private Insurance Plan (HAPI). Makes individuals who are not enrolled in another specified health plan and who are not opposed to coverage for religious reasons responsible for enrolling themselves and their dependent children in a HAPI plan offered through their state of residence. Sets forth penalties for failure to enroll. Establishes standardized coverage and state options for HAPI plans. Requires the Secretary of Health and Human Services to promulgate guidelines concerning the benefits, items, and services to be covered. Sets forth requirements for setting premiums. Requires the Secretary to establish the Healthy America Advisory Committee to provide annual recommendations concerning modifications to the benefits,[...] show full description | | Also tagged in: Access to health care, Administrative fees, Administrative procedure, Administrative remedies, Animals, Antibiotics, Authorization, Budgets, Business, Cancer, Child health, Children, Civil liberties, Clinical trials, Communications, Computer security measures Latest Action: 07/16/2007 - Received in the Senate. Read twice. Placed on Senate Legislative Calendar under General Orders. Calendar No. 270.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs and for medical devices, to enhance the postmarket authorities of the Food and Drug Administration with respect to the safety of drugs, and for other purposes. 7/11/2007--Passed House amended. (There is 1 other summary) Food and Drug Administration Amendments Act of 2007 - Title I: Prescription Drug User Fee Amendments of 2007 - (Sec. 101) Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to include postmarket safety activities within the process for the review of human drug applications or supplements, including: (1) developing and using improved adverse event data collection systems and improved analytical tools to assess potential safety problems; (2) implementing and enforcing provisions relating to postapproval studies, clinical trials, labeling changes, and risk [...] show full description | | Also tagged in: Budgets, Business, Drug industry, Government trust funds, Intellectual property, Law, Licenses, Medical care, Medicine, Patent infringement, User charges Latest Action: 06/27/2007 - Committee on Health, Education, Labor, and Pensions. Date of scheduled consideration. S-211. 11:00 a.m.
Bill TextA bill to amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences, and for other purposes. 6/26/2007--Introduced. Biologics Price Competition and Innovation Act of 2007 - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product). Requires the Secretary of Health and Human Services to license the biological product if it is biosimilar to or interchangeable with the reference product. Allows a determination of interchangeability if the product is: (1) biosimilar to the reference product and can be expected to produce the same clinical result in any given patient; and (2) the risk in terms of safety or diminished efficacy of alternating or switching between the products is not greater than the risk of using the reference product without [...] show full description | | Also tagged in: Access to health care, Advertising, Alternative medicine, Australia, Business, Canada, Communication in medicine, Communications, Consumers, Customs unions, Deceptive advertising, Dietary supplements, Drug industry, Drug interactions, Drugs, East Asia Latest Action: 06/14/2007 - Referred to the Subcommittee on Health.
Bill TextTo permit an individual to be treated by a health care practitioner with any method of medical treatment such individual requests, and for other purposes. 6/14/2007--Introduced. Access to Medical Treatment Act - Gives an individual the right to be treated by a health care practitioner with any medical treatment that the individual desires, including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services, if: (1) the practitioner has personally examined the individual and agrees to treat the individual; and (2) the administration of such treatment does not violate licensing laws.Authorizes health care practitioners to provide any method of treatment to such an individual if certain requirements are met, including that: (1) there is no reason to conclude that such treatment will cause danger to the individual; and (2) the patient is informed in writing that such treatment has not been approved, certified, or licensed by [...] show full description | | Also tagged in: Accident insurance, Actions and defenses, Blood, Bribery, Business, Child health, Children, Collection of accounts, Conflict of interests, Consumers, Criminal justice, Damages, Department of Health and Human Services, Disability insurance, Disabled, Drug industry Latest Action: 06/06/2007 - Referred to the Committee on the Judiciary, and in addition to the Committee on Energy and Commerce, for a period to be subsequently determined by the Speaker, in each case for consideration of such provisions as fall within the jurisdiction of the commit
Bill TextTo improve patient access to health care services and provide improved medical care by reducing the excessive burden the liability system places on the health care delivery system. 6/6/2007--Introduced. Help Efficient, Accessible, Low Cost, Timely Healthcare (HEALTH) Act of 2007 - Sets conditions for lawsuits arising from health care liability claims regarding health care goods or services or any medical product affecting interstate commerce. Sets a statute of limitations of three years after the date of manifestation of injury or one year after the claimant discovers the injury, with certain exceptions. Provides that nothing in this Act limits recovery of the full amount of available economic damages. Limits noneconomic damages to $250,000. Makes each party liable only for the amount of damages directly proportional to such party's percentage of responsibility. Allows the court to restrict the payment of attorney contingency fees. Limits the fees to a decreasing [...] show full description | | Also tagged in: Administrative remedies, Business, Child health, Children, Clinical trials, Congress, Congressional investigations, Consumers, Department of Health and Human Services, Drug industry, Drugs, Executive departments, Food and Drug Administration (FDA), Government information, Government paperwork, Government publicity Latest Action: 06/06/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to reauthorize and amend the Best Pharmaceuticals for Children Act and the Pediatric Research Equity Act. 6/6/2007--Introduced. Improving Pharmaceuticals for Children Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions relating to market exclusivity for pediatric drug studies on new or already approved drugs to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than one year prior to the expiration of such period. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective in the pediatric population if such formulation is not introduced onto the market within one year; and (2) order the labeling of a drug to include information [...] show full description | | Also tagged in: Biotechnology, Consumers, Department of Health and Human Services, Drug adulteration, Drugs, Executive departments, Executive reorganization, Federal advisory bodies, Intellectual property, Labeling, Medical care, Medicine, Patents, Science policy Latest Action: 05/24/2007 - Sponsor introductory remarks on measure. (CR S6867)
Bill TextA bill to amend the Public Health Service Act to provide for the approval of biosimilars, and for other purposes. 5/24/2007--Introduced. Affordable Biologics for Consumers Act - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biosimilar, which is defined as a biological product that is claimed to be similar to a qualified biological product (the reference product). Defines a "qualified biological product" as a biotechnology-derived therapeutic biological or protein product licensed or approved under the Federal Food, Drug, and Cosmetic Act.Allows the Secretary of Health and Human Services to approve an application for a biosimilar only: (1) for indications for which the reference product is approved; and (2) if the application conforms to the applicable final product class-specific rule and the Secretary concludes that the product is safe, pure, and potent.Authorizes a person [...] show full description | | Also tagged in: Administrative fees, Animals, Budgets, Business, Clinical trials, Communication in medicine, Communications, Conflict of interests, Consumer education, Consumer protection, Consumers, Data banks, Department of Health and Human Services, Drug advertising, Drug industry, Drugs Latest Action: 05/10/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to provide for the deposit in the general fund of the Treasury of fees that are collected from manufacturers of drugs and devices under chapter VII of such Act, to terminate the authority of the Food and Drug Administration to negotiate with the manufacturers on particular uses of the fees, to establish a Center for Postmarket Drug Safety and Effectiveness, to establish additional authorities to ensure the safe and effective use of drugs, and for other purposes. 5/10/2007--Introduced. Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons [...] show full description | | Also tagged in: Access to health care, Aged, AIDS (Disease), Alaska, American studies, Asian American ethnic groups, Black colleges, Boundaries, Budgets, Building construction, Cancer, Centers for Disease Control and Prevention (CDC), Child health, Children, Civil rights, Civil rights enforcement Latest Action: 09/11/2007 - Referred to the Subcommittee on Early Childhood, Elementary, and Secondary Education.
Bill TextTo improve the health of minority individuals, and for other purposes. 7/12/2007--Introduced. Health Equity and Accountability Act of 2007 - Amends the Public Health Service Act to require the Secretary of Health and Human Services to establish the Robert T. Matsui Center for Cultural and Linguistic Competence in Health Care.Provides for health care workforce diversity activities, including the establishment of: (1) a technical clearinghouse on health workforce diversity; and (2) Regional Minority Centers of Excellence Programs.Requires health-related programs of the Department of Health and Human Services (HHS) to collect data on race, ethnicity, and primary language.Directs each federal health agency to implement a strategic plan to eliminate disparities and improve the health and health care of minority populations. Requires the Secretary to establish: (1) an Office of Health Disparities within the Office of Civil Rights; and (2) civil rights [...] show full description | | Also tagged in: Biotechnology, Business, Congressional reporting requirements, Consumers, Deceptive advertising, Drug industry, Drugs, Executive departments, Federal advisory bodies, Health policy, Labeling, Licenses, Medical care, Medicine, Proteins, Technology Latest Action: 04/20/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Public Health Service Act to provide for the approval of similar biological products, and for other purposes. 4/19/2007--Introduced. Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved [...] show full description | | Also tagged in: Budgets, Centers for Disease Control and Prevention (CDC), Civil liberties, Clinical trials, Communication in medicine, Communication in science, Communications, Conflict of interests, Congressional reporting requirements, Data banks, Department of Health and Human Services, Drug industry, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research Latest Action: 04/20/2007 - Referred to the Subcommittee on Health.
Bill TextTo improve vaccine safety research, and for other purposes. 4/19/2007--Introduced. Vaccine Safety and Public Confidence Assurance Act of 2007 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services. Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships [...] show full description | | Also tagged in: Business, Children, Clinical trials, Congress, Congressional investigations, Congressional reporting requirements, Consumers, Drug industry, Drugs, Education, Executive departments, Federal advisory bodies, Government information, Government publicity, Higher education, Labeling Latest Action: 04/18/2007 - Sponsor introductory remarks on measure. (CR S4694-4695)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize the Best Pharmaceuticals for Children program. 4/18/2007--Introduced. Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective that is not [...] show full description | | Also tagged in: Administrative remedies, Antibiotics, Business, Children, Clinical trials, Consumer education, Consumers, Department of Health and Human Services, Drug industry, Drug utilization, Executive departments, Generic drugs, Intellectual property, Labeling, Law, Marketing Latest Action: 04/11/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to market exclusivity for certain drugs, and for other purposes. 4/11/2007--Introduced. Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting [...] show full description | | Also tagged in: Abortion, Actions and defenses, Administrative fees, Administrative procedure, Agriculture, Agriculture in foreign trade, Animals, Antibiotics, Biomedical engineering, Budgets, Business, Canada, Cancer, Chemotherapy, Child health, Children Latest Action: 05/10/2007 - Received in the House.
Bill TextAn act to amend the Federal Food, Drug, and cosmetic Act and the Public Health Service Act to reauthorize drug and device user fees and ensure the safety of medical products, and for other purposes. 5/9/2007--Passed Senate amended. (There are 2 other summaries) Food and Drug Administration Revitalization Act - Title I: Prescription Drug User Fees - (Sec. 101) - Prescription Drug User Fee Amendments of 2007 - (Sec. 102) Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth as a purpose that authorized prescription drug fees be dedicated toward expediting the drug development process, the process for the review of human drug applications, and postmarket drug safety. Sets forth reporting requirements, including requiring the Secretary of Human Services (the Secretary) to present to Congress recommendations developed for achieving certain goals for the review process of human drug applications and for reauthorization of user [...] show full description | | Also tagged in: Access to health care, Aged, Biomedical engineering, Budgets, Cancer, Case management, Chemotherapy, Children, Clinical trials, Colon cancer, Congress, Congressional reporting requirements, Continuum of care, Department of Health and Human Services, Drug abuse, Education Latest Action: 03/29/2007 - Sponsor introductory remarks on measure. (CR S4188)
Bill TextA bill to provide for a comprehensive Federal effort relating to early detection of, treatments for, and the prevention of cancer, and for other purposes. 3/29/2007--Introduced. National Cancer Act of 2007 - Amends the Public Health Service Act to require the Director of the National Cancer Institute to establish a loan repayment program for health professionals agreeing to engage in cancer prevention research. Provides for research on cancer treatments that target cancer cells, the cancer care workforce, cancer survivorship, environmental risk factors for cancer, and treatment disparities.Requires the Secretary of Health and Human Services, acting through the Director of the Centers for Disease Control and Prevention (CDC), to carry out demonstration programs on: (1) lung cancer early detection using Computer Tomography (CT) scanning; and (2) colorectal screening.Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions for chemoprevention [...] show full description | | Also tagged in: Clinical trials, Consumer education, Consumers, Drug interactions, Drug utilization, Executive departments, Federal advisory bodies, Health information systems, Health surveys, Internet, Medical care, Medical ethics, Medical records, Medical statistics, Medicine, Pharmaceutical research Latest Action: 03/29/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA 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. 3/29/2007--Introduced. Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.Requires the Secretary to establish and implement procedures under which the Secretary may routinely [...] show full description | | Also tagged in: Children, Congress, Congressional investigations, Congressional reporting requirements, Consumers, Government information, Government paperwork, Governmental investigations, Labeling, Medical care, Medicine, Pediatrics, Pharmaceutical research, Science policy Latest Action: 03/27/2007 - Sponsor introductory remarks on measure. (CR S3842)
Bill TextA bill to improve pediatric research. 3/27/2007--Introduced. Pediatric Research Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct an applicant seeking to waive submission requirements related to pediatric assessments of the safety and effectiveness of a drug or biological product to submit to the Secretary of Health and Human Services documentation detailing why a pediatric formulation cannot be developed. Requires an applicant seeking to defer submission of some or all of such assessments to submit to the Secretary a timeline for the completion of pediatric studies.Requires the Secretary to create an internal committee to review pediatric assessment requests issued, pediatric assessments conducted, and deferral and waiver requests. Considers a supplement to a new drug or biological license application proposing a labeling change as a result of any pediatric assessments to be a priority supplement. Sets forth dispute resolution [...] show full description | | Also tagged in: Accreditation (Medical care), Budgets, Consumers, Continuing education, Data banks, Deceptive advertising, Distance education, Environmental health, Environmental protection, Federal aid to education, Federal aid to health facilities, Genetic counseling, Genetic research, Genetics, Governmental investigations, Health education Latest Action: 03/23/2007 - Sponsor introductory remarks on measure. (CR S3708-3710)
Bill TextA bill to secure the promise of personalized medicine for all Americans by expanding and accelerating genomics research and initiatives to improve the accuracy of disease diagnosis, increase the safety of drugs, and identify novel treatments. 3/23/2007--Introduced. Genomics and Personalized Medicine Act of 2007 - Directs the Secretary of Health and Human Services to: (1) establish the Genomics and Personalized Medicine Interagency Working Group (IWG) to facilitate collaboration, coordination, and integration of activities among federal agencies relating to genomic research and initiatives; (2) establish a national biobanking distributed database for the collection and integration of genomic data and associated environmental and clinical health information; (3) establish a grant program for academic medical centers and other entities to develop or expand biobanking initiatives; (4) improve genetics and genomics training for diagnosis, treatment, and counseling of adults and [...] show full description | | Also tagged in: Biomedical engineering, Business, Clinical trials, Conflict of interests, Consumers, Data banks, Directories, Drug industry, Drugs, Executive departments, Federal advisory bodies, Government information, Government paperwork, Health information systems, Health policy, Health surveys Latest Action: 03/20/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 3/19/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety.[...] show full description | | Also tagged in: Administrative procedure, Antibiotics, Biotechnology, Business, Clinical trials, Communicable diseases, Congressional reporting requirements, Department of Health and Human Services, Drug industry, Drug resistance in microorganisms, Executive departments, Executive reorganization, Federal advisory bodies, Food and Drug Administration (FDA), Government information, Government paperwork Latest Action: 04/20/2007 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Bill TextTo provide incentives for pharmaceutical companies, biotechnology companies, and medical device companies to invest in research and development with respect to antibiotic drugs, antivirals, diagnostic tests, and vaccines that may be used to identify, treat, or prevent serious and life-threatening infectious diseases. 3/13/2007--Introduced. Beating Infections through Research and Development Act of 2007 - Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products.Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval.Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products.Amends the Internal Revenue Code to establish [...] show full description | | Also tagged in: AIDS (Disease), Business, Child health, Children, Communicable diseases, Competition, Congress, Congressional reporting requirements, Developing countries, Development credit institutions, Drug industry, Epidemics, Foreign investments, Foreign policy, Health planning, Health policy Latest Action: 04/13/2007 - Referred to the Subcommittee on Domestic and International Monetary Policy, Trade, and Technology.
Bill TextTo accelerate efforts to develop vaccines for diseases primarily affecting developing countries, and for other purposes. 3/7/2007--Introduced. Vaccines for the Future Act of 2007- Directs the President to establish a strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS, malaria, and tuberculosis, which shall: (1) expand public-private partnerships; (2) create economic incentives for such vaccines' research, development, and manufacturing; (3) include the negotiation of advanced market commitments; (4) address related intellectual property and regulatory approval issues; (5) maximize U.S. capabilities to support clinical trials in developing countries; (6) expand the purchase and delivery of existing vaccines; and (7) address the challenges of advance delivery of vaccines in developing countries. Directs the Secretary of the Treasury to enter into negotiations with the World Bank, the International Development Association,[...] show full description | | Also tagged in: Access to health care, Administrative remedies, Admission of nonimmigrants, Advice and consent of the Senate, Aged, AIDS (Disease), Alcoholism, Aliens, Ambulances, Ambulatory care, Anesthetics, Armed forces, Birth control, Block grants, Budgets, Business Latest Action: 04/24/2007 - Sponsor introductory remarks on measure. (CR H4034-4035)
Bill TextTo provide for health care for every American and to control the cost and enhance the quality of the health care system. 2/27/2007--Introduced. American Health Security Act of 2007 - Establishes the State-Based American Health Security Program to provide every U.S. resident who is a U.S. citizen, national, or lawful resident alien with health care services. Requires each participating state to establish a state health security program. Eliminates benefits under: (1) titles XVIII (Medicare), XIX (Medicaid), and XXI (State Children's Health Insurance) (SCHIP) of the Social Security Act; (2) the Federal Employees Health Benefits Program; and (3) the Civilian Health and Medical Program of the Uniformed Services (CHAMPUS). Requires each state health security program to prohibit the sale of health insurance in that state that duplicates benefits provided under the program. Establishes the American Health Security Standards Board to: (1) develop policies,[...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Budgets, Business, Censorship, Civil liberties, Civil rights, Communication in medicine, Communication in science, Communications, Congressional reporting requirements, Consumers, Criminal justice, Criminal justice information, Damages, Deceptive advertising Latest Action: 02/27/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs, to establish whistleblower protections for certain individuals, and for other purposes. 2/16/2007--Introduced. Swift Approval, Full Evaluation Drug Act or the SAFE Drug Act - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services to: (1) order postmarket studies of approved drugs upon receiving evidence of a significant issue regarding the safety or lack of effectiveness of such a drug; and (2) establish restrictions on the distribution or use of the drug during the period in which the study is conducted.Directs the Secretary to amend regulations to require postmarket studies of drugs approved under an accelerated approval process for new drugs for serious or life-threatening illnesses. Deems a drug or device to be misbranded if there is a failure to comply with requirements under [...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Advertising, Agriculture, Budgets, Business, Business records, Cancer, Carcinogens, Cardiovascular diseases, Chemicals, Child health, Children, Cigarettes, Civil liberties, Communications Latest Action: 04/02/2008 - Committee Consideration and Mark-up Session Held.
Bill TextTo protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 2/15/2007--Introduced. Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization [...] show full description | | Also tagged in: Access to health care, Centers for Disease Control and Prevention (CDC), Clinical trials, Communication in medicine, Communications, Congress, Congressional oversight, Congressional reporting requirements, Department of Health and Human Services, Drug abuse, Drug abuse prevention, Drug abuse treatment, Education, Executive departments, Executive reorganization, Food and Drug Administration (FDA) Latest Action: 02/15/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services. 2/15/2007--Introduced. Women's Health Office Act of 2007 - Amends the Public Health Service Act to establish an Office on Women's Health within the Office of the Secretary of Health and Human Services. Requires the Secretary, acting through the Director of the Office, to establish: (1) a Department of Health and Human Services Coordinating Committee on Women's Health; and (2) a National Women's Health Information Center. Transfers the functions of the Office on Women's Health of the Public of Health Service to the Office on Women's Health within the Department of Health and Human Services (HHS). Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to establish separate Offices of Women's Health within the Office of the Director of the Centers for Disease Control and Prevention [...] show full description | | Also tagged in: Access to health care, Centers for Disease Control and Prevention (CDC), Clinical trials, Communication in medicine, Communications, Congress, Congressional oversight, Congressional reporting requirements, Department of Health and Human Services, Drug abuse, Drug abuse prevention, Drug abuse treatment, Education, Executive departments, Executive reorganization, Food and Drug Administration (FDA) Latest Action: 02/16/2007 - Referred to the Subcommittee on Health.
Bill TextTo improve the health of women through the establishment of Offices of Women's Health within the Department of Health and Human Services. 2/15/2007--Introduced. Women's Health Office Act of 2007 - Amends the Public Health Service Act to establish an Office on Women's Health within the Office of the Secretary of Health and Human Services. Requires the Secretary, acting through the Director of the Office, to establish: (1) a Department of Health and Human Services Coordinating Committee on Women's Health; and (2) a National Women's Health Information Center. Transfers the functions of the Office on Women's Health of the Public of Health Service to the Office on Women's Health within the Department of Health and Human Services (HHS). Amends the Public Health Service Act, the Social Security Act, and the Federal Food, Drug, and Cosmetic Act to establish separate Offices of Women's Health within the Office of the Director of the Centers for Disease Control and Prevention [...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Business, Clinical trials, Congressional reporting requirements, Consumers, Department of Health and Human Services, Drug industry, Executive departments, Food and Drug Administration (FDA), Injunctions, Intellectual property, Judicial opinions, Judicial review, Labeling, Law Latest Action: 02/27/2007 - Star Print ordered on S. 623.
Bill TextA bill to amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/15/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the [...] show full description | | Also tagged in: Administrative procedure, Administrative remedies, Advertising, Agriculture, Budgets, Business, Business records, Cancer, Carcinogens, Cardiovascular diseases, Chemicals, Child health, Children, Cigarettes, Civil liberties, Communications Latest Action: 08/01/2007 - Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Bill TextA bill to protect the public health by providing the Food and Drug Administration with certain authority to regulate tobacco products. 2/15/2007--Introduced. Family Smoking Prevention and Tobacco Control Act - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of tobacco products by the Secretary of Health and Human Services through the Food and Drug Administration, including through disclosure, annual registration, inspection, recordkeeping, and user fee requirements. Sets forth criteria by which tobacco products are deemed adulterated or misbranded. Allows the Secretary to require prior approval of all label statements. Allows the Secretary to restrict the sale or distribution of tobacco products, including advertising and promotion, if the Secretary determines that such regulation would be appropriate for the protection of the public health. Prohibits such regulations from: (1) limiting product sales or distribution to authorization [...] show full description | | Also tagged in: Actions and defenses, Administrative remedies, Business, Clinical trials, Congressional reporting requirements, Consumers, Department of Health and Human Services, Drug industry, Executive departments, Food and Drug Administration (FDA), Injunctions, Intellectual property, Judicial opinions, Judicial review, Labeling, Law Latest Action: 02/15/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products, and for other purposes. 2/14/2007--Introduced. Access to Life-Saving Medicine Act - Amends the Public Health Service Act to establish a process for the approval of an abbreviated biological product application for products that contain the same or similar active ingredients as a previously licensed biological product (the reference product). Allows a person to file an abbreviated biological product application with the Secretary of Health and Human Services that includes: (1) data demonstrating that the product is comparable to or interchangeable with the reference product; (2) information to show that the conditions or conditions of use prescribed, recommended, or suggested in the labeling proposed for the biological product have been previously approved for the reference product; and (3) information to show that the route of administration, the dosage [...] show full description | | Also tagged in: AIDS (Disease), Business, Child health, Children, Communicable diseases, Competition, Congress, Congressional reporting requirements, Developing countries, Development credit institutions, Drug industry, Epidemics, Foreign investments, Foreign policy, Health planning, Health policy Latest Action: 02/13/2007 - Sponsor introductory remarks on measure. (CR S1912)
Bill TextA bill to accelerate efforts to develop vaccines for diseases primarily affecting developing countries and for other purposes. 2/13/2007--Introduced. Vaccines for the Future Act of 2007 - Directs the President to establish a comprehensive strategy to accelerate efforts to develop vaccines and microbicides for neglected diseases such as HIV/AIDS, malaria, and tuberculosis. States that such strategy shall: (1) expand public-private partnerships and seek to leverage foreign country and private sector resources; (2) include the negotiation of advance market commitments and other economic incentives for the research, development, and manufacturing of vaccines and microbicides for HIV/AIDS, tuberculosis, malaria, and other neglected diseases; (3) address related intellectual property and regulatory issues; (4) maximize U.S. capabilities to support clinical trials of vaccines and microbicides in developing countries; and (5) expand the purchase and delivery of existing vaccines.[...] show full description | | Also tagged in: Access to health care, Administrative procedure, Aged, Business, Cardiovascular diseases, Clinical trials, Communication in medicine, Communication in science, Congress, Congressional investigations, Congressional reporting requirements, Data banks, Department of Health and Human Services, Drug industry, Drugs, Education Latest Action: 05/01/2007 - Subcommittee Consideration and Mark-up Session Held.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...] show full description | | Also tagged in: Access to health care, Administrative procedure, Aged, Business, Cardiovascular diseases, Clinical trials, Communication in medicine, Communication in science, Congress, Congressional investigations, Congressional reporting requirements, Data banks, Department of Health and Human Services, Drug industry, Drugs, Education Latest Action: 02/13/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to improve the prevention, diagnosis, and treatment of heart disease, stroke, and other cardiovascular diseases in women. 2/13/2007--Introduced. Heart Disease Education, Analysis Research, and Treatment for Women Act or the HEART for Women Act - Amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to require an application for approval or for investigation of a drug, device, or biological product to include information stratified by sex, race, and ethnicity, including any differences in safety and effectiveness. Requires the Secretary of Health and Human Services to: (1) withhold approval of such an application or place a clinical hold on an investigation if such information is not included; and (2) report to the scientific community and make information available to the public on such stratified data upon approval of an application.Requires the Comptroller [...] show full description | | Also tagged in: Agricultural subsidies, Agriculture, Animals, Antibiotics, Business, Business records, Consumers, Drug industry, Drug resistance in microorganisms, Drugs, Families, Family farms, Food, Food safety, Government information, Government paperwork Latest Action: 02/12/2007 - Sponsor introductory remarks on measure. (CR S1853-1854)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases. 2/12/2007--Introduced. Preservation of Antibiotics for Medical Treatment Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms.Requires the Secretary of Health and Human Services to withdraw approval of a nontherapeutic [...] show full description | | Also tagged in: Accreditation (Medical care), Actions and defenses, Administrative fees, Administrative procedure, Administrative remedies, Aged, Appropriations, Armed forces, Auditing, Australia, Budgets, Business, Business records, Canada, Capital gains tax, Caribbean area Latest Action: 02/12/2007 - Sponsor introductory remarks on measure. (CR S1855-1857)
Bill TextA bill to reduce the Federal budget deficit, and for other purposes. 2/12/2007--Introduced. Act for Our Kids - Repeals the Television Broadcasting to Cuba Act. Amends the Cuban Liberty and Democratic Solidarity (LIBERTAD) Act of 1996 to prohibit federal funding of television broadcasting to Cuba. Terminates the U.S. Court of Federal Claims. Requires federal agencies to reduce administrative expenses. Eliminates the Medicare Advantage Regional Plan Stabilization (SLUSH) Fund. Amends the federal criminal code to prohibit profiteering and fraud involving a contract or the provision of goods or services in connection with a war or military action. Requires: (1) suspension and debarment of unethical contractors; (2) disclosure by federal agencies, upon request, to the appropriate committee chairman or ranking member of audit reports regarding federal contractors; and (3) public access to information on federal contractor penalties and [...] show full description | | Also tagged in: Agriculture, Animal diseases, Animals, Antibiotics, Business, Business records, Consumers, Drug industry, Drug resistance in microorganisms, Drugs, Food, Food safety, Government information, Government paperwork, Government publicity, Livestock Latest Action: 02/09/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to preserve the effectiveness of medically important antibiotics used in the treatment of human and animal diseases. 2/8/2007--Introduced. Preservation of Antibiotics for Medical Treatment Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing [...] show full description | | Also tagged in: Administrative procedure, Armed forces, Biological warfare, Child health, Children, Communication in medicine, Communications, Criminal justice, Defense policy, Department of Health and Human Services, Drug adulteration, Emergency management, Executive departments, Government information, Government publicity, Hazardous substances Latest Action: 02/08/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to reduce human exposure to mercury through vaccines. 2/7/2007--Introduced. Mercury-Free Vaccines Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to provide that a vaccine is a banned mercury-containing vaccine if one dose of the vaccine contains one or more micrograms of mercury in any form. Authorizes the Secretary of Health and Human Services to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period. Requires the Secretary to prohibit the distribution of banned mercury-containing influenza vaccines that are approved as biological products to: (1) any child under the age of three years old (effective July 1, 2007); (2) pregnant women if the vaccine contains thimerosal (effective July 1,[...] show full description | | Latest Action: 02/05/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. 2/5/2007--Introduced. Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer. | | Also tagged in: Biomedical engineering, Business, Clinical trials, Conflict of interests, Congress, Congressional reporting requirements, Consumers, Corporations, Data banks, Department of Health and Human Services, Drug industry, Drug interactions, Drug utilization, Drugs, Executive departments, Executive reorganization Latest Action: 03/14/2007 - Committee on Health, Education, Labor, and Pensions. Hearings held.
Bill TextA bill to amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight, and for other purposes. 2/1/2007--Introduced. Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product [...] show full description | | Also tagged in: Administrative remedies, Advertising, Biomedical engineering, Business, Clinical trials, Congress, Congressional reporting requirements, Consumer education, Consumers, Cost effectiveness, Data banks, Department of Health and Human Services, Drug adulteration, Drug industry, Epidemiology, Executive departments Latest Action: 02/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients or the [...] show full description | | Also tagged in: Administrative procedure, Auditing, Business, Cancer, Chemotherapy, Child health, Children, Clinical trials, Communication in medicine, Communications, Congress, Congressional reporting requirements, Consumers, Data banks, Department of Health and Human Services, Drug advertising Latest Action: 01/31/2007 - Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text of measure as introduced: CR S1449-1454)
Bill TextA bill to amend the Public Health Service Act to expand the clinical trials drug data bank. 1/31/2007--Introduced. Fair Access to Clinical Trials Act of 2007 or the FACT Act - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the National Institutes of Health (NIH), to establish and operate a data bank of information on clinical trials, to include: (1) a clinical trials registry of health-related interventions conducted to test the safety or effectiveness of any drug, biological product, or device intended to treat serious or life-threatening diseases and conditions; and (2) a clinical trial results database of health-related interventions to test the safety or effectiveness of any drug, biological product, or device. Requires the Commissioner of Food and Drugs to make available to the public: (1) the full reviews conducted by the Food and Drug Administration (FDA) of new or supplemental new drug [...] show full description | | Also tagged in: Administrative remedies, Advertising, Biomedical engineering, Business, Clinical trials, Congress, Congressional reporting requirements, Consumer education, Consumers, Cost effectiveness, Data banks, Department of Health and Human Services, Drug adulteration, Drug industry, Epidemiology, Executive departments Latest Action: 01/31/2007 - Sponsor introductory remarks on measure. (CR S1454-1455)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act with respect to drug safety, and for other purposes. 1/31/2007--Introduced. Food and Drug Administration Safety Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to establish the Center for Postmarket Evaluation and Research for Drugs and Biologics within the Food and Drug Administration (FDA). Requires the Director of the Center to conduct activities to ensure the safety and effectiveness of FDA-approved drugs and licensed biological products, including by: (1) conducting postmarket risk assessment and surveillance of such drugs and products; (2) determining whether a postmarket study is required; (3) contracting, or requiring the sponsor of such a drug or product to contract, with the holders of domestic and international patient databases to conduct epidemiologic and other observational studies; (4) determining whether a drug or product may present an unreasonable risk to the health of patients [...] show full description | | Latest Action: 01/30/2007 - Sponsor introductory remarks on measure. (CR S1351-1352)
Bill TextA bill to amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of authorized generic drugs. 1/30/2007--Introduced. Fair Prescription Drug Competition Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer. | | Also tagged in: Access to health care, Aged, Budgets, Business, Catastrophic health insurance, Child health, Children, Chronically ill, Congress, Congressional reporting requirements, Consumer education, Consumers, Drug advertising, Drug industry, Drugs, Education Latest Action: 04/24/2008 - S.AMDT.4577 Referred to the Committee on Finance.
Bill TextA bill to provide affordable, guaranteed private health coverage that will make Americans healthier and can never be taken away. 1/18/2007--Introduced. Healthy Americans Act - Requires each adult individual to have the opportunity to purchase a Healthy Americans Private Insurance Plan (HAPI). Makes individuals who are not enrolled in another specified health plan and who are not opposed to coverage for religious reasons responsible for enrolling themselves and their dependent children in a HAPI plan offered through their state of residence. Sets forth penalties for failure to enroll. Establishes standardized coverage and state options for HAPI plans. Requires the Secretary of Health and Human Services to promulgate guidelines concerning the benefits, items, and services to be covered. Sets forth requirements for setting premiums. Requires the Secretary to establish the Healthy America Advisory Committee to provide annual recommendations concerning modifications to [...] show full description | | Also tagged in: |
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