Top Legislation - View All
Also tagged in: Administrative fees, Administrative procedure, Advertising, Budgets, Business, Consumer education, Consumers, Criminal investigation, Criminal justice, Data banks, Defective products, Drug utilization, Drugs, Electronic commerce, Electronic data interchange, Executive departments, Federal reserve system, Finance, Internet, Law, Licenses, Medical care, Medical records, Medicine, Pharmacies, Pharmacists, Prescription pricing, Sales promotion, State and local government, State laws, Technology, Telecommunication, Web sites
Latest Action: 02/14/2007 - 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 to provide for the regulation of Internet pharmacies. 2/14/2007--Introduced. Safe Internet Pharmacy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to set forth the conditions under which a licensed Internet pharmacy may dispense or offer to dispense a prescription drug to a person in the United States. Requires an Internet pharmacy to: (1) maintain patient medication profiles; (2) ensure patient confidentiality; (3) offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient; (4) establish a mechanism for patients to report errors and suspected and adverse drug reactions and for the pharmacy to document its response and report such information to the Food and Drug Administration (FDA); and (5) verify the validity of prescriptions. Allows an Internet pharmacy to dispense a prescription for a controlled substance only if the treating provider confirms the accuracy of [...] show full description
Also tagged in: Clinical trials, Consumer education, Consumers, Drug approvals, Drug utilization, Executive departments, Federal advisory bodies, Health information systems, Health surveys, Internet, Medical care, Medical ethics, Medical records, Medical statistics, Medicine, Pharmaceutical research, Product safety, Risk, Science policy, Standards, Technology, Telecommunication, Web sites
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: 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, Clinical trials, Communicable diseases, Communication in medicine, Communications, Conflict of interests, Congress, Congressional investigations, Congressional oversight, Congressional reporting requirements, Consumer education, Consumers, Cosmetics, Counterfeiting, Criminal justice, Data banks, Defective products, Department of Health and Human Services, Drug abuse, Drug adulteration, Drug approvals, Drug industry, Drug law enforcement, Drug therapy, Drug utilization, Drugs, Education, Electronic data interchange, Elementary and secondary education, Environmental protection, Executive departments, Eye diseases, Families, Federal advisory bodies, Federal aid to education, Federal aid to research, Federal reserve system, Fines (Penalties), Food, Food additives, Food and Drug Administration (FDA), Food industry, Food preservation, Food safety, Food supply, Foodborne diseases, Foundations, Fraud, Generic drugs, Genetic counseling, Genetic engineering, Genetics, Government information, Government paperwork, Government publicity, Hazardous substances, Health information systems, Health surveys, Health warnings, Higher education, Imaging systems in medicine, Import restrictions, Intellectual property, Internet, Labeling, Law, Marijuana, Meat, Medical care, Medical education, Medical instruments and apparatus, Medical laboratories, Medical records, Medical statistics, Medical supplies, Medicinal plants, Medicine, Orphan drugs, Packaging, Parent and child, Parental consent, Patent infringement, Pediatrics, Pesticides, Pets, Pharmaceutical research, Pharmacists, Physical examinations, Politics and government, Preschool education, Prescription pricing, Prices, Produce trade, Product development, Product safety, Protection of animals, Public meetings, Research and development, Research grants, Restrictive trade practices, Risk, Salmonella, Scholarships, Science policy, Seafood, Shellfish, Skin cancer, Skin diseases, Small business, Social services, Strategic planning, Student loan funds, Technology, Telecommunication, Trade, Turtles, User charges, Web sites
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, Advertising, Alternative medicine, Australia, Business, Canada, Communication in medicine, Communications, Consumers, Customs unions, Deceptive advertising, Dietary supplements, Drug approvals, Drug industry, Drugs, East Asia, Europe, European Union, Evidence (Law), Food, Food industry, Food labeling, Government information, Government paperwork, Health policy, Health warnings, Informed consent (Medical law), Japan, Labeling, Law, Medical care, Medical instruments and apparatus, Medical supplies, Medicine, New Zealand, Oceania, Patients' rights, Trade
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: 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, Conflict of interests, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Cosmetics, Data banks, Deceptive advertising, Department of Health and Human Services, Directories, Drug advertising, Drug approvals, Drug industry, Drugs, Electronic data interchange, Electronic government information, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research, Food, Food and Drug Administration (FDA), Food safety, Foreign corporations, Foundations, Fund raising, Gifts, Government information, Government paperwork, Government publicity, Health information systems, Health policy, Identification devices, Imaging systems in medicine, Imports, Intellectual property, Inventions, Inventors, Labeling, Law, Licenses, Medical care, Medical ethics, Medical innovations, Medical instruments and apparatus, Medical records, Medical research, Medical supplies, Medicine, National Institutes of Health (NIH), Nonprofit organizations, Nosocomial infections, Nuclear medicine, Orphan drugs, Patents, Pediatrics, Performance measurement, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Profit, Public-private partnerships, Research and development, Research grants, Right of privacy, Risk, Science policy, Small business, Social services, Technology, Telecommunication, Telephone, Television advertising, Trade, User charges, Veterinary medicine
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: Biomedical engineering, Business, Clinical trials, Conflict of interests, Congress, Congressional reporting requirements, Consumers, Corporations, Data banks, Department of Health and Human Services, Drug approvals, Drug industry, Drug utilization, Drugs, Executive departments, Executive reorganization, Federal advisory bodies, Finance, Financial disclosure, Food and Drug Administration (FDA), Generic drugs, Government information, Government paperwork, Government publicity, Health information systems, Labeling, Medical care, Medical instruments and apparatus, Medical supplies, Medical technology, Medicine, Nonprofit organizations, Pharmaceutical research, Politics and government, Product development, Product safety, Research centers, Risk, Science policy, Social services, Technological innovations, Technology
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
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Latest Legislation - View All
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, Conflict of interests, Congressional investigations, Congressional reporting requirements, Consumer education, Consumers, Cosmetics, Data banks, Deceptive advertising, Department of Health and Human Services, Directories, Drug advertising, Drug approvals, Drug industry, Drugs, Electronic data interchange, Electronic government information, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research, Food, Food and Drug Administration (FDA), Food safety, Foreign corporations, Foundations, Fund raising, Gifts, Government information, Government paperwork, Government publicity, Health information systems, Health policy, Identification devices, Imaging systems in medicine, Imports, Intellectual property, Inventions, Inventors, Labeling, Law, Licenses, Medical care, Medical ethics, Medical innovations, Medical instruments and apparatus, Medical records, Medical research, Medical supplies, Medicine, National Institutes of Health (NIH), Nonprofit organizations, Nosocomial infections, Nuclear medicine, Orphan drugs, Patents, Pediatrics, Performance measurement, Pharmaceutical research, Physicians, Product counterfeiting, Product development, Product safety, Profit, Public-private partnerships, Research and development, Research grants, Right of privacy, Risk, Science policy, Small business, Social services, Technology, Telecommunication, Telephone, Television advertising, Trade, User charges, Veterinary medicine
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: Access to health care, Advertising, Alternative medicine, Australia, Business, Canada, Communication in medicine, Communications, Consumers, Customs unions, Deceptive advertising, Dietary supplements, Drug approvals, Drug industry, Drugs, East Asia, Europe, European Union, Evidence (Law), Food, Food industry, Food labeling, Government information, Government paperwork, Health policy, Health warnings, Informed consent (Medical law), Japan, Labeling, Law, Medical care, Medical instruments and apparatus, Medical supplies, Medicine, New Zealand, Oceania, Patients' rights, Trade
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: 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, Clinical trials, Communicable diseases, Communication in medicine, Communications, Conflict of interests, Congress, Congressional investigations, Congressional oversight, Congressional reporting requirements, Consumer education, Consumers, Cosmetics, Counterfeiting, Criminal justice, Data banks, Defective products, Department of Health and Human Services, Drug abuse, Drug adulteration, Drug approvals, Drug industry, Drug law enforcement, Drug therapy, Drug utilization, Drugs, Education, Electronic data interchange, Elementary and secondary education, Environmental protection, Executive departments, Eye diseases, Families, Federal advisory bodies, Federal aid to education, Federal aid to research, Federal reserve system, Fines (Penalties), Food, Food additives, Food and Drug Administration (FDA), Food industry, Food preservation, Food safety, Food supply, Foodborne diseases, Foundations, Fraud, Generic drugs, Genetic counseling, Genetic engineering, Genetics, Government information, Government paperwork, Government publicity, Hazardous substances, Health information systems, Health surveys, Health warnings, Higher education, Imaging systems in medicine, Import restrictions, Intellectual property, Internet, Labeling, Law, Marijuana, Meat, Medical care, Medical education, Medical instruments and apparatus, Medical laboratories, Medical records, Medical statistics, Medical supplies, Medicinal plants, Medicine, Orphan drugs, Packaging, Parent and child, Parental consent, Patent infringement, Pediatrics, Pesticides, Pets, Pharmaceutical research, Pharmacists, Physical examinations, Politics and government, Preschool education, Prescription pricing, Prices, Produce trade, Product development, Product safety, Protection of animals, Public meetings, Research and development, Research grants, Restrictive trade practices, Risk, Salmonella, Scholarships, Science policy, Seafood, Shellfish, Skin cancer, Skin diseases, Small business, Social services, Strategic planning, Student loan funds, Technology, Telecommunication, Trade, Turtles, User charges, Web sites
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: Clinical trials, Consumer education, Consumers, Drug approvals, Drug utilization, Executive departments, Federal advisory bodies, Health information systems, Health surveys, Internet, Medical care, Medical ethics, Medical records, Medical statistics, Medicine, Pharmaceutical research, Product safety, Risk, Science policy, Standards, Technology, Telecommunication, Web sites
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: Administrative fees, Administrative procedure, Advertising, Budgets, Business, Consumer education, Consumers, Criminal investigation, Criminal justice, Data banks, Defective products, Drug utilization, Drugs, Electronic commerce, Electronic data interchange, Executive departments, Federal reserve system, Finance, Internet, Law, Licenses, Medical care, Medical records, Medicine, Pharmacies, Pharmacists, Prescription pricing, Sales promotion, State and local government, State laws, Technology, Telecommunication, Web sites
Latest Action: 02/14/2007 - 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 to provide for the regulation of Internet pharmacies. 2/14/2007--Introduced. Safe Internet Pharmacy Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to set forth the conditions under which a licensed Internet pharmacy may dispense or offer to dispense a prescription drug to a person in the United States. Requires an Internet pharmacy to: (1) maintain patient medication profiles; (2) ensure patient confidentiality; (3) offer interactive and meaningful consultation by a licensed pharmacist to the caregiver or patient; (4) establish a mechanism for patients to report errors and suspected and adverse drug reactions and for the pharmacy to document its response and report such information to the Food and Drug Administration (FDA); and (5) verify the validity of prescriptions. Allows an Internet pharmacy to dispense a prescription for a controlled substance only if the treating provider confirms the accuracy of [...] show full description
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 approvals, Drug industry, Drug utilization, Drugs, Executive departments, Executive reorganization, Federal advisory bodies, Finance, Financial disclosure, Food and Drug Administration (FDA), Generic drugs, Government information, Government paperwork, Government publicity, Health information systems, Labeling, Medical care, Medical instruments and apparatus, Medical supplies, Medical technology, Medicine, Nonprofit organizations, Pharmaceutical research, Politics and government, Product development, Product safety, Research centers, Risk, Science policy, Social services, Technological innovations, Technology
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
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