| Also tagged in: Antibiotics, Business, Communicable diseases, Income tax, Medical care, Medical tests, Medicine, Pharmaceutical research, Preventive medicine, Research and development tax credit, Science policy, Taxation, Vaccines, Virus diseases Latest Action: 11/15/2007 - Referred to the House Committee on Ways and Means.
Bill TextTo amend the Internal Revenue Code of 1986 to provide a tax credit for medical research related to developing qualified infectious disease products. 11/15/2007--Introduced. Amends the Internal Revenue Code to allow a general business tax credit for 50% of expenses paid for research and development of any qualified infectious disease product. Defines "qualified infectious disease product" as any antibiotic drug, antiviral, diagnostic test, biological product, or vaccine developed to treat, detect, prevent, or identify certain pathogens. Terminates such credit after 2012. | | Also tagged in: Antibiotics, Business, Communicable diseases, Income tax, Medical care, Medical tests, Medicine, Pharmaceutical research, Preventive medicine, Research and development tax credit, Science policy, Taxation, Vaccines, Virus diseases Latest Action: 11/14/2007 - Read twice and referred to the Committee on Finance.
Bill TextA bill to amend the Internal Revenue Code of 1986 to provide a tax credit for medical research related to developing qualified infectious disease products. 11/14/2007--Introduced. Amends the Internal Revenue Code to allow a general business tax credit for 50% of expenses paid for research and development of any qualified infectious disease product. Defines "qualified infectious disease product" as any antibiotic drug, antiviral, diagnostic test, biological product, or vaccine developed to treat, detect, prevent, or identify certain pathogens. Terminates such credit after 2012. | | Also tagged in: Ambulatory care, Birth control, Business, Clinics, Consumers, Drugs, Education, Health policy, Higher education, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Students, Welfare Latest Action: 11/13/2007 - Read twice and referred to the Committee on Finance.
Bill TextA bill to restore and protect access to discount drug prices for university-based and safety-net clinics. 11/13/2007--Introduced. Prevention Through Affordable Access Act - Amends title XIX (Medicaid) of the Social Security Act to revise requirements for the best price component of the formula for determination of the Medicaid rebate for a covered single source outpatient drug or a covered innovator multiple source outpatient drug. (Under current law, best prices shall not take into account prices that are merely nominal in amount.) Revises the list of entities to which sales by a manufacturer of covered outpatient drugs at nominal prices shall be considered to be sales at a nominal price, or merely nominal in amount (and thus excluded from computation of the best price for such drugs). Adds to such list any entity that is: (1) operated by a health center of an institution of higher education, primarily for its students (university-based clinic); or (2) a public [...] show full description | | Also tagged in: Administrative procedure, Business, Congress, Congressional reporting requirements, Consumer education, Consumers, Deceptive advertising, Department of Health and Human Services, Drug adulteration, Drugs, Executive departments, Food and Drug Administration (FDA), Labeling, Law, Medical care, Medicine Latest Action: 11/06/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to provide for the amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced. Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. | | Also tagged in: Administrative procedure, Business, Congress, Congressional reporting requirements, Consumer education, Consumers, Deceptive advertising, Department of Health and Human Services, Drug adulteration, Drugs, Executive departments, Food and Drug Administration (FDA), Labeling, Law, Medical care, Medicine Latest Action: 11/06/2007 - 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 amendment or repeal of monographs, to expand the Food and Drug Administration's authority to regulate drug advertising, and for other purposes. 11/6/2007--Introduced. Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements. Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress. | | Also tagged in: Ambulatory care, Birth control, Business, Clinics, Consumers, Drugs, Education, Health policy, Higher education, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Students, Welfare Latest Action: 11/01/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend title XIX of the Social Security Act to restore and protect access to Medicaid discount drug prices for university-based and safety-net clinics. 11/1/2007--Introduced. Prevention Through Affordable Access Act - Amends title XIX (Medicaid) of the Social Security Act to revise requirements for the best price component of the formula for determination of the Medicaid rebate for a covered single source outpatient drug or a covered innovator multiple source outpatient drug. (Under current law, best prices shall not take into account prices that are merely nominal in amount.) Revises the list of entities to which sales by a manufacturer of covered outpatient drugs at nominal prices shall be considered to be sales at a nominal price, or merely nominal in amount (and thus excluded from computation of the best price for such drugs). Adds to such list any entity that is: (1) operated by a health center of an institution of higher education, primarily for its students [...] show full description | | Also tagged in: Budgets, Business, Children, Consumer education, Consumers, Criminal justice, Drug abuse, Drug abuse prevention, Drug traffic, Drugs, Drugs and youth, Fines (Penalties), Government information, Government paperwork, Grants-in-aid, Health education Latest Action: 03/12/2008 - Committee on the Judiciary Senate Subcommittee on Crime and Drugs. Hearings held.
Bill TextA bill to amend the Controlled Substances Act to prevent the abuse of dextromethorphan, and for other purposes. 10/31/2007--Introduced. Dextromethorphan Abuse Reduction Act of 2007 - Amends the Controlled Substances Act to: (1) set forth definitions relating to dextromethorphan in unfinished or finished dosage form; (2) classify unfinished dextromethorphan as a Schedule V controlled substance; and (3) impose civil penalties for sales of products containing dextromethorphan to individuals under the age of 18.Expresses the sense of the Senate that: (1) manufacturers of products containing dextromethorphan should provide warnings about the dangers of dextromethorphan misuse; and (2) retailers should impose safeguards to protect against the theft of products containing dextromethorphan. Directs the Director of National Drug Control Policy to make grants to the Partnership for a Drug-Free America and the Community Anti-Drug Coalition of America for education programs [...] show full description | | Also tagged in: Auditing, Awards, medals, prizes, Budgets, Business, Commemorations, Communicable diseases, Congress, Congressional investigations, Cost effectiveness, Drug approvals, 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: Animals, Budgets, Business, Consumers, Food, Food industry, Food safety, Medical care, Medical instruments and apparatus, Medicine, Product safety, User charges, Veterinary medicine Latest Action: 10/18/2007 - Sponsor introductory remarks on measure. (CR S13087)
Bill TextA bill to establish a user fee for follow-up reinspections under the Federal Food, Drug, and Cosmetic Act. 10/18/2007--Introduced. Directs the Secretary of Health and Human Services to collect a user fee from each manufacturer of a food, drug, device, biological product, or animal drug for which a followup reinspection is required to ensure correction of a violation of a Good Manufacturing Practices requirement under the Federal Food, Drug, and Cosmetic Act found by the Secretary during the initial inspection of the manufacturer. | | Also tagged in: Animals, Bacterial diseases, Budgets, Business, Business records, Congress, Congressional investigations, Congressional reporting requirements, Department of Health and Human Services, Drug resistance in microorganisms, Drugs, Epidemiology, Executive departments, Executive reorganization, Federal advisory bodies, Federal aid to research Latest Action: 11/08/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Public Health Service Act to address antimicrobial resistance. 9/27/2007--Introduced. Strategies to Address Antimicrobial Resistance Act - Amends the Public Health Service Act to direct the Secretary of Health and Human Services to: (1) establish, and appoint the Director of, the Office of Antimicrobial Resistance in the Office of the Assistant Secretary for Health to develop plans for addressing antimicrobial resistance in the United States and internationally; (2) establish the Public Health Antimicrobial Advisory Board to assist the Director; and (3) develop an antimicrobial resistance strategic research plan. Renews the Antimicrobial Resistance Task Force and sets forth its membership and duties.Requires sponsors of human and animal antimicrobial drug products to report to the Office of Antimicrobial Resistance the amount of such drug products sold or distributed in the United States in a calendar year. Requires the Director to make summaries of drug [...] show full description | | Also tagged in: Ambulatory care, Business, Drugs, Government information, Government paperwork, Health policy, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Welfare Latest Action: 11/08/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend title XIX of the Social Security Act to ensure that individuals eligible for medical assistance under the Medicaid Program continue to have access to prescription drugs, and for other purposes. 9/27/2007--Introduced. Fair Medicaid Drug Payment Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to direct the Secretary of Health and Human Services to calculate the federal upper reimbursement limit as no less than 300% of the weighted average (based on utilization) of the most recent average manufacturer prices (AMPs) for pharmaceutically and therapeutically equivalent multiple source drug products available for purchase by retail community pharmacies on a nationwide basis. Directs the Secretary to implement a smoothing process for AMPs to ensure that federal upper reimbursement limits do not vary significantly from month to month as a result of rebates, discounts, and other pricing practices. Requires a state plan to subject to prior authorization [...] show full description | | Latest Action: 09/25/2007 - Read twice and referred to the Committee on Finance.
Bill TextA bill to amend title XVIII of the Social Security Act to reduce the coverage gap in prescription drug coverage under part D of such title based on savings to the Medicare program resulting from the negotiation of prescription drug prices. 9/25/2007--Introduced. Medicare Prescription Drug Gap Reduction Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act (SSA) to reduce the coverage gap in prescription drug coverage under SSA part D (Voluntary Prescription Drug Benefit Program), based on savings to the Medicare program resulting from the negotiation of prescription drug prices.Grants the Secretary of Health and Human Services authority similar to that of other federal entities that purchase prescription drugs in bulk to negotiate contracts with manufacturers of covered part D drugs.States that the Secretary shall be required to: (1) negotiate contracts with manufacturers of covered part D drugs for each fallback prescription drug plan; and (2) [...] show full description | | 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: Aged, Business, Children, Drugs, Federal aid to child health services, Government information, Government paperwork, Health insurance, Health policy, Medicaid, Medical care, Medical instruments and apparatus, Medical supplies, Medically uninsured, Medicare, Medicine Latest Action: 09/06/2007 - Sponsor introductory remarks on measure. (CR S11217-11218)
Bill TextA bill to amend title XI of the Social Security Act to provide for transparency in the relationship between physicians and manufacturers of drugs, devices, or medical supplies for which payment is made under Medicare, Medicaid, or SCHIP. 9/6/2007--Introduced. Physician Payments Sunshine Act of 2007 - Amends part A of title XI of the Social Security Act to require quarterly transparency reports to the Secretary of Health and Human Services of payments to physicians or their employers by manufacturers of covered drugs, devices, or medical supplies under titles XVIII (Medicare), XIX (Medicaid), or XXI (State Children's Health Insurance Program (SCHIP)) of the Social Security Act. | | Also tagged in: Ambulatory care, Business, Drugs, Government information, Government paperwork, Health policy, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Welfare Latest Action: 08/02/2007 - Read twice and referred to the Committee on Finance.
Bill TextA bill to amend title XIX of the Social Security Act to ensure that individuals eligible for medical assistance under the Medicaid program continue to have access to prescription drugs, and for other purposes. 8/2/2007--Introduced. Fair Medicaid Drug Payment Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to direct the Secretary of Health and Human Services to calculate the federal upper reimbursement limit as no less than 300% of the weighted average (based on utilization) of the most recent average manufacturer prices (AMPs) for pharmaceutically and therapeutically equivalent multiple source drug products available for purchase by retail community pharmacies on a nationwide basis. Directs the Secretary to implement a smoothing process for AMPs to ensure that federal upper reimbursement limits do not vary significantly from month to month as a result of rebates, discounts, and other pricing practices. Requires a state plan to subject to prior authorization [...] show full description | | Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR E1698)
Bill TextTo amend title XIX of the Social Security Act to require, at the option of a State, drug manufacturers to pay rebates to State prescription drug discount programs as a condition of participation in a rebate agreement for outpatient prescription drugs under the Medicaid Program. 8/1/2007--Introduced. Voluntary State Discount Prescription Drug Plan Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program. | | Also tagged in: Biomedical engineering, Business, Clinical trials, Finance, Income tax, Investment tax credit, Investments, Losses, Medical care, Medical research, Medicine, Orphan drugs, Pharmaceutical research, Research and development tax credit, Science policy, Small business Latest Action: 08/02/2007 - Sponsor introductory remarks on measure. (CR E1689-1690)
Bill TextTo amend the Internal Revenue Code of 1986 to modernize the tax treatment of biomedical research corporations. 7/31/2007--Introduced. American Life Sciences Competitiveness Act of 2007 - Amends the Internal Revenue Code to allow biomedical research corporations to: (1) engage in investment activity involving shifts in ownership without incurring limitations on net operating loss carryforwards; (2) claim a full research and development tax credit for contract research expenses (currently, limited to 65%); (3) claim a business tax credit for 20% of eligible countermeasures research expenses (for biomedical threats); and (4) claim a tax-free rollover of gain from stock sales reinvested in another biomedical research corporation.Expands the tax credit for clinical testing expenses for drugs to treat rare diseases (orphan drugs) to include expenses incurred after an application is made to the Food and Drug Administration (FDA) but before receipt of an orphan drug designation.[...] show full description | | Also tagged in: Administrative procedure, Advertising, Business, Communications, Consumer protection, Consumers, Deceptive advertising, Department of Health and Human Services, Drugs, Executive departments, Hazardous substances, Health education, Health policy, Labeling, Law, Medical care Latest Action: 07/18/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo require the Food and Drug Administration to establish a standard for broad-spectrum protection in sunscreen products, and for other purposes. 7/18/2007--Introduced. Skin Cancer Prevention, Education, and Consumer Right-To-Know Act - Amends the Federal Food, Drug, and Cosmetic Act to deem a drug that is a sunscreen product whose labeling violates this Act to be adulterated.Prohibits the labeling of a drug that is a sunscreen product that fails to meet the standards adopted under this Act from: (1) describing the product using the term "broad-spectrum"; or (2) including a specified symbol adopted to indicate broad-spectrum.Requires the Secretary of Health and Human Services to adopt: (1) a standard for broad-spectrum protection in sunscreen products; and (2) an easily recognized symbol for inclusion in the labeling of sunscreen products meeting such standards.Sets forth minimum standards that the Secretary shall adopt for such broad-spectrum [...] show full description | | Also tagged in: Business, Business records, Drugs, Fines (Penalties), Gifts, Government information, Government paperwork, Government publicity, Governmental investigations, Health insurance, Health maintenance organizations, Health policy, Hospitals, Injunctions, Law, Marketing Latest Action: 07/12/2007 - Referred to the Subcommittee on Health.
Bill TextTo require the manufacturers, packers, and distributors of prescription drugs and medical devices to disclose certain gifts provided in connection with detailing, promotional, or other marketing activities, and for other purposes. 7/12/2007--Introduced. Drug and Medical Device Company Gift Disclosure Act - Amends the Federal Food, Drug, and Cosmetic Act to require prescription drug or medical device manufacturers, packers, and distributors to annually disclose to the Commissioner of Food and Drugs the value, nature, and purpose of any : (1) gift made in connection with detailing, promotion, or other marketing activity to any physician, nurse, therapist, hospital, nursing home, pharmacist, health benefit plan administrator, or any other person authorized to prescribe or dispense prescription drugs; and (2) cash rebate, discount, or other financial consideration given to any pharmaceutical benefit manager in connection with such marketing activities. Defines "gift"[...] show full description | | Also tagged in: Access to health care, Aged, Budgets, Business, Coinsurance, Communications, Congressional reporting requirements, Consumer complaints, Consumer discounts, Consumer education, Consumers, Deceptive advertising, Drug therapy, Drugs, Government information, Government paperwork Latest Action: 07/12/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend title XVIII of the Social Security Act to provide comprehensive improvements to the Medicare Prescription Drug Program, and for other purposes. 7/12/2007--Introduced. Medicare Prescription Drug Savings for Our Seniors (Medicare Prescription Drug SOS) Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to direct the Secretary of Health and Human Services to: (1) offer one or more Medicare operated prescription drug plans (PDPs) with a service area consisting of the entire United States; and (2) negotiate with pharmaceutical manufacturers to reduce the purchase cost of covered part D drugs. Requires the monthly beneficiary premium for qualified prescription drug coverage and access to negotiated prices to be uniform nationally. Provides for auto-enrollment of subsidy eligible individuals in Medicare operated PDPs.Amends SSA title XIX (Medicaid) to provide for the use of 2005 [...] show full description | | Also tagged in: Ambulatory care, Business, Drugs, Health policy, Managed care, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Welfare Latest Action: 07/12/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations. 7/12/2007--Introduced. Medicaid Prescription Drug Rebate Equalization Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending to such organizations the discounts offered under fee-for-service Medicaid plans.Requires the state contract with a Medicaid managed care organization to provide that: (1) payment for covered outpatient drugs dispensed to Medicaid-eligible individuals enrolled with the organization shall be subject to the same rebate as the state is subject to; and (2) the state shall allow the organization to collect such rebates from manufacturers.Requires also that capitation rates paid to the organization [...] show full description | | Also tagged in: Business, Business records, Consumer discounts, Consumer education, Consumer protection, Consumers, Contracts, Drug utilization, Drugs, Fees, Finance, Financial statements, Fines (Penalties), Generic drugs, Government information, Government paperwork Latest Action: 07/10/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo ensure integrity in the operation of pharmacy benefit managers. 7/10/2007--Introduced. Pharmacy Benefit Manager Transparency Act of 2007 - Prohibits any pharmaceutical drug manufacturer from having a controlling interest in an entity that is a pharmacy benefit manager. Allows the Secretary of Health and Human Services to issue civil penalties for violations as necessary. Prohibits pharmacy benefit managers from making drug interchanges: (1) to a drug with a greater cost; (2) without disclosure to the individual of the savings associated with the interchange; or (3) from a drug with generic equivalents to a drug without generic equivalents, unless the latter is lower in cost than each of the generic equivalents of the drug from which the prescription would be changed. Requires pharmacy benefit managers to annually disclose all compensation received from drug manufacturers to the Antitrust Division of the Department of Justice (DOJ) and to the client plans [...] 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: Access to health care, Business, Developing countries, Drugs, Foreign policy, Free trade, Generic drugs, Health policy, Intellectual property, International affairs, Medical care, Medical research, Medicine, Patents, Pharmaceutical research, Research and development Latest Action: 06/28/2007 - Referred to the House Committee on Ways and Means.
Bill TextExpressing the sense of the House of Representatives that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. 6/28/2007--Introduced. Urges the United States to: (1) honor U.S. commitments made in the 2001 World Trade Organization Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health, which allows World Trade Organization (WTO) members to fully use the flexibilities in the TRIPS Agreement to protect public health and promote access to medicines for all; (2) not place countries on the "Special 301" Priority Watch List for exercising such flexibilites, such as issuing compulsory licenses to obtain generic medicines; (3) not ask developing countries that are trading partners to adopt measures to protect public health intellectual property rights [...] show full description | | Also tagged in: Budgets, Business, Drug approvals, 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: Business, Communications, Consumer education, Consumers, Corporation taxes, Deceptive advertising, Drug advertising, Drugs, Government information, Government paperwork, Income tax, Labeling, Medical care, Medicine, Tax deductions, Taxation Latest Action: 06/21/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend the Internal Revenue Code of 1986 to deny any deduction for direct-to-consumer advertisements of prescription drugs that fail to provide certain information or to present information in a balanced manner, to amend the Federal Food, Drug, and Cosmetic Act to require reports regarding such advertisements, and to amend such Code to deny any deduction for direct-to-consumer advertisements of qualified prescription drugs for a two-year period. 6/21/2007--Introduced. Fair Balance Prescription Drug Advertisement Act of 2007 - Amends the Internal Revenue Code to disallow a tax deduction for: (1) expenses for direct-to-consumer prescription drug advertising that fails to provide adequate information on drug side effects, contraindications, or lack of effectiveness; and (2) expenses for direct-to-consumer prescription drug advertising of a new drug, a new combination of active substances, or a new delivery system for an existing drug for a two-year period after the introduction [...] show full description | | Also tagged in: Access to health care, Business, Developing countries, Drugs, Foreign policy, Free trade, Generic drugs, Health policy, Intellectual property, International affairs, Medical care, Medical research, Medicine, Patents, Pharmaceutical research, Research and development Latest Action: 06/20/2007 - Referred to the Committee on Finance. (text of measure as introduced: CR S8088-8089)
Bill TextA resolution expressing the sense of the Senate that the United States should reaffirm the commitments of the United States to the 2001 Doha Declaration on the TRIPS Agreement and Public Health and to pursuing trade policies that promote access to affordable medicines. 6/20/2007--Introduced. Urges the United States to: (1) honor U.S. commitments made in the 2001 World Trade Organization Doha Declaration on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement and Public Health, which allows World Trade Organization (WTO) members to fully use the flexibilities in the TRIPS Agreement to protect public health and promote access to medicines for all; (2) not place countries on the "Special 301" Priority Watch List for exercising such flexibilites, such as issuing compulsory licenses to obtain generic medicines; (3) not ask developing nations that are trading partners to adopt measures to protect public health intellectual property rights in excess [...] show full description | | Also tagged in: Business, Civil liberties, Consumers, Drug advertising, Drugs, Fines (Penalties), Government information, Government publicity, Identification devices, Intellectual property, Labeling, Law, Medical care, Medicine, Packaging, Product counterfeiting Latest Action: 06/14/2007 - Referred to the Subcommittee on Health.
Bill TextTo direct the Secretary of Health and Human Services to require the incorporation of counterfeit-resistant technologies into the packaging of prescription drugs, and for other purposes. 6/14/2007--Introduced. Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: [...] 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 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: Ambulatory care, Business, Drugs, Health policy, Managed care, Medicaid, Medical care, Medicine, Prescription pricing, Rebates, Welfare Latest Action: 06/11/2007 - Sponsor introductory remarks on measure. (CR S7454-7455, S7455-7458)
Bill TextA bill to amend title XIX of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending the discounts offered under fee-for-service Medicaid to such organizations.. 6/11/2007--Introduced. Drug Rebate Equalization Act of 2007 - Amends title XIX (Medicaid) of the Social Security Act to reduce the costs of prescription drugs for enrollees of Medicaid managed care organizations by extending to such organizations the discounts offered under fee-for-service Medicaid plans. Requires the state contract with a Medicaid managed care organization to provide that: (1) payment for covered outpatient drugs dispensed to Medicaid-eligible individuals enrolled with the organization shall be subject to the same rebate as the state is subject to; and (2) the state shall allow the organization to collect such rebates from manufacturers. Requires also that capitation rates paid to the organization be: (1) based [...] show full description | | Also tagged in: Access to health care, Administrative remedies, Ambulatory care, Business, Department of Health and Human Services, Drugs, Executive departments, Generic drugs, Health policy, Hospitals, Law, Medicaid, Medical care, Medicine, Prescription pricing, Rural affairs Latest Action: 06/07/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend section 340B of the Public Health Service Act to revise and expand the drug discount program under that section to improve the provision of discounts on drug purchases for certain safety net providers. 6/7/2007--Introduced. 340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such requirements, including for drugs unavailable through the program and [...] 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 approvals 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 approvals, 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: Administrative remedies, Business, Colleges, Conflict of interests, Congressional reporting requirements, Consumers, Department of Health and Human Services, Drugs, Education, Executive departments, Health policy, Higher education, Law, Medical care, Medical innovations, Medical instruments and apparatus Latest Action: 06/06/2007 - Referred to the House Committee on Energy and Commerce.
Bill TextTo amend the Federal Food, Drug, and Cosmetic Act to provide for one or more Critical Path Public-Private Partnerships to implement the Critical Path Initiative of the Food and Drug Administration, and for other purposes. 6/6/2007--Introduced. Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any [...] show full description | | Also tagged in: Alcohol tax, Business, Finance, Food, Food additives, Food industry, Free ports and zones, Medical care, Medicine, Surety and fidelity, Tax penalties, Taxation, Trade Latest Action: 06/06/2007 - Sponsor introductory remarks on measure. (CR H2571)
Bill TextTo amend the Internal Revenue Code of 1986 and the Foreign Trade Zones Act to simplify the tax and eliminate the drawback fee on certain distilled spirits used in nonbeverage products manufactured in a United States foreign trade zone for domestic use and export. 6/5/2007--Introduced. Amends the Internal Revenue Code and the Foreign Trade Zones Act to permit the transfer of distilled spirits used in a foreign trade zone for the manufacture or production of nonbeverage products (i.e., medicines, medicinal preparations, food products, flavors, flavoring extracts, or perfume, which are unfit for beverage purposes) to an activated foreign trade zone without payment of applicable excise taxes. Authorizes the Secretary of the Treasury to: (1) require manufacturers and producers of such nonbeverage products to file an adequate bond and permit; and (2) examine records and compel testimony to enforce the provisions of this Act. | | Also tagged in: Alcohol tax, Business, Finance, Food, Food additives, Food industry, Free ports and zones, Medical care, Medicine, Surety and fidelity, Tax penalties, Taxation, Trade Latest Action: 05/25/2007 - Read twice and referred to the Committee on Finance.
Bill TextA bill to amend the Internal Revenue Code of 1986 and the Foreign Trade Zones Act to simplify the tax and eliminate the drawback fee on certain distilled spirits used in nonbeverage products manufactured in a United States foreign trade zone for domestic use and export. 5/25/2007--Introduced. Amends the Internal Revenue Code and the Foreign Trade Zones Act to permit the transfer of distilled spirits used in a foreign trade zone for the manufacture or production of nonbeverage products (i.e., medicines, medicinal preparations, food products, flavors, flavoring extracts, or perfume, which are unfit for beverage purposes) to an activated foreign trade zone without payment of applicable excise taxes. Authorizes the Secretary of the Treasury to: (1) require manufacturers and producers of such nonbeverage products to file an adequate bond and permit; and (2) examine records and compel testimony to enforce the provisions of this Act. | | Also tagged in: Access to health care, Administrative remedies, Ambulatory care, Business, Department of Health and Human Services, Drugs, Executive departments, Generic drugs, Health policy, Hospitals, Law, Medicaid, Medical care, Medicine, Prescription pricing, Rural affairs Latest Action: 05/14/2007 - Sponsor introductory remarks on measure. (CR S6057)
Bill TextA bill to amend the Public Health Service Act to revise and expand the drug discount program under section 340B of such Act to improve the provision of discounts on drug purchases for certain safety net provides. 5/14/2007--Introduced. 340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain children's hospitals, critical access hospitals, and rural referral centers or sole community hospitals. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such prohibition, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Expands the program to include a drug used in connection with an inpatient or outpatient service [...] 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 approvals, 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: Aged, AIDS (Disease), Bribery, Business, Coinsurance, Criminal justice, Drugs, Finance, Health insurance, Health maintenance organizations, Health policy, Hospitals, Indian medical care, Managed care, Medical care, Medical economics Latest Action: 05/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo include costs incurred by the Indian Health Service, a federally qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program in providing prescription drugs toward the annual out of pocket threshold under part D of title XVIII of the Social Security Act and to provide a safe harbor for assistance provided under a pharmaceutical manufacturer patient assistance program. 4/26/2007--Introduced. Helping Fill the Medicare Rx Gap Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), with respect to the annual out of pocket threshold, to count costs incurred in providing prescription drugs by the Indian Health Service, a federally-qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program.Amends SSA title XI, with respect to criminal penalties [...] show full description | | Also tagged in: Aged, Business, Drugs, Finance, Health policy, Insurance premiums, Medical care, Medical economics, Medicare, Medicine, Prescription pricing, Public contracts Latest Action: 05/02/2007 - Referred to the Subcommittee on Health.
Bill TextTo amend title XVIII of the Social Security Act to provide for a Medicare operated prescription drug plan option to deliver a meaningful drug benefit and lower prescription drug prices under the Medicare Program. 4/26/2007--Introduced. Medicare Drug Savings Through Choice Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) offer a Medicare operated prescription drug plan with a service area that consists of the entire United States; (2) negotiate with pharmaceutical manufacturers to reduce the purchase cost of covered Medicare part D drugs; and (3) encourage the use of more affordable therapeutic equivalents. Requires the monthly beneficiary premium charged under such a plan to be uniform nationally. Requires adjustment of such premium amount in case of supplemental prescription drug coverage. | | 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 approvals, 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: Biotechnology, Business, Congressional reporting requirements, Consumers, Deceptive advertising, Drug approvals, 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: Business, Children, Clinical trials, Congress, Congressional investigations, Congressional reporting requirements, Consumers, Drug approvals, 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: Business, Claims, Competition, Consumer protection, Consumers, Contracts, Drugs, Generic drugs, Government information, Government paperwork, Health policy, Intellectual property, Marketing, Medical care, Medicine, Patent infringement Latest Action: 05/04/2007 - Referred to the Subcommittee on Courts, the Internet, and Intellectual Property.
Bill TextTo prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market, and for other purposes. 4/17/2007--Introduced. Protecting Consumer Access to Generic Drugs Act of 2007 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition [...] show full description | | Also tagged in: Aged, AIDS (Disease), Business, Drugs, Health policy, Hospitals, Indian medical care, Medical care, Medicare, Medicine, Minorities, Prescription pricing Latest Action: 04/12/2007 - Sponsor introductory remarks on measure. (CR S4442-4444)
Bill TextA bill to amend title XVIII of the Social Security Act to include costs incurred by the Indian Health Service, a Federally qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program in providing prescription drugs toward the annual out of pocket threshold under part D of the Medicare program. 4/12/2007--Introduced. Helping Fill the Medicare Rx Gap Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA), with respect to the annual out of pocket threshold, to count costs incurred in providing prescription drugs by the Indian Health Service, a federally-qualified health center, an AIDS drug assistance program, certain hospitals, or a pharmaceutical manufacturer patient assistance program. | | Also tagged in: Administrative remedies, Antibiotics, Business, Children, Clinical trials, Consumer education, Consumers, Department of Health and Human Services, Drug approvals, 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: Biomedical engineering, Business, Clinical trials, Conflict of interests, Consumers, Data banks, Directories, Drug approvals, 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 approvals, 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: Antitrust law, Business, Competition, Generic drugs, Intellectual property, Marketing, Medical care, Medicine, Patent infringement, Pharmaceutical research, Restrictive trade practices, Science policy Latest Action: 03/12/2007 - Referred to the Subcommittee on Commerce, Trade and Consumer Protection.
Bill TextTo prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market. 3/9/2007--Introduced. Preserve Access to Affordable Generics Act - Amends the Clayton Act to make it unlawful for a person, in connection with the sale of a drug product, to be a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market, or sell the generic product for any period. Excludes a resolution or settlement that includes no more than the right to market the generic product prior to the expiration of the patent. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer [...] show full description | | |
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