Drug utilization Legislation - Federal Government

A 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 [...]

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A 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 [...]

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A bill to improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers. 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 [...]

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An 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 [...]

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A 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 [...]

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To 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,[...]

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A bill to amend title XVIII of the Social Security Act to require prompt payment to pharmacies under part D, to restrict pharmacy co-branding on prescription drug cards issued under such part, and to provide guidelines for Medication Therapy Management Services programs offered by prescription drug plans and MA-PD plans under such part. 7/19/2007--Introduced. Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require prompt payment of clean claims to pharmacies by prescription drug plans and Medicare Advantage prescription drug plans. Defines prompt payment as within 14 days from submission for claims submitted electronically, and within 30 days for claims submitted otherwise. Requires payment of interest, also, if a payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days. Prohibits a Medicare [...]

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An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2008 and including the appropriate budgetary levels for fiscal years 2007 and 2009 through 2012. 5/16/2007--Conference report filed in House.    (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2008, including the appropriate budgetary levels for FY2007 and FY2009-FY2012. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2007-FY2012, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security and specified major functional categories for FY2007-FY2012. Title II: Budget Process [...]

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To 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 [...]

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A bill to amend title XVIII of the Social Security Act to require prompt payment to pharmacies under part D, to restrict pharmacy co-branding on prescription drug cards issued under such part, and to provide guidelines for Medication Therapy Management Services programs offered by prescription drug plans and MA-PD plans under such part. 7/19/2007--Introduced. Pharmacist Access and Recognition in Medicare (PhARM) Act of 2007 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require prompt payment of clean claims to pharmacies by prescription drug plans and Medicare Advantage prescription drug plans. Defines prompt payment as within 14 days from submission for claims submitted electronically, and within 30 days for claims submitted otherwise. Requires payment of interest, also, if a payment is not issued, mailed, or otherwise transmitted within the applicable number of calendar days. Prohibits a Medicare [...]

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To 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 [...]

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A 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 [...]

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An 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 [...]

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A bill to improve the underlying science of drug safety decisionmaking and strengthen the ability of the Food and Drug Administration to assess, manage, and communicate drug safety information to patients and providers. 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 [...]

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An original concurrent resolution setting forth the congressional budget for the United States Government for fiscal year 2008 and including the appropriate budgetary levels for fiscal years 2007 and 2009 through 2012. 5/16/2007--Conference report filed in House.    (There are 4 other summaries) Sets forth the congressional budget for the federal government for FY2008, including the appropriate budgetary levels for FY2007 and FY2009-FY2012. Title I: Recommended Levels and Amounts - (Sec. 101) Lists recommended budgetary levels and amounts, for FY2007-FY2012, with respect to: (1) federal revenues; (2) new budget authority; (3) budget outlays; (4) deficits; (5) debt subject to limit; and (6) debt held by the public. (Sec. 102) Lists the appropriate levels of new budget authority, outlays, and administrative expenses for Social Security and specified major functional categories for FY2007-FY2012. Title II: Budget Process [...]

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