jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2012-09-21 00:00:00

Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances. Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; (2) require the sponsor of a new drug or biological product to submit PMI as part of the new drug or abbreviated (generic) new drug application and provide for approval or disapproval of the PMI as part of the application process; (3) require the sponsor of any drug lawfully marketed in the United States to submit PMI for the drug to the Secretary for approval or disapproval of the PMI; (4) require the PMI for a generic drug to be identical to the PMI for the listed drug, except for excluding any portion of such PMI that is protected by patent or an exclusivity period under FFDCA; and (5) provide for the development of a publicly accessible electronic repository for all PMI. Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.
Topic: Health — Drug Industry
Subject: International affairs
Date: 2012-10-12 00:00:00

Trafficking in Organs Victims Protection Act - States that it shall be U.S. policy to: (1) end the offensive practice of exploiting the poor and vulnerable for the purpose of harvesting and trafficking their organs, and (2) combat criminal trade in human organs. Amends the Foreign Assistance Act of 1961 to include in the annual country reports on human rights practices information on post-operative and rehabilitation care for victims of trafficking in human organs and the extent to which violations of a country's laws against trafficking in human organs have occurred. Amends the Trafficking Victims Protection Act of 2000 to include in the definition of "coercion" exploitation of a person through the promise of payments or benefits in order to compel or entice the person to consent to the removal of one or more of the person's organs for a transplant operation in a manner contrary to certain World Health Organization (WHO) standards. Defines: (1) "trafficking in human organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by coercion, abduction, deception, abuse of power, or transfer of payments or benefits, and the illicit transportation and transplantation of those organs in one or more other persons for profit or any other purpose; and (2) "organ" as the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof, and any other human organ or subpart (including that derived from a fetus) specified by the President. Includes in the definition of "severe forms of trafficking in persons" trafficking in human organs. Amends the State Department Basic Authorities Act of 1956 to prohibit the issuance of a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense. Authorizes the President to exercise specified authorities under the International Emergency Economic Powers Act in connection with: (1) the export of anti-rejection human organ transplant drugs to countries identified as the largest source of illegally trafficked human organs or the largest recipients of illegally trafficked human organs, or (2) the travel abroad by U.S. citizens to participate in any activity relating to human organ trafficking.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-11-02 00:00:00

Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug. Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state. Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition. Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act. Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety. Sets forth a required label statement for any drug compounded pursuant to this Act. Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-11-29 00:00:00

Patient Access to Drugs in Shortage Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act (SSA), with respect to use of average sales price payment methodology for drugs and biologicals, to prescribe a formula for determining the payment amount, using the volume-weighted wholesale acquisition cost, for a multiple source or a single source sterile injectable drug product with three or fewer active manufacturers, if there is no period of exclusivity in effect or available. Incorporates such payment methodology under the hospital outpatient department prospective payment system for any such drug furnished between July 1, 2013, and January 1, 2020. Amends SSA title XIX (Medicaid) to exempt from the rebate agreement requirement a multiple source drug furnished between July 1, 2013, and January 1, 2020, and for which payment may be made under Medicare part B (Supplementary Medicare Insurance). Amends the Public Health Service Act to exclude such multiple source drugs from the term "covered outpatient drug" subject to specified price limitations under the "340B" drug pricing program. Directs the Secretary to contract with an independent entity to study the effects of this Act on patient access to sterile products. Amends the Patient Protection and Affordable Care Act to exclude certain branded prescription drugs on a specified drug shortage list from the annual fee imposed on branded prescription pharmaceutical manufacturers and importers.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-12-03 00:00:00

Health Care Innovation and Marketplace Technologies Act of 2012 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year. Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health information technology for the professional's medical practice. Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the National Coordinator for Health Information Technology, to award grants for the development of an effective product, process, or structure that enhances the use, particularly by patients, of health information technology. Requires the Secretary, acting through the National Coordinator, to award prizes for development in areas of health information technology that are not adequately addressed by certified electronic health records (EHR) technologies and the use of such technologies. Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Wireless Health Technology. Requires the Health Information Technology Research Center to provide support for mobile health software application technology. Authorizes the National Coordinator to award grants for training health care workers in health information technology.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-12-18 00:00:00

Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding that a drug intended for human use may constitute a threat to the public health to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug; and (2) amend the order to include a recall if necessary.
Topic: Health — Drug Industry
Subject: Education
Date: 2012-12-27 00:00:00

Cainaan Putuga Wendt Shock of Life Act - Directs the Secretary of Education to award matching grants to local educational agencies (LEAs) to: (1) purchase automated external defibrillators (AEDs) for use in public or private secondary schools within their district, and (2) provide training to meet the grant requirement that at least five adult employees or volunteers at each school where a purchased AED is to be used are or will be certified in its use and in cardiopulmonary resuscitation (CPR). Requires LEA grant applicants also to demonstrate that: (1) the AEDs are integrated into the schools' emergency response procedures, and (2) emergency services personnel are notified of their locations. Gives grant priority to LEAs that have secondary schools that: (1) lack an AED; (2) typically have a significant number of students, staff, and visitors present during the day; and (3) generally have a longer wait for emergency medical services than other public facilities in the community.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-01-25 00:00:00

Medical Device Access and Innovation Protection Act - Repeals the Internal Revenue Code provision, added by the Health Care and Education Reconciliation Act, that imposes an excise tax on medical devices.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2011-01-25 00:00:00

Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects. Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent. Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act. Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2011-01-31 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to deem genetically-engineered fish to be unsafe under provisions related to new animal drugs and adulterated food.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-02-03 00:00:00

Repeals the provision of the Internal Revenue Code, added by the Health Care and Education Reconciliation Act of 2010, that imposes an excise tax on medical devices. Rescinds $39 billion of appropriated but unobligated discretionary funds. Exempts unobligated funds of the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Requires the Director of the Office of Management and Budget (OMB) to determine and identify from which appropriation accounts such recissions shall apply and report to the Secretary of the Treasury and Congress on such recissions.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-02-10 00:00:00

Pharmaceutical Market Access and Drug Safety Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by a registered importeror an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-02-16 00:00:00

Fair Prescription Drug Competition Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the 180-day exclusivity period granted to the generic manufacturer.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-03-08 00:00:00

Prescription Drug Abuse Prevention and Treatment Act of 2011 - Amends the Public Health Service Act to direct the Administrator of the Substance Abuse and Mental Health Services Administration to award grants to states and nonprofit entities for consumer education about opioid abuse, including methadone abuse. Amends the Controlled Substances Act to: (1) set forth training requirements for practitioners registered to prescribe or dispense methadone or other opioids; and (2) require each registered opioid treatment clinic to make acceptable arrangements for each patient who is restricted from having a take-home dose of a controlled substance related to treatment to receive a dose of that substance under appropriate supervision when the clinic is closed. Prohibits any individual or entity (except hospitals that provide direct patient supervision) from prescribing or dispensing a 40-mg diskette of methadone unless such prescription or dispensation is consistent with the current Drug Enforcement Administration (DEA) methadone policy, until the date the Controlled Substances Clinical Standards Commission: (1) publishes dosing guidelines for methadone, and (2) finds that such 40-mg diskettes are safe and clinically appropriate. Requires the Secretary of Health and Human Services (HHS) to establish such Commission to develop and publish guidelines related to methadone use, including safe dosing guidelines for all forms of methadone and benchmark guidelines for the reduction of methadone abuse. Requires states receiving controlled substances monitoring program grants to: (1) provide information, upon request, to drug enforcement officials relating to an individual who is the subject of an active drug-related investigation; and (2) require opioid-related deaths to be reported to the Administrator. Directs the Administrator to develop a Model Opioid Treatment Program Mortality Report. Requires the Administrator to establish and implement, through the National Center for Health Statistics, a National Opioid Death Registry to track opioid-related deaths.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-05-05 00:00:00

Hearing Aid Assistance Tax Credit Act - Amends the Internal Revenue Code to allow an individual taxpayer to elect once every five years a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for use by the taxpayer or a dependent.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-05-25 00:00:00

Sunscreen Labeling Protection Act of 2011 or the SUN Act - Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time.