jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2008-05-21 00:00:00

Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.
Topic: Health — Drug Industry
Subject: Transportation and public works
Date: 2008-05-22 00:00:00

Requires automobiles manufactured or sold in the United States, beginning with model year 2013, to be equipped with a real time and average fuel economy display that is visible to the driver.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-06-17 00:00:00

Medicare DMEPOS Competitive Acquisition Reform Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act to delay generally until after 2011 full implementation of the Medicare competitive acquisition program for the purchase of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).Revises such program, dividing its implementation into two rounds, and specifying covered item updates for 2009-2014.Prescribes requirements for application of accreditation in implementing quality standards.Requires suppliers to disclose subcontractors.Directs the Secretary of Health and Human Services to provide for a competitive acquisition ombudsman within the Centers for Medicare & Medicaid Services to respond to complaints and inquiries by suppliers and individuals.Specifies topics for the Comptroller General's required study and report to Congress on the impact of competitive acquisition of DME on suppliers, manufacturers, and patients.Sets forth a special rule for the competitive acquisition program for diabetic testing strips.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-06-18 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to require that priority review vouchers, which are given by the Secretary of Health and Human Services to the sponsor of a tropical disease product application, are transferable to sponsors of human drug applications for approval of a new drug or biological product. Prohibits such vouchers from being redeemed to affect the review of a pending human drug application.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-07-31 00:00:00

Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-07-31 00:00:00

Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.Includes in the definition of "drug" a precursor ingredient.Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.Expands the information required to be included for registration of establishments.Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.Sets forth provisions governing importation of a drug. Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.Establishes actions manufacturers must take regarding any defective drug.Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy of information submitted and personal knowledge of such information.Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.Directs the Secretary of Health and Human Services to establish and maintain a corps of inspectors dedicated to inspections of foreign establishments and foreign facilities.Authorizes the Secretary to conduct investigations, subpoena witnesses, and compel attendance of witnesses as necessary to carry out authority under the FFDCA or provisions governing the regulation of biological products.Requires reports to the Secretary regarding certain civil actions involving a regulated product.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-09-17 00:00:00

Organ Transplant Authorization Act of 2008 - Amends the Public Health Service Act to increase the maximum amount of funds provided for the establishment and operation of the Organ Procurement and Transplantation Network for any fiscal year.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-09-26 00:00:00

Transparency in Drug Labeling Act - Amends the Federal Food, Drug, and Cosmetic Act to deem a drug to be misbranded unless the labeling of such drug lists the identity of the country of manufacture of each active ingredient and each inactive ingredient of the drug, listed in descending order based on the percentage of the number of such ingredients in the final dosage form manufactured in such countries.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-06 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to exempt prescription drugs that have been shipped directly from a state to the U.S. Virgin Islands from restrictions on importation of exported drugs.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-06 00:00:00

Prescription Drug Affordability Act - Amends the Internal Revenue Code to allow a nonrefundable tax credit for 80 percent of the amount paid for a prescribed drug during the taxable year (and not compensated for by insurance or otherwise) by a taxpayer who has attained social security retirement age.Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to repeal provisions restricting the importation of prescription drugs. Allows a person who meets applicable legal requirements to be an importer of prescription drugs upon application to the Secretary of Health and Human Services. Requires the Secretary to approve such an application if the drug meets all FFDCA requirements for admission into the United States, including that the drug has been approved by the Food and Drug Administration (FDA) and is not adulterated or misbranded.Prohibits the Secretary from taking any action against any of the persons involved with the interstate sale of a prescription drug through an Internet site if: (1) the sale was made in compliance with FFDCA, the Controlled Substances Act, and applicable state laws; and (2) accurate information regarding compliance with such laws is posted on the Internet site.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-09 00:00:00

Prevention Through Affordable Access Act of 2009 - 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 or private nonprofit entity that provides family planning services under the Public Health Service Act (safety-net clinic).
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-09 00:00:00

340B Program Improvement and Integrity Act of 2009 - 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 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 by enrolled hospitals. (Currently, only outpatient drugs are covered under the program.)Requires hospitals enrolled in the 340B drug discount program to provide to each state a credit on the estimated annual costs to such hospital of single source and innovator multiple source drugs and noninnovator multiple source drugs provided to Medicaid recipients for inpatient use. Sets forth a formula for calculating the credit. Allows a hospital to avoid paying such credits under certain circumstances. Requires the Secretary to: (1) carry out activities to improve compliance by manufacturers and covered entities with the requirements of the drug discount program; and (2) establish an administrative process for resolving claims by covered entities and manufacturers of violations of such requirements.Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-15 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the exclusivity period granted to the generic manufacturer.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-28 00:00:00

Food and Drug Administration Globalization Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth provisions governing food safety, including requiring for each food facility: (1) a hazard analysis of facilities that manufacture, process, pack, transport, or hold food for consumption in the United States; (2) identification and implementation of preventive controls; and (3) a written food safety plan.Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to significantly minimize, prevent, or eliminate the occurrence of such hazards; (2) establish science-based minimum standards for the safe production and harvesting of fruits and vegetables as necessary; (3) establish a risk-based inspection schedule; and (4) establish a program to expedite the movement of certified food through the importation process.Provides for: (1) an accreditation system for food facilities; and (2) certification of laboratories to conduct sampling and testing of food.Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish an active surveillance system for food.Sets forth provisions governing drug and device safety, including: (1) providing for risk-based inspection schedules; (2) requiring quality risk management plans for establishments; (3) requiring country of origin labeling; and (4) providing for the recall of drugs.Sets forth provisions governing cosmetic safety, including requiring cosmetic establishments to: (1) submit to the Secretary a cosmetic and ingredient statement for each cosmetic; (2) report any serious and unexpected adverse event in the United States associated with the use of the cosmetic; and (3) conform with good manufacturing practices.Sets forth provisions governing the Food and Drug Administration (FDA), including provisions: (1) regarding the reorganization of FDA; and (2) authorizing the Commissioner of Food and Drugs to issue subpoenas for any proceeding regarding a violation of the FFDCA.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2009-01-28 00:00:00

Prohibits any federal department, agency, or court from taking any action (administrative, civil, criminal, or otherwise) that would prohibit, interfere with, regulate, or otherwise restrict the interstate traffic of milk, or a milk product, that is unpasteurized and packaged for direct human consumption, solely on the basis that the milk or milk product is unpasteurized and is therefore adulterated, misbranded, or otherwise in violation of federal law.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2009-02-03 00:00:00

Protect Consumers Act of 2009 - Requires the Secretary of Health and Human Services, upon a determination that it is necessary to implement a mandatory recall of any product regulated by the Food and Drug Administration (FDA), to issue an order requiring the appropriate person to: (1) immediately cease distribution, manufacture, and sale of such product; (2) immediately provide notice to individuals subject to the risks associated with the use of such product; and (3) implement an immediate recall of such product. Directs that the order shall provide for an informal hearing within ten days. Treats the failure to obey such an order as a prohibited act under the Federal Food, Drug, and Cosmetic Act. Requires the Secretary to study and implement new procedures for voluntary and mandatory recalls.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-02-12 00:00:00

Shingles Prevention Act - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to provide for coverage of the shingles vaccine and its administration.
Topic: Health — Drug Industry
Subject: Environmental protection
Date: 2009-02-25 00:00:00

Safe Drug Disposal Act of 2009 - Amends the Controlled Substances Act to direct the Attorney General to promulgate regulations to: (1) authorize an ultimate user or care taker (a person responsible for taking care of one or more individuals or animals) to dispose of a controlled substance in accordance with a prescribed state program; (2) include five model state programs providing for such disposal through delivery to a designated facility; and (3) allow a state to work with the Attorney General to devise an alternative disposal program that is consistent with this Act. Requires each such program to: (1) require a state to enact legislation as a prerequisite to its adoption and implementation; (2) protect the public safety; (3) allow disposal of controlled substances through persons other than law enforcement personnel; (4) incorporate environmentally sound practices for disposal; (5) be cost-effective; (6) include convenient take-back options for urban and rural locations; and (6) not restrict the funding a state may use to implement it. Allows such a program to apply similarly to a drug or biological product other than a controlled substance. Directs the Comptroller General to collect data on state take-back disposal programs and periodically report to Congress. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services: (1) in approving drug applications and in licensing biological products, to ensure that the drug or product labeling does not include any recommendation or direction to dispose of the drug by means of a wastewater treatment system, such as by flushing it down the toilet; and (2) to review the labeling of existing drugs and products and order revision of any labeling that includes such a recommendation or direction. Deems any drug or product whose labeling is in violation of such an order to be misbranded.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2009-02-25 00:00:00

Community Pharmacy Fairness Act of 2009 - Entitles independent pharmacies negotiating contract terms with a health plan for the provision of health care items or services to the same treatment under the antitrust laws as the treatment to which bargaining units recognized under the National Labor Relations Act are entitled. Treats such a pharmacy as an employee engaged in concerted activities in connection with such negotiations. Exempts actions taken in good faith reliance on this Act from being subject to criminal sanctions or civil penalties beyond actual damages incurred. Provides that this Act does not exempt from application of antitrust laws any agreement or unlawful conspiracy that: (1) would have the effect of boycotting any independent pharmacy; (2) would exclude, limit the participation or reimbursement of, or otherwise limit the scope of services to be provided by any independent pharmacy or group of independent pharmacies with respect to the performance of services that are within their scope of practice as defined or permitted by relevant law or regulation; (3) allocates a market among competitors; (4) unlawfully ties the sale or purchase of one product or service to the sale or purchase of another product or service; or (5) monopolizes or attempts to monopolize a market. Requires the Comptroller General to study the impact of this Act after five years.Provides that this Act does not preclude the Federal Trade Commission (FTC) or the Department of Justice (DOJ) from overseeing the conduct of independent pharmacies covered under this Act.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2009-03-03 00:00:00

Dextromethorphan Distribution Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act. Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between registered, licensed, or approved persons.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-04 00:00:00

Pharmaceutical Market Access and Drug Safety Act of 2009 - 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: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services 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: Crime and law enforcement
Date: 2009-03-05 00:00:00

Secure and Responsible Drug Disposal Act of 2009 - Amends the Controlled Substances Act to allow an ultimate user who has lawfully obtained a controlled substance to deliver that substance to another person, without being registered, for the purpose of disposal if: (1) the person receiving the substance is authorized to engage in such activity; and (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances. Permits the Attorney General to authorize long-term care facilities to dispose of controlled substances on behalf of ultimate users in a manner that will provide effective controls against diversion and that is consistent with public health and safety.