jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-20 00:00:00

Unique Device Identification System for Medical Devices Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations requiring the labeling of medical devices to bear a unique identifier.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-21 00:00:00

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 of such drug into interstate commerce.Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to report to the Secretary of the Treasury on misbranding and other violations relating to direct-to-consumer prescription drug advertising.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-07-12 00:00:00

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" to include any fee, payment, subsidy, amenity, object, service, or other economic benefit, except: (1) free samples of prescription drugs; (2) reasonable compensation and reimbursement of expenses in connection with a bona fide clinical trial; and (3) certain scholarships or other support for medical students, residents, or fellows to attend conferences. Applies such provisions only if the total value of the gift or gifts is $50 or more during the calendar year. Requires the Commissioner to: (1) make such information available to the public; and (2) keep confidential any information related to a trade secret. Establishes civil penalties for violations.Gives the Commissioner authority to investigate compliance with this Act. Authorizes the Commissioner to file a petition in the United States District Court for an order requiring submission of a report or other appropriate relief.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-07-18 00:00:00

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 protection, including a minimum ratio of UVA protection factor to sun protection factor, a minimum level of UVB radiation protection, and specified truth in labeling requirements. Requires sun protection factors to be measured using standardized, reproducible testing methods that take photo-degradation into account.Requires the Secretary to implement an education campaign identifying the risks posed by sun exposure without the use of a sunscreen providing broad-spectrum protection.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-08-01 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-08-04 00:00:00

Community Clinical Laboratory Fairness in Competition Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to repeal the mandate for a Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services. Amends federal civil service to subject the Centers for Medicare & Medicaid Services of the Department of Health and Human Services (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) to the requirement to submit to a small business advocacy review panel for comment any proposed rule which will have a significant economic impact on a substantial number of small entities.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-09-24 00:00:00

Everson Walls and Ron Springs Gift for Life Act of 2007 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services, acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries 24 hours a day; (3) ensure that funded registries comply with requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse.Requires the Secretary to award grants or cooperative agreements to eligible entities for such registries. Requires recipients to agree to establish benchmarks for improvement in organ and tissue donation and to maintain registries that: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death, 24 hours a day; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent.Directs the Comptroller General to study and report to Congress on the feasibility of establishing a living donor database to track short- and long-term health effects for donors associated with living organ donation.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-11-05 00:00:00

Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2007 - 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 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 of reasonable probability that a drug intended for human use would cause serious health consequences or death, 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 or prescribing the drug; and (2) amend the order to include a recall if necessary.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-11-06 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-03-13 00:00:00

Pathway for Biosimilars Act - 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 approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product.Prohibits licensure under this Act of a biological product containing specified agents or toxins.Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.Provides for confidentiality of information received pursuant to this Act.Sets forth provisions governing patent infringement actions related to this Act.Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-04-17 00:00:00

Safeguarding America's Pharmaceuticals Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and certain adulterated or misbranded imported drugs.Requires the manufacturer of a prescription drug to provide to each wholesale distributor or dispenser a packing list or comparable document that includes information identifying the drug's proprietary and established names and National Drug Code number.Requires each person engaged in wholesale distribution of a prescription drug to provide information on each prior transaction involving the drug.Requires the Secretary of Health and Human Services (the Secretary) to report to Congress on the feasibility and operational efficiencies of adopting security technologies, including track and trace technology throughout the prescription drug supply chain. Phases in requirements for standardized numerical identifiers that are unique to each unit of a prescription drug.Requires the Secretary to issue regulations to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for such an identifier.Requires the Comptroller General to study the availability and cost of technologies to dispensers to comply with this Act.Requires the Secretary to: (1) award matching grants for drug identification and tracking systems to ensure the security and integrity of the drug supply chain; and (2) issue guidelines for wholesale distributors that prescribe requirements that include mandatory background checks and physical inspection of facilities.Sets forth civil penalties for violations of this Act.Requires the Secretary to study threats to the domestic prescription drug supply chain and make recommendations for improvements.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-05-14 00:00:00

Early Access to Treatment Act - Amends the Federal Food, Drug, and Cosmetic Act to require a drug that is not approved for marketing, but that is under clinical investigation for a serious or immediately life-threatening disease condition in patients for whom no comparable or satisfactory alternative drug or other therapy is available, to be made available for treatment use by an individual patient if: (1) the drug is intended to treat such condition; (2) there is no comparable or satisfactory alternative available to treat that stage of the disease; (3) the drug is under investigation in a controlled clinical trial as an investigational new drug or all clinical trials have been completed; and (4) an application for treatment use has been filed with the Food and Drug Administration (FDA) by a licensed practitioner which sets forth the intended use of the drug, an explanation of the rationale for its use, the treatment protocol, statements of the practitioner's qualifications to use the drug and familiarity with its safety and effectiveness, and a notarized statement of the patient's informed consent. Requires the Secretary of Health and Human Services, within 30 days after an application is filed, to grant permission to the sponsor to furnish such drug to the practitioner under such terms as the sponsor, practitioner, and patient determine to be appropriate, including any agreement to waive liability. Provides for application transmission by telephone or other means of rapid communication and for rapid action on it in an emergency situation.Requires (current law authorizes) the Secretary to approve an application under the Public Health Service Act for a fast track product determined to have an effect on a clinical endpoint or on a surrogate endpoint that is reasonably likely to predict clinical benefit.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-05-22 00:00:00

Responsibility in Drug and Device Advertising Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising in the first three years after approval of a new drug or device. Authorizes the Secretary of Health and Human Services to: (1) waive such prohibition if such advertising would have an affirmative value to public health; and (2) continue such prohibition in subsequent years if the drug or device has significant adverse health effects.Requires any direct-to-consumer advertisement to include a fair balance of the benefits and risks associated with the drug or device.Deems a drug to be misbranded if a direct-to-consumer television advertisement for such drug does not prominently display a statement encouraging individuals to report negative side effects of prescription drugs to the Food and Drug Administration (FDA). Requires the Secretary to discontinue the study designed to determine if such a statement is appropriate for television advertisements.Deems a device to be misbranded if a direct-to-consumer television advertisement for such device does not include a statement encouraging individuals to report negative side effects of medical devices to the FDA.Sets forth civil monetary penalties for violations relating to the advertising and promotion of a drug or device. Allows the Secretary to order the distribution of materials to notify the public and the medical community of such a violation and to provide corrective information.Requires the Secretary to conduct an education campaign to increase public awareness of risks that, for some patients, may outweigh the benefits of using a particular drug or device.Authorizes additional appropriations to regulate direct-to-consumer drug and device advertisements.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-06-12 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: Health
Date: 2008-06-26 00:00:00

Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product.Requires the Secretary of Health and Human Services, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available.Requires the Secretary to annually report to Congress on the implementation of debarment provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-06-26 00:00:00

Strengthening of FDA Integrity Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services to initiate debarment not later than one year after a person or individual is convicted of a felony. Requires the Secretary, in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-06-26 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: 2008-07-10 00:00:00

Stephanie Tubbs Jones 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. Directs the Secretary of Health and Human Services to request that the Executive Director of the Network report to Congress on the effects of the heart allocation policy change of 2006. Conditions increased funding on submission of such a report.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-07-24 00:00:00

Savings for the Uninsured on Rx Expenses (SURE) Act of 2008 - Requires the Secretary of Health and Human Services to establish a prescription drug discount card program modeled on the Medicare drug discount card program to provide access to prescription drug discounts for eligible individuals. Defines as "eligible" an individual who: (1) is a U.S. citizen, national, or alien lawfully admitted for permanent residence; (2) is not eligible for outpatient prescription drug coverage; and (3) is not eligible to enroll for prescription drug coverage under part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act. Applies the Medicare drug discount card program requirements related to enrollment and card features, with certain exceptions. Requires a prescription drug card sponsor to disseminate information concerning the use of health savings accounts to cover the costs of prescriptions drugs for which discounts are provided. Directs the Secretary to require that sponsors demonstrate that they have a marketing plan to effectively reach out to eligible individuals. Disallows judicial review of a determination not to endorse a prescription drug discount card program or not to enter into a contract with a sponsor.