jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2010-09-22 00:00:00

Amends the Public Health Service Act (PHSA) to revise provisions of the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees) to permit a covered entity receiving assistance under title XXVI of the PHSA (popularly known as the Ryan White Care Act) to resell or transfer a drug to an individual with HIV/AIDS in connection with medication regimen adherence services being provided to the individual by a licensed health care professional of the entity. Excludes certain entities, including state and local governments.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2010-09-29 00:00:00

Requires a mail-order pharmacy to inform a customer to whom it dispenses a prescription brand name drug when a generic drug that is the pharmaceutical equivalent becomes available. Permits a mail-order pharmacy to substitute a generic drug for a brand name drug or a brand name drug for a generic drug if the mail order pharmacy: (1) notifies the customer that the pharmacy will request that the prescriber provide an authorization to make such a substitution; and (2) after providing such notification, obtains the express written authorization of the prescriber of the drug to make such a substitution. Requires the prescriber to provide notice to the customer of an authorization. Permits the Secretary of Health and Human Services (HHS) to assess civil penalties against a mail-order pharmacy for violations of this Act. Declares that this Act preempts state laws to the extent any are inconsistent with this Act.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2010-09-29 00:00:00

Amends the Internal Revenue Code to exempt a qualified emergency medical device from the excise tax on medical devices. Defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.
Topic: Health — Drug Industry
Subject: Health
Date: 2010-12-17 00:00:00

Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to expand safety and inspection requirements for the manufacture and importation of drugs by: (1) expanding registration requirements for foreign and domestic drug producers; (2) requiring drug manufacturers to have in effect and implement an effective quality system; (3) expanding and equalizing inspection requirements for foreign and domestic drug producers; (4) imposing additional requirements relating to the notification, nondistribution, and recall of adulterated or misbranded drugs; (5) permitting the detention of drugs found to be in violation of drug safety requirements; (6) allowing for the destruction of drugs that pose a significant adverse health effect; (7) providing enhanced civil and criminal penalties and forfeiture for violations of drug safety requirements and enhanced subpoena authority for investigating violations; (8) prohibiting the importation of drugs into the United States lacking documentation of safety; (9) requiring unique identification numbers for drug establishments and importers; and (10) expanding protections for whistleblowers who refuse to violate, or who disclose violations of, this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-06 00:00:00

Generics First Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to exclude from coverage under the Medicare part D prescription drug program all nongeneric (brand name) drugs unless no generic drug has been approved, and the brand name drug is determined to be medically necessary.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-06 00:00:00

Pharmaceutical Market Access Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, and wholesalers to import qualifying drugs from certain countries into the United States. Sets forth registration requirements for exporters. Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters. Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies. Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order. Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement. Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug. Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-01-22 00:00:00

Physician Payments Sunshine Act of 2009 - Amends part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers. Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services. Requires any such manufacturer, or related group purchasing organization, also to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year. Prescribes administrative penalties for failure to comply with these requirements. Requires report submission procedures to ensure public availability of required information on a website.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2009-02-03 00:00:00

Preserve Access to Affordable Generics Act - Declares as the purposes of this Act to: (1) enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers; and (2) support the purpose and intent of antitrust laws by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers. 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 product. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the drug product 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 procompetitive 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 a new drug application holder to a filer of an abbreviated new drug application is the right to market the drug product in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right that would prevent the marketing of such drug, a payment for reasonable litigation expenses not exceeding $7.5 million, and a covenant not to sue on any claim that the filer 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 set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any 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 provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs 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: Health
Date: 2009-02-26 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 exclusivity period granted to the generic manufacturer.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-05 00:00:00

Medical Device Safety Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit specified provisions preempting state and local requirements for medical devices intended for human use from being 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: 2009-03-17 00:00:00

Prohibits the use of funds by the Food and Drug Administration (FDA) to process a biologics license application for any biologic product that is, bears, or contains an agent or toxin listed in federal regulations as dangerous to life, property, or the environment and that has been marketed, sold, or distributed to the Islamic Republic of Iran by an entity under investigation for potential violations of the Iran Sanctions Act of 1996.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-17 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-03-26 00:00:00

Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product). Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications. Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period. Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes. Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-04-23 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to permit a Medicare beneficiary to elect to take, or decline to take, ownership of a Group 3 Support Surface item of complex durable medical equipment (DME) after the 13-month capped rental period ends.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-04-23 00:00:00

Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration; and (2) provide for risk-based inspections. Includes in the definition of "drug" a precursor ingredient. Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs. 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. Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met. Sets forth provisions governing importation of a drug and its components. 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 and personal knowledge of information submitted. Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device. Requires the Secretary to contract with the Institute of Medicine to evaluate: (1) the organizational structure and operations of the Food and Drug Administration (FDA) with respect to the review of medical devices for clearance and for premarket approval under FFDCA; and (2) the analytical and methodological tools used to conduct such reviews. Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities. Sets forth enforcement provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-05-01 00:00:00

Preserve Patient Access to Reputable DMEPOS Providers Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act to declare that the surety bond requirement under the Medicare program for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) shall apply only to a state-licensed retail pharmacy if there has been a final adverse action that is not subject to administrative or judicial appeal taken against such pharmacy during the 10-year period preceding the issuance (or renewal) of the provider number involved. (Thus exempts from the surety bond requirement any state-licensed retail pharmacy that has not been subject to such an adverse action for at least 10 years. Such adverse actions refer to: (1) a Medicare-imposed revocation of any Medicare billing privileges; (2) suspension or revocation of a license to provide health care by any state licensing authority; (3) revocation or suspension by an accreditation organization; (4) conviction of a federal or state felony offense within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) an exclusion or debarment from participation in a federal or state health care program.)
Topic: Health — Drug Industry
Subject: Health
Date: 2009-05-20 00:00:00

Sunscreen Labeling Protection Act of 2009 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.
Topic: Health — Drug Industry
Subject: Health
Date: 2009-06-10 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: Health
Date: 2009-06-22 00:00:00

Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.
Topic: Health — Drug Industry
Subject: Environmental protection
Date: 2009-06-24 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: Taxation
Date: 2009-07-22 00:00:00

Amends the Internal Revenue Code to exempt fixed-wing aircraft used to provide acute care emergency medical services from certain restrictions on tax-exempt bond financing.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2009-10-08 00:00:00

Protecting Americans from Drug Marketing Act - Amends the Internal Revenue Code to deny a business expense tax deduction for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals.