jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2014-11-20 00:00:00

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an “orphan disease”).

Allows the Secretary to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.

Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons.

Requires the Secretary to notify the public of products that receive this extension.

Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.

Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-08 00:00:00

Andrea Sloan Compassionate Use Reform and Enhancement Act or the Andrea Sloan CURE Act - Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of a “breakthrough drug” (which is a drug that qualifies for expedited approval, is an infectious disease product, or qualifies the sponsor for a priority review voucher) to submit to the Secretary of Health and Human Services (HHS) and make available to the public a policy on requests for access to the drug for compassionate use, including the minimum criteria for consideration or approval of requests and the time needed to make a decision.

Requires a breakthrough drug sponsor to explain a denied request for compassionate use to the person who made the request.

Directs HHS to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access.

Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-08 00:00:00

Protecting Access to Diabetes Supplies Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to revise the special competitive acquisition program rule applied to diabetic testing strips to require the volume for such types of products to be determined through the use of multiple sources of data that measure consumption and utilization of such strips among individuals in the United States.

Directs the Secretary of Health and Human Services to reject any bid submitted by an entity under the competitive acquisition program that does not demonstrate that it can furnish the types of strips included in its bid.

Requires an entity to furnish to an individual the brand of strips compatible with the individual's home blood glucose monitor.

Prohibits an entity from attempting to influence or incentivize an individual to switch the brand of glucose monitor or testing strips selected.

Prohibits an entity from communicating directly to such an individual until it has given the individual verbally standardized information about the individual's rights with respect to the entity.

Directs the Secretary to establish a process under which an individual furnished with diabetic testing strips under a competitive acquisition program may reject them by notifying the supplier and the Secretary. Permits the individual to obtain different strips from another supplier and have a new claim processed.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-08 00:00:00

Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act with respect to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

Prohibits the Secretary of Health and Human Services (HHS) from accepting a bid from an entity for an area unless it: (1) meets state licensure requirements for the area for all items in the submitted bid for a product category, and (2) has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Prescribes requirements for the treatment of losing bidders and successful bidders that do not accept a contract.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-11 00:00:00

Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the importation, distribution, or sale of investigational drugs or devices for terminally ill patients.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-11 00:00:00

Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) 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 a 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 Department 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 using technologies that HHS determines are technically feasible and assist in preventing such violations.

Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations.

Requires HHS to educate the public and health care professionals on counterfeit drugs.

Directs HHS, 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. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate.

Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2013-02-04 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: Taxation
Date: 2013-02-07 00:00:00

Medical Device Access and Innovation Protection Act - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-02-13 00:00:00

Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 - Amends title II (Old Age, Survivors and Disability Benefits) (OASDI) of the Social Security Act (SSA) to extend the months of coverage of immunosuppressive drugs for kidney transplant patients.

Amends SSA title XVIII (Medicare) to make eligible for enrollment in Medicare part B (Supplementary Medical Insurance), solely for the purpose of such drug coverage, every individual whose insurance benefits under Medicare part A (Hospital Insurance) have ended by reason of a kidney transplant or the end of any requirement for a regular course of dialysis.

Directs the Secretary of Health and Human Services (HHS) to determine a monthly premium rate for such individuals equal to 35% of the monthly actuarial rate for enrollees age 65 and over. Prescribes a formula for detemination of a government contribution to such a premium.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2013-02-27 00:00:00

Amends the Internal Revenue Code to add vaccines against seasonal influenza to the list of those vaccines subject to the excise tax on taxable vaccines.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-03-07 00:00:00

Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.

Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.

Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.

Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-03-20 00:00:00

Medical Innovation Prize Fund Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Fund for Medical Innovation Prizes, in lieu of such market exclusivity.

Establishes: (1) the Fund for Medical Innovation Prizes; and (2) a Board of Trustees for such Fund, which shall award prize payments for medical innovation and establish independent expert advisory committees.

Directs the Board to award prize payments for medical innovation relating to a drug, a biological product, or a new manufacturing process for a drug or biological product to: (1) the first person to receive market clearance with respect to the drug or biological product; (2) the holder of the patent with respect to a manufacturing process; or (3) persons or communities that as an open source contribution openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis.

Requires the Board to establish and periodically modify minimum levels of funding for such awards for priority research and development, including global neglected diseases, orphan diseases, and global infectious diseases and other global public health priorities.

Allows the Board of Trustees to authorize multiple nonprofit intermediaries to reward projects for interim research and development of products or for open source dividend prizes.

Requires the Comptroller General (GAO) to conduct annual audits to determine the Board's effectiveness in bringing to market new drugs, vaccines, biological products, and manufacturing processes in a cost-effective manner and in addressing society's global medical needs.

Establishes an annual fee for health insurers to fund this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-04-17 00:00:00

Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act 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; and (2) 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: Health
Date: 2013-04-24 00:00:00

Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-08 00:00:00

Antimicrobial Data Collection Act - Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to develop a research program to study the relationship between the sales, distribution, and end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. Requires the Secretary to analyze data from the program to determine the data's contribution to studying antimicrobial resistance and establishing an antimicrobial data collection strategy.

Requires the Secretary to: (1) report to Congress on the program's research design and goals, including a needs assessment to improve the FDA's evaluation of antimicrobial resistance; and (2) report to Congress and the public within two years with the comprehensive results of the program and recommendations for developing an antimicrobial data collection strategy.

Amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for the annual summaries of antimicrobial animal drug information, including by requiring the Secretary to maximize the quality, accuracy, detail, and specificity of the data made publicly available in the summaries. Requires the Secretary to conduct an annual evaluation of the effectiveness of and compliance with relevant FDA programs and policies regarding antimicrobial drug sales for food-producing animals, and the use of such drugs and antimicrobial resistance.

Directs the Secretary to publish a final version of voluntary guidance for drug sponsors on new animal drugs and new animal drug combination products administered in or on medicated feed or drinking water of food-producing animals.

Requires the Comptroller General (GAO) to evaluate the FDA's approaches to eliminate injudicious use of antimicrobial drugs in food-producing animals and the effectiveness of the FDA's data collection activities regarding antimicrobial resistance.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-09 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-06-27 00:00:00

Preventing Antibiotic Resistance Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2013-08-01 00:00:00

Dietary Supplement Labeling Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing or processing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured or processed; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.

Requires the Secretary of Health and Human Services (HHS) to compile a list of dietary supplement ingredients and proprietary blends of ingredients that could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women.

Directs the Secretary to enter into a contract with the Institute of Medicine to: (1) evaluate the safety of dietary supplement ingredients and proprietary blends of ingredients that the Institute determines could cause potentially serious adverse events, drug interations, contraindications, or potential risks to subgroups; and (2) identify proprietary blends of ingredients for which the weight per serving of the ingredient in the proprietary blend should be provided on the label.

Deems a dietary supplement that does not meet the requirements of this Act to be misbranded.

Requires the Secretary to establish a definition for the term “conventional food” for purposes of the FFDCA, taking in account foods marketed as dietary supplements.