jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-03-23 00:00:00

Medical Device Tax Elimination Act

This bill amends the Internal Revenue Code to repeal the excise tax on medical devices and offsets the cost of such repeal by: (1) eliminating the tax deduction for income attributable to oil, natural gas, or primary products thereof for major integrated oil companies (companies that have an average daily worldwide annual production of crude oil of at least 500,000 barrels and annual gross receipts in excess of $1 billion); (2) prohibiting the use of the last-in, first-out (LIFO) accounting method by major integrated oil companies; and (3) denying the foreign tax credit to major integrated oil companies that are dual taxpayers (companies that receive an economic benefit from a foreign country or a possession of the United States that does not impose a generally applicable income tax).
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-23 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2015

This bill 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 from antimicrobial resistance attributable to the nontherapeutic use of the drug.

Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization’s list of critically important antimicrobials.

 Two years after enactment of this Act, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

 The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-24 00:00:00

Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.)

If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-04-28 00:00:00

Diagnostic Imaging Services Access Protection Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to prohibit the Secretary of Health and Human Services from applying a multiple procedure payment reduction policy to the professional component of imaging services furnished: (1) after a specified date in the year this Act is enacted; or (2) in any subsequent year before the Secretary conducts and publishes, as part of the Medicare Physician Fee Schedule for a year, an analysis of the Resource-Based Relative Value Scale Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-01 00:00:00

Safe and Affordable Drugs from Canada Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

 Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-14 00:00:00

This bill amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services to provide for a pharmaceutical and technology ombudsman within the Centers for Medicare and Medicaid Services.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-14 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices.

Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation.

To expedite the development and review of designated medical devices, the FDA must:

 assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)

Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.

Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-19 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)

The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.

The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-20 00:00:00

Everson Walls and Ron Springs Gift for Life Act of 2015

This bill amends the Public Health Service Act to require the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

The Center must: (1) advance the development, expansion, and evaluation of state organ donor registries; (2) facilitate timely exchange of donor information between state registries; and (3) maintain a clearinghouse for information on registry best practices.

The Department of Health and Human Services must award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. A state registry that receives a grant must be accessible to individual donors and the Center.

A person taking an individual's organs is not civilly liable as long as the person verified the individual's consent with a state organ donor registry.

The Government Accountability Office must study the feasibility of establishing a database to track the health effects of living organ donation.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-20 00:00:00

This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that:

 facilitate meaningful use of the Internet by product sponsors for dissemination of truthful, non-misleading information about medical products; recognize that such sponsors may use the Internet to disseminate, in character-limited applications, truthful, introductory information about medical products and to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and treat such hyperlinked information as if it appeared in such introductory information, for regulatory purposes. HHS is required, after providing notice and an opportunity for public comment, to: (1) publish final regulations and guidance addressing such matters within 18 months after publication of proposed regulations and guidance; and (2) review and update such regulations and guidance periodically.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-21 00:00:00

Surrogate Endpoint Improvement and Utilization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.)

The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-21 00:00:00

Medical Imaging Modernization Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to make a special rule reducing by 20% the payment under the physician fee schedule and the hospital outpatient prospective payment system for the technical component of imaging services that are x-rays taken using film.

Imaging services that are x-rays taken using computed radiography technology shall have the technical component payment: (1) for services furnished from 2018 through 2022 reduced by 7%; and (2) for services furnished during 2023 or a subsequent year reduced by 10%.

Reduced expenditures attributable to incentives to transition to digital radiography under the physician fee schedule are exempt from budget-neutrality calculation.

The Department of Health and Human Services may not apply a multiple procedure payment reduction to the professional component of imaging services furnished before it publishes, as part of the Medicare Physician Fee Schedule Proposed Rule for a year, a empirical analysis of the Resource-Based Relative Value Scale (commonly known as the "RBRVS") Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.

These payment reductions under the hospital outpatient prospective payment system for the transition from traditional x-ray imaging to digital radiography shall apply without regard to budget neutrality.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-01 00:00:00

Accelerating Innovation in Medicine Act of 2015 or the AIM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying for it and for any related services.

Directs the Secretary to post on a public HHS website or other publicly accessible media an updated list of the medical devices on the AIM list.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-03 00:00:00

Part D Beneficiary Appeals Fairness Act

 Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

States that in no case may the Secretary of Health and Human Services allow a PDP sponsor to make any formulary tier of the tiered cost-sharing structure (including a formulary tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-03 00:00:00

Antibiotic Development to Advance Patient Treatment Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication.

A medication approved for use in a limited population must be labeled accordingly.

The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.)

The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.)

Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate.

The FDA may allow marketing of medical devices that use these criteria without premarket approval.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-18 00:00:00

Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS).

Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing.

For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication.

A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health.

License holders are not liable for claims arising from a product developer testing the medication.

The FDA may waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the product developer is unable to finalize terms for a shared system with the license holder of the approved drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-07-09 00:00:00

Right to Try Act of 2015

Bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law.

Defines an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (3) is not approved, licensed, or cleared for commercial distribution under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.
Topic: Health — Drug Industry
Subject: Armed forces and national security
Date: 2015-07-29 00:00:00

Veterans Access to Orthotic and Prosthetic Care Act

This bill directs the Department of Veterans Affairs (VA) to ensure that: (1) each VA prosthetist and orthotist and each VA employee who provides prosthetic or orthotic services meets all current certification and licensing requirements, and (2) each VA orthotic or prosthetic facility and laboratory that provides prosthetic and orthotic services is certified by one of the nationally recognized accrediting bodies.