jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2013-11-05 00:00:00

Restoring Access to Medication Act - Repeals provisions of the Patient Protection and Affordable Care Act that restrict payments from health savings accounts, medical savings accounts, and health flexible spending arrangements for medications to prescription drugs and insulin only (thus allowing payments for over-the-counter medications).
Topic: Health — Drug Industry
Subject: Health
Date: 2014-06-26 00:00:00

Safe and Affordable Drugs from Canada Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services (HHS) to promulgate regulations permitting individuals to safely import into the United States, with exceptions, 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. Provides criteria for approval of a Canadian pharmacy.

Requires HHS to publish a list of approved Canadian pharmacies, including their website address, from which individuals may purchase prescription drugs in accordance with this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-11-20 00:00:00

Medicaid Generic Drug Price Fairness Act - Amends title XIX (Medicaid) of the Social Security Act to extend to manufacturers of generic drugs the requirement that drug manufacturers in certain circumstances pay an additional rebate to state Medicaid programs.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-12-10 00:00:00

Promise for Antibiotics and Therapeutics for Health Act or the PATH Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to establish a program to approve an antibacterial drug intended to treat a serious medical condition and address an unmet medical need within an identifiable limited population as a limited population antibacterial drug.

Requires the sponsor of a drug eligible for approval as a limited population antibacterial drug to demonstrate the safety and effectiveness of the drug for its intended use.

Requires an HHS determination of the safety and effectiveness of a limited population antibacterial drug to reflect the drug's benefit-risk profile in the intended limited population. Prohibits a lack of evidence of a favorable benefit-risk profile in a broader population from resulting in a denial of approval.

Directs HHS to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination.

Directs HHS to describe considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas.

Requires HHS to conduct postapproval monitoring programs to study how antibacterial drugs approved through the limited population pathway are used and to monitor changes in bacterial drug resistance.

Allows HHS to remove the labeling, marketing, and postapproval monitoring requirements of a limited population antibacterial drug if the drug is approved for broader use.

Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-01-06 00:00:00

Protect Medical Innovation Act of 2015

(Sec. 2) This bill amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

This repeal applies to sales in calendar quarters beginning after the enactment of this Act.

(Sec. 3) Prohibits the budgetary effects of this Act from being entered on either PAYGO scorecard under the Statutory Pay-As-You-Go Act of 2010.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-12 00:00:00

Medicare DMEPOS Competitive Bidding Improvement Act of 2015

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 an entity from submitting a bid for a competitive acquisition area, during calendar 2017-2019, unless it has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Requires the forfeit of any bid bond submitted for a competitive acquisition area if the bidding entity does not accept a contract offered for any product category when its composite bid was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category and the area. Requires the Secretary of Health and Human Services to collect on the forfeited bond.

Requires return of a bid bond within a specified 90-day period to a bidding entity that does not meet such bid forfeiture conditions.

Prohibits the Secretary from awarding a contract to any entity that does not meet state licensure requirements.

Directs the Government Accountability Office to study the effect of this bid surety bond requirement on the participation of small suppliers in the Medicare DMEPOS competitive acquisition program.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-13 00:00:00

Medical Testing Availability Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit a product labeled for research use only from being deemed adulterated or misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product for a purpose other than research, or (2) engages in business communications with an end user regarding the product.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-20 00:00:00

Combination Drug Development Incentive Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to provide a five-year marketing exclusivity period to a new drug approved by the Food and Drug Administration that is a novel combination of active ingredients. The application for the combination drug must contain reports of new clinical investigations that are essential to approval and were conducted or sponsored by the applicant. Currently, a new drug that includes an active ingredient that has already been approved is provided a three-year marketing exclusivity period.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-22 00:00:00

Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 or the DISARM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) recognize the costs of DISARM antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the DISARM antimicrobial drugs, and (4) make a proportional adjustment in standardized payment amounts to assure that the requirements of this Act do not result in aggregate payments greater or less than those that would otherwise be made for a fiscal year.

(Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)

Defines a "DISARM antimicrobial drug" as one approved or licensed by the Food and Drug Administration on or after January 1, 2015, which, among other things, is intended to treat an infection:

 caused by, or likely to be caused by, a qualifying pathogen; associated with high rates of mortality or significant patient morbidity; and for which there is an unmet medical need. Requires that the mechanism established by the Secretary to recognize the costs of new medical services and technologies that are not DISARM antimicrobial drugs under the Medicare payment system is applicable to new medical services or technology if the service or technology is not a DISARM antimicrobial drug.

Directs the Comptroller General to study the barriers that prevent the development of DISARM antimicrobial drugs and develop recommendations for actions to be taken in order to overcome those barriers.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-01-22 00:00:00

First Responder Medical Device Tax Relief Act

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: 2015-01-28 00:00:00

Pharmacy and Medically Underserved Areas Enhancement Act

Amends title XVIII (Medicare) of the Social Security Act to cover pharmacist services.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-28 00:00:00

Clinical Trial Cancer Mission 2020 Act

Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome.

Requires the responsible party of any clinical trials funded in whole or in part by the Department of Defense (DOD) to certify in all required grant or progress forms that the required submissions to the clinical trial registry data bank have been made. Requires DOD to verify that the clinical trial information has been submitted before releasing any remaining grant funds or funding future grants.

Makes a clinical trial grantee of the Department of Health and Human Services or DOD who fails to submit the required information to the data bank ineligible for the remaining grant funds or future funds. Makes the grantee liable for repayment of grant amounts already provided.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2015-02-02 00:00:00

(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.)

Improving Regulatory Transparency for New Medical Therapies Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

(Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

(Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-03 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: 2015-02-05 00:00:00

Protecting Access to Diabetes Supplies Act of 2015

 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: 2015-02-05 00:00:00

Compassionate Freedom of Choice Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

The FDA is prohibited from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device is not liable under state or federal law for loss, damage, or injury from: (1) the development, testing, production, acquisition, or use of such drugs or devices; or (2) their safety or effectiveness.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-05 00:00:00

Ensuring Seniors Access to Local Pharmacies Act of 2015 

 Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct any prescription drug plan that has in its network one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs, to extend to any pharmacy located in that area, or among that population, the option to be an in-network pharmacy under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-12 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 an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving requests and the time needed to make a decision.

Requires an investigational drug sponsor to explain a denied request for expanded access to the person who made the request.

Directs the Department of Health and Human Services 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 the FDA 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: 2015-02-12 00:00:00

Helping Effective Antibiotics Last Act of 2015 or the HEAL Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population.

A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy.

The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance.

Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.

To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies.

The FDA must issue guidance on the development of target product profiles for antibacterial drugs.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-13 00:00:00

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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 FDA to revoke an extension if the application for the new indication contained an untrue material statement.

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

Requires the FDA to notify the public of products that receive this extension and patents related to those products.

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: 2015-02-25 00:00:00

Clinical Trials Modernization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications.

The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials.

The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-13 00:00:00

Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.

A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:

 promote greater patient adherence to an approved treatment regime, reduce the public health risks associated with the drug, reduce side effects or adverse events, provide benefits to the health-care system, or provide other comparable patient benefits.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-16 00:00:00

Patient Choice Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.

Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity of the drug is unlikely to be greater than the combined risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in one of the countries specified and data adequate for the approval of that marketing authorization has been submitted to HHS.

Prohibits HHS from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).

Applies the provisional approval only to the indication for which the drug was: (1) designated as a fast track product, and (2) demonstrated to be adequately safe.

Prescribes requirements for termination of provisional approval, withdrawal of provisional approval, and application of market exclusivity to fast-track approval products.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-18 00:00:00

Speeding Access to Already Approved Pharmaceuticals Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or device that has been approved in the European Union.