jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Commerce
Date: 2013-05-09 00:00:00

Drug Testing Integrity Act of 2013 - Makes it unlawful to knowingly manufacture, market, sell, ship, or otherwise provide to another individual any product with the intent to assist such individual to use such product to defraud a drug test.

Treats a violation of this Act as an unfair or deceptive act or practice under the Federal Trade Commission Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-14 00:00:00

Gray Market Drug Reform and Transparency Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-15 00:00:00

Gluten in Medicine Disclosure Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-22 00:00:00

Patient Choice Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary 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 caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary 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 specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary.

Prohibits the Secretary 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 the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety.

Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-23 00:00:00

Cardiac Arrest Survival Act of 2013 - Amends the Public Health Service Act to expand immunity from civil liability related to automated external defibrillator devices (AEDs), including by giving immunity to: (1) a person who owns, occupies, or manages the premises from which an AED is taken or at which an AED is used or attempted to be used on a victim of a perceived medical emergency; and (2) the owner-acquirer of an AED for any harm resulting from the use or attempted use of such device, unless the harm was proximately caused by the failure of the owner-acquirer to properly maintain the device according to the guidelines of the device manufacturer. Applies immunity regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used or attempted to use the AED complied with such signage, had received training on such use, or was assisted or supervised by any other person, including a licensed physician.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2013-05-23 00:00:00

Human Cloning Prohibition Act of 2012 - Amends the federal criminal code to prohibit any public or private person or entity, in or affecting interstate commerce, from: (1) performing or attempting to perform human cloning; (2) participating in an attempt to perform human cloning; or (3) shipping, receiving, or importing the product of human cloning for any purpose. Sets forth criminal and civil penalties for violations.

Provides that nothing in this Act shall restrict areas of scientific research not specifically prohibited by this Act, including research in the use of nuclear transfer or other cloning techniques to produce molecules, DNA, cells other than human embryos, tissues, organs, plants, or animals other than humans.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-05-23 00:00:00

Verifying Authority and Legality In Drug Compounding Act of 2013 or VALID Compounding Act - Amends the Federal Food, Drug, and Cosmetic Act with respect to the regulation of compounding drugs.

Requires the Secretary of Health and Human Services (HHS) to develop and maintain a list of bulk substances from which drug products may be compounded that specifies any limitation on compounding of the substance and the particular medical need that is met by placing such substance on the list. Requires the Secretary to receive and consider petitions from any person identifying a substance that should be added to or removed from the list. Sets forth requirements for such petitions. Requires the Secretary also to develop and maintain a list of drug products that should not be compounded.

 Allows a pharmacy to compound drugs which are not for an identified individual patient based on the receipt of a prescription order if the pharmacy registers with the Secretary and agrees to comply with any condition of operation or limitation of activity the Secretary specifies. Sets forth information that must be included in any such registration.

Authorizes the compounding of a drug that is a copy of a commercially available drug product if: (1) the drug is on the drug shortage list with notice given to the Secretary by the pharmacy, or (2) the drug product is necessary to protect public health and well-being. Requires the pharmacy to demonstrate to the Secretary that controls will be used that are comparable to elements required for safe use for a drug subject to a risk evaluation and mitigation strategy.

Requires the Secretary to establish standards, processes, and procedures for high-risk sterile compounding.

Establishes requirements related to inspections, labeling, and adverse event reporting for compounded drugs.

Requires the Secretary to assess an annual establishment fee from compounding pharmacies and a reinspection fee for any pharmacy subject to a reinspection in a fiscal year. Sets forth a methodology for setting such fees and requires reduced fees for small businesses (pharmacies with $1 million or less in annual sales).

States that the requirements of this Act do not preempt any non-federal requirement that is in addition to, and compatible with, such requirements.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-06-06 00:00:00

Clinical Trial Cancer Mission 2020 Act - Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH).

Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial information within the 30-day correction period for noncompliance.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-06-10 00:00:00

Infant Formula Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to deem an infant formula, including an infant formula powder, to be adulterated if its use-by date has passed.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-06-11 00:00:00

Preserving Access to Orphan Drugs Act of 2013 - Amends the Patient Protection and Affordable Care Act (PPACA) to exclude any drug or biological product which is approved or licensed by the Food and Drug Administration (FDA) for marketing solely for one or more rare diseases or conditions (orphan drug) from the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

Makes this Act effective as if included in PPACA.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-06-13 00:00:00

Health Care Innovation and Marketplace Technologies Act of 2013 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year.

Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health information technology for the professional's medical practice.

Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the National Coordinator for Health Information Technology, to award grants for the development of an effective product, process, or structure that enhances the use, particularly by patients, of health information technology.

Requires the Secretary, acting through the National Coordinator, to award prizes for development in areas of health information technology that are not adequately addressed by certified electronic health records (EHR) technologies and the use of such technologies.

Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Wireless Health Technology.

Requires the Health Information Technology Research Center to provide support for mobile health software application technology.

Authorizes the National Coordinator to award grants for training health care workers in health information technology.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-08-02 00:00:00

Combination Drug Development Incentive Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to the five-year bar on a new drug application (or abbreviated drug application) by anyone that has not obtained a right of reference or use from the original and approved drug approval applicant by or for whom investigations under the original, subsequently approved application were conducted.

Applies this five-year bar, and the requirement of a grant of a right of reference or use, with respect to an approved drug application (or abbreviated drug application) if: (1) the application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, (2) the application is for a drug which contains a combination of active ingredients (combination drug), and (3) no such combination of active ingredients has been approved in any other application.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-08-02 00:00:00

Medical Testing Availability Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act with respect to labeling in the shipment or delivery of an in vitro diagnostic product for an investigation exempt from compliance with a performance standard or the requirement of premarket approval.

Declares that such a product whose labeling states "For Research Use Only. Not for use in diagnostic procedures." may not be deemed misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product in a manner inconsistent with such statement, or (2) engages in business communications regarding the product with an end user.

Defines "business communications": (1) as oral, written, or electronic contact between a manufacturer or distributor of such a product and an end user regarding the product's functioning; and (2) includes any such contact consisting of technical support, customer service, assistance with the installation of such product, communication relating to ensuring the performance of the product, and other similar contacts.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-08-02 00:00:00

Supporting Access to Formulated and Effective Compounded Drugs Act of 2013 or S.A.F.E. Compounded Drugs Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounded drugs.

Eliminates authority for compounding pharmacies to compound any drug product that is a copy of a commercially available drug. Prohibits such pharmacies from compounding: (1) any drug product appearing on a list of active ingredients and dosage forms that the Secretary of Health and Human Services (HHS) determines should not be compounded, or (2) in violation of promulgated minimum standards for the safe production of compounded drug products.

Establishes notification requirements before a patient is prescribed, dispensed, or administered a compounded drug, which must include providing the patient a document concerning the availability, safety, and production of such drugs.

 Requires a drug product compounded under the FFDCA to be clearly labeled as a “non-FDA approved compounded drug product.” Authorizes the Secretary of Health and Human Services (HHS) to establish different labeling requirements for compounded drugs.

Requires the Secretary to establish a process for pharmacies to register as compounding pharmacies. Exempts pharmacies that employ fewer than 20 full-time employees and perform traditional compounding of drug products for use in a single state.

Requires the Secretary to: (1) establish a database of information on compounding pharmacies licensed in more than one state for oversight purposes, (2) establish minimum standards for the safe production of compounded drugs as well as for which drugs must meet those standards, and (3) conduct regional training for state agencies that regulate compounding pharmacies.

 Directs the Secretary to establish advisory committees on labeling of compounded drugs and on the database under this Act. Requires the Secretary to convene an Advisory Committee on Pharmacy Compounding as appropriate to consider issues related to the safety and availability of compounded drugs.

Directs the Comptroller General (GAO) to review: (1) the extent to which federal health care programs ensure that compounded drug products they pay for are compounded in FFDCA-compliant facilities, (2) whether the reimbursement rates for such products under these federal programs are appropriate, and (3) whether these programs encourage the use of compounded drug products in place of otherwise available lawfully marketed drug products.

Prescribes criminal penalties for violations of prohibitions concerning compounded drug products that are committed: (1) knowingly and intentionally to defraud or mislead, or (2) with conscious or reckless disregard of a risk of death or serious bodily injury.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-09-12 00:00:00

Compounding Clarity Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the regulation of compounding drugs.

Revises the exemption of compounded drugs from certain new drug, labeling, and biological product requirements. Adds an exemption for drug products compounded by a licensed pharmacist or a licensed physician, pursuant to a non-patient-specific purchase order, which: (1) will be administered by a health care practitioner within a physician's office, a hospital, or another health care setting; and (2) meet other specified criteria.

Revises requirements for exempted bulk drug substances.

Prohibits the sale of a drug product by an entity other than the pharmacy or physician that compounded it.

Directs the Secretary of Health and Human Services (HHS) to develop a system for receiving and reviewing submissions from state boards of pharmacy: (1) describing actions taken against compounding pharmacies, or (2) expressing concerns that a compounding pharmacy may be acting in violation of one or more requirements of this section. Requires the Secretary to review such submissions and determine whether the pharmacy involved may be in violation of one or more compounding requirements.

Authorizes the Secretary to inspect a pharmacy's records to determine whether the pharmacy is in violation of one or more FFDCA requirements.

Exempts from certain new drug, labeling, and biological product requirements a drug product compounded for human use by a licensed pharmacist in a registered outsourcing facility if specified conditions, including labeling requirements, are met.

 Establishes annual registration requirements for any outsourcing facility. Requires a facility to report to the Secretary biannually on what drugs are compounded in it and to submit adverse event reports. Subjects such facilities to a risk-based inspection schedule.

Requires the Secretary to: (1) publish a list of drugs presenting demonstrable difficulties for compounding that are reasonably likely to lead to an adverse effect on the safety or effectiveness of the drug, taking into account the risk and benefits to patients; and (2) convene an advisory committee on compounding before creating the list.

Requires the Secretary to assess an annual establishment fee on each outsourcing facility and a reinspection fee, as necessary.

Prohibits the intentional falsification of a required prescription, a purchase order, or patient name for a compounded drug.

Prohibits the intentional failure of an outsourcing facility to register.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-09-17 00:00:00

Medicare Orthotics and Prosthetics Improvement Act of 2013 - Amends title XVIII (Medicare) of the Social Security Act, for application of quality standards for certain accredited suppliers of prosthetic devices, orthotics, and certain prosthetics, to require the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization with respect to such suppliers only if that organization is the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/ Prosthetist Certification (or a program with essentially equivalent accreditation and approval standards). Exempts from such standards any suppliers who: (1) are physicians, occupational therapists, or physical therapists licensed or otherwise regulated by the state in which they practice; and (2) receive Medicare payments. Applies to custom-fitted orthotics the special payment rules for certain prosthetics and custom-fabricated orthotics. Exempts from such rules off-the-shelf orthotics included in a competitive acquisition program.

Modifies the Medicare payment rules for orthotics and prosthetics to account for supplier qualifications and complexity of care.

Directs the Secretary to report to Congress on: (1) HHS steps taken to ensure that the state licensure and accreditation requirements are enforced, and (2) the effects of requirements of this Act on the occurrence of Medicare fraud and abuse with respect to orthotics and prosthetics.

Requires the Secretary, acting through the Chief Actuary of the Centers for Medicare and Medicaid Services, to submit to Congress a projection on the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2014-2018 that will result from implementation of this Act. Requires the Secretary, if the Chief Actuary projects that implementation of this Act will not result in a cumulative spending reduction of at least $250 million for 2014-2018, to issue an interim final regulation to strengthen the licensure, accreditation, and quality standards applicable to orthotics and prosthetics suppliers in order to produce such a cumulative reduction by the end of 2018. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-10-22 00:00:00

Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed:

 to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider and which, if followed, would change the structure or any function of the body of man or other animals. Excludes from such definition software whose primary purpose is integral to the functioning of a drug or device and is not a component of a device. Excludes clinical software and health software (defined as follows) from FDCA regulation.

Defines "clinical software" as software that: (1) captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals; and (2) is intended for use only by a health care provider in a health care setting.

Defines "health software" as software that is not medical software or clinical software and that: (1) captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or (2) has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.

Expresses the sense of Congress concerning the value of clinical software and health software to health care quality and efficacy and the need for legislation that establishes a risk-based regulatory framework that reduces regulatory burdens, promotes patient safety, and fosters innovation.

Excludes medical software, clinical software, and health software from the FDCA definition of "device."