zli12321/Bills huggingface dataset:
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.

Date: 2012-05-22
Topic: Health (Drug Industry)
Subject: Health
Preventing Abuse of Cough Treatments Act of 2012 or the PACT Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale or offering for sale of a drug containing dextromethorphan, and not subject to practitioner supervision requirements, to an individual under age 18, except if the sale is: (1) made pursuant to a validly issued prescription; or (2) to an individual who provides proof of being married, the parent of a child, or actively enrolled in the military. Imposes civil monetary penalties that escalate upon repeated violation. Deems to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act. Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services (HHS) as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between registered, licensed, or approved persons. Imposes additional civil monetary penalties for such possession and distribution violations.

Date: 2012-07-11
Topic: Health (Drug Industry)
Subject: Health
Taking Essential Steps for Testing Act or the TEST Act - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.

Date: 2012-07-17
Topic: Health (Drug Industry)
Subject: Health
Ethical Pathway Act of 2012 - Directs the Commissioner of Food and Drugs (FDA) to establish a mechanism by which an applicant to sell any new pharmaceutical drug, vaccine, biologic product, or medical device that requires regulatory approval by the Secretary of Health and Human Services (HHS) (regulated product) may request a cost-sharing arrangement under which the applicant shall: (1) verify that intended clinical investigations involving humans or vertebrate animals have not been performed or initiated by another person; (2) make reasonable efforts to obtain voluntary agreements to use existing evidence regarding the safety and efficacy of new pharmaceutical drugs or biological products used to obtain marketing approval for use in humans or vertebrate animals (regulatory test data); and (3) notify the Commissioner if there is a failure to reach a voluntary agreement, at which point the Commissioner shall ask the parties to agree to binding arbitration to determine the reasonable and fair fee for relying upon relevant regulatory test data. Permits such applicant to request such arrangement if, but for the arrangement: (1) the applicant would be required to conduct clinical investigations involving human subjects that violate Article 20 of the Declaration of Helsinki on Ethical Principles for Medical Research Involving Human Subjects in order to obtain regulatory approval of the regulated product, or (2) the duplication of the clinical investigations required for such application would violate other applicable ethical standards concerning the testing of products on humans or other vertebrate animals. Requires the fee for reliance by the applicant on such regulatory test data to be determined after considering: (1) the actual out-of-pocket costs of the applicable clinical investigations; (2) the risks of the investigations; (3) any federal grants, tax credits, or other subsidies; (4) the expected share of the global market for the product involved; and (5) the amount of time the holders of the relevant applications or licenses have benefited from exclusive rights and the cumulative revenue earned on the products that relied upon the data at issue. Directs the Secretary to adopt procedures and rules under which sufficient information about costs and fees will be made public.

Date: 2012-08-02
Topic: Health (Drug Industry)
Subject: Health
Medicaid Information Technology to Enhance Community Health Act of 2012 or MITECH Act - Amends title XIX (Medicaid) of the Social Security Act to extend payments to encourage the adoption and use of certified electronic health record (EHR) technology to qualified safety net clinics (QSNCs). Defines a QSNC as a clinic or network of clinics operated by a private non-profit or public entity at least 30% percent of whose patient volume is attributable to needy individuals. Defines a "QSNC-based" individual as one who furnishes substantially all of his or her professional services in a QSNC and through use of the clinic's facilities and equipment, including qualified EHRs. Directs the Secretary of Health and Human Services (HHS) to establish a procedure through which a QSNC may demonstrate meaningful use of certified EHR technology in order to receive incentive payments.

Date: 2012-09-13
Topic: Health (Drug Industry)
Subject: Health
Small Supplier Fairness in Bidding Competition Act of 2013 - Amends part B (Supplementary Medical Insurance Benefits for Aged and Disabled) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare competitive acquisition program for durable medical equipment and prosthetics, orthotics, and supplies (DMEPOS).

Requires the Administrator of the Centers for Medicare & Medicaid Services (CMS) to report to Congress on the impact of competitive bidding on small clinical laboratories.

Includes CMS (solely with respect to its capacity to issue rules governing the Medicare part B fee schedule for clinical laboratory services) as an agency for purposes of the requirement to assure the opportunity for participation of small entities in the making of rules that will have a significant economic impact on them.

Date: 2013-01-03
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-01-14
Topic: Health (Drug Industry)
Subject: Health
Stop Tampering of Prescription Pills Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for abuse-deterrent drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects.

Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not abuse-deterrent if an abuse-deterrent drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need.

Requires an abbreviated new (generic) drug application for an abuse-deterrent drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is abuse-deterrent and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug.

Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes abuse-deterrent unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug.

Prescribes requirements governing when a drug which is not abuse-deterrent may have its approval withdrawn or suspended.

Date: 2013-02-04
Topic: Health (Drug Industry)
Subject: Health
Protect Medical Innovation Act of 2013 - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

Date: 2013-02-06
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2013-02-06
Topic: Health (Drug Industry)
Subject: Taxation
Amends the National Organ Transplant Act to prohibit acquiring, receiving, or otherwise transferring a cord blood unit (the neonatal blood collected from the placenta and umbilical cord of a single newborn baby) for valuable consideration for use in human transplantation if the transfer affects interstate commerce.

Date: 2013-02-06
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-02-15
Topic: Health (Drug Industry)
Subject: Health
Say No to Drug Ads Act - Amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertisement of a prescription drug.

Date: 2013-02-28
Topic: Health (Drug Industry)
Subject: Taxation
Preservation of Antibiotics for Medical Treatment 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.

Date: 2013-03-14
Topic: Health (Drug Industry)
Subject: Health
Asthma Inhalers Relief Act of 2013 - Directs the Administrator of the Environmental Protection Agency (EPA) to: (1) permit the distribution, sale, and consumption in the United States of remaining inventories of CFC epinephrine inhalers manufactured pursuant to the exception for medical devices under the Clean Air Act; (2) not take any enforcement action or otherwise seek to restrict the distribution, sale, or consumption of such inhalers on the basis of any federal law implementing the Montreal Protocol on Substances that Deplete the Ozone Layer; and (3) issue, in response to a request of any distributor or seller of such inhalers, a No Action Assurance Letter stating that the EPA will not initiate an enforcement action relating to the distribution or sale of any such inhaler occurring prior to August 1, 2013.

Defines "CFC epinephrine inhaler" to mean any epinephrine inhaler containing chlorofluorocarbons that was manufactured and classified as over-the-counter before January 1, 2012.

Terminates this Act on August 1, 2013.

Date: 2013-03-15
Topic: Health (Drug Industry)
Subject: Environmental protection
Hearing Aid Assistance Tax Credit Act 2013 - Amends the Internal Revenue Code to allow a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for the taxpayer, the taxpayer's spouse, or a dependent of the taxpayer. Denies such tax credit to any taxpayer whose modified adjusted gross income exceeds $200,000.

Date: 2013-03-21
Topic: Health (Drug Industry)
Subject: Taxation
Stop Oxy Abuse Act of 2013 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain.

Date: 2013-03-21
Topic: Health (Drug Industry)
Subject: Health
Safe Cosmetics and Personal Care Products Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to provide for the regulation of cosmetics by the Secretary of Health and Human Services (HHS).

Requires any brand owner engaged in bringing a cosmetic to market for use in the United States to register annually and pay a fee for oversight and enforcement of this Act.

Requires the Secretary to: (1) establish labeling requirements, (2) establish a safety standard that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic and that protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient, and (3) issue guidance prescribing good manufacturing practices for cosmetics and ingredients.

Requires brand owners to submit to the Secretary safety data for the ingredients listed on the cosmetic label and the cosmetic itself, which shall be published in a database.

Requires the Secretary to review and evaluate the safety of cosmetics and ingredients of cosmetics that are marketed in interstate commerce, including nanotechnology and contaminants of concern linked to severe acute reactions or long-term adverse health effects.

Requires the Secretary, based on an initial review and evaluation, to establish three lists for ingredients: (1) a prohibited and restricted list, (2) a safe without limits list, and (3) a priority assessment list.

Authorizes the Secretary to order a recall or cease of distribution for a cosmetic that is adulterated, misbranded, or otherwise in violation of the FFDCA.

 Requires reporting of any serious adverse event associated with cosmetics.

Requires the Secretary to take action to minimize the use of animal testing of ingredients and cosmetics.

Establishes an Interagency Council on Cosmetic Safety.

Requires the Secretary of Labor to promulgate an occupational safety and health standard relating to cosmetics for professional use.

Date: 2013-03-21
Topic: Health (Drug Industry)
Subject: Commerce
Title I: Animal Drug User Fee Amendments - Animal Drug User Fee Amendments of 2013 - (Sec. 103) Amends the Federal Food, Drug, and Cosmetic Act to extend for FY2014-FY2018 the authority of the Food and Drug Administration (FDA) to collect animal drug user fees, specifically new animal drug application or supplemental animal drug application fees, animal drug product fees, animal drug establishment fees, and animal drug sponsor fees.

Revises the due date for annual user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the amount of revenue such fees can generate. Specifies percentages of the total revenue that shall be derived from each type of user fee.

Requires the Secretary of Health and Human Services (HHS) to adjust the total revenue amounts for FY2015 and subsequent fiscal years for inflation.

Authorizes the Secretary to accept payment of user fees prior to their due date.

Requires the total fees collected for FY2016-FY2018 to be increased by the cumulative amount, if any, by which the amount of user fees collected and appropriated for prior fiscal year falls below the cumulative amount of fees authorized.

(Sec. 104) Extends requirements for the FDA to report to Congress on achieving goals related to animal drug development and review processes and implementation of authority to collect animal drug user fees.

(Sec. 107) Terminates the authority to collect user fees October 1, 2018.

Title II: Animal Generic Drug User Fee Amendments - Animal Generic Drug User Fee Amendments of 2013 - (Sec. 202) Extends for FY2014-FY2018 the authority of the FDA to collect generic animal drug user fees, specifically abbreviated application fees for generic new animal drugs, generic new animal drug product fees, and generic new animal drug sponsor fees.

Subjects generic animal drug applications to a fee 50% of the amount of the normal fee if the application is for an animal drug which contains more than one active ingredient, or the labeling of the drug prescribes, recommends, or suggests use of the drug in combination with one or more other animal drugs, and the active ingredients or drugs intended for use in the combination have previously been separately approved.

Revises the due date for annual generic animal drug user fees to the later of January 31 of each year or the first business day after enactment of an appropriations act providing for the collection and obligation of fees for the fiscal year.

Establishes the total amount of revenue each type of generic user fee shall generate.

Authorizes the Secretary to accept payment of user fees prior to their due date.

(Sec. 203) Extends requirements for the FDA to report to Congress on achieving goals related to the generic animal drug development and review process and the implementation of the authority to collect generic animal drug fees.

(Sec. 206) Terminates the authority to collect generic animal drug user fees October 1, 2018.

Date: 2013-04-09
Topic: Health (Drug Industry)
Subject: Health
Medicare Drug Savings Act of 2013 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to require drug manufacturers to pay the Secretary of Health and Human Services (HHS) drug rebates for rebate eligible (low-income) individuals. Excludes from Medicare coverage as a part D drug any drug or biological manufactured by a manufacturer that has not entered into and have in effect a rebate agreement with the Secretary.

Requires a rebate agreement to require a drug or biological manufacturer to provide to the Secretary a rebate, determined according to a specified formula, for each rebate period ending after December 31, 2011, for any covered Medicare part D drug dispensed after that date to any rebate eligible individual for which payment was made by a prescription drug plan (PDP) sponsor or MedicareAdvantage (MA) organization for such period.

Specifies a formula for determination of Medicaid rebate amounts for such drugs or biologicals.

Amends SSA title XIX (Medicaid) to exclude any amounts paid under a rebate agreement from the determination of best price and average manufacturer price under the Medicaid program.

Date: 2013-04-16
Topic: Health (Drug Industry)
Subject: Health
Medicare DMEPOS Market Pricing Program Act of 2013 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act (SSA) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program, which is terminated as of December 31, 2013. Terminates contracts awarded before enactment of this Act on July 1, 2013.

Prescribes requirements for transitional payments for items and services, including payments for diabetic supplies and off-the-shelf orthotics, in areas designated for rounds 1 and 2 of the erstwhile phase-in of the competitive acquistion program, as well as during the initial two-year period of the market pricing program.

Directs the Secretary to: (1) conduct market-priced auctions in eligible auction areas throughout the United States for the furnishing of market priced items and services, (2) establish an auction design through a specified process and meeting certain requirements, and (3) ensure that the first auction will be conducted for all eligible auction areas not later than 14 months after contracting with an auction expert.

Directs the Secretary to: (1) select a combination of two categories of items and services for each auction, (2) establish a lead product for each product category, (3) establish for each market priced item and service a clearing price equal to the highest cost bid that will meet capacity targets in the market area, (4) award a contract to any entity in an auction's eligible market area whose bid is at or below the clearing price, and (5) monitor the performance of suppliers that are awarded a contract to ensure their compliance with certain requirements. Requires the Secretary, through the Office of the Assistant Secretary for Planning and Evaluation, to contract with an auction expert and a market monitor to assist in the design, development, implementation, and functioning of the auction. Requires the market monitor, on an ongoing basis, also to monitor suppliers and the effects of the market pricing program.

Rescinds unobligated balances of all discretionary appropriations for each fiscal year (except those for accounts, programs, projects and activities operated by the Department of Defense [DOD] or the Department of Veterans Affairs [VA]) in an amount necessary to make this Act budget neutral for such fiscal year.

Date: 2013-04-24
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-05-09
Topic: Health (Drug Industry)
Subject: Commerce
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.

Date: 2013-05-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-05-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-05-22
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-05-23
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-05-23
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
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.

Date: 2013-05-23
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-06-06
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-06-10
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-06-11
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-06-13
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-08-02
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-08-02
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-08-02
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-09-12
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2013-09-17
Topic: Health (Drug Industry)
Subject: Health