jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2011-05-24 00:00:00

Medicare Orthotics and Prosthetics Improvement Act of 2011 - 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. Modifies the Medicare payment rules for orthotics and prosthetics to account for practitioner 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 Chief Actuary of the Centers for Medicare and Medicaid Services to submit to Congress a projection of the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2012-2016 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 2012-2016, 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 2016. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-05-25 00:00:00

States' Medical Marijuana Patient Protection Act - Requires the Secretary of Health and Human Services (HHS), within six months of enactment of this Act, to submit to the Administrator of the Drug Enforcement Administration (DEA) a recommendation on the listing of marijuana within the Controlled Substances Act (CSA) and to recommend listing it as other than a Schedule I or Schedule II substance. Requires the Administrator of DEA, within 12 months of enactment of this Act, based upon the recommendation of the National Academy of Sciences, to issue a notice of proposed rulemaking for the rescheduling of marijuana within the CSA, which shall include a recommendation to list marijuana as other than a Schedule I or Schedule II substance. Declares that no provision of the CSA or the Federal Food, Drug and Cosmetic Act shall prohibit or otherwise restrict, in a state in which the medical use of marijuana is legal under state law: (1) the prescription or recommendation of marijuana for medical use by a medical professional or the certification by a medical professional that a patient has a condition for which marijuana may have therapeutic benefit; (2) an individual from obtaining, manufacturing, possessing, or transporting within their state marijuana for medical purposes, provided the activities are authorized under state law; (3) a pharmacy or other entity authorized to distribute medical marijuana from obtaining, possessing, or distributing marijuana to authorized individuals; or (4) an entity authorized by a state or local government from producing, processing, or distributing marijuana for such purposes.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2011-05-25 00:00:00

Small Business Tax Equity Act of 2011 - Amends the Internal Revenue Code to allow a tax deduction for expenses incurred in the trade or business of selling marihuana intended for patients for medical purposes pursuant to state law.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2011-05-26 00:00:00

Freedom of Health Speech Act - Amends the Federal Trade Commission Act to prohibit the content of any publication from being considered advertising regulated under the Act unless the content is intended by a product seller to promote that product's sale and the content includes the name of the product, an express offer to sell, and a purchase price. Prohibits any content excerpted in whole or part from a peer-reviewed scientific publication from being considered advertising regulated under the Act. Prohibits the Federal Trade Commission (FTC) from attributing to an advertiser any advertising statement not actually made by that advertiser. Requires the FTC to notify an advertiser of a dietary supplement before authorizing an investigation of false advertisement and include a date by which the advertiser may voluntarily discontinue use of the statement. Prohibits the FTC from beginning an investigation of possible false advertising regarding a dietary supplement or a dietary ingredient unless the FTC already possesses clear and convincing evidence that the advertisement is false and misleading. Places the burden of proof on the FTC to show, by clear and convincing evidence, that an advertisement for a dietary supplement or dietary ingredient is false, that the advertisement actually caused consumers to be misled into believing to be true that which is false, and that, but for the false advertising content, the consumer would not have made the purchase at the price paid. Requires the FTC to prove that a health claim alleged to be false advertising is false based on expert scientific opinion and published peer-reviewed scientific evidence.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-06-02 00:00:00

Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2011 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2014: (1) certification in each medical imaging or radiation therapy modality and service they plan or perform from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants from the requirements of this Act. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a process for the certification of individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program; and (4) publish a list of approved accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to ensure access to quality medical imaging. Amends title XVIII (Medicare) of the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-06-16 00:00:00

Medical Gas Safety Act - Amends the Federal Food, Drug, and Cosmetic Act to set forth provisions regarding the regulation of medical gases, including to establish a certification and approval process for medical gases. Lists designated medical gases, including oxygen, nitrous oxide, and medical air. Requires the Secretary to: (1) approve a certification for designated medical gases; and (2) establish by rule appropriate procedures for the approval of medical gases that are not designated medical gases. Requires the Secretary to establish regulations for medical gases, including: (1) appropriate current good manufacturing practice requirements, (2) separate labeling requirements, (3) separate wholesale distribution requirements, (4) a streamlined electronic process for registration and listing of medical gases, and (5) separate and proportionate product tracking and anti-counterfeiting rules for medical gases. Requires the Secretary to establish: (1) a separate risk-based inspection regime specific to medical gas manufacturers that ensures coordination with state and local inspection activities, and (2) the Medical Gas Advisory Committee to provide the Secretary with regular guidance and specific advice on medical gas regulatory activities. Directs the Secretary to assess and collect fees with respect to drugs that are non-designated medical gases, and establish the amount of fees to generate the total amount of costs of the Food and Drug Administration's (FDA's) regulation of non-designated medical gases. Exempts medical gases from new drug fees and new animal drug fees.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-06-21 00:00:00

Preserving Access to Life-Saving Medications Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the manufacturer of a prescription drug marketed in interstate commerce to notify the Secretary of Health and Human Services (HHS) of a discontinuance or interruption in the manufacture of such drug. Requires the notification to be submitted six months prior to the date of a discontinuance or interruption, if possible. Allows the reduction of the notification period if the manufacturer certifies to the Secretary that good cause exists for the reduction. Authorizes the Secretary to reduce the notification period based on the type of discontinuance or interruption at issue or any other factor. Treats any information provided to the Secretary under this Act as a trade secret or confidential information. Establishes civil monetary penalties for violations. Requires the Secretary to publish on the website of the Food and Drug Administration (FDA) and distribute to the appropriate health care providers and patient organizations information on discontinuances, interruptions, and drug shortages. Requires the Secretary to notify a manufacturer of: (1) any determination by the Secretary that a drug may be vulnerable to a drug shortage, and (2) the Secretary's duty to collaborate to improve continuity of supply. Prohibits the Secretary from requiring a manufacturer to: (1) manufacture a drug in the event of a discontinuance or interruption, or (2) delay or alter a discontinuance or interruption. Declares that no provision of federal law shall be construed to prohibit a manufacturer from, or penalize a manufacturer for, allocating distribution of its products in order to manage an actual or potential drug shortage. Requires the Comptroller General to examine issues related to drug shortages.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-07-26 00:00:00

Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription. Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment. Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers. Sets forth civil penalties and establishes a a private cause of action for violations of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-07-27 00:00:00

Preserving Access to Orphan Drugs Act of 2011 - 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 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: Commerce
Date: 2011-09-13 00:00:00

Testimonial Free Speech Act of 2011 - Prohibits any federal official or employee from restricting the dissemination of a testimonial containing a consumer's actual perception of the mitigative, preventive, or curative properties of any food or dietary supplement based on the consumer's experience with that food or dietary supplement. Declares that a person is not violating federal law if such person disseminates a testimonial that he or she reasonably believed is covered by this Act. Applies this Act to the dissemination of a testimonial by the manufacturer of a food or dietary supplement for purposes of marketing.
Topic: Health — Drug Industry
Subject: Environmental protection
Date: 2011-09-15 00:00:00

Pharmaceutical Stewardship Act of 2011 - Establishes the National Pharmaceutical Stewardship Organization as a nonprofit private corporation whose board of directors shall be appointed by the Administrator of the Environmental Protection Agency (EPA). Requires the Organization to begin implementation of a certified national pharmaceutical stewardship program within two years. Requires each manufacturer and brand owner of a drug marketed in the United States to participate in such program or another certified national pharmaceutical stewardship program. Establishes requirements for program certification, including requirements to: (1) provide a system to facilitate the collection and disposal of any drug that is a household waste, as defined under the Resource Conservation and Recovery Act, that is delivered to the program by an individual in the United States; and (2) collect and dispose of drugs in a manner that is safe and secure, that results in incineration of the drug in accordance with the hazardous waste incineration requirements under the Solid Waste Disposal Act, that protects patient information, and that is accessible and, in the case of a controlled substance, consistent with the Controlled Substances Act. Prohibits programs from imposing fees on individuals for delivery or disposal of a drug. Establishes a program certification process, including requiring the Administrator to consult with the Administrator of the Drug Enforcement Agency (DEA) on the adequacy of the proposed program's security measures for collection, transportation, and disposal of drugs, disposal systems, and mechanisms for secure tracking and handling. Authorizes the Administrator to suspend certification of a program if necessary to protect the public from imminent danger. Requires the Director of National Drug Control Policy to establish a campaign to increase public awareness of how drugs may be lawfully disposed consistent with public safety, public health, and environmental protection. Requires the Administrator to establish an interagency commission, to be known as the Commission on Drug Disposal and its Public Safety, Public Health, and Environmental Impacts, to develop a strategy to: (1) prevent the entry of drugs into the nation's water supply and environment consistent with current public safety standards, and (2) protect public health and promote public safety by reducing diversion and the risk of abuse and accidental overdose. Requires the Comptroller General (GAO) to report on drugs and drug byproducts in surface water and groundwater in the United States within a year.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-09-22 00:00:00

Safeguarding America's Pharmaceuticals Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of the Treasury to destroy imported counterfeit drugs and adulterated or misbranded imported drugs with a value of less than $2,000. Requires the manufacturer of a prescription drug to provide to its wholesale distributors or dispensers a packing list or comparable document containing identifying information, including the National Drug Code number, container size, and lot number of the drug. Requires each manufacturer or repackager of a prescription drug to: (1) apply a standardized numerical identifier that is unique to each unit of the drug to at least 50% of its drugs by January 1, 2015, and to all of its drugs by January 1, 2016; and (2) notify the Secretary of Health and Human Services (HHS) of the method it will use to meet such requirement. Requires the Secretary to establish an effective drug identification and tracking system to authenticate the wholesale distribution history of any prescription drug that is subject to a requirement for a standardized numerical identifier. Expands the requirements for the licensing of wholesale distributors, including to require mandatory background checks. Disqualifies a person who has been convicted of certain felonies or who has engaged in a pattern of violative behavior. Establishes civil monetary penalties for violations of this Act. Requires penalties paid to the United States to be used by the Secretary of HHS to prevent and address unlawful counterfeiting and diversion of drugs. Authorizes a state to enforce the requirements of this Act under certain circumstances. Requires the Secretary of HHS to study threats to the domestic prescription drug supply chain.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-11 00:00:00

Medicare Safe Needle Disposal Coverage Act of 2011 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to cover as a part D drug any devices approved for home use by the Food and Drug Administration (FDA) for the safe and effective containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps container, decontamination/destructive device, or sharps-by-mail program or similar program.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services (HHS) classifies the device as a class III device in response to the person filing a notice of intent to market the device.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Guidance Accountability and Transparency Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), when issuing guidance documents that set forth initial interpretations of a statute or regulation, set forth changes in interpretation or policy that are of more than a minor nature, include complex scientific issues, or cover highly controversial issues (Level 1 guidance documents), to: (1) publish notice in the Federal Register of the Secretary's intent to prepare such a document at least three months before issuance of a draft, and (2) meet with interested stakeholders and solicit public comment during preparation and before issuance of a draft. Includes within such guidance documents a notice to industry guidance letter, a notice to industry advisory letter, and any similar notice. Sets forth other procedures if the Secretary for good cause finds compliance with such requirements is impracticable, unnecessary, or contrary to the public interest. Requires the Secretary: (1) upon issuing a draft, to designate it as proposed or final; and (2) to issue a final draft within 12 months after issuing a proposed draft. Treats the proposed draft as null and void if the Secretary fails to finalize the draft within such time. Directs the Secretary to conduct a retrospective analysis of a final Level 1 guidance document not less than every five years to ensure it is not outmoded, ineffective, insufficient, or excessively burdensome and to modify or repeal the document accordingly.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise and extend through October 1, 2017, provisions authorizing accredited persons to provide classification reports for a medical device and to inspect class II device or class III device facilities. Deems a recommendation of an accredited person as to the classification of a medical device to be accepted by the Secretary of Health and Human Services (HHS) if the Secretary fails to make a determination with respect to the recommendation within 30 days. Requires the Secretary to regularly publish: (1) detailed decision summaries for each clearance of a device, classification of a device, approval of an application of a device, or grant of exemption for a device occurring after the enactment of this Act; and (2) total product life cycles information for devices. Expands the devices for which an accredited person may perform a review to include: (1) a class II device for which clinical data is required in the report, and (2) a class II device which is intended to be permanently implantable or life sustaining or supporting only if notification is provided to the Secretary before such a review. Deems the review permissible if the Secretary does not object within 60 days. Requires the Secretary to provide for the initial training and periodic updating of training of accredited persons. Makes accreditation valid for three years. Sets forth provisions regarding reaccreditation. Prohibits an accredited person from being a sole practitioner. Provides that the prohibitions against an accredited person being owned or controlled by a manufacturer, supplier, or vendor of devices or engaging in the design, manufacture, promotion, or sale of devices shall apply only if the devices are of the same type for which the person is accredited.