jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-27 00:00:00

Prescription Drug and Health Improvement Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to negotiate lower prices on behalf of Medicare and Medicare Advantage (MA) beneficiaries for covered prescription drugs that CMS deems appropriate for negotiation based on: (1) program and per-beneficiary spending, (2) unit cost increases over the preceding years, (3) initial launch price, and (4) any other criteria determined by CMS.

CMS may negotiate lower prices on behalf of Medicare and MA beneficiaries for other covered prescription drugs, as well.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-05-10 00:00:00

Trickett Wendler Right to Try Act of 2016

This bill bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, or dispensing of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law. The federal government may not restrict the possession or use of such a treatment by a patient certified by a physician as having exhausted all other treatment options.

A producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.

The outcome of production, manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.

The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.

Not later than 30 days after enactment of this bill, and every 30 days thereafter until implementation is complete, the FDA must report on its progress in implementing a streamlined application process for compassionate use of experimental drugs and biological products.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-05-24 00:00:00

Budgeting for Opioid Addiction Treatment Act 

This bill amends the Internal Revenue Code to impose a one cent per milligram excise tax on the sale of active opioids by the manufacturer, producer, or importer. The tax excludes prescription drugs used exclusively for the treatment of opioid addiction as part of a medically assisted treatment effort.

The Department of Health and Human Services (HHS) must establish a program to provide rebates or discounts to cancer and hospice patients to ensure that they do not pay the tax.

The bill amends the Public Health Service Act to require any increase in federal revenues from the tax after rebates and discounts are subtracted to be distributed to states under the Substance Abuse Prevention and Treatment Block Grant program to be used exclusively for substance abuse (including opioid abuse) efforts in the states, including specified treatment programs.

HHS must report to Congress on the impact of this bill on the retail cost of opioids and patient access to opioid medication, the effectiveness of the discount or rebate for cancer and hospice patients, how the funds are being used to improve substance abuse treatment efforts, and suggestions for improving access to opioids for cancer and hospice patients and substance abuse treatment efforts.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-05-25 00:00:00

This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to add standards for drug compendia used by physicians with respect to payment for certain drugs under the Medicare and Medicaid programs.

Specifically, such compendia shall include compendia that, as determined by the Centers for Medicare & Medicaid Services: (1) are used by health care providers and utilized nationwide by the health insurance industry; (2) have a publicly available policy on disclosures of conflicts of interest; (3) use an international, widely recognized standard to evaluate clinical evidence for inclusion; and (4) are accepted by at least one state board of pharmacy or equivalent licensing body.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-05-26 00:00:00

DXM Abuse Prevention Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Civil monetary penalties that escalate upon repeated violation are imposed.

To possess or receive unfinished DXM, a person must be registered with the Department of Health and Human Services as a producer of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Unfinished DXM may be distributed only to these authorized persons. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-14 00:00:00

Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016

This bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved medication alleging that the license holder: (1) declined to make available sufficient quantities of the approved medication for the developer's testing; or (2) failed to agree on, or refused to allow the developer to join, a single, shared system of elements to assure safe use (ETASU) of the medication. (Under current law, a generic version of a medication with ETASU must join the brand name medication's system of ETASU unless the developer of the generic has a waiver from the Food and Drug Administration.) The bill does not apply to medications for which there is a shortage, unless the shortage will not be promptly resolved.

In a civil action regarding the availability of sufficient quantities of a medication, it is an affirmative defense that the license holder: (1) is not manufacturing or marketing the medication and does not have access to a supply of the medication to make available, or (2) sells the medication without restrictions through other entities and the developer can purchase sufficient quantities of the medication from those entities.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-16 00:00:00

Addiction Prevention and Responsible Opioid Practices Act

This bill addresses prescription opioid misuse.

 The Food and Drug Administration (FDA) must: (1) seek recommendations concerning opioid drugs from an FDA advisory committee relating to the approval of a new drug that is an opioid, and the labeling of opioid drugs for pediatric prescriptions; (2) develop recommendations for education programs for prescribers of opioids; and (3) issue guidance for labeling that deters opioid abuse.

The bill amends the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of opioid drugs to ensure that certain information about the risk factors associated with opioid drugs are included on the drug labels.

The bill amends the Controlled Substances Act by: (1) addressing annual narcotic manufacturing quotas with respect to fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone; and (2) directing the Department of Justice (DOJ) to require medical practitioners to complete a training program on prescribing opioids for chronic pain before they are certified to prescribe controlled substances in schedule II, III, or IV.

The bill establishes requirements for prescription drug monitoring systems to prevent over-prescribing controlled substances.

The Department of Health and Human Services must: (1) submit a plan of action for addressing outliers in opioid prescribing practices and ensuring an adequate response to protect the public health, and (2) study the expansion of Medicare coverage for alternatives to opioid treatments.

The bill amends the Internal Revenue Code to impose an excise tax on manufacturers or producers of opioid pain relievers. A portion of the amount generated from the tax must be used for substance abuse treatment programs.

DOJ must establish a take-back program for the safe and environmentally responsible disposal of controlled substances.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-07-13 00:00:00

Prescription Drug Monitoring Act of 2016

This bill requires a state that receives grant funds under the prescription drug monitoring program (PDMP) or the controlled substance monitoring program to comply with specified requirements. The Department of Justice (DOJ) or Department of Health and Human Services may withhold grant funds from a state that fails to comply.

Additionally, the bill requires a state to share its PDMP data with other states through a data-sharing hub established by DOJ.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-07 00:00:00

Carl's Law

This bill amends the Federal Food, Drug, and Cosmetic Act to require the label of a drug containing an opioid to prominently state that the drug contains an opioid and addiction to the drug is possible. (Opioids are drugs with effects similar to opium, such as certain pain medications.)
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-15 00:00:00

Fair Accountability and Innovative Research Drug Pricing Act of 2016

This bill amends the Public Health Service Act to require manufacturers of certain drugs and biological products to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the price of a drug over a 12-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1.

Manufacturers that do not submit a required report are subject to a civil penalty. The Inspector General of HHS must review drug price information to determine compliance. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency.

HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-22 00:00:00

Safely Advancing Valuable and Inexpensive New Generic Solutions Act or the SAVINGS Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of certain generic drug applications and act on them within 150 days. This generic fast track review applies to applications for drugs: (1) that are not under patent or for which patents will expire soon, (2) for which there is no marketing exclusivity in effect, and (3) for which a generic has not recently been introduced to the market by more than one manufacturer.

The FDA must report on applications subject to generic fast track review and provide an annual accounting of how it has spent generic drug user fees.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-28 00:00:00

This bill amends the Public Health Service Act to require the Department of Health and Human Services to research and report on medication adherence with respect to federal health care programs. ("Medication adherence" refers to the extent to which patients take their medications as prescribed.)

In addition, the bill amends titles XI (General Provisions) and XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services to:

 upon request by a prescription drug plan (PDP) sponsor, provide the plan with Medicare enrollee claims data to provide context for an enrollee's medication regimen; in calculating the minimum medical loss ratio with respect to PDPs, include medication management as an activity that improves health care quality; and through the Center for Medicare and Medicaid Innovation, test a model for enhanced medication therapy management for PDPs under Medicare Advantage.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-28 00:00:00

Pharmaceutical Supply and Value Enhancement Act or the Pharmaceutical SAVE Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness.

Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive market if: (1) there are fewer than five holders of approved applications for commercially available brand name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) patents on the active ingredient of the drug have expired.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-29 00:00:00

Accelerating New Pharmaceutical Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to permit brand name drug applications to rely upon investigations conducted in certain foreign countries if the drug has been approved in the foreign country where the investigations were conducted. The Food and Drug Administration (FDA) has 90 days to act on these applications.

The bill revises a provision regarding the effective date of the approval of a generic drug that is subject to a patent infringement action.

The FDA must prioritize the review of, and act within 150 days on, generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.
Topic: Social Welfare — Disabled Assistance
Subject: Social welfare
Date: 2007-01-04 00:00:00

Disability Benefit Fairness Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act (SSA) to eliminate: (1) the five-month waiting period for an individual (including a disabled widow or widower) to be eligible for benefits based on disability; and (2) any intervening reconsideration from the review process governing decisions on benefit entitlement.
Topic: Social Welfare — Disabled Assistance
Subject: Social welfare
Date: 2007-01-24 00:00:00

Social Security and Medicare Improved Burn Injury Treatment Access Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to direct the Commissioner of Social Security to waive the application of the five-month Social Security disability waiting period in cases of individuals with disabling burn injuries. Eliminates the 24-month Medicare disability waiting period in cases of individuals with disabling burn injuries.
Topic: Social Welfare — Disabled Assistance
Subject: Taxation
Date: 2007-05-17 00:00:00

Financial Security Accounts for Individuals with Disabilities Act of 2007 - Amends the Internal Revenue Code to establish tax-exempt financial security accounts for individuals with disabilities to pay certain expenses of such individuals, including expenses for education, medical care, and employment training.
Topic: Social Welfare — Disabled Assistance
Subject: Health
Date: 2007-05-17 00:00:00

Danielle's Act - Amends title XIX (Medicaid) of the Social Security Act to require state Medicaid plans to require staff working with persons with a developmental disability or traumatic brain injury to call emergency services in the event of a life-threatening situation.
Topic: Social Welfare — Disabled Assistance
Subject: Civil rights and liberties, minority issues
Date: 2007-06-22 00:00:00

Amends the Developmental Disabilities Assistance and Bill of Rights Act of 2000 to require states, in order to receive allotments under provisions relating to state councils on developmental disabilities or provisions relating to the protection and advocacy of individual rights, to obtain the authorization of the individual with a developmental disability or the individual's legal representative before pursuing any legal or other remedy on behalf of the individual.
Topic: Social Welfare — Disabled Assistance
Subject: Social welfare
Date: 2007-06-28 00:00:00

Claire Collier Social Security Disability Insurance Fairness Act - Amends title II (Old Age, Survivors and Disability Insurance) of the Social Security Act to provide that the eligibility requirement for disability insurance benefits under which an individual must have 20 quarters of Social Security coverage in the 40 quarters preceding a disability shall not apply in the case of a disabled individual suffering from a covered terminal disease.
Topic: Social Welfare — Disabled Assistance
Subject: Civil rights and liberties, minority issues
Date: 2007-07-26 00:00:00

ADA Amendments Act of 2008 - (Sec. 4) Amends the Americans with Disabilities Act of 1990 (ADA) to redefine the term "disability," including by defining "major life activities" and "being regarded as having such an impairment."Sets forth rules of construction regarding the definition of "disability," including that: (1) such term shall be construed in favor of broad coverage of individuals under the Act; (2) an impairment that substantially limits one major life activity need not limit other major life activities in order to be a disability; (3) an impairment that is episodic or in remission is a disability if it would substantially limit a major life activity when active; and (4) the determination of whether an impairment substantially limits a major life activity shall be made without regard to the ameliorative effects of specified mitigating measures.Defines the term "auxiliary aids and services."(Sec. 5) Prohibits employment discrimination against a qualified individual on the basis of disability. (Current law prohibits employment discrimination against a qualified individual with a disability because of the disability.)Prohibits the use of qualification standards, employment tests, or other selection criteria based on an individual's uncorrected vision unless the standard, test, or other selection criteria, as used by the covered entity, is shown to be related to the position and is consistent with business necessity.(Sec. 6) Declares that nothing in the Act: (1) alters the standards for determining eligibility for benefits under state worker's compensation laws or under state and federal disability benefit programs; (2) alters the requirement to make reasonable modifications in policies or procedures, unless such modifications would fundamentally alter the nature of the goods, services, facilities, or accommodations involved; or (3) provides the basis for a claim by a person without a disability that he or she was subject to discrimination because of the lack of disability.Declares that the authority of the Equal Employment Opportunity Commission (EEOC), the Attorney General, and the Secretary of Transportation to issue regulations includes the authority to issue regulations implementing the definitions of this Act.(Sec. 7) Makes conforming amendments to the Rehabilitation Act of 1973.
Topic: Social Welfare — Disabled Assistance
Subject: Civil rights and liberties, minority issues
Date: 2007-09-05 00:00:00

ADA Notification Act of 2007 - Amends the Americans with Disabilities Act of 1990 to deny jurisdiction to a court in a civil action for remedies for disability discrimination in public accommodations and certain services provided by private entities unless: (1) the plaintiff notified the defendant in writing of the alleged violations prior to filing the complaint; (2) the notice identified the specific facts that constitute the alleged violation; (3) 90 or more days has elapsed after the date on which the notice was provided; (4) the notice informed the defendant that the civil action could not be commenced for 90 days; and (5) the complaint states that the defendant has not corrected the alleged violation. Excludes civil actions seeking preliminary injunctive relief or temporary restraining orders from such notification requirements.
Topic: Social Welfare — Disabled Assistance
Subject: Social welfare
Date: 2007-10-15 00:00:00

Blind Persons Earnings Fairness Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to increase, by specified increments over five years, the level of earnings demonstrating the ability of a blind person to engage in substantial gainful activity for purposes of determining disability insurance benefit payments.
Topic: Social Welfare — Disabled Assistance
Subject: Law
Date: 2007-10-30 00:00:00

Prohibits any entity that receives funds from the federal government from using them to file a class action lawsuit against an intermediate care facility for the mentally retarded on behalf of any facility resident unless the resident (or the resident's legal representative), after receiving notice of the proposed class action lawsuit, has the opportunity to elect not to have the action apply to the resident.
Topic: Social Welfare — Disabled Assistance
Subject: Housing and community development
Date: 2007-11-15 00:00:00

Inclusive Home Design Act of 2007 - Requires, with exceptions, newly constructed, federally assisted single family houses and town houses to include at least one level that complies with the following accessibility features for persons with disabilities: (1) accessible entrance; (2) accessible interior doors; (3) accessible environmental controls; and (4) accessible habitable space and an accessible bathroom. Requires: (1) each applicant for federal financial assistance to submit compliance assurances to the relevant federal agency; and (2) each person who arranges for design or construction of a covered dwelling to submit architectural and construction plans for state or local approval. Prohibits federal financial assistance to a state or local government unit unless the recipient is taking certain enforcement actions with regard to covered dwellings. Permits: (1) private civil actions in a U.S. District Court or state court for violations under this Act; and (2) the Attorney General to commence civil actions or intervene in civil actions under this Act.
Topic: Social Welfare — Disabled Assistance
Subject: Social welfare
Date: 2008-07-31 00:00:00

Social Security Disability Insurance Demonstration Authority Act of 2008 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to reestablish the Social Security Administration's disability insurance demonstration project authority.
Topic: Social Welfare — Disabled Assistance
Subject: Taxation
Date: 2007-03-15 00:00:00

Amends the Internal Revenue Code to make permanent the suspension of the taxable income limitation on percentage depletion for oil and natural gas produced from marginal properties.