jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-09-17 00:00:00

Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less than four hours the presence, concentration, or characteristics of a serious or life-threatening infection.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-09-25 00:00:00

Orphan Drug Fairness Act

This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

This Act is effective as if included in PPACA.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-09-29 00:00:00

Gluten in Medicine Disclosure Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of 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 does not include a parenthetical statement identifying the source of that ingredient.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-10-01 00:00:00

Preserving Access to Orphan Drugs Act of 2015

This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax credit for clinical trials was allowed are considered orphan drugs.

This Act applies to fees paid after 2014.
Topic: Health — Drug Industry
Subject: International affairs
Date: 2015-10-06 00:00:00

Strategy To Oppose Predatory Organ Trafficking Act or the STOP Organ Trafficking Act

 (Sec. 3) This bill expresses the sense of Congress that:

 kidnapping or coercion of individuals to extract their organs for profit contradicts the standards for ethical behavior upon which the United States has based its laws; illegal harvesting of organs from children is a violation of the chid's human rights and a breach of international medical ethical standards; illegal harvesting and trafficking of human organs violates the Universal Declaration of Human Rights; and establishing efficient national organ donation systems with strong enforcement mechanisms is the most effective way to combat trafficking of persons for the removal of their organs. (Sec. 4) It shall be U.S. policy to: (1) combat trafficking of persons for the removal of their organs, (2) promote the establishment of voluntary organ donation systems with effective enforcement mechanisms, and (3) promote the dignity and security of human life.

(Sec. 5) The Passport Act of 1926 is amended to authorize the Department of State to refuse to issue a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense.

(Sec. 6) The Trafficking Victims Protection Act of 2000 is amended to define "trafficking of persons for the removal of their organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by:

 coercion, abduction, deception, fraud, abuse of power, or transfer of payments or benefits to achieve the consent of an individual having control over such person for the purpose of removing the person's organs. "Organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ specified by the Department of Health and Human Services.

Trafficking of persons for the removal of their organs is included in the definition of "severe forms of trafficking in persons."

 The Interagency Task Force To Monitor and Combat Trafficking is tasked with collecting and organizing data from human rights officers at U.S. embassies on host country's laws against trafficking of persons for the removal of their organs and any instances of violations of such laws.

(Sec. 7) The State Department shall report annually through 2024 to Congress regarding: (1) the trafficking of persons for the removal of their organs, and (2) preventive activities undertaken by the State Department and other countries.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-11-04 00:00:00

E-Free Act

This bill requires the Food and Drug Administration to withdraw approval for Essure, a medical device for permanent, non-surgical female sterilization.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-11-05 00:00:00

Meaningful Use Hardship Relief Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to create a blanket exception for providers from the application of certain negative payment adjustments for failing to comply, during the 2015 reporting period, with requirements related to the meaningful use of electronic health records. Under current law, providers may be exempted due to significant hardship on a case-by-case basis.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-12-02 00:00:00

Cardiac Arrest Survival Act of 2015

This bill 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; and (2) the owner of an AED for any harm resulting from the use of the AED, unless the harm was caused by the failure of the owner to properly maintain the AED.

This immunity applies regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used the AED complied with signage, had received training on use of the AED, or was assisted or supervised, including by a licensed physician.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-12-08 00:00:00

Protecting Access through Competitive-pricing Transition Act of 2015 or the PACT Act of 2015

This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions relating to payment for durable medical equipment (DME) under the Medicare and Medicaid programs. (DME includes certain medically necessary equipment such as walkers, wheelchairs, and hospital beds.)

With respect to DME furnished in areas that are not competitive acquisition areas, current regulations require the Centers for Medicare & Medicaid (CMS) to phase in, over a two-year period, Medicare payment adjustments using information from competitive acquisition programs. (Through such programs, payment amounts for each area are determined based on competitive bids submitted by suppliers, rather than according to an established fee schedule.) The bill codifies this requirement and specifies that CMS shall adjust fee schedule amounts to the lesser of: (1) a specified percentage of the regional amount; and (2) the amount that would otherwise be determined according to the fee schedule, with specified adjustments.

In determining Medicare payment adjustments for areas that are not competitive acquisition areas, CMS shall solicit stakeholder input and take into account several specified factors.

CMS may not accept a bid under the competitive acquisition program unless the bidder: (1) meets applicable state licensure requirements; and (2) has submitted a cash deposit as a bond, as specified by the bill.

CMS must establish a six-year market pricing demonstration project, under which auctions are conducted in eligible areas for the furnishing of market-priced DME items and services. The bill establishes project requirements related to auction design, contract terms, transparency, and monitoring.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-02-12 00:00:00

Responsibility in Drug Advertising Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising of a drug in the first three years after the drug's approval. The Food and Drug Administration may: (1) waive the third year of this prohibition for a drug if direct-to-consumer advertising of the drug would have an affirmative value to public health, or (2) extend the prohibition if the drug has significant adverse health effects.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-02-23 00:00:00

(This measure has not been amended since it was reported to the House on May 10, 2016. The summary of that version is repeated here.)

Lali's Law

(Sec. 2) This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)

Grants may be used for:

 developing standing orders for opioid overdose reversal medication for pharmacies; encouraging pharmacies to dispense medication pursuant to such a standing order; implementing best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients; developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and educating the public on the availability and public health benefits of opioid overdose reversal medication. States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication.

(Sec. 3) As an offset, this bill reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-02 00:00:00

Advancing Standards in Regenerative Medicine Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The FDA must work with this body to develop standards to support the development and review of regenerative medicine products.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-03 00:00:00

Removing Barriers to Clinical Research Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to expand Medicare coverage of costs associated with clinical trials. Under current law, Medicare covers routine costs of care furnished to a beneficiary enrolled in a category A (experimental) clinical trial of a medical device intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The bill requires Medicare to also cover, with respect to a beneficiary enrolled in a category B (non-experimental) clinical trial, routine costs of care as well as the cost of the device under investigation.

A trial of a medical device shall, for purposes of Medicare coverage, be deemed to meet the definition of a category A or category B clinical trial, as the case may be, if the trial is conducted under the Federal Food, Drug, and Cosmetic Act's investigational use exemption.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-16 00:00:00

Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act

This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed.

An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval.

The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy.

The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials.

A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device.

The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components.

The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-17 00:00:00

Lower Drug Costs through Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of 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.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

Beginning FY2018, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the end of FY2021.

The FDA must periodically report on generic drug applications filed before FY2017 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2016-03-23 00:00:00

Prevent Abuse By Using Interstate Exchange Act of 2016 or the Prevent ABUSE Act of 2016

This bill requires a state that receives a prescription drug monitoring program implementation and enhancement grant to set aside at least 20% of grant funds to facilitate interstate electronic information sharing about prescriptions for controlled substances.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-12 00:00:00

This bill requires the Centers for Disease Control and Prevention to issue guidance for the safe prescribing of opioids for the treatment of acute pain. (Opioids are drugs with effects similar to opium, such as certain pain medications.)
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2016-04-13 00:00:00

Pharmaceutical Stewardship Act of 2016

This bill requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-15 00:00:00

Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device.

Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device.

The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers.

The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-15 00:00:00

Preventing Superbugs and Protecting Patients Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization.

The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-18 00:00:00

(This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)

Opioid Review Modernization Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."
Topic: Health — Drug Industry
Subject: Health
Date: 2016-04-29 00:00:00

Curb Opioid Misuse By Advancing Technology Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to extend the marketing exclusivity period for certain brand name drugs that the Food and Drug Administration approves: (1) on the basis of new clinical abuse potential studies, and (2) with labeling that characterizes the drug's abuse-deterrent properties. This extension does not apply to the marketing exclusivity period for new chemical entities.

The bill also extends the marketing exclusivity period for generics of these drugs.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2016-05-11 00:00:00

Safe Drug Disposal Tax Credit Act of 2016 

This bill amends the Internal Revenue Code to establish a tax credit for 30% of the program costs of an entity to establish or maintain a drug disposal site where individuals can deposit drugs to be disposed of legally at no cost to the individual. The credit includes the costs of materials for the site, outreach and training about the use of the site, and the safe disposal of drugs collected at the site.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2016-05-24 00:00:00

Empowering Pharmacists in the Fight Against Opioid Abuse Act

This bill requires the Drug Enforcement Administration (DEA) to develop and disseminate training programs and materials on: (1) the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion; and (2) federal requirements related to such refusal.

The DEA must seek input from relevant stakeholders.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-05-26 00:00:00

Organ Donation Clarification Act of 2016

This bill allows the exchange of human organs for valuable consideration (anything of value) under pilot programs approved by the Department of Health and Human Services to measure the effect of removing disincentives or providing a noncash benefit that may increase organ availability. (Currently, exchanging human organs for valuable consideration is prohibited by the National Organ Transplant Act.)

In addition to reimbursements permitted in the National Organ Transplant Act, this bill declares that valuable consideration does not include:

 dependent care needs related to organ donation, medical expenses related to donation and all related follow-up care including preventive follow-up care and medication, paperwork or legal costs related to donation, or an insurance policy against the risk of death or disability as a result of donating an organ or the longer-term health effects of having donated an organ.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2016-05-26 00:00:00

Alzheimer's Breakthrough Sunshine Act 

This bill amends the Internal Revenue Code to exclude from gross income for seven years amounts received from the sale of certain drugs for treating Alzheimer's disease and related dementias.

The exclusion applies to the sale of a drug approved or licensed as a disease-modifying treatment for Alzheimer's disease and that has been designated as a breakthrough therapy under the Federal Food, Drug, and Cosmetic Act. The drug must be sold through an arm's length transaction by a holder of the approved application for the drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-08 00:00:00

Ariel Grace's Law

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-08 00:00:00

Medical Device Guardians Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring physicians to report to the Food and Drug Administration about significant adverse experiences caused by medical devices.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-16 00:00:00

Deliver for Our Nation At Times of Emergency Act of 2016

This bill requires the Department of Health and Human Services to provide for increased flexibility in blood donor screening, while maintaining a safe blood donor pool, during times of national or local need.