jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-23 00:00:00

Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

This bill amends the Public Health Service Act to allow biosimilars to be marketed seven years after the reference brand name biological product is licensed. Currently, brand name biological products are provided a 12-year marketing exclusivity period.

This shortened marketing exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-06-28 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: Armed forces and national security
Date: 2016-07-12 00:00:00

Veterans Transplant Coverage Act of 2016

This bill authorizes the Department of Veterans Affairs (VA) to: (1) provide for an operation on a live donor to carry out a transplant procedure for an eligible veteran notwithstanding that the live donor may not be eligible for VA health care, and (2) provide for such an operation at a VA or a non-VA facility.

The VA shall furnish to such a donor any care or services that may be required before and after conducting with such procedure.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-07-13 00:00:00

Prostate Cancer Misdiagnosis Elimination Act of 2016

This bill specifies that, unless the physician ordering a DNA Specimen Provenance Assay (DSPA) test recommends otherwise, a DSPA test furnished with respect to a positive prostate cancer biopsy shall be deemed to be medically necessary for purposes of Medicare.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-07-14 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: 2016-07-14 00:00:00

Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act

This bill amends the Federal Food, Drug, and Cosmetic Act to expand requirements for assessing the use of medications in pediatric populations.

Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.

The FDA may require the sponsor of an approved medication that could be used to treat pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients.

The bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.

The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-07-18 00:00:00

Accurate Labeling of Menstrual Products Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require menstrual cups, menstrual pads, tampons, and therapeutic vaginal douche apparatuses to include a list of ingredients on the label.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2016-07-18 00:00:00

Menstrual Products Tax Credit Act of 2016 

This bill amends the Internal Revenue Code to provide taxpayers with a refundable tax credit of $120 for each individual: (1) for whom a taxpayer is allowed a deduction for a personal exemption, and (2) who uses menstrual products. The credit must be adjusted for inflation after 2017 and is limited to taxpayers with modified adjusted gross incomes below specified amounts.

The Department of Health and Human Services must determine and provide the Internal Revenue Service with a definition for "menstrual products," which must include tampons, pads, liners, cups, and similar products used by women with respect to menstruation.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2016-09-22 00:00:00

Contact Lens Consumer Health Protection Act of 2016

This bill amends the Fairness to Contact Lens Consumers Act to require contact lens sellers to provide a toll-free telephone number and email address that prescribers can use to ask questions about a seller's prescription verification request.

Under current law, a prescription is considered verified if the prescriber fails to communicate with the seller within eight business hours after receiving the seller-provided verification information. The bill requires the prescription to be considered unverified until the seller obtains affirmative confirmation of the accuracy of the prescription from the prescriber in cases where a prescriber communicates a question or concern about the accuracy or verification of the prescription to a seller through the toll-free telephone service or email address before the end of that eight-hour period.

The bill removes the Federal Trade Commission's authority to adjust the eight-hour period.

If a prescriber communicates a question or concern about the accuracy of a prescription before the deadline: (1) the seller shall not fill the prescription, and (2) the prescriber shall provide the seller with an accurate prescription.

Sellers must offer prescribers different communication methods that the prescribers may select as their preferred method for verification requests.

The bill allows a seller to alter a prescription only if: (1) a private label contact lens is included on the prescription and the same contact lens is manufactured by the same company and sold under multiple labels to individual providers; and (2) the seller fills the prescription with a contact lens of exactly the same material, design, and power as manufactured by that company under another label.

Sellers must maintain a database of the issuance and expiration dates of each prescription they receive. The bill prohibits advertisements representing that a contact lens prescription may be filled after the prescription expires.

Sellers violating certain prescriber verification requirements are subject to increased penalties of up to $40,000 per violation. Such requirements apply to all contact lens sales in the United States, notwithstanding where the seller is located.

The Centers for Disease Control and Prevention must examine the potentially adverse effects of seller violations on consumers.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-27 00:00:00

Closing Loopholes for Orphan Drugs Act

This bill amends the Public Health Service Act to revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-28 00:00:00

Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country.

For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.

The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective.

The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device.

Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process.

User fees apply to requests for reciprocal marketing approval.

The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-28 00:00:00

Protecting Our Kids' Medicine Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. The Food and Drug Administration may waive the requirement for metric units if that requirement would not benefit public health.

Over-the-counter liquid drugs labeled for pediatric use may not be sold without a flow restrictor or another mechanism to reduce accidental ingestion.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-09-28 00:00:00

Eliminate Price Increases Act of 2016 or the EPI Act

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the manufacturer of a brand name drug from authorizing or commencing the manufacturing, marketing, selling, or distributing of a generic version of the drug from the time the manufacturer is notified by a generic manufacturer that a generic drug application has been submitted until the expiration or forfeiture of the 180-day exclusivity period granted to the generic manufacturer.
Topic: Health — Drug Industry
Subject: Finance and financial sector
Date: 2016-09-28 00:00:00

Making Online Banking Initiation Legal and Easy Act of 2016 or the MOBILE Act of 2016

This bill authorizes a financial institution, with an individual's consent, to record personal information from a swipe or copy of an individual's driver's license or personal identification card and store the information electronically for the purpose of verifying the authenticity of the driver's license or identification card, verifying the identity of the individual, or complying with legal requirements.

Financial institutions must not sell, rent, transfer, or make the personal information available to another person, other than an affiliate.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-12-07 00:00:00

Patient Safety and Toxicology Modernization Act of 2016

This bill requires the Food and Drug Administration to issue and periodically update guidance on: (1) novel tools for testing the toxicology and efficacy of medications, and (2) three-dimensional human tissue models.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-11-16 00:00:00

Protecting Access to Diabetes Supplies Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to modify provisions relating to Medicare's competitive acquisition program (through which rates are set through a competitive bidding program rather than by an established fee schedule) with respect to diabetic testing strips. Specifically, the bill requires the Centers for Medicare & Medicaid Services (CMS) to:

 use specified data to determine whether a bid satisfies certain requirements related to volume of coverage with respect to such products, reject a bid if the bidder does not demonstrate its ability to furnish such products in a manner consistent with its bid, and establish a process to monitor the extent to which an entity continues to cover the product types included in its bid. CMS may terminate a contract if it determines that an entity, for reasons other than product discontinuation or market-wide shortage, fails to maintain ready access to such products included its bid.

In addition, the bill specifies that an entity furnishing such products to beneficiaries under the program: (1) must furnish to each beneficiary a brand of strips that is compatible with the beneficiary's home blood glucose monitor, (2) may not attempt to influence or incentivize a beneficiary to switch the brand of either type of product, and (3) must contact and receive a request from a beneficiary no more than 14 days prior to dispensing a refill to the beneficiary.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-12-01 00:00:00

Over-the-Counter Hearing Aid Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must provide reasonable assurances of safety and efficacy and describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.

State and local governments may not establish or continue in effect requirements for over-the-counter hearing aids that are not identical to FDA requirements.

Until the FDA updates its draft guidance regarding hearing aids, previous draft guidance is in effect.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-08 00:00:00

Safe and Affordable Drugs from Canada Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

 Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-08 00:00:00

Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act

This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to disqualify from being a “first applicant” an applicant submitting an abbreviated new drug application (for a generic drug) to the Food and Drug Administration that has entered into a specified agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a “first applicant” and is granted a 180-day marketing exclusivity period.

An agreement that disqualifies a generic drug applicant from being a first applicant is an agreement between the applicant and the holder of the application or a patent for the brand name drug whereby the applicant agrees not to seek approval or begin marketing the generic drug until the expiration of the exclusivity period awarded to another applicant.

“First applicant” is expanded to include applicants that did not submit an application on the first day an application was submitted. These first applicants must not have a patent infringement action pending against them and must not have been found to have infringed a patent. If an applicant that submitted an application on the first day an application was submitted has begun marketing the drug, a first applicant that submitted after the first day cannot begin marketing until 30 days after the first day applicant began marketing.

A first applicant that has entered into an agreement not to seek approval of an application or begin marketing at the earliest possible date cannot seek approval or begin marketing until the earlier of: (1) the latest date set forth in the agreement, or (2) 180 days after a first day applicant begins marketing.

An action for infringement of a drug patent must be brought within the 45-day period described in FFDCA.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-01-13 00:00:00

Medical Device Access and Innovation Protection Act

This bill amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-13 00:00:00

No Obamacare Mandate Act 

This bill repeals provisions of the Patient Protection and Affordable Care Act that impose: (1) an excise tax on medical devices, (2) a requirement that individuals obtain minimum essential health care coverage, and (3) a penalty on large employers who fail to offer health care coverage to their eligible employees.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-01-16 00:00:00

Promise for Antibiotics and Therapeutics for Health Act or the PATH Act

(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to encourage the health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service to report on antibacterial drug use, bacterial resistance to antibacterial drugs, and antibiotic stewardship programs.

HHS must: (1) annually publish information on antibacterial resistance and antibiotic stewardship; (2) disseminate guidance and materials regarding antibiotic stewardship; (3) continue working with state and local public health departments on antibacterial resistance programs; and (4) collect, evaluate, and publish data from the antibiotic stewardship activities of health care facilities.

(Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration (FDA), at the request of the drug sponsor, to approve an antibiotic drug for use in a limited population if the drug is intended to treat a serious infection in a limited population of patients with unmet medical needs. The FDA must issue guidance on demonstrating the safety and effectiveness of such drugs. The FDA's determination of the safety and effectiveness of such a drug must reflect the drug's use in the intended limited population.

The label and prescribing information of such a drug must indicate that the drug has been approved for use only in a limited population. The sponsor of such a drug must submit promotional materials for the drug to the FDA prior to dissemination. The FDA may remove these requirements for such a drug that is approved for broader use.

The FDA must report the number of requests for approval and the number of approvals of such drugs. The Government Accountability Office must report on activities to combat antimicrobial resistance and the limited population drug approval process established by this bill.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-12 00:00:00

Improving Regulatory Transparency for New Medical Therapies Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

(Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

(Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-02-12 00:00:00

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.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-03-04 00:00:00

Medicare Formulary Improvement Act of 2015

This bill amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require a sponsor offering a prescription drug plan (PDP) to include all covered part D drugs in the following categories and classes of drugs in the formulary: (1) anticonvulsants, (2) antidepressants, (3) antineoplastics, (4) antipsychotics, (5) antiretrovirals, and (6) immunosuppressants for the treatment of transplant rejection. Currently the Secretary of Health and Human Services is required to identify categories and classes of drugs of clinical concern.

The Secretary is required, however, to establish any exceptions that permit a PDP sponsor to exclude from its formulary a particular covered part D drug only through promulgation of a regulation, including a public notice and comment period.
Topic: Health — Drug Industry
Subject: Taxation
Date: 2015-03-24 00:00:00

This bill repeals the excise tax on medical devices and offsets the cost of such repeal by prohibiting: (1) major integrated oil companies from using the last-in, first-out (LIFO) accounting method; and (2) the issuance of new oil or natural gas production leases in the Gulf of Mexico under the Outer Continental Shelf Lands Act to any person who does not renegotiate their existing leases to generate payment of royalties from such leases.