jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2013-12-02 00:00:00

Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances.

Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after the fee is due.

Prohibits the Secretary, in determining whether to grant such waiver or reduction, from considering anything other than the circumstances and assets of the owner and any affiliate of the owner.

Makes these provisions applicable to fees authorized to be assessed and collected for FY2014-FY2017.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2013-12-11 00:00:00

Protecting Consumer Access to Generic Drugs Act of 2013 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.
Topic: Health — Drug Industry
Subject: Armed forces and national security
Date: 2013-12-12 00:00:00

Servicemembers and Veterans Prescription Drug Safety Act of 2013 - Directs the Secretary of Defense (Secretary) and the Attorney General (AG) to jointly carry out a program under which a member of the Armed Forces (member), an individual receiving or entitled to military retired or retainer pay, a dependent-beneficiary of a member, or any person lawfully entitled to dispose of the property of any of such individuals may deliver a personal-use controlled substance (the prescription medication of a deceased individual) for disposal at a facility to be specified by the Secretary and the AG. Requires the Secretary and AG, in implementing the program, to develop appropriate guidelines and procedures to prevent the diversion, misuse, theft, or loss of such delivered substances.

Directs the Secretary and the AG to jointly carry out a program under which a veteran, a veteran's spouse or dependent, a person in receipt of medical services at a Department of Veterans Affairs (VA) facility, or any person lawfully entitled to dispose of the property of any of such individuals may deliver such a controlled substance for disposal at a specified facility, subject to the same guidelines and procedures with respect to such delivered substances.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-12-12 00:00:00

Personal Drug Importation Fairness Act of 2013 - Allows a drug to be imported into the United States, and re-imported into the United States by a person other than the drug's manufacturer, if the drug: (1) has the same active ingredients, route of administration, and strength as a prescription drug approved under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) regarding adulterated drugs; (2) may be lawfully marketed in, and is imported or reimported from, a qualified country; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer from the qualified country; (5) is shipped or imported in quantities that do not exceed a 90-day supply; and (6) is accompanied by a copy of a valid prescription.

Defines: (1) "drug" for purposes of this Act as excluding any controlled substance; and (2) "qualified country" to mean any of specified countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member-state of the European Union, or a country in the European Economic Area) that is determined by the Commissioner of Food and Drugs (FDA) to have standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards.
Topic: Health — Drug Industry
Subject: Health
Date: 2013-12-12 00:00:00

Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-01-09 00:00:00

Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to revise the Medicare durable medical equipment face-to-face encounter documentation requirement.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-03-11 00:00:00

Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 or DISARM Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to: (1) recognize the costs of new antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the new antimicrobial drugs, and (4) further reduce each of the average standardized payment amounts in a specified manner to maintain budget neutrality in a fiscal year beginning with FY2015.

(Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)

Directs the Comptroller General (GAO) to study the barriers that prevent the development of new antimicrobial drugs and develop recommendations for actions to be taken in order to overcome such barriers.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-03-11 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to cover pharmacist services.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-03-13 00:00:00

Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2014-03-24 00:00:00

Independent Innovator and Repurposing Act - Establishes procedures under which the term of an unexpired patent claiming a method of using a biological product shall be extended for five years from its original expiration date.

 Requires an application for such an extension to demonstrate that: (1) the patent was issued to an independent innovator, and (2) the owner of record is the independent innovator or a small business (with fewer than 500 employees and which is not affiliated with the holder of the marketing application approved under licensing requirements of the Public Health Service Act for the commercial marketing of such biological product) in which the independent innovator has an ownership interest.

Defines "independent innovator" as a person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved application for the commercial marketing of the product.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2014-03-26 00:00:00

Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-04-10 00:00:00

Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Declares that, except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device shall not be liable in any action under state or federal law for loss, damage, or injury arising out of, relating to, or resulting from: (1) the design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of such drugs or devices; or (2) their safety or effectiveness.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-05-06 00:00:00

Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct any prescription drug plan that has in its network one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs, to extend to any pharmacy located in that area, or among that population, the option to be an in-network pharmacy under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-06-17 00:00:00

Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.

Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is:

 intended to avoid serious adverse events or to treat a serious or life-threatening disease or condition, intended for safer or more effective treatment for either men or women than a currently available product approved to treat the general population or the other sex, and supported by results of clinical trials that include and separately examine outcomes for men and women. Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. Requires, in such cases, disaggregation of results according to sex. Provides guidelines for ensuring that sex differences are examined and analyzed.

Authorizes the Secretary of Health and Human Services (HHS) to support the continued operation and expansion of Special Centers of Research on Sex Differences.

Requires the Comptroller General (GAO) to provide to Congress updated versions of the reports entitled “Women's Health: NIH Has Increased Its Efforts To Include Women in Research” and “Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement,” including in the reports examination of:

 the inclusion of women, female animals, and female-derived cells and tissues in federally funded research over the past decade; federal reporting and analysis of subgroup information and the translation of differences to the medical community and patients; the effect of inclusion rates in research on the quality of women’s health care; and current efforts within government agencies to encourage the sharing of research data on sex differences and mechanisms to improve such sharing.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-06-19 00:00:00

Speeding Access to Already Approved Pharmaceuticals Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), under procedures for expedited approval of products to treat a serious or life-threatening disease or condition, to facilitate the development and expedite the review of new drugs or devices approved for marketing in the European Union.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-06-19 00:00:00

Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to require state licensure and a bid and surety bond of at least $50,000 for each area for bidding entities under the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-07-28 00:00:00

Everson Walls and Ron Springs Gift for Life Act of 2014 - Amends the Public Health Service Act to require the Administrator of the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

Requires the Center to: (1) advance the development, expansion, and evaluation of state organ donor registries; (2) facilitate timely exchange of donor information between state registries; and (3) maintain a clearinghouse for information on registry best practices.

Directs the Secretary of Health and Human Services (HHS) to award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. Requires a state registry that receives a grant to be accessible to individual donors and the Center.

Eliminates civil liability for a person taking an individual's organs as long as the person verified the individual's consent with a state organ donor registry.

Requires the Comptroller General (GAO) to study the feasibility of establishing a database to track the health effects of living organ donation.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-07-30 00:00:00

Living Donor Protection Act of 2014 - Prohibits discrimination based on a person's status as a living organ donor in the offering, issuance, cancellation, coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy.

Revises the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition that entitles a covered employee to leave under that Act.

Requires the Secretary of Health and Human Services (HHS) to update public service announcements, websites, and other media regarding live organ donation to educate the public on the benefits of live organ donation and access to insurance for living organ donors.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-07-31 00:00:00

Label and Transport Tissues Safely Act of 2014 or the LATTS Act of 2014 - Sets forth guidelines for handling human tissue specimens.

Prohibits sale of human tissue for research or education unless the seller has a non-transplant tissue bank license and each package of tissue is labeled with specified information.

Directs the Secretary of Health and Human Services (HHS) to establish a process for the approval, suspension, and revocation of non-transplant tissue bank licenses.

Prohibits falsely labeling packages of human tissue.

Allows HHS or any accrediting body authorized by HHS to enter and inspect any establishment engaged in the preparation of any human tissue specimen.

Requires HHS to recall any human tissue specimen that is an imminent or substantial hazard to public health.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-09-18 00:00:00

Protecting Our Kids' Medicine Act of 2014 - 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. Allows the Secretary of Health and Human Services (HHS) to waive the requirement for metric units if that requirement would not benefit public health.

Prohibits the sale of over-the-counter liquid drugs labeled for pediatric use that do not have a flow restrictor or another mechanism to reduce accidental ingestion.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-09-18 00:00:00

Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).

Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.

Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.

Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.

Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.

Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.

Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.

Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2014-11-20 00:00:00

Medicaid Generic Drug Price Fairness Act of 2014 - Amends title XIX (Medicaid) of the Social Security Act to extend to manufacturers of generic drugs the requirement that drug manufacturers in certain circumstances pay an additional rebate to state Medicaid programs.