jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-13 00:00:00

Beating Infections through Research and Development Act of 2007 - Sets forth circumstances under which the term of a patent may be extended for qualified infectious disease products.Requires the Secretary of Health and Human Services to designate qualified infectious disease products as fast-track products for approval.Amends the Public Health Service Act to require the Director of the National Institute of Allergy and Infectious Diseases to expand and intensify efforts to assist small manufacturers to conduct end-stage clinical trials on qualified infectious disease products.Amends the Internal Revenue Code to establish an infectious disease research credit and a qualified infectious disease products manufacturing facilities investment credit.Establishes the Commission on Infectious Diseases Product Development to identify drug-resistant infectious pathogens that are a significant threat to public health and make recommendations to the Secretary on how best to address such pathogens.Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary, acting through the Commissioner of Food and Drugs, to issue guidelines for the conduct of clinical trials with respect to antibiotic drugs.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-14 00:00:00

Universal Health Act of 2007: Repeal of the Late Enrollment Penalty in Medicare Part D - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to repeal the Medicare prescription drug benefit late enrollment penalty.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-19 00:00:00

Enhancing Drug Safety and Innovation Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for approval for a new drug or biological product to include a proposed risk evaluation and mitigation strategy, which must include: (1) labeling for the drug for use by health care providers; (2) submission of reports for the drug; and (3) a statement as to whether the analysis and surveillance are sufficient to assess the serious risks of the drug. Establishes a Drug Safety Oversight Board. Requires the Secretary of Health and Human Services to establish the Reagan-Udall Institute for Applied Biomedical Research as a nonprofit corporation to advance the Critical Path Initiative to modernize medical product development, accelerate innovation, and enhance product safety. Requires the Institute to have a Board of Directors. Allows the Board to coordinate and collaborate with other entities to conduct research, education, and outreach and to modernize the sciences of developing, manufacturing, and evaluating the safety and effectiveness of diagnostics, devices, biologics, and drugs. Amends the Public Health Service Act to require the Secretary, acting through the Director of the National Institutes of Health (NIH), to establish and administer a clinical trial registry database and a clinical trial results database. Requires a responsible part for a clinical trial to submit clinical trial information to the Director for inclusion in the databases. Requires each individual under consideration for a term on an advisory committee providing advice or recommendations to the Secretary regarding FDA activities to disclose industry financial interests.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-04-17 00:00:00

Protecting Consumer Access to Generic Drugs Act of 2007 - 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 provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems 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: Health
Date: 2007-04-19 00:00:00

Patient Protection and Innovative Biologic Medicines Act of 2007 - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.Allows the Secretary of Health and Human Services to approve such a similar biological product: (1) only if the applicant demonstrates that the product conforms to the applicable final product-class specific guidance and the Secretary concludes the product is safe, pure, and potent; (2) only for indications for which the reference product is approved; and (3) to be effective only after at least 14 years have elapsed since the reference product was approved or licensed.Prohibits the Secretary from designating a similar biological product as therapeutically equivalent to the reference product.Prohibits the Secretary from approving a product that is claimed to be similar to or the same as a reference product under any other provision of law.Authorizes any person to request issuance of product-class specific guidance applicable to a qualified biological product and its class.Requires the Secretary to establish a Similar Biological Products Advisory Committee.Sets forth provisions governing the naming of biotechnology-derived therapeutic protein and other biological products. Amends the Federal Food, Drug, and Cosmetic Act to deem a biotechnology-derived therapeutic protein to be misbranded if its labeling fails to meet the requirements of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-04-19 00:00:00

Vaccine Safety and Public Confidence Assurance Act of 2007 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services. Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-01 00:00:00

Mercury in Dental Fillings Disclosure and Prohibition Act - Amends the Federal Food, Drug, and Cosmetic Act to deem any drug or device to be adulterated if it contains mercury intended for use in a dental filling, effective January 1, 2009.Deems a device that contains mercury intended for use in a dental filling to be misbranded, effective December 31, 2007, unless it bears a specified warning label that it: (1) contains mercury, a highly toxic element; (2) should not be administered to children under age 18 or to pregnant or lactating women; and (3) poses health risks.
Topic: Health — Drug Industry
Subject: Armed forces and national security
Date: 2007-05-03 00:00:00

Amputee Veteran Assistance Act - Directs the Secretary of Veterans Affairs to ensure that all Department of Veterans Affairs (VA) orthotic-prosthetic laboratories and clinics are certified by either the American Board for Certification in Orthotics and Prosthetics or the Board of Orthotics and Prosthetic Certification. Requires the Secretary to contract with a non-VA entity for the service and repair of prosthetic devices for a veteran if: (1) the Secretary determines that VA facilities are unable to perform such service or repair due to a lack of technology or any other reason; or (2) the veteran needing such service or repair resides more than 55 miles from the nearest VA facility capable of furnishing such service or repair. Directs the Secretary to: (1) develop and carry out a plan to inform disabled veterans at least twice a year of technological advances in the field of prosthetics; (2) review all VA orthotic-prosthetic laboratories and clinics to ensure that the VA is capable of servicing and repairing the most technologically advanced prosthetic devices; and (3) review VA prosthetists and orthotists to determine the level and kinds of education required to ensure their qualification to provide the most technologically advanced prosthetic devices.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-10 00:00:00

Food and Drug Administration Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, and animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. Allows the Secretary to require manufacturers of approved drugs to conduct studies of an identified significant safety issue with the drug. Deems a drug to be misbranded if it does not meet the Secretary's requirements, including requirements for labeling and conducting postmarket studies. Requires the Secretary to follow the interpretation that the FDA used in 1999 that the FFDCA and Public Health Service Act establish minimal standards but do not preclude additional state requirements. Requires the Secretary to cease intervening in product liability civil actions to argue another interpretation. Sets forth procedures for advisory committee meetings to ensure that the committee is fairly balanced. Prohibits any exemptions from being granted to advisory committee members from rules prohibiting members from having a personal financial interest in the outcome. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.
Topic: Health — Drug Industry
Subject: Armed forces and national security
Date: 2007-05-15 00:00:00

TRICARE Mail-Order Pharmacy Pilot Program Act - Directs the Secretary of Defense to conduct a two-year pilot program to educate and motivate beneficiaries to voluntarily increase their use of the TRICARE (a Department of Defense [DOD] managed care program) mail-order pharmacy. Requires the program to include at least 2,000 eligible beneficiaries in each TRICARE region, of whom at least 1,000 in each region shall be enrolled in Medicare Part B.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-24 00:00:00

FDA Scientific Fairness for Women Act - Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Women's Health within the Office of the Commissioner of the Food and Drug Administration (FDA). Deems a breast implant to be a class III medical device. Requires premarket approval of breast implants irrespective of whether the implant has been cleared for commercial distribution in interstate commerce before the date of enactment of this Act.Prohibits the Secretary of Health and Human Services from finding that a reasonable assurance of safety has been shown for an application for premarket approval for a a breast implant unless the applicant involved has demonstrated its safety for the life of the implant. Deems an already approved breast implant to be unsafe under the conditions of use prescribed, recommended, or suggested in the labeling. Requires the Secretary to: (1) issue appropriate, voluntary guidance for clinical care, removal, and replacement for breast implants; (2) require such guidance to be clearly expressed in the labeling and all marketing materials; and (3) require dissemination of such guidance to patients who have already received the implant. Requires the Breast Implant Advisory Panel of the General and Plastic Surgery Advisory Committee to review the results and quality of the research on saline breast implants and silicone gel implants.Requires the Secretary to study the ionization and levels of platinum in silicone breast implants.Requires the Secretary, acting through the Commissioner of Food and Drugs, to convene a scientific workshop to review and evaluate current scientific data on the use of emergency contraception by females of childbearing potential under the age of 18.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-05 00:00:00

Human Cloning Prohibition Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make it unlawful for any person, including a governmental entity, to: (1) perform or attempt to perform human cloning; or (2) ship, mail, transport, or receive the product of human somatic cell nuclear transfer technology knowing that such product is for the purpose of human cloning. Sets forth criminal and civil penalties for violations of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-06 00:00:00

Safe and Effective Drug Development Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, to enter into Critical Path Public-Private Partnerships with eligible entities to implement the Critical Path Initiative of the Food and Drug Administration (FDA) by developing research, education, and outreach projects to foster medical product innovation, accelerate medical product development, and enhance medical product safety. Prohibits such an entity from accepting any funding for the technical programs of a Critical Path Public-Private Partnership from any individual or organization that manufactures, distributes, or sells any FDA-regulated product. Establishes an exception for accepting funds from a consortium of companies whose products are FDA-regulated if the Secretary determines that such acceptance would not result in any conflict of interest and issues a waiver.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-06 00:00:00

Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription.Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment.Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers.Sets forth civil penalties and establishes a a private cause of action for violations of this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-07 00:00:00

340B Program Improvement and Integrity Act of 2007 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. Prohibits enrolled hospitals from obtaining covered outpatient drugs through a group purchasing arrangement. Requires the Secretary of Health and Human Services to establish reasonable exceptions to such requirements, including for drugs unavailable through the program and to facilitate generic substitution when a generic covered drug is available at a lower price. Expands the program to include a drug used in connection with an inpatient or outpatient service by enrolled hospitals. (Currently, only outpatient drugs are covered under the program.)Requires hospitals enrolled in the 340B drug discount program to provide to each state a credit on the estimated annual costs to such hospital of single source and innovator multiple source drugs and noninnovator multiple source drugs provided to Medicaid recipients for inpatient use. Sets forth a formula for calculating the credit. Allows a hospital to avoid paying such credits under certain circumstances. Requires the Secretary to: (1) carry out activities to improve compliance by manufacturers and covered entities with the requirements of the drug discount program; and (2) establish an administrative process for resolving claims by covered entities and manufacturers of violations of such requirements.Requires manufacturers to offer each covered entity covered drugs for purchase at or below the applicable ceiling price if such a drug is made available to any other purchaser at any price.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-14 00:00:00

Reducing Fraudulent and Imitation Drugs Act of 2007 - Directs the Secretary of Health and Human Services to require prescription drug packaging to incorporate: (1) radio frequency tagging technology or similar trace and track technologies; (2) tamper-indicating technologies; and (3) blister security packaging when possible. Directs the Secretary to: (1) require that such technologies be used exclusively to authenticate the pedigree of prescription drugs; and (2) prohibit such technologies from containing or transmitting any identifying information of a health care practitioner or consumer, or any advertisement or information about indications or off-label uses. Requires the Secretary to encourage prescription drug manufacturers and distributors to incorporate: (1) overt optically variable counterfeit-resistant technologies into packaging; and (2) required prescription drug packaging technologies into multiple elements of the physical packaging of the drugs. Requires prescription drug shipments to include a label on the shipping container that incorporates packaging technologies. Deems a prescription drug to be misbranded if the packaging or labeling of the drug is in violation of a requirement or prohibition of this Act. Requires the Secretary to publish the National Specified List of Susceptible Prescription Drugs, consisting of not less than 30 of the most frequently counterfeited prescription drugs in the United States.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2007-06-14 00:00:00

DSHEA Full Implementation and Enforcement Act of 2007 - Authorizes and makes appropriations to: (1) carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and all applicable regulatory requirements for dietary supplements under the Federal Food, Drug, and Cosmetic Act; and (2) expand research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Food and Drug Administration (FDA) to fully and appropriately use such funds to regulate dietary supplements. Directs the Secretary of Health and Human Services to report to Congress on the implementation and enforcement of DSHEA.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-06-14 00:00:00

Safe Tissue Act - Requires the Food and Drug Administration (FDA) to inspect, at least once every two years, each establishment that engages in the manufacture of human cells, tissues, and cellular and tissue-based products. Allows the Secretary of Health and Human Services to establish a user fee to fund such inspections. Requires the FDA to conduct periodic audits of all documentation submitted by each such establishment to determine compliance with all applicable requirements, including requirements related to ensuring: (1) that human cells, tissues, or cellular or tissue-based products are obtained legally; (2) that donor eligibility and donor medical history interviews are based on accurate information that was not provided or obtained in a fraudulent manner; and (3) current good tissue practice. Requires the Secretary to publish a model form containing minimum requirements for establishments to use in obtaining consent from a potential donor of human cells, tissues, or cellular or tissue-based products. Sets forth penalties for failing to comply with model form requirements or for knowingly using fraudulent information. Directs the Secretary to: (1) accredit establishments and the personnel of such establishments who participate in the recovery, processing, storage, labeling, packaging, or distribution of human cells, tissues, or cellular or tissue-based products; and (2) define "reasonable payments" that are associated with donation of human tissue and tissue-based products for purposes of the National Organ Transplant Act.