jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to financial interests of Food and Drug Administration (FDA) advisory committee members to require the Secretary of Health and Human Services (HHS) to ensure that individual appointments to advisory committees are made to promote scientific and technical expertise while at the same time minimizing any potential conflicts of interest. Requires the Secretary to consider, with respect to any financial interest constituting a potential conflict of interest, the type, nature, and magnitude of the financial interest. Declares that no specific factor shall be dispositive in the Secretary's evaluation of a particular financial interest. Repeals the prohibition specifically applicable to FDA that prevents a member of an advisory committee from participating with respect to a particular matter if such individual or an immediate family member of such individual has a financial interest that could be affected by the advice given to the Secretary.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Modernizing Laboratory Test Standards for Patients Act of 2011 - Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS) to establish a single publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests, which shall include information on the purpose of each test, the claimed use or uses of each test, and information regarding the analytical validity of each test. Requires notification to the Secretary: (1) before marketing such a test, (2) after any significant modification of such a test, or (3) if the evidence of clinical validity is inadequate to support one or more of the claimed uses. Requires the Secretary, within 90 days of receiving such notification, to determine whether the notification demonstrates clinical validity. Deems the Secretary to have authorized marketing of the test if no response is received within 90 days. Gives the Secretary authority to order a laboratory or test-offering entity to cease offering or marketing a test if the information submitted in notifications does not demonstrate the clinical validity of the claimed uses and the test poses a risk of immediate harm to the public health. Sets forth requirements for: (1) registration of a test-offering entity, (2) information that must be included in disseminated materials and advertising, (3) notice to the Secretary if a test may have caused or contributed to a death or serious bodily injury, and (4) sanctions for violations of this Act. Requires the Secretary to administer this section solely through the Centers for Medicare and Medicaid Services (CMS).
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Patients Come First Act of 2011 - Directs the Secretary of Health and Human Services (HHS): (1) within 90 days after enactment of this Act, to establish the schedule required under the Federal Food, Drug, and Cosmetic Act for the promulgation of regulations requiring premarket approval for medical devices required to remain in class III; and (2) not later than one year after the schedule is established, to issue a final regulation for each such device. Directs the Secretary to: (1) establish a program to assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices, (2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner, (3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall, and (4) document the basis for each Food and Drug Administration (FDA) termination of a device recall.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Premarket Predictability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to assign a tracking number to a medical device upon submission of: (1) an application for an exemption of a device for investigational use, (2) a request to classify a device, or (3) a premarket report or notification related to a device. Requires the Secretary to use the tracking number to record interactions between the Secretary and applicant with respect to the device. Directs the Secretary to: (1) assign a reviewer with prior review experience with the type of of device or technology involved or other relevant expertise to review an application for an exemption of a device for investigational use, and (2) evaluate whether the investigational study can be conducted ethically with reasonable risk in determining whether to grant an exemption for investigational use. Prohibits the Secretary from disapproving an application because the investigation does not or may not meet any requirement relating to the approval or clearance of a device because the Secretary believes that a different clinical testing design or plan could produce data more relevant to an approval or clearance decision. Revises the procedures relating to submission of an application to investigate a class II or a class III device, which may include a plan for determining whether the device is substantially equivalent to or is at least as safe and effective as a legally marketed device that is not subject to premarket approval requirements. Sets forth requirements for the Secretary to meet in determining the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval. Requires the Secretary to document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures. Requires the Secretary to regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Humanitarian Device Reform Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to repeal provisions that prohibit the sale of a medical device approved under the humanitarian device exemption (available for devices designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States) for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. Adds provisions clarifying that the 4,000 individuals that must be affected in the United States under the humanitarian device exemption is 4,000 individuals per year so affected.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-14 00:00:00

Keeping America Competitive Through Harmonization Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to enter into agreements with listed countries (countries eligible for exports of drugs or biological products that have not been approved under certain circumstances) regarding methods and approaches to harmonizing regulatory requirements for premarket review, inspections, and common international labeling symbols. Requires the Secretary to report on the agreements entered under this Act and to itemize the methods and approaches that have been harmonized pursuant to this Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-11-03 00:00:00

Affordable Medicines Utilization Act of 2011 - Amends title XIX (Medicaid) of the Social Security Act (SSA), with respect to FY2012-FY2014, to require an increase in the quarterly Medicaid payment to a state by 50% of the generic drug utilization savings amount if the state's generic substitution rate for the most recent preceding fiscal year for which data is available is greater than its rate for the most recent second preceding fiscal year for which data is available. Directs the Secretary of Health and Human Services (HHS) to determine the state's generic substitution rate for such fiscal years. Defines "generic substitution rate" as the share of all drug units for which Medicaid payment is made to a state for the 20 most widely prescribed multiple source drugs under the state program that have a specific National Drug Code. Directs the Secretary to provide for payments to eligible states for implementation of programs to achieve reductions in expenditures under Medicaid or under SSA title XVIII (Medicare) (innovative health care savings program).
Topic: Health — Drug Industry
Subject: Health
Date: 2011-11-04 00:00:00

Dietary Supplement Protection Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to exempt dietary supplements containing a dietary ingredient marketed before January 1, 2007 (currently, October 15, 1994) from the requirement to provide premarket evidence of safety for the dietary ingredient to the Secretary of Health and Human Services (HHS).
Topic: Health — Drug Industry
Subject: Health
Date: 2011-11-29 00:00:00

Everson Walls and Ron Springs Gift for Life Act of 2011 - Amends the Public Health Service Act to direct the Secretary of Health and Human Services (HHS), acting through the Administrator of the Health Resources and Services Administration, to establish a National Organ and Tissue Donor Registry Resource Center, which shall: (1) advance the development, expansion, and evaluation of state organ and tissue donor registries; (2) facilitate timely access to, and the exchange of accurate donor information between, such registries; (3) ensure that registries funded through this Act comply with applicable requirements; (4) provide technical assistance to states for such registries; and (5) maintain a registry information clearinghouse to collect, synthesize, and disseminate best practices information. Requires the Secretary to award grants or cooperative agreements to states for the development, enhancement, expansion, and evaluation of organ and tissue donor registries. Sets forth requirements for registries, including that such registries: (1) allow a donor to include a statement or symbol that the donor has made, amended, or revoked an anatomical gift; (2) allow organ procurement organizations to access that information, at or near the donor's death; and (3) bar the use or disclosure of personally identifiable information for any other purpose without the donor's consent. Prohibits any person from being held civilly liable for having harvested or taken an individual's organs or tissues without obtaining valid consent if: (1) such person verified that the individual was registered as a donor with a state organ and tissue donor registry, and (2) the harvesting or taking was within the scope of the consent given for purposes of such registration. Directs the Comptroller General to report on the feasibility of establishing a living donor database to track health effects for donors associated with living organ donation.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-12-20 00:00:00

Unlocking Lifesaving Treatments for Rare-Diseases Act or ULTRA - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to approve an application for a drug as a fast track product using a surrogate endpoint, based on the existence of reasonable scientific data that support and qualify the relevance of such endpoint to the disease state and treatment, if the Secretary: (1) makes an initial determination that the drug is eligible for approval as a drug designated for a rare disease or condition (orphan drug) and as a fast track product, and (2) determines that the drug is a treatment for a disease or condition that affects a small number of patients in the United States. Prohibits the Secretary from requiring clinical treatment or other historical clinical data on such endpoint as a prerequisite to assessment of that endpoint if such scientific data is not available. Directs the Secretary to issue guidance providing details and options for qualifying surrogate endpoints without clinical data, taking into account and balancing: (1) the unmet need served by the drug and the adverse effects of the rare disease or condition on quality and length of life, (2) the very low likelihood that clinical data would exist or that clinical studies would be completed to support a surrogate endpoint due to the small size of the U.S. patient population and other significant barriers inherent in performing such studies due to the prevalence of the disease or related factors, and (3) the full scope of available basic scientific data and information that the Secretary deems reasonably predictive of a clinical benefit in the absence of clinical data.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-01-31 00:00:00

Drug Shortage Prevention Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to: (1) define the term "critical drug" based on the medical necessity and vulnerability to shortage of a drug or biological product; (2) establish, make publicly available, and update semiannually a list identifying each critical drug and its manufacturers; (3) promptly remove from such list any drug or biological product that no longer meets such definition; and (4) establish, make publicly available, and update monthly a list identifying each critical drug that is in a critical drug shortage in the United States, the severity of and reason for the shortage, alternate therapies and regions particularly affected, and an estimated date by which the necessary quantities of the drug will begin reaching providers. Allows manufacturers to request removal of a drug from such lists on the basis that it doesn't meet the definition of "critical drug" or is not in a critical drug shortage. Directs the Secretary to: (1) establish a proactive system for giving notice to the public concerning modifications to the critical drug shortage list, (2) establish a system for giving notice of any imminent critical drug shortage to critical drug manufacturers and wholesale distributors and manufacturers of alternative therapies, (3) notify the Attorney General of any critical drug shortage, (4) study the feasibility of creating a national contingency plan addressing critical drug shortages, (5) expedite the review of applications for approval of critical drugs and requests by sponsors of such drugs to approve manufacturing process changes or alternate suppliers of active ingredients, and (6) improve the process for regulating critical drugs. Express the sense of Congress that the Food and Drug Administration (FDA) should increase the number of personnel responsible for identifying and addressing critical drug shortages. Amends the Controlled Substances Act to direct the Attorney General to increase a quota as appropriate for a drug listed in a critical drug shortage that is or contains a controlled substance.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-01-31 00:00:00

Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order. Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor. Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device. Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal. Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device. Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-08 00:00:00

Amends the Pediatric Medical Device Safety and Improvement Act to authorize appropriations through FY2017 for grants for demonstration projects to promote pediatric device development. Amends the Federal Food, Drug, and Cosmetic Act to allow an exception to the prohibition against selling a device that is designed to treat or diagnose a disease or condition which affects fewer than 4,000 individuals in the United States and that is exempt from the effectiveness requirements of such Act for an amount that exceeds the costs of research and development, fabrication, and distribution of the device where the request for such exemption is submitted on or before October 1, 2017 (currently, October 1, 2012). Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) entitled "Medical Devices; Pediatric Uses of Devices; Requirement for Submission of Information on Pediatric Subpopulations That Suffer From a Disease or Condition That a Device Is Intended to Treat, Diagnose, or Cure" to take effect on January 1, 2013, unless such Commissioner issues the final rule before such date.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-08 00:00:00

Religious Liberty Protection Act of 2012 - Prohibits the Secretary of Health and Human Services (HHS) from implementing or enforcing any provision of the interim final rule published on July 19, 2010, related to the coverage of preventive health services under the Patient Protection and Affordable Care Act (PPACA) or any amendment to such rule insofar as such provision or amendment require any individual or entity to provide coverage of sterilization or contraceptive services to which the individual or entity is opposed on the basis of religious belief. Amends PPACA to declare that a health plan shall not be considered to have failed to provide essential health benefits, to fail to be a qualified health plan, or to fail to fulfill any other requirements on the basis that the plan does not provide or pay for coverage of sterilization or contraceptive services because: (1) providing or paying for such coverage is contrary to the religious or moral beliefs of the sponsor, issuer, or other entity offering the plan; or (2) such coverage, in the case of individual coverage, is contrary to the religious or moral beliefs of the purchaser or beneficiary of the coverage.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-08 00:00:00

Generic Drug and Biosimilar User Fee Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), beginning FY2013, to assess and collect the following fees related to generic drugs: (1) a one-time backlog fee for abbreviated new drug applications pending on October 1, 2012; (2) a drug master file fee; (3) an abbreviated new drug application and prior approval supplement filing fee, as well as an additional fee for active pharmaceutical ingredient information not included by reference to Type II active pharmaceutical ingredient drug master file; and (4) a generic drug facility fee and active pharmaceutical ingredient facility fee. Provides that submission of an application for a positron emission tomography drug or active pharmaceutical ingredient for a positron emission tomography drug shall not require the payment of any fee. Sets forth provisions relating to fee amounts and due dates. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified safety, access, and transparency goals with respect to generic drugs. Biosimilar User Fee Act of 2012 - Directs the Secretary, beginning FY2013, to assess and collect the following fees related to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar biological development fee, an annual biosimilar biological product development fee, and a reactivation fee; (2) a biosimilar biological product application and supplement fee; (3) a biosimilar biological product establishment fee; and (4) a biosimilar biological product fee. Waives the above fees for the first biosimilar biological product application of a small business. Terminates the above provisions on October 1, 2017. Requires the Secretary to report to Congress on the progress of the Food and Drug Administration (FDA) in achieving specified goals with respect to biosimilar biological products.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2012-02-09 00:00:00

Protecting Consumer Access to Generic Drugs Act of 2012 - 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: Health
Date: 2012-02-16 00:00:00

Science and Technology Regulatory Relief Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a state or political subdivision from conducting or requiring an inspection of a factory, warehouse, or establishment in which a drug or device is manufactured, processed, packed, or held by a manufacturer or wholesale distributor for introduction into interstate commerce, or after such introduction, for purposes of verifying compliance with such Act, Public Health Service Act requirements regarding the regulation of biological products, or any similar requirements established pursuant to state law. Makes exceptions for such an inspection if: (1) the state or subdivision makes a determination that a drug or device presents a threat of serious adverse health consequences or death; (2) the Secretary of Health and Human Services (HHS) orders a recall of a drug, biological product, or device manufactured, processed, packed, or held at the factory, warehouse, or establishment; or (3) the Secretary requests or authorizes the state to conduct or require the inspection.