jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2011-06-15 00:00:00

Preservation of Antibiotics for Medical Treatment Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met. Directs specified congressional committees to hold hearings on the implementation of such a withdrawal of approval.
Topic: Health — Drug Industry
Subject: Agriculture and food
Date: 2011-06-30 00:00:00

Dietary Supplement Labeling Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days. Requires the Secretary of Health and Human Services (HHS) to compile a list of dietary supplement ingredients and proprietary blends of ingredients that the Secretary determines could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women. Directs the Secretary to enter into a contract with the Institute of Medicine to: (1) evaluate the safety of dietary supplement ingredients and proprietary blends of ingredients that the Institute determines could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups; and (2) identify proprietary blends of ingredients for which the weight per serving of the ingredient in the proprietary blend should be provided on the label. Deems a dietary supplement that does not meet the requirements of this Act to be misbranded. Requires the Secretary to establish a definition for the term “conventional food” for purposes of the FFDCA, taking in account foods marketed as dietary supplements.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-09-20 00:00:00

Drug Safety and Accountability Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug, (2) each active and inactive ingredient of each drug, and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health. Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug. Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act. Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas. Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation. Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health. Sets forth whistleblower protection provisions.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-13 00:00:00

Medical Device Regulatory Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS), in determining the least burdensome appropriate means of evaluating device effectiveness, to: (1) not request information unrelated or irrelevant to demonstration of reasonable assurance of device safety and effectiveness; (2) consider alternative approaches to evaluating device safety and effectiveness; (3) use all reasonable mechanisms to lessen review times and render regulatory decisions; (4) determine whether pre-clinical data can meet the statutory threshold for approval; and (5) utilize, whenever practicable, alternatives to randomized, controlled clinical trials if clinical data are needed. Requires the Secretary, in determining the least burdensome means of determining substantial equivalence, to: (1) focus on whether the device has the same intended use as the predicate device and is as safe and effective as a legally marketed device, (2) not request or accept information unrelated or irrelevant to the substantial equivalence evaluation, (3) review the labeling of the device to assess the intended use of the device and not evaluate issues that do not present a major impact on the intended use as set forth in the labeling, (4) consider alternative approaches to evaluating substantial equivalence, and (5) use all reasonable mechanisms to lessen review times and render regulatory decisions. Repeals conflict-of-interest provisions that are specific to the Food and Drug Administration (FDA) and provides for the continued applicability of conflict-of-interest provisions otherwise applicable to advisory committees, federal employees, and special government employees. Requires the Secretary to contract with an eligible entity for a review of the management and regulatory processes at the Center for Devices and Radiological Health.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-10-20 00:00:00

Freedom to Breathe Act of 2011 - Nullifies the final rule entitled "Use of Ozone-Depleting Substances; Removal of Essential-Use Designation (Epinephrine)." Prohibits the Secretary of Health and Human Services (HHS) from reissuing such rule in substantially the same form or issuing a new rule that prohibits the production and distribution of oral pressurized metered-dose inhalers because such inhalers may emit greenhouse gas emissions, unless the reissued or new rule is specifically authorized by a law enacted after this Act's enactment.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-11-16 00:00:00

Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patentholder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant). Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing. Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug. Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement. Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-12-05 00:00:00

Novel Device Regulatory Relief Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to allow a person to request the Secretary of Health and Human Services (HHS) to classify a device regardless of whether the person has received written notice of classification into class III (premarket approval) under the initial classification procedures applicable to devices introduced or delivered for introduction into interstate commerce before May 28, 1976. Allows a person that is required to submit a report preceding the introduction of device into interstate commerce, and determines that there is no legally marketed device upon which to base a determination of substantial equivalence, to request an initial classification of the device and to recommend to the Secretary a classification. Allows the Secretary to decline to undertake such a request when the Secretary identifies a legally marketed device that would permit a determination of substantial equivalence.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-12-14 00:00:00

Medical Device Patient Safety Act - Directs the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs, to establish a program to enhance the oversight by the Food and Drug Administration (FDA) of medical device recalls. Requires the program to routinely and systematically assess: (1) information submitted to the Secretary pursuant to a device recall order issued under the Federal Food, Drug, and Cosmetic Act (FDCA); and (2) information required to be reported by a device manufacturer to the Secretary regarding the manufacturer's correction or removal of a device. Requires the Secretary to use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices. Requires such program to be designed to identify such things as recall trends, the causes of recalls, and the time to complete a recall. Requires the Secretary to develop explicit criteria for assessing whether a person subject to a recall order or the manufacturer's reporting requirement has performed an effective correction or removal action. Requires the Secretary to document and publish specified information concerning termination of a recall. Permits the Secretary to conditionally clear for introduction into interstate commerce for commercial distribution a medical device intended for human use if such medical device is cleared pursuant to specified FDCA reporting requirements concerning the introduction of devices into interstate commerce. Permits the Secretary, as part of such conditional clearance, to: (1) impose specified restrictions on the sale, distribution, or use of the device; (2) require specified labeling for the device; and (3) require the maintenance of specified records that enable the FDA to track the device and determine the safety and effectiveness of the device.
Topic: Health — Drug Industry
Subject: Health
Date: 2011-12-15 00:00:00

Online Pharmacy Safety Act - Amends the the Federal Food, Drug, and Cosmetic Act to permit the dispensing of drugs only pursuant to a "valid prescription" and requires such a prescription to include at least one in-person medical evaluation of the patient by a licensed health care practitioner. Requires the the Secretary of Health and Human Services (HHS) to establish a Registry of Legitimate Online Pharmacy Websites for the purpose of educating consumers and promoting public health and safety. Allows only those pharmacies designated as legitimate by the Secretary on the site. Sets forth criteria for determining the legitimacy of a pharmacy. Requires the Secretary to: (1) engage in a campaign to educate consumers on the availability and use of the Registry to promote public health and safety; and (2) make consumer education materials available, on the Food and Drug Administration's (FDA) website, regarding how to safely purchase drugs over the Internet.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-02 00:00:00

Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs the Secretary of Health and Human Services (HHS), within 120 days of enactment of this Act, to establish the schedule for the promulgation of a regulation requiring premarket approval for a medical device that the Secretary requires to remain in class III. Directs the Secretary, within 18 months, to: (1) issue a final regulation for each device that the Secretary requires to remain in class III, and (2) establish the required special controls for each device that is classified into class II pursuant to a determination revising such devise's classification. Amends the Federal Food, Drug, and Cosmetic Act to permit a person to: (1) submit a request for initial classification of a device that has not previously been classified under such Act if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination; and (2) recommend to the Secretary a classification for the device and include in the request an initial draft proposal for applicable special and general controls that are necessary to provide reasonable assurance of safety and effectiveness. Permits the Secretary to decline to undertake a classification request if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence or if the Secretary determines that the device submitted is not of low-moderate risk.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-17 00:00:00

Medicare Orthotics and Prosthetics Improvement Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act, for application of quality standards for certain accredited suppliers of prosthetic devices, orthotics, and certain prosthetics, to require the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization with respect to such suppliers only if that organization is the American Board for Certification in Orthotics and Prosthetics, Inc. or the Board for Orthotist/ Prosthetist Certification (or a program with essentially equivalent accreditation and approval standards). Exempts from such standards any suppliers who: (1) are physicians, occupational therapists, or physical therapists licensed or otherwise regulated by the state in which they practice; and (2) receive Medicare payments. Applies to custom-fitted orthotics the special payment rules for certain prosthetics and custom-fabricated orthotics. Exempts from such rules off-the-shelf orthotics included in a competitive acquisition program. Modifies the Medicare payment rules for orthotics and prosthetics to account for practitioner qualifications and complexity of care. Directs the Secretary to report to Congress on: (1) HHS steps taken to ensure that the state licensure and accreditation requirements are enforced, and (2) the effects of requirements of this Act on the occurrence of Medicare fraud and abuse with respect to orthotics and prosthetics. Requires the Secretary, acting through the Chief Actuary of the Centers for Medicare and Medicaid Services, to submit to Congress a projection on the effect on cumulative federal spending under Medicare part B (Supplementary Medical Insurance) for 2013-2017 that will result from implementation of this Act. Requires the Secretary, if the Chief Actuary projects that implementation of this Act will not result in a cumulative spending reduction of at least $250 million for 2013-2017, to issue an interim final regulation to strengthen the licensure, accreditation, and quality standards applicable to orthotics and prosthetics suppliers in order to produce such a cumulative reduction by the end of 2017. Exempts from such regulation any qualified physical therapist or qualified occupational therapist.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-03-15 00:00:00

Ensuring Safe Medical Devices for Patients - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend procedures under such Act to expand the postmarket risk identification and analysis system to include and apply to devices in a comparable manner as such system includes and applies to drugs; and (2) ensure that such amended procedures give priority for inclusion in the system to class III and class II devices that are implantable, life-supporting, or life-sustaining or that pose significant risk to users. Directs the Secretary to: (1) issue final regulations establishing a unique device identification system for medical devices by December 31, 2012, and (2) implement the system not later than one year after the final regulations are issued.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-03-26 00:00:00

Advancing Breakthrough Therapies for Patients Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS), at the request of the sponsor of a drug, to expedite the drug's development and review if: (1) it is intended, either alone or in combination, to treat a serious life-threatening disease or condition; and (2) preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. Authorizes the drug's sponsor to request the Secretary to designate the drug as a breakthrough therapy. Requires the Secretary, within 60 days of such request, to determine whether the drug meets such criteria and, if so, make such designation, followed by appropriate actions to expedite its development and review for approval. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Secretary to contract with an independent entity to evaluate the manner by which the Food and Drug Administration (FDA) has applied the processes for the breakthrough therapy determination, and the impact of such processes on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-03-29 00:00:00

Interstate Drug Monitoring Efficiency and Data Sharing Act of 2012 or the ID MEDS Act - Directs the Attorney General to establish national interoperability standards to facilitate the exchange of prescription information by states receiving grant funds under the Harold Rogers Prescription Drug Monitoring Program (Rogers Program) and the Controlled Substance Monitoring Program (CS Program). Directs the Attorney General to ensure that such standards: (1) implement open standards that are freely available to promote broad implementation; (2) provide for the use of exchange intermediaries to facilitate interstate interoperability; (3) support transmissions that are fully secured, using industry standard methods of encryption, to ensure that protected health information and personally identifiable information are not compromised during transmission; and (4) employ access control methodologies to share protected information solely in accordance with state laws and regulations. Requires a grant recipient under the Rogers Program to ensure that the state databases comply with the national interoperability standards. Allows a recipient of an enhancement grant under such Program to use grant funds to standardize the technology architecture used by the recipient to comply with such standards. Amends the Public Health Service Act to require states to ensure that databases established under the CS Program comply with such standards. Directs the Attorney General to report on enhancing the interoperability of state prescription monitoring programs with other technologies and databases used for detecting and reducing fraud, diversion, and abuse of prescription drugs.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-04-18 00:00:00

Patient Safety and Generic Labeling Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act to allow the holder of an approved abbreviated new drug application (generic drug approval) to change the labeling of a drug so approved in the same manner authorized by regulation for the holder of an approved new drug application. Allows conforming changes to be ordered to the labeling of the equivalent listed drug and each drug approved under the abbreviated new drug application process that corresponds to such listed drug.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-05-22 00:00:00

Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs. Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances. Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and (2) provide for the development of a publicly accessible electronic repository for all PMI. Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.