jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-24 00:00:00

Prescription Drug Labeling Promotion Act of 2012 - Directs the Secretary of Health and Human Services (HHS) to establish a working group to develop best practices on access to prescription drug labeling for the visually impaired. Requires the working group to: (1) include equal representation of consumer and industry advocates; (2) promulgate guidance on best practices for pharmacies to ensure that blind and visually impaired individuals have safe, consistent, reliable, and independent access to the information in the labeling of prescription drugs; (3) consider the use of Braille, specified auditory means, and enhanced visual means to provide such access; and (4) consider whether there are technical, financial, manpower, or other factors that may fundamentally impact the ability of pharmacies with 20 or fewer retail locations to implement the best practices. Directs the Commissioner of Food and Drugs (FDA) to conduct an informational and educational program to inform the public and pharmacists about such guidance and practices. Directs the Comptroller General: (1) 18 months after such guidance and practices are published, to review pharmacy compliance and the extent to which access barriers continue; and (2) by September 30, 2016, to report on such review, including recommendations for reducing such barriers.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-02-28 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: 2012-03-05 00:00:00

Faster Access to Specialized Treatments Act or FAST Act - Expresses the sense of Congress that the Food and Drug Administration (FDA) should apply specified accelerated approval and the fast track provisions to expedite the development and availability of treatments for serious or life-threatening diseases or conditions while maintaining appropriate safety and effectiveness standards. 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 new drug, to include as a fast track product a new drug, either alone or in combination with one or more other drugs, that is intended for the treatment of a serious or life-threatening disease or condition. Permits the Secretary to approve an application for approval of a product for a serious or life-threatening disease or condition, including a fast track product, upon a determination that the product has an effect on: (1) a surrogate endpoint that is reasonably likely to predict clinical benefit; or (2) on a clinical endpoint, including an endpoint that can be measured earlier than irreversible morbidity or mortality, that is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit. Directs the Secretary, in conjunction with other planned reviews of the new drug review process, to contract with an independent entity with expertise in assessing biopharmaceutical development and regulatory review programs to evaluate the FDA's application of the fast track processes on the development and availability of innovative treatments for patients suffering from serious or life-threatening conditions.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-03-26 00:00:00

Cosmetics Safety Enhancement Act of 2012 - Amends the the Federal Food, Drug, and Cosmetic Act to require the registration of cosmetic products and cosmetic manufacturing facilities, including, for each product: (1) a unique facility identifier, (2) every product's brand name, and (3) product ingredients. Sets registration fees. Requires a cosmetic manufacturer: (1) before the introduction into interstate commerce of a cosmetic product, to establish a file containing scientific evidence substantiating the product's safety; (2) to report any serious adverse event information received that is associated with the use of a cosmetic product; and (3) maintain records concerning any cosmetic product that may be adulterated, misbranded, or otherwise in violation of the Act, including all records relating to cosmetic product safety substantiation or relating to serious adverse event reports. Deems a cosmetic product adulterated if its manufacture, packing, or holding do not conform to current good manufacturing practice regulations. Provides each manufacturer with an opportunity to cease distribution and recall of a cosmetic product if it is determined that there is a reasonable probability that the product is adulterated and the use of, or exposure to, such product will cause serious adverse health consequences or death to humans. Permits the issuance of an order requiring a recall if there is not a voluntary recall of an adulterated product.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-03-29 00:00:00

Generic Drug Application Review Fairness Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to extend from 30 to 60 months after application the period for a first applicant of a generic drug to obtain tentative approval without forfeiting the 180-day exclusivity period with respect to such drug, unless the failure in meeting the extended period is caused by a change in or review of approval requirements. Limits extension coverage to applications filed within 30 months preceding the enactment of this Act. Reduces such extended period by six months per year over a five-year period, beginning on October 1, 2013. Directs the Secretary of Health and Human Services (HHS) to maintain the Office of Generic Drugs as a separate office within the Center for Drug Evaluation and Research of the Food and Drug Administration (FDA).
Topic: Health — Drug Industry
Subject: Health
Date: 2012-04-18 00:00:00

Patient Safety and Drug 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: Commerce
Date: 2012-04-18 00:00:00

Cosmetic Safety Amendments Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the registration of every domestic and foreign establishment engaged in the manufacture of a cosmetic intended to be marketed in the United States with the Secretary of Health and Human Services (HHS). Requires such manufacturers to submit to the Secretary: (1) a cosmetic and ingredient statement for each manufactured cosmetic containing a unique registration number for the manufacturing establishment where the cosmetic is manufactured, the brand name for the cosmetic, the ingredients in the cosmetic, and contact information for individuals responsible for filing and maintaining the cosmetic and ingredient statement; and (2) a report on any serious and unexpected adverse event allegedly associated with the use of a cosmetic product. Requires the Secretary to: (1) establish good manufacturing practices for the manufacture, processing, filling, or packaging of cosmetics; and (2) establish and maintain in the Center for Food Safety and Applied Nutrition of the Food and Drug Administration (FDA) an electronic National Cosmetic Regulatory Databank to hold information pertaining to the regulation of cosmetics. Grants the Secretary authority to review the findings of the Cosmetic Ingredient Review Expert Panel with respect to any cosmetic products. Authorizes the Secretary to: (1) establish a tolerance level for a nonfunctional constituent in a cosmetic product, (2) evaluate the safety of any ingredient in a cosmetic product, and (3) obtain access to and copy records for determining whether a cosmetic product is adulterated and presents a threat of serious adverse health consequences or death to humans. Denies entry into the United States of a cosmetic product if: (1) the importer does not present the unique cosmetic establishment registration number and the unique cosmetic and ingredient statement number, or (2) either of such numbers is not correct.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-04-27 00:00:00

Gluten in Medicine Identification Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be misbranded any drug intended for human use that contains an ingredient (other than a polyol) that constitutes or is derived from a grain or starch-containing ingredient and whose label fails to include a parenthetical statement identifying the source of the ingredient so constituted or derived.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-04-27 00:00:00

Revises clinical trial registry data bank provisions of the Public Health Service Act to: (1) include a device or drug clinical trial whether or not it results in a positive or negative outcome, and (2) subject clinical trials funded by the Department of Defense (DOD) to requirements to certify information submissions to the Director of the National Institutes of Health (NIH). Restricts funding for a grantee and makes the grantee liable to the United States for repayment of any grant amount provided, if the grantee has not submitted clinical trial information within the 30-day correction period for noncompliance.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-05-07 00:00:00

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. Requires an annual report from the Secretary to Congress on drugs for which breakthrough designations were requested and approved. Directs the Secretary to issue guidance on implementing requirements with respect to breakthrough therapies and to amend promulgated regulations. Requires the Comptroller General to assess the manner by which the Food and Drug Administration (FDA) has applied the processes established by this Act and their impact on the development and timely availability of innovative treatments for patients affected by serious or life-threatening conditions.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-05-22 00:00:00

Gray Market Drug Reform and Transparency Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to: (1) make it a prohibited act and a misbranding for a wholesale distributor of prescription drugs to purchase or receive a prescription drug from a pharmacy or a pharmacist, (2) require annual reporting by wholesale distributors of prescription drugs, (3) require the Secretary of Health and Human Services (HHS) to establish and maintain a national database of information reported by wholesale distributors of prescription drugs and to require such database to include information on actions taken by states against wholesale distributors (e.g., disciplinary actions and license revocations), (4) require the Secretary to assess and collect fees from wholesale distributors of prescription drugs, and (5) require wholesale distributors of prescription drugs to provide to recipients of a prescription drug in shortage the sales price for such drug at the time of its sale and at the time of any prior sale of such drug when it was in shortage.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-05-30 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: 2012-07-12 00:00:00

Taking Essential Steps for Testing Act of 2012 - Amends the Public Health Service Act to revise sanctions for laboratories that intentionally refer proficiency testing samples required for certification to another laboratory for analysis by: (1) giving the Secretary of Health and Human Services (HHS) discretion to substitute intermediate sanctions for such violations instead of the two-year prohibition against ownership or operation which would otherwise apply, and (2) making the one-year certificate revocation for such a laboratory optional rather than mandatory.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2012-07-17 00:00:00

Truth in Trials Act - Amends the federal criminal code to: (1) allow any person on trial for a federal marijuana-related offense to introduce evidence that the alleged marijuana-related activities were performed in compliance with state law regarding the medical use of marijuana, (2) allow an affirmative defense to a marijuana prosecution that the alleged marijuana-related activities complied with state law regarding the medical use of marijuana, (3) limit the criminal liability of persons convicted of federal marijuana-related offenses, (4) require the preservation and return (if a defendant is acquitted) of property seized in connection with a marijuana prosecution, and (5) prohibit the seizure of plants grown or stored under a physician's recommendation or by order of a state or municipal agency in accordance with state law regarding the medical use of marijuana.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-07-19 00:00:00

Stop Tampering of Prescription Pills Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to prescribe new drug application requirements for tamper-resistant drugs: (1) containing as an active moiety (the part of the drug that makes it work the way it does) a controlled substance classified as opium, an opiate, or a derivative; (2) formulated for oral administration; (3) exhibiting physicochemical properties making them significantly more difficult or ineffective in altering the drug's characteristics for purposes of misuse or abuse; and (4) containing one or more additional ingredients intended to deter abuse through potential pharmacological effects. Requires the Secretary to refuse a new drug application for any new (brand name) drug containing opium, an opiate, or a derivative as an active moiety that is not tamper-resistant if a tamper-resistant drug containing the same active moiety has been approved and has not been discontinued from marketing. Authorizes the Secretary to approve an application failing to meet such requirements, however, if approval is necessary to prevent or alleviate a drug shortage or otherwise address a significant unmet public health need. Requires an abbreviated new (generic) drug application for a tamper-resistant drug to include testing information demonstrating that the generic drug resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Authorizes the Secretary to deny approval of a generic application if the listed drug is tamper-resistant and one or more of the generic drug's active moieties differ in any material respect from those of the listed drug. Declares that an approved generic drug shall not be considered bioequivalent to, or as having the same therapeutic effect as, a listed drug if the listed drug becomes tamper-resistant unless and until the generic drug demonstrates that it resists manipulation or the effect of manipulation to a degree at least comparable to the listed drug. Prescribes requirements governing when a drug which is not tamper-resistant may have its approval withdrawn or suspended.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-08-02 00:00:00

Patient Choice Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Secretary of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug. Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity caused directly by an adverse effect of the drug is unlikely to be greater than the combined direct and secondary risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in specified countries and data adequate for the approval of such marketing authorization has been submitted to the Secretary. Prohibits the Secretary from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug). Applies the provisional approval only to the indication for the drug: (1) which is related to the treatment of the condition with respect to which the drug was designated as a fast track product, and (2) for which the drug is demonstrated to be adequately safety. Prescribes requirements for termination of provisional approval, withdrawal of such approval, and application of market exclusivity to fast-track approval products.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-08-02 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-09-21 00:00:00

Medicare DMEPOS Market Pricing Program Act of 2012 - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to establish a market pricing program for durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS) as a replacement for the competitive acquisition program for DMEPOS, which is hereby terminated. Directs the Secretary to: (1) conduct annual market-priced auctions from among entities supplying market priced items and services in an eligible market area selected in the auction design, (2) establish a lead product for each of specified product categories, and (3) award a contract to any entity in an eligible market area in which an auction is conducted whose bid is below a clearing price equal to the highest cost bid that will meet capacity targets in the market area. Requires the Secretary to contract with an auction expert to assist in, and a market monitor to monitor, the design, development, and functioning of the auction. Adjusts the covered DME item update for 2012 through 2014 and each subsequent year.
Topic: Health — Drug Industry
Subject: Health
Date: 2012-09-21 00:00:00

Life-Threatening Diseases Compassion through Combination Therapy Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to authorize the Secretary of Health and Human Services (HHS) to designate a combination of drugs as a significant drug combination if such combination: (1) includes two or more drugs or biological products that, when used in combination, offer the potential to significantly advance treatment for a serious or life-threatening disease and, in combination, meet the criteria for co-development of drug combinations in Food and Drug Administration (FDA) guidance; and (2) includes at least two drugs that are not approved. Requires the Secretary to develop, publish, and revise annually a list of combinations of two or more drugs designated as significant drug combinations. Extends the market exclusivity for a drug by six months if it is designated as a significant drug combination before it is approved as a new drug. Requires the Secretary to review and take action on a drug in a significant drug combination designated under this Act within six months after receiving an application for approval of a new drug application or licensure of a biosimilar biological product. Requires the Secretary, at the request of the sponsor of a drug, to expedite development and review for designated drug combinations. Requires the Secretary to establish an interagency task force to encourage the co-development of drugs in significant drug combinations. Requires the task force to develop, revise in response to public comments, and update annually a list of types of drug combinations it recommends that the Secretary designate as significant drug combinations. Directs the Secretary to study the impact of the extension of market exclusivity under this Act.