jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-01 00:00:00

Laboratory Test Improvement Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a laboratory-developed test that is a direct-to-consumer test to be a prescription test if it satisfies the requirements of this Act. Deems any laboratory-developed test to be a medical device.Sets forth labeling and registration requirements for laboratory-developed tests.Requires the manufacturer of a laboratory-developed test that has not been cleared or approved for its intended use to submit the analytical and clinical validity of the test for its intended use to the Secretary of Health and Human Services. Requires the Secretary to include such information in a public database.Requires the Secretary to provide guidance to: (1) facilitate the use of reviews of the peer-reviewed biomedical literature and other information and data about the clinical validity of laboratory-developed tests and in vitro diagnostic products when clearing or approving such tests and products under the FFDCA; and (2) clarify when modifications to a laboratory-developed test require updating of the submitted information.Sets forth provisions regarding classification of laboratory-developed tests.Requires the Secretary to issue a proposed rule to establish a specialty area for the certification of laboratories for laboratory-developed tests to acquire genetic information, which shall include standards for proficiency testing of such tests.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-08 00:00:00

Pediatric Medical Device Safety and Improvement Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to require an application for the approval of a medical device or a product development protocol to include: (1) a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and (2) the number of affected pediatric patients. Excludes a medical device distributed pursuant to the humanitarian device exemption from the prohibition that no device be sold for an amount that exceeds the cost of the device if: (1) the device is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients; and (2) other specified requirements are met. Requires the Director of the National Institutes of Health (NIH) to designate a contact point to help innovators and physicians access funding for pediatric medical device development. Requires the Secretary of Health and Human Services to award grants for demonstration projects to promote pediatric device development. Includes as a duty of the Office of Pediatric Therapeutics increasing pediatric access to medical devices. Allows the Secretary to require: (1) postmarket surveillance on certain devices that are expected to have significant use in pediatric populations; and (2) a prospective surveillance period of more than 36 months for such devices, as necessary. Requires the Secretary, acting through the Commissioner of Food and Drugs, to establish a publicly accessible database of all studies and surveillance of medical devices.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2007-03-23 00:00:00

Ryan Haight Online Pharmacy Consumer Protection Act of 2008 - Amends the Controlled Substances Act to prohibit the delivery, distribution, or dispensing of controlled substances over the Internet without a valid prescription. Exempts telemedicine practitioners. Defines "valid prescription" as a prescription that is issued for a legitimate purpose by a practitioner who has conducted at least one in-person medical evaluation of the patient. Adds definitions to the Controlled Substances Act relating to online pharmacies and the issuance of prescriptions over the Internet.Imposes registration and reporting requirements on online pharmacies.Requires an online pharmacy to: (1) display on its Internet homepage a statement that it complies with the requirements of this Act; (2) comply with state laws for the licensure of pharmacies in each state in which it operates or sells controlled substances; (3) post on its Internet homepage specified information, including the name, address, and telephone number of the pharmacy, the qualifications of its pharmacist-in-charge, and a certification of its registration under this Act; and (4) notify the Attorney General and applicable state boards of pharmacy at least 30 days prior to offering to sell, deliver, distribute, or dispense controlled substances over the Internet.Authorizes the Attorney General to issue a special registration under this Act for telemedicine practitioners.Increases criminal penalties involving controlled substances in Schedules III, IV, and V of the Controlled Substances Act. Authorizes states to apply for injunctions or obtain damages and other civil remedies against online pharmacies that are deemed a threat to state residents.Requires the U.S. Sentencing Commission, in determining whether to amend or establish new sentencing guidelines to conform the guidelines and policy statements to this Act, to consult with the Department of Justice (DOJ), experts, and other affected parties concerning which penalties for scheduled substances should be reflected.Requires the Drug Enforcement Administration (DEA) to report to Congress after the enactment of this Act and annually for two years after such initial report on: (1) the foreign supply chains and sources of controlled substances offered for sale without a valid prescription on the Internet; (2) DEA efforts and strategy to decrease such foreign supply chains; and (3) DEA efforts to work with domestic and multinational pharmaceutical companies and others in combating the sale of controlled substances over the Internet without a valid prescription.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-03-29 00:00:00

Safer Drug Assessment Technology Advancement Act or the Safer DATA Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to establish: (1) minimum standards for collection and transmission of postmarketing data elements from electronic health data systems; and (2) a validated and integrated postmarket risk identification and analysis system to integrate and analyze safety data from multiple sources.Directs the Secretary to establish and maintain an active surveillance infrastructure to collect and report data for pharmaceutical postmarket risk identification and analysis.Requires the Secretary to establish and implement procedures under which the Secretary may routinely collaborate with a qualified entity to: (1) clean, classify, or aggregate data collected and data that is publicly available or that is provided by the Secretary; (2) perform advanced research on identified drug safety risks; (3) identify safety questions that require further clinical study; and (4) convene an expert advisory committee to oversee the establishment of standards for the ethical and scientific uses for, and communication of, postmarketing data collected.Requires the Secretary to improve the transparency of pharmaceutical data and allow patients and health care providers better access to pharmaceutical data by developing and maintaining an Internet site that: (1) provides comprehensive drug safety information for prescription drugs; and (2) improves communication of drug safety information to patients and providers.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-04-11 00:00:00

Lower Prices Reduced with Increased Competition and Efficient Development of Drugs Act or the Lower PRICED Drugs Act - Amends the Federal Food, Drug, and Cosmetic Act to require an abbreviated application for a new drug containing certain antibiotics, the approved labeling for which includes a method of use that is claimed by a patent, to include a statement: (1) that identifies the relevant patent and the approved use covered by the patent; and (2) that the applicant is not seeking approval of such use. Requires the court to consider the totality of circumstances and the public interest in deciding whether to shorten the 30-month period that delays the approval of an abbreviated drug application when a patent infringement case is filed against the applicant. Limits market exclusivity provided for conducting pediatric studies of new or already approved drugs to only those drugs for which the Secretary of Health and Human Services approves labeling that provides specific, therapeutically meaningful information about the use of the drug in pediatric patients. Reduces market exclusivity for such studies for drugs with sales revenue that is $1 billion or more. Prohibits the Secretary from delaying approval of a new drug application while a petition seeking any action relating to such an application is being reviewed or considered. Requires the Secretary to take final agency action on a petition within 180 days of receipt, with no extensions allowed. Extends the 30-month period that the Secretary has to approve or disapprove an abbreviated application for a new drug by the amount of time that lapses from the date the Secretary receives a petition and the date of the final agency action on the petition, without regard to whether the Secretary grants or denies the petition.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-04-18 00:00:00

Best Pharmaceuticals for Children Amendments of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to make changes to provisions in regard to market exclusivity for pediatric drug studies on new drugs or already approved drugs, including to: (1) require that appropriate labeling changes are timely made; and (2) prohibit the Secretary of Health and Human Services from extending the period of market exclusivity later than nine months prior to the expiration of such period.Requires an applicant or holder who does not agree with a request to conduct pediatric studies to submit to the Secretary the reasons such pediatric formulation cannot be developed. Directs the Secretary to: (1) publish a notice identifying any drug for which a pediatric formulation was developed, studied, and found to be safe and effective that is not introduced onto the market within one year; and (2) create an internal review committee to review all written requests issued and all reports submitted. Reduces market exclusivity for pediatric studies from six months to three months for drugs for which combined annual gross sales exceed $1 billion.Requires the Secretary to order the labeling of a drug to include information about the result of a pediatric study whether such study does or does not demonstrate that the drug is safe and effective.Requires the Comptroller General to submit a report to Congress that addresses the effectiveness of providing market exclusivity for pediatric studies in ensuring that medicines used by children are tested and properly labeled.Includes pediatric pharmacological research within the pediatric research loan repayment program.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-14 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 children's hospitals, critical access hospitals, and rural referral centers or sole community hospitals. 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 prohibition, 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: 2007-05-14 00:00:00

Dextromethorphan Distribution Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to deem to be adulterated any unfinished dextromethorphan that is possessed, received, or distributed in violation of this Act.Prohibits a person from: (1) possessing or receiving unfinished dextromethorphan unless the person is registered with the Secretary of Health and Human Services as a producer of a drug or device or otherwise registered, licensed, or approved pursuant to federal or state law to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of pharmaceutical ingredients; or (2) distributing unfinished dextromethorphan to any person other than a registered or otherwise authorized person. Excludes from such prohibitions common carriers that possess, receive, or distribute unfinished dextromethorphan for purposes of distributing it between authorized persons.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-23 00:00:00

Amends title XVIII (Medicare) of the Social Security Act to provide for Medicare coverage of certain medical mobility devices approved as a class III medical device pursuant to a premarket approval application under the Federal Food, Drug, and Cosmetic Act.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-24 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.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-24 00:00:00

Home Oxygen Patient Protection Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to restore Medicare treatment of ownership of oxygen equipment that existed prior to the enactment of the Deficit Reduction Act of 2005. Repeals the limitation of Medicare payment to the supplier for such equipment (including portable oxygen equipment) to 36 months of continuous use.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-05-24 00:00:00

Affordable Biologics for Consumers Act - Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biosimilar, which is defined as a biological product that is claimed to be similar to a qualified biological product (the reference product). Defines a "qualified biological product" as a biotechnology-derived therapeutic biological or protein product licensed or approved under the Federal Food, Drug, and Cosmetic Act.Allows the Secretary of Health and Human Services to approve an application for a biosimilar only: (1) for indications for which the reference product is approved; and (2) if the application conforms to the applicable final product class-specific rule and the Secretary concludes that the product is safe, pure, and potent.Authorizes a person to request the issuance of a product class-specific rule applicable to a qualified biological product and its class. Requires the Secretary to establish a Biosimilars Advisory Committee.Prohibits the approval of a biosimilar until at least 14 years have elapsed from approval of the reference product.Prohibits the Secretary from: (1) approving a product that is claimed to be similar to or the same as a reference product under any other provision of law; (2) approving another biosimilar for one year after approving the first biosimilar that relies on the same reference product; and (3) designating a biosimilar as interchangeable with (or therapeutically equivalent to) the applicable reference product.Sets forth provisions related to patents for a reference product. Allows approval of an application for a biosimilar to be effective even if patent litigation has not concluded.Amends the Federal Food, Drug, and Cosmetic Act to deem as misbranded a biotechnology-derived therapeutic protein if its labeling fails to meet specified requirements.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-09-26 00:00:00

Preserving Access to Laboratory Services Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to repeal the mandate for a Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services.
Topic: Health — Drug Industry
Subject: Commerce
Date: 2007-10-15 00:00:00

Community Pharmacy Fairness Act of 2007 - Entitles independent pharmacies negotiating contract terms with a health plan for the provision of health care items or services to the same treatment under the antitrust laws as the treatment to which bargaining units recognized under the National Labor Relations Act are entitled. Treats such a pharmacy as an employee engaged in concerted activities in connection with such negotiations. Exempts actions taken in good faith reliance on this Act from being subject to criminal sanctions or civil penalties beyond actual damages incurred. Prohibits: (1) exempting from the antitrust laws any agreement or otherwise unlawful conspiracy that excludes, limits the participation or reimbursement of, or otherwise limits the scope of services to be provided by any independent pharmacy or group of independent pharmacies with respect to the performance of services that are within their scope of practice as defined or permitted by relevant law or regulation; and (2) applying this Act to negotiations between independent pharmacies and health plans pertaining to federal health benefits.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-10-23 00:00:00

Transparency in Medical Device Pricing Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to require manufacturers of implantable medical devices to report annually to the Secretary of Health and Human Services on sales prices and related data about such devices.
Topic: Health — Drug Industry
Subject: Health
Date: 2007-11-13 00:00:00

Prevention Through Affordable Access Act - Amends title XIX (Medicaid) of the Social Security Act to revise requirements for the best price component of the formula for determination of the Medicaid rebate for a covered single source outpatient drug or a covered innovator multiple source outpatient drug. (Under current law, best prices shall not take into account prices that are merely nominal in amount.) Revises the list of entities to which sales by a manufacturer of covered outpatient drugs at nominal prices shall be considered to be sales at a nominal price, or merely nominal in amount (and thus excluded from computation of the best price for such drugs). Adds to such list any entity that is: (1) operated by a health center of an institution of higher education, primarily for its students (university-based clinic); or (2) a public or private nonprofit entity that provides family planning services under the Public Health Service Act (safety-net clinic).
Topic: Health — Drug Industry
Subject: Health
Date: 2007-12-03 00:00:00

Medicare Advanced Laboratory Diagnostics Act of 2007 - Directs the Secretary of Health and Human Services to: (1) establish a demonstration project to evaluate new approaches to coding and payment under the Medicare program (title XVIII of the Social Security Act (SSA)) for clinical diagnostic laboratory tests; and (2) appoint a standing panel to determine tests to be included in the project and make recommendations derived from project results to the Secretary of Health and Human Services. Amends SSA title XVIII with respect to: (1) correction of erroneous determinations and other changes in fee schedule and national limitation amounts for clinical diagnostic laboratory tests; (2) issuance of regulations on gap-filling methodology in determining the Medicare fee schedule for such tests; (3) increased transparency of the process for determining fee schedule amounts for new tests; and (4) mandatory advance notice of clinical diagnostic laboratory test amounts being considered for adjustment under inherent reasonableness authority.
Topic: Health — Drug Industry
Subject: Health
Date: 2008-05-15 00:00:00

Food and Drug Administration Accountability and Transparency Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to publish in the Federal Register postmarket surveillance plans for medical devices, unless such information is exempted under the Freedom of Information Act. Subjects medical device manufacturers that fail to comply with postmarket surveillance requirements to civil monetary penalties. Requires the Secretary to take into consideration whether the manufacturer is making efforts toward correcting the violation in determining the amount of the civil penalty. Authorizes the Secretary to order notification of health personnel and other relevant persons if a violation of postmarket surveillance requirements of a device presents an unreasonable risk of substantial harm to the public health, such notification is necessary to eliminate such risk, and no more practicable means is available to eliminate such risk.