zli12321/Bills huggingface dataset:
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.

Date: 2012-09-21
Topic: Health (Drug Industry)
Subject: Health
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) 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; (2) require the sponsor of a new drug or biological product to submit PMI as part of the new drug or abbreviated (generic) new drug application and provide for approval or disapproval of the PMI as part of the application process; (3) require the sponsor of any drug lawfully marketed in the United States to submit PMI for the drug to the Secretary for approval or disapproval of the PMI; (4) require the PMI for a generic drug to be identical to the PMI for the listed drug, except for excluding any portion of such PMI that is protected by patent or an exclusivity period under FFDCA; and (5) 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.

Date: 2012-09-21
Topic: Health (Drug Industry)
Subject: Health
Trafficking in Organs Victims Protection Act - States that it shall be U.S. policy to: (1) end the offensive practice of exploiting the poor and vulnerable for the purpose of harvesting and trafficking their organs, and (2) combat criminal trade in human organs. Amends the Foreign Assistance Act of 1961 to include in the annual country reports on human rights practices information on post-operative and rehabilitation care for victims of trafficking in human organs and the extent to which violations of a country's laws against trafficking in human organs have occurred. Amends the Trafficking Victims Protection Act of 2000 to include in the definition of "coercion" exploitation of a person through the promise of payments or benefits in order to compel or entice the person to consent to the removal of one or more of the person's organs for a transplant operation in a manner contrary to certain World Health Organization (WHO) standards. Defines: (1) "trafficking in human organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by coercion, abduction, deception, abuse of power, or transfer of payments or benefits, and the illicit transportation and transplantation of those organs in one or more other persons for profit or any other purpose; and (2) "organ" as the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof, and any other human organ or subpart (including that derived from a fetus) specified by the President. Includes in the definition of "severe forms of trafficking in persons" trafficking in human organs. Amends the State Department Basic Authorities Act of 1956 to prohibit the issuance of a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense. Authorizes the President to exercise specified authorities under the International Emergency Economic Powers Act in connection with: (1) the export of anti-rejection human organ transplant drugs to countries identified as the largest source of illegally trafficked human organs or the largest recipients of illegally trafficked human organs, or (2) the travel abroad by U.S. citizens to participate in any activity relating to human organ trafficking.

Date: 2012-10-12
Topic: Health (Drug Industry)
Subject: International affairs
Verifying Authority and Legality In Drug Compounding Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) with respect to the regulation of compounding drugs. Eliminates authority for compounding pharmacies to: (1) compound drugs before the receipt of a valid prescription order, or (2) compound any drug product that is a copy of a commercially available drug. Requires the Secretary of Health and Human Services (HHS) to develop, maintain and transmit to the appropriate state agencies a list of drug products that should not be compounded, including: (1) drug products whose compounding is reasonably likely to cause an adverse effect on their safety or effectiveness; and (2) drug products that have been withdrawn or removed from the market because they have been found to be unsafe or not effective. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if compounding the drug product is necessary to address a drug shortage, or to protect public health or well-being. Prohibits the Secretary from authorizing a state to grant such waivers. Authorizes the Secretary to waive the requirement that a drug product must be compounded for an individually identified patient based on a valid prescription order or similar notation if the pharmacy or pharmacist: (1) submits a satisfactory application to the Secretary; and (2) agrees to comply with any condition or limitation specified by the Secretary. Makes a pharmacy or pharmacist required to be registered under the FFDCA as a drug producer ineligible for a waiver. Permits the Secretary to authorize a state to grant such waivers applicable to compounded drug products sold or dispensed within the state pursuant to a memorandum of understanding between the Secretary and the state. Authorizes the Secretary to waive the prohibition against compounding any drug product that is a copy of a commercially available drug if it is necessary to protect public health or well-being. Prohibits the Secretary from authorizing a state to waive such prohibition. Subjects the facilities of any pharmacy receiving a waiver under this Act to inspection to determine compliance with this Act. Requires the Secretary to publish notice at least 30 days before cancelling a waiver, unless it is necessary to prevent an adverse impact on public health or safety. Sets forth a required label statement for any drug compounded pursuant to this Act. Requires a pharmacist or physician compounding a drug product to report any adverse event associated with the use of the product within a specified time frame.

Date: 2012-11-02
Topic: Health (Drug Industry)
Subject: Health
Patient Access to Drugs in Shortage Act of 2012 - Amends title XVIII (Medicare) of the Social Security Act (SSA), with respect to use of average sales price payment methodology for drugs and biologicals, to prescribe a formula for determining the payment amount, using the volume-weighted wholesale acquisition cost, for a multiple source or a single source sterile injectable drug product with three or fewer active manufacturers, if there is no period of exclusivity in effect or available. Incorporates such payment methodology under the hospital outpatient department prospective payment system for any such drug furnished between July 1, 2013, and January 1, 2020. Amends SSA title XIX (Medicaid) to exempt from the rebate agreement requirement a multiple source drug furnished between July 1, 2013, and January 1, 2020, and for which payment may be made under Medicare part B (Supplementary Medicare Insurance). Amends the Public Health Service Act to exclude such multiple source drugs from the term "covered outpatient drug" subject to specified price limitations under the "340B" drug pricing program. Directs the Secretary to contract with an independent entity to study the effects of this Act on patient access to sterile products. Amends the Patient Protection and Affordable Care Act to exclude certain branded prescription drugs on a specified drug shortage list from the annual fee imposed on branded prescription pharmaceutical manufacturers and importers.

Date: 2012-11-29
Topic: Health (Drug Industry)
Subject: Health
Health Care Innovation and Marketplace Technologies Act of 2012 - Amends the Internal Revenue Code to allow a medical care provider to deduct from gross income the amount paid or incurred for qualified health information technology placed in service during the taxable year. Amends the Small Business Act to authorize the Administrator of the Small Business Administration (SBA) to guarantee up to 90% of the amount of a loan, up to specified loan amounts, to a small business health professional to be used for the acquisition and installation of health information technology for the professional's medical practice. Amends the Public Health Service Act to require the Secretary of Health and Human Services (HHS), acting through the National Coordinator for Health Information Technology, to award grants for the development of an effective product, process, or structure that enhances the use, particularly by patients, of health information technology. Requires the Secretary, acting through the National Coordinator, to award prizes for development in areas of health information technology that are not adequately addressed by certified electronic health records (EHR) technologies and the use of such technologies. Amends the Federal Food, Drug, and Cosmetic Act to establish the Office of Wireless Health Technology. Requires the Health Information Technology Research Center to provide support for mobile health software application technology. Authorizes the National Coordinator to award grants for training health care workers in health information technology.

Date: 2012-12-03
Topic: Health (Drug Industry)
Subject: Health
Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding that a drug intended for human use may constitute a threat to the public health to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug; and (2) amend the order to include a recall if necessary.

Date: 2012-12-18
Topic: Health (Drug Industry)
Subject: Health
Cainaan Putuga Wendt Shock of Life Act - Directs the Secretary of Education to award matching grants to local educational agencies (LEAs) to: (1) purchase automated external defibrillators (AEDs) for use in public or private secondary schools within their district, and (2) provide training to meet the grant requirement that at least five adult employees or volunteers at each school where a purchased AED is to be used are or will be certified in its use and in cardiopulmonary resuscitation (CPR). Requires LEA grant applicants also to demonstrate that: (1) the AEDs are integrated into the schools' emergency response procedures, and (2) emergency services personnel are notified of their locations. Gives grant priority to LEAs that have secondary schools that: (1) lack an AED; (2) typically have a significant number of students, staff, and visitors present during the day; and (3) generally have a longer wait for emergency medical services than other public facilities in the community.

Date: 2012-12-27
Topic: Health (Drug Industry)
Subject: Education
Medical Device Access and Innovation Protection Act - Repeals the Internal Revenue Code provision, added by the Health Care and Education Reconciliation Act, that imposes an excise tax on medical devices.

Date: 2011-01-25
Topic: Health (Drug Industry)
Subject: Taxation
Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects. Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent. Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act. Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

Date: 2011-01-25
Topic: Health (Drug Industry)
Subject: Commerce
Amends the Federal Food, Drug, and Cosmetic Act to deem genetically-engineered fish to be unsafe under provisions related to new animal drugs and adulterated food.

Date: 2011-01-31
Topic: Health (Drug Industry)
Subject: Agriculture and food
Repeals the provision of the Internal Revenue Code, added by the Health Care and Education Reconciliation Act of 2010, that imposes an excise tax on medical devices. Rescinds $39 billion of appropriated but unobligated discretionary funds. Exempts unobligated funds of the Department of Defense (DOD) or the Department of Veterans Affairs (VA). Requires the Director of the Office of Management and Budget (OMB) to determine and identify from which appropriation accounts such recissions shall apply and report to the Secretary of the Treasury and Congress on such recissions.

Date: 2011-02-03
Topic: Health (Drug Industry)
Subject: Taxation
Pharmaceutical Market Access and Drug Safety Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions governing the importation of prescription drugs. Waives the limitation on importation of prescription drugs that have been exported from the United States. Prohibits the importation of a qualifying drug unless such drug is imported by a registered importeror an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system.

Date: 2011-02-10
Topic: Health (Drug Industry)
Subject: Health
Fair Prescription Drug Competition Act - Amends the Federal Food, Drug, and Cosmetic Act to prohibit a holder of a new, approved drug application from commencing to manufacture, market, sell, or distribute a generic version of such drug from the time of the receipt of notice from the generic manufacturer that an abbreviated new drug application has been submitted for approval until the expiration or forfeiture of the 180-day exclusivity period granted to the generic manufacturer.

Date: 2011-02-16
Topic: Health (Drug Industry)
Subject: Health
Prescription Drug Abuse Prevention and Treatment Act of 2011 - Amends the Public Health Service Act to direct the Administrator of the Substance Abuse and Mental Health Services Administration to award grants to states and nonprofit entities for consumer education about opioid abuse, including methadone abuse. Amends the Controlled Substances Act to: (1) set forth training requirements for practitioners registered to prescribe or dispense methadone or other opioids; and (2) require each registered opioid treatment clinic to make acceptable arrangements for each patient who is restricted from having a take-home dose of a controlled substance related to treatment to receive a dose of that substance under appropriate supervision when the clinic is closed. Prohibits any individual or entity (except hospitals that provide direct patient supervision) from prescribing or dispensing a 40-mg diskette of methadone unless such prescription or dispensation is consistent with the current Drug Enforcement Administration (DEA) methadone policy, until the date the Controlled Substances Clinical Standards Commission: (1) publishes dosing guidelines for methadone, and (2) finds that such 40-mg diskettes are safe and clinically appropriate. Requires the Secretary of Health and Human Services (HHS) to establish such Commission to develop and publish guidelines related to methadone use, including safe dosing guidelines for all forms of methadone and benchmark guidelines for the reduction of methadone abuse. Requires states receiving controlled substances monitoring program grants to: (1) provide information, upon request, to drug enforcement officials relating to an individual who is the subject of an active drug-related investigation; and (2) require opioid-related deaths to be reported to the Administrator. Directs the Administrator to develop a Model Opioid Treatment Program Mortality Report. Requires the Administrator to establish and implement, through the National Center for Health Statistics, a National Opioid Death Registry to track opioid-related deaths.

Date: 2011-03-08
Topic: Health (Drug Industry)
Subject: Health
Hearing Aid Assistance Tax Credit Act - Amends the Internal Revenue Code to allow an individual taxpayer to elect once every five years a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for use by the taxpayer or a dependent.

Date: 2011-05-05
Topic: Health (Drug Industry)
Subject: Taxation
Sunscreen Labeling Protection Act of 2011 or the SUN Act - Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time.

Date: 2011-05-25
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-06-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-06-30
Topic: Health (Drug Industry)
Subject: Agriculture and food
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.

Date: 2011-09-20
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-10-13
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-10-20
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-11-16
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-12-05
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-12-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2011-12-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-02-02
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-02-17
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-03-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-03-26
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-03-29
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2012-04-18
Topic: Health (Drug Industry)
Subject: Health