zli12321/Bills huggingface dataset:
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).

Date: 2007-11-13
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2007-12-03
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2008-05-15
Topic: Health (Drug Industry)
Subject: Health
Access, Compassion, Care, and Ethics for Seriously Ill Patients Act or the ACCESS Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to permit an investigational drug, biological product, or device to be made available for expanded access under a treatment investigational new drug application or treatment investigational device exemption if specified Compassionate Investigational Access requirements are met.Gives immunity to the manufacturer, distributor, administrator, sponsor, or physician from suit or liability relating to products approved under this Act. Establishes a procedure for accelerated approval of an investigational drug, biological product, or device that is reasonably likely to predict clinical benefit to a patient suffering from a serious or life-threatening condition.Requires the Secretary to establish: (1) the Accelerated Approval Advisory Committee; (2) a new program to expand access to investigational treatments for individuals with serious or life threatening conditions and diseases; and (3) a demonstration project under the Medicare program to pay for drugs, biological, products, and devices approved under this Act.Amends title XVIII (Medicare) of the Social Security Act to revise the definition of "medically accepted indication" to provide for coverage of a covered Part D drug based on the sponsor's or organization's determination that the drug is for a medically accepted indication.Requires the Secretary to consider the clinical judgment and risks to the patient from the disease or condition in evaluating the safety and effectiveness of drugs, biological products, and devices that treat serious or life-threatening diseases or conditions, including the evaluation of nonstatistical information.Requires any committee evaluating investigational drugs, devices, or biological product applications to have at least two patient representatives as voting members.

Date: 2008-05-21
Topic: Health (Drug Industry)
Subject: Health
Requires automobiles manufactured or sold in the United States, beginning with model year 2013, to be equipped with a real time and average fuel economy display that is visible to the driver.

Date: 2008-05-22
Topic: Health (Drug Industry)
Subject: Transportation and public works
Medicare DMEPOS Competitive Acquisition Reform Act of 2008 - Amends title XVIII (Medicare) of the Social Security Act to delay generally until after 2011 full implementation of the Medicare competitive acquisition program for the purchase of durable medical equipment (DME), prosthetics, orthotics, and supplies (DMEPOS).Revises such program, dividing its implementation into two rounds, and specifying covered item updates for 2009-2014.Prescribes requirements for application of accreditation in implementing quality standards.Requires suppliers to disclose subcontractors.Directs the Secretary of Health and Human Services to provide for a competitive acquisition ombudsman within the Centers for Medicare & Medicaid Services to respond to complaints and inquiries by suppliers and individuals.Specifies topics for the Comptroller General's required study and report to Congress on the impact of competitive acquisition of DME on suppliers, manufacturers, and patients.Sets forth a special rule for the competitive acquisition program for diabetic testing strips.

Date: 2008-06-17
Topic: Health (Drug Industry)
Subject: Health
Amends the Federal Food, Drug, and Cosmetic Act to require that priority review vouchers, which are given by the Secretary of Health and Human Services to the sponsor of a tropical disease product application, are transferable to sponsors of human drug applications for approval of a new drug or biological product. Prohibits such vouchers from being redeemed to affect the review of a pending human drug application.

Date: 2008-06-18
Topic: Health (Drug Industry)
Subject: Health
Medical Device Safety Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act to provide that provisions preempting state and local requirements for medical devices intended for human use shall not be construed to modify or otherwise affect any action for damages or the liability of any person under state law. Makes this Act effective as if it were included in the Medical Device Amendments of 1976 and applicable to any civil action pending or filed on or after the date of enactment of this Act.

Date: 2008-07-31
Topic: Health (Drug Industry)
Subject: Health
Drug and Device Accountability Act of 2008 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to deem a drug or device to be misbranded unless certain conditions related to registration of establishments, identification of prior transactions, labeling for country of manufacture, and provision of required information on importation are met.Includes in the definition of "drug" a precursor ingredient.Repeals the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs.Expands the information required to be included for registration of establishments.Deems a drug to be adulterated if certain conditions related to verification of identity and purity, identification of establishments, consistency with current manufacturing technologies, and conformity with good distribution and import practices are not met.Sets forth provisions governing importation of a drug. Sets forth required actions, including cessation of distribution, if there is a reasonable probability that a drug intended for human use would cause serious, adverse health consequences or death.Establishes actions manufacturers must take regarding any defective drug.Sets forth additional required certifications for submissions related to drugs and devices regarding accuracy of information submitted and personal knowledge of such information.Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device.Directs the Secretary of Health and Human Services to establish and maintain a corps of inspectors dedicated to inspections of foreign establishments and foreign facilities.Authorizes the Secretary to conduct investigations, subpoena witnesses, and compel attendance of witnesses as necessary to carry out authority under the FFDCA or provisions governing the regulation of biological products.Requires reports to the Secretary regarding certain civil actions involving a regulated product.

Date: 2008-07-31
Topic: Health (Drug Industry)
Subject: Health
Organ Transplant Authorization Act of 2008 - Amends the Public Health Service Act to increase the maximum amount of funds provided for the establishment and operation of the Organ Procurement and Transplantation Network for any fiscal year.

Date: 2008-09-17
Topic: Health (Drug Industry)
Subject: Health
Transparency in Drug Labeling Act - Amends the Federal Food, Drug, and Cosmetic Act to deem a drug to be misbranded unless the labeling of such drug lists the identity of the country of manufacture of each active ingredient and each inactive ingredient of the drug, listed in descending order based on the percentage of the number of such ingredients in the final dosage form manufactured in such countries.

Date: 2008-09-26
Topic: Health (Drug Industry)
Subject: Health
Pharmaceutical Market Access and Drug Safety Act of 2007 - 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: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary 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: 1/10/2007
Topic: Health (Drug Industry)
Subject: Health
Amends the Federal Food, Drug, and Cosmetic Act to exempt prescription drugs that have been shipped directly from a state to the U.S. Virgin Islands from restrictions on importation of exported drugs.

Date: 2009-01-06
Topic: Health (Drug Industry)
Subject: Health
Prescription Drug Affordability Act - Amends the Internal Revenue Code to allow a nonrefundable tax credit for 80 percent of the amount paid for a prescribed drug during the taxable year (and not compensated for by insurance or otherwise) by a taxpayer who has attained social security retirement age.Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to repeal provisions restricting the importation of prescription drugs. Allows a person who meets applicable legal requirements to be an importer of prescription drugs upon application to the Secretary of Health and Human Services. Requires the Secretary to approve such an application if the drug meets all FFDCA requirements for admission into the United States, including that the drug has been approved by the Food and Drug Administration (FDA) and is not adulterated or misbranded.Prohibits the Secretary from taking any action against any of the persons involved with the interstate sale of a prescription drug through an Internet site if: (1) the sale was made in compliance with FFDCA, the Controlled Substances Act, and applicable state laws; and (2) accurate information regarding compliance with such laws is posted on the Internet site.

Date: 2009-01-06
Topic: Health (Drug Industry)
Subject: Health
Prevention Through Affordable Access Act of 2009 - 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).

Date: 2009-01-09
Topic: Health (Drug Industry)
Subject: Health
340B Program Improvement and Integrity Act of 2009 - Amends the Public Health Service Act to expand the drug discount program to allow participation as a covered entity by certain: (1) children's hospitals; (2) critical access hospitals; (3) entities providing maternal and child health services, community mental health services, or treatment services for substance abuse; (4) Medicare-dependent, small rural hospitals; (5) sole community hospitals; and (6) rural referral centers. 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 requirements, 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.

Date: 2009-01-09
Topic: Health (Drug Industry)
Subject: Health
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 exclusivity period granted to the generic manufacturer.

Date: 2009-01-15
Topic: Health (Drug Industry)
Subject: Health
Food and Drug Administration Globalization Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to set forth provisions governing food safety, including requiring for each food facility: (1) a hazard analysis of facilities that manufacture, process, pack, transport, or hold food for consumption in the United States; (2) identification and implementation of preventive controls; and (3) a written food safety plan.Requires the Secretary of Health and Human Services to: (1) issue science-based performance standards to significantly minimize, prevent, or eliminate the occurrence of such hazards; (2) establish science-based minimum standards for the safe production and harvesting of fruits and vegetables as necessary; (3) establish a risk-based inspection schedule; and (4) establish a program to expedite the movement of certified food through the importation process.Provides for: (1) an accreditation system for food facilities; and (2) certification of laboratories to conduct sampling and testing of food.Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to establish an active surveillance system for food.Sets forth provisions governing drug and device safety, including: (1) providing for risk-based inspection schedules; (2) requiring quality risk management plans for establishments; (3) requiring country of origin labeling; and (4) providing for the recall of drugs.Sets forth provisions governing cosmetic safety, including requiring cosmetic establishments to: (1) submit to the Secretary a cosmetic and ingredient statement for each cosmetic; (2) report any serious and unexpected adverse event in the United States associated with the use of the cosmetic; and (3) conform with good manufacturing practices.Sets forth provisions governing the Food and Drug Administration (FDA), including provisions: (1) regarding the reorganization of FDA; and (2) authorizing the Commissioner of Food and Drugs to issue subpoenas for any proceeding regarding a violation of the FFDCA.

Date: 2009-01-28
Topic: Health (Drug Industry)
Subject: Health
Prohibits any federal department, agency, or court from taking any action (administrative, civil, criminal, or otherwise) that would prohibit, interfere with, regulate, or otherwise restrict the interstate traffic of milk, or a milk product, that is unpasteurized and packaged for direct human consumption, solely on the basis that the milk or milk product is unpasteurized and is therefore adulterated, misbranded, or otherwise in violation of federal law.

Date: 2009-01-28
Topic: Health (Drug Industry)
Subject: Agriculture and food
Protect Consumers Act of 2009 - Requires the Secretary of Health and Human Services, upon a determination that it is necessary to implement a mandatory recall of any product regulated by the Food and Drug Administration (FDA), to issue an order requiring the appropriate person to: (1) immediately cease distribution, manufacture, and sale of such product; (2) immediately provide notice to individuals subject to the risks associated with the use of such product; and (3) implement an immediate recall of such product. Directs that the order shall provide for an informal hearing within ten days. Treats the failure to obey such an order as a prohibited act under the Federal Food, Drug, and Cosmetic Act. Requires the Secretary to study and implement new procedures for voluntary and mandatory recalls.

Date: 2009-02-03
Topic: Health (Drug Industry)
Subject: Commerce
Shingles Prevention Act - Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to provide for coverage of the shingles vaccine and its administration.

Date: 2009-02-12
Topic: Health (Drug Industry)
Subject: Health
Safe Drug Disposal Act of 2009 - Amends the Controlled Substances Act to direct the Attorney General to promulgate regulations to: (1) authorize an ultimate user or care taker (a person responsible for taking care of one or more individuals or animals) to dispose of a controlled substance in accordance with a prescribed state program; (2) include five model state programs providing for such disposal through delivery to a designated facility; and (3) allow a state to work with the Attorney General to devise an alternative disposal program that is consistent with this Act. Requires each such program to: (1) require a state to enact legislation as a prerequisite to its adoption and implementation; (2) protect the public safety; (3) allow disposal of controlled substances through persons other than law enforcement personnel; (4) incorporate environmentally sound practices for disposal; (5) be cost-effective; (6) include convenient take-back options for urban and rural locations; and (6) not restrict the funding a state may use to implement it. Allows such a program to apply similarly to a drug or biological product other than a controlled substance. Directs the Comptroller General to collect data on state take-back disposal programs and periodically report to Congress. Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services: (1) in approving drug applications and in licensing biological products, to ensure that the drug or product labeling does not include any recommendation or direction to dispose of the drug by means of a wastewater treatment system, such as by flushing it down the toilet; and (2) to review the labeling of existing drugs and products and order revision of any labeling that includes such a recommendation or direction. Deems any drug or product whose labeling is in violation of such an order to be misbranded.

Date: 2009-02-25
Topic: Health (Drug Industry)
Subject: Environmental protection
Community Pharmacy Fairness Act of 2009 - 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. Provides that this Act does not exempt from application of antitrust laws any agreement or unlawful conspiracy that: (1) would have the effect of boycotting any independent pharmacy; (2) would exclude, limit the participation or reimbursement of, or otherwise limit 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; (3) allocates a market among competitors; (4) unlawfully ties the sale or purchase of one product or service to the sale or purchase of another product or service; or (5) monopolizes or attempts to monopolize a market. Requires the Comptroller General to study the impact of this Act after five years.Provides that this Act does not preclude the Federal Trade Commission (FTC) or the Department of Justice (DOJ) from overseeing the conduct of independent pharmacies covered under this Act.

Date: 2009-02-25
Topic: Health (Drug Industry)
Subject: Commerce
Dextromethorphan Distribution Act of 2009 - 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 drug 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 registered, licensed, or approved persons.

Date: 2009-03-03
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Pharmaceutical Market Access and Drug Safety Act of 2009 - 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: (1) a registered importer; or (2) an individual for personal use. Establishes registration conditions for importers and exporters. Requires the Secretary of Health and Human Services 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: 2009-03-04
Topic: Health (Drug Industry)
Subject: Health
Secure and Responsible Drug Disposal Act of 2009 - Amends the Controlled Substances Act to allow an ultimate user who has lawfully obtained a controlled substance to deliver that substance to another person, without being registered, for the purpose of disposal if: (1) the person receiving the substance is authorized to engage in such activity; and (2) the disposal takes place in accordance with regulations issued by the Attorney General to prevent diversion of controlled substances. Permits the Attorney General to authorize long-term care facilities to dispose of controlled substances on behalf of ultimate users in a manner that will provide effective controls against diversion and that is consistent with public health and safety.

Date: 2009-03-05
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product). Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications. Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period. Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes. Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

Date: 2009-03-11
Topic: Health (Drug Industry)
Subject: Health
Counterfeit Drug Prevention Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to establish criminal penalties of a fine and imprisonment for not more than 20 years, or both, for any person who commits a prohibited act relating to counterfeiting knowing that: (1) the conduct concerns the rendering of a drug as a counterfeit drug; (2) the conduct will cause a drug to be a counterfeit drug; or (3) a drug, held, sold, or dispensed is a counterfeit drug. Increases the term of imprisonment to any term of years or for life if the use of a counterfeit drug is the proximate cause of a consumer's death. Modifies provisions pertaining to criminal fines for committing certain prohibited acts involving food, drugs, devices, or cosmetics.

Date: 2009-03-11
Topic: Health (Drug Industry)
Subject: Health
Pathway for Biosimilars Act - Amends the Public Health Service Act to allow a person to submit an application for licensure of a biological product based on its similarity to a licensed biological product (the reference product).Requires the Secretary of Health and Human Services to approve the application if: (1) the biological product is biosimilar to the reference product with respect to each condition of use for which the reference product is approved; and (2) the applicant consents to the inspection of the facility that is the subject of the application. Sets forth requirements for a determination by the Secretary that a biological product is interchangeable with a reference product.Prohibits a biological product from being evaluated against more than one reference product. Prohibits licensure under this Act of a biological product containing specified agents or toxins or a schedule I or II controlled substance unless the Secretary determines there would be no increased risk to the security or health of the public from licensing such a biological product. Prohibits the Secretary from making approval of an application under this Act effective until 12 yeas after the date on which the reference product was first licensed.Provides for confidentiality of information received pursuant to this Act.Sets forth provisions governing patent infringement actions related to this Act.Deems as patent infringement the submission of a statement under this Act by the applicant setting forth reasons why the making, use, or sale of the biosimilar product would not infringe the patent, or why the patent is invalid or unenforceable, if the purpose of such submission is to obtain approval to engage in the commercial manufacture, use, or sale before the expiration of such patent.

Date: 2009-03-17
Topic: Health (Drug Industry)
Subject: Health
Preservation of Antibiotics for Medical Treatment Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services 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: 2009-03-17
Topic: Health (Drug Industry)
Subject: Health
Hearing Aid Assistance Tax Credit Act - Amends the Internal Revenue Code to allow a nonrefundable income tax credit of up to $500 for the purchase of a qualified hearing aid for an individual who is either: (1) age 55 or older; or (2) is claimed as a dependent of the taxpayer. Denies such tax credit to any taxpayer whose modified adjusted gross income exceeds $200,000.

Date: 2009-03-19
Topic: Health (Drug Industry)
Subject: Taxation
Protecting Consumer Access to Generic Drugs Act of 2009 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period; or (2) the waiver of a patent infringement claim for damages. Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers. Amends the Federal Food, Drug, and Cosmetic Act to provide that a generic drug applicant forfeits market exclusivity for failing to market the drug 75 days after: (1) a court dismisses a declaratory judgment action for lack of subject matter jurisdiction; or (2) the applicant files with the Secretary of Health and Human Services a covenant that the patent owner will not sue the applicant for patent infringement. Deems an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

Date: 2009-03-25
Topic: Health (Drug Industry)
Subject: Commerce
Voluntary State Discount Prescription Drug Plan Act of 2009 - Amends title XIX (Medicaid) of the Social Security Act to require drug manufacturers to pay rebates to state prescription drug discount programs as a condition of participating in a Medicaid rebate agreement for outpatient prescription drugs, but only if the state has elected to establish an optional state prescription drug discount program.

Date: 2009-03-25
Topic: Health (Drug Industry)
Subject: Health
Medicare Prescription Drug Affordability Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to: (1) limit Medicare part D prescription drug plan (PDP) cost increases to the Social Security cost-of-living increase; and (2) direct the Secretary of Health and Human Services to negotiate with pharmaceutical manufacturers the prices that may be charged to PDP sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or under an MA-Prescription Drug (MA-PD) plan.

Date: 2009-03-31
Topic: Health (Drug Industry)
Subject: Health
Independent Drug Education and Outreach Act of 2009 - Amends the Public Health Service Act to require the Secretary of Health and Human Services, acting through the Director of the Agency for Healthcare Research and Quality, to award grants or contracts for: (1) the development and production of educational materials concerning the evidence available on the relative safety, effectiveness, and cost of prescription drugs, nonprescription drugs, and nondrug interventions for treating selected conditions, to be distributed and presented to health care providers who prescribe such drugs and their patients; and (2) the development and implementation of a program to appropriately train and deploy health professionals to distribute such materials to, and otherwise educate, physicians and other drug prescribers concerning such drugs and interventions. Requires that grantees receive no support from any entity that manufactures products used to treat the medical conditions discussed.

Date: 2009-04-01
Topic: Health (Drug Industry)
Subject: Health
Promoting Wellness for Individuals with Disabilities Act of 2009 - Amends the Rehabilitation Act of 1973 to require the Architectural and Transportation Barriers Compliance Board to issue and periodically review standards setting forth the minimum technical criteria for medical diagnostic equipment used in medical settings, to ensure that such equipment: (1) is accessible to and usable by individuals with disabilities; and (2) allows independent entry to, use of, and exit from the equipment by such individuals to the maximum extent possible. Applies such standards to examination tables and chairs, weight scales, mammography equipment, x-ray machines, and other radiological equipment commonly used for diagnostic purposes by health professionals. Sets forth interim standards for such equipment. Amends the Public Health Service Act to allow the Secretary of Health and Human Services to make grants for programs to promote good health, disease prevention, and wellness for individuals with disabilities and prevent secondary conditions in such individuals. Requires the Secretary to establish a National Advisory Committee on Wellness for Individuals With Disabilities to set priorities to carry out such programs, review grant proposals, make recommendations for funding, and annually evaluate the progress of such programs in implementing the priorities.Provides for training programs to improve competency and clinical skills for providing health care and communicating with patients with disabilities through training integrated into the core curriculum and patient interaction in community-based settings.

Date: 2009-04-02
Topic: Health (Drug Industry)
Subject: Health
Preserve Patient Access to Reputable DMEPOS Providers Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act to declare that the surety bond requirement under the Medicare program for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) shall apply only to a state-licensed retail pharmacy if there has been a final adverse action that is not subject to administrative or judicial appeal taken against such pharmacy during the 10-year period preceding the issuance (or renewal) of the provider number involved. (Thus exempts from the surety bond requirement any state-licensed retail pharmacy that has not been subject to such an adverse action for at least 10 years. Such adverse actions refer to: (1) a Medicare-imposed revocation of any Medicare billing privileges; (2) suspension or revocation of a license to provide health care by any state licensing authority; (3) revocation or suspension by an accreditation organization; (4) conviction of a federal or state felony offense within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) an exclusion or debarment from participation in a federal or state health care program.)

Date: 2009-04-02
Topic: Health (Drug Industry)
Subject: Health
Medicare Orthotics and Prosthetics Improvement Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act with respect to recognized independent accreditation organizations which apply quality standards for suppliers of items and services relating to prosthetic devices and orthotics and prosthetics. Directs the Secretary of Health and Human Services (HHS) to designate and approve an independent accreditation organization for such purposes only if it is the American Board for Certification in Orthotics and Prosthetics, Inc., the Board for Orthotist/Prosthetist Certification, or a program that the Secretary determines has accreditation and approval standards essentially equivalent to those of such a Board. Requires such organization to satisfy all applicable criteria of the provider qualification designation for each of specified categories of prosthetics and orthotics. Requires application to prosthetic devices and orthotics and prosthetics generally of existing accreditation and licensure requirements for certain custom-fabricated prosthetics and custom-fabricated orthotics, as well as those categorized as custom-fitted high or custom-fitted low. Modifies the Medicare payment methodology for prosthetic devices and orthotics and prosthetics to require the Secretary, for payment purposes, to take into account practitioner qualifications and complexity of care. Directs the Secretary to report to Congress on: (1) the steps taken by the Department of HHS to ensure that such licensure and accreditation requirements are enforced; and (2) the effect of the requirements of this Act on the occurrence of fraud and abuse under the Medicare program with respect to prosthetic devices and orthotics and prosthetics.

Date: 2009-05-19
Topic: Health (Drug Industry)
Subject: Health
Mercury-Free Vaccines Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to deem a banned mercury-containing vaccine to be adulterated. Amends the Public Health Service Act to provide that a vaccine is a banned mercury-containing vaccine if one dose of the vaccine contains one or more micrograms of mercury in any form. Authorizes the Secretary of Health and Human Services (HHS) to declare that an actual or potential bioterrorist incident or other public health emergency makes the administration of such vaccines advisable for a specified period. Requires the Secretary to prohibit the distribution of banned mercury-containing influenza vaccines that are approved as biological products to: (1) any child under the age of three years old (effective July 1, 2009); (2) pregnant women if the vaccine contains thimerosal (effective July 1, 2009); and (3) any child under the age of six (effective July 1, 2010). Requires the Secretary to revise the vaccine information included with mercury-containing vaccines to include: (1) a statement that indicates the presence of mercury in the vaccine; (2) information on the availability of any mercury-free or mercury-reduced alternative vaccine and instructions on how to obtain such an alternative vaccine; and (3) a recommendation against administration of any mercury-containing vaccine to a pregnant woman. Expresses the sense of Congress that the Centers for Disease Control and Prevention (CDC) should disseminate, with any vaccine-related information, a recommendation against administration of any thimerosal-containing vaccine to a pregnant woman.

Date: 2009-05-21
Topic: Health (Drug Industry)
Subject: Health
Vaccine Safety and Public Confidence Assurance Act of 2009 - Amends the Public Health Service Act to establish the Agency for Vaccine Safety Evaluation in the Office of the Secretary of Health and Human Services (HHS). Requires the Director for Vaccine Safety Evaluation to: (1) conduct or support safety research and monitor licensed vaccines; (2) develop a vaccine safety research agenda; (3) evaluate means to promote compliance with federal adverse reaction reporting requirements; (4) provide a clearinghouse for vaccine studies; (5) ensure that functions relating to vaccine monitoring or research on adverse reactions are not carried out by anyone with a conflict of interest; (6) oversee the Vaccine Safety Datalink Project; and (7) resolve U.S. conflicts of interest related to international agreements, partnerships, and activities. Allows the Director to establish a program of awarding fellowships for research on vaccine safety. Requires the Commissioner of Food and Drugs to provide the Director, upon request, with complete access to all vaccine-related information submitted to the Food and Drug Administration (FDA) by vaccine manufacturers. Requires the Director to require vaccine manufacturers to: (1) provide for postmarketing surveillance and clinical testing for any acute or chronic adverse reactions associated with the vaccine; and (2) register in a qualified public registry each clinical trial conducted or supported by the manufacturer with respect to the vaccine. Transfers to the Agency Centers for Disease Control and Prevention (CDC) responsibilities for the Vaccine Safety Datalink Project, the Clinical Immunization Safety Assessment Centers, or any other post-licensure vaccine safety monitoring activities. Requires the Secretary to establish an advisory council in the Agency.

Date: 2009-05-21
Topic: Health (Drug Industry)
Subject: Health