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

affordable biologics consumers act amends public_health_service_act allow person submit application approval biologics license biosimilar defined biological product claimed similar qualified biological product reference product defines qualified biological product biotechnology derived therapeutic biological protein product licensed approved cosmetic act allows secretary health_and_human_services approve application biosimilar indications reference product approved application conforms applicable final product class specific rule secretary concludes product safe authorizes person request issuance product class specific rule applicable qualified biological product class requires secretary establish prohibits approval biosimilar years elapsed approval reference product prohibits secretary approving product claimed similar reference product provision law approving biosimilar year approving biosimilar relies reference product designating biosimilar interchangeable therapeutically equivalent applicable reference product sets forth provisions related patents reference product allows approval application biosimilar effective patent litigation concluded amends cosmetic act deem misbranded biotechnology derived therapeutic protein labeling fails meet specified requirements


Summary: Access to Birth Control Act - Amends the Public Health Service Act to require pharmacies to comply with certain rules related to contraceptives, including: (1) providing a customer a contraceptive without delay if it is in stock; (2) immediately informing a customer if the contraceptive is not in stock and either transferring the prescription to a pharmacy that has the contraceptive in stock or expediting the ordering of the contraceptive and notifying the customer when it arrives, based on customer preference; and (3) ensuring that pharmacy employees do not take certain actions relating to a request for contraception, including intimidating, threatening, or harassing customers, interfering with or obstructing the delivery of services, intentionally misrepresenting or deceiving customers about the availability of contraception or its mechanism of action, breaching or threatening to breach medical confidentiality, or refusing to return a valid, lawful prescription.Provides that a pharmacy is not prohibited from refusing to provide a contraceptive to a customer if: (1) it is unlawful to dispense the contraceptive to the customer without a valid, lawful prescription and no such prescription is presented; (2) the customer is unable to pay for the contraceptive; or (3) the employee of the pharmacy refuses to provide the contraceptive on the basis of a professional clinical judgment.Provides that this Act does not preempt state law or any professional obligation of a state board that provides greater protections for customers.Sets forth civil penalties and establishes a a private cause of action for violations of this Act.

access birth control act amends public_health_service_act require pharmacies comply certain rules related contraceptives including providing customer contraceptive delay stock immediately informing customer contraceptive stock transferring prescription pharmacy contraceptive stock expediting ordering contraceptive notifying customer arrives based customer preference ensuring pharmacy employees certain actions relating request contraception including intimidating threatening harassing customers interfering obstructing delivery services intentionally misrepresenting deceiving customers availability contraception mechanism action breaching threatening breach medical confidentiality refusing return valid lawful prescription provides pharmacy prohibited refusing provide contraceptive customer unlawful dispense contraceptive customer valid lawful prescription prescription presented customer unable pay contraceptive employee pharmacy refuses provide contraceptive basis professional clinical judgment provides act preempt state law professional obligation state board provides greater protections customers sets forth civil penalties establishes private cause action violations act


Summary: Biologics Price Competition and Innovation Act of 2007 - 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). Sets forth application requirements, including that the application demonstrate that: (1) the biological is biosimilar to a reference product based upon data derived from studies; (2) the biological product and reference product utilize the same mechanism of action; and (3) the route of administration, the dosage form, and the strength of the biological product are the same as those of the reference product. Allows an application to include information demonstrating that the biological product is interchangeable with the reference product.Requires the Secretary of Health and Human Services to license the biological product if the information submitted in the application is sufficient to show that the biological product is biosimilar to or interchangeable with the reference product. Allows products to be determined to be interchangeable if: (1) the biological product is biosimilar to the reference product and can be expected to produce the same clinical result as the reference product in any given patient; and (2) the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is not greater than the risk of using the reference product without such alternation or switch.Prohibits a biological product from being evaluated against more than one reference product.Prohibits the Secretary from determining that a second or subsequent biological product is interchangeable with a reference product for any condition of use for specified periods based on the marketing of, and the presence or status of litigation involving, the first biosimilar biological product deemed interchangeable with the same reference product. Prohibits approval of an application under this Act from being made effective until 12 years after the reference product was first licensed.Authorizes the Secretary to issue guidance with respect to the licensure of a biological product after public comment. Requires the Secretary to establish a process through which the public may provide the Secretary with input regarding priorities for issuing guidance. Sets forth requirements for any product class-specific guidance that may be issued by the Secretary, including that such guidance include a description of the criteria that the Secretary will use to determine whether a biological product is highly similar to or interchangeable with a reference product in such product class. Allows the Secretary to indicate in a guidance document that the science and experience with respect to a product or product class does not allow approval of an application for a license under this Act.Sets forth provisions governing the exchange of confidential information related to patents for biological products. Requires confidential information to be used for the sole and exclusive purpose of determining whether a claim of patent infringement could reasonably be brought against the biosimilar biological product. Deems a disclosure of any confidential information in violation of this Act to cause the applicant to suffer irreparable harm for which there is no adequate legal remedy.Requires good faith negotiations between the reference product sponsor and an applicant under this Act. Sets forth provisions regarding patent infringement lawsuits, including the time frame for a reference product sponsor to bring an action for patent infringement.Requires the Secretary to: (1) develop recommendations with respect to the goals for the review process of biosimilar biological product applications; (2) collect and evaluate data regarding the cost of reviewing such applications; and (3) determine whether to alter the user fee applicable to such applications.Establishes the Biological Product Savings Fund in the Treasury to be funded with savings to the federal government as a result of the enactment of this Act and to be expended on activities authorized under the Public Health Service Act.Directs the Comptroller General to study and report to Congress on: (1) the extent to which pediatric studies of biological products are required under the Federal Food, Drug, and Cosmetic Act; and (2) any pediatric needs not being met under existing authority.Extends the time frame for a sponsor to have market exclusivity for a biological product designated for a rare disease or condition.

biologics price competition innovation act amends public_health_service_act allow person submit application licensure biological product based similarity licensed biological product reference product sets forth application requirements including application demonstrate biological biosimilar reference product based data derived studies biological product reference product utilize mechanism action route administration dosage form strength biological product reference product allows application include information demonstrating biological product interchangeable reference product requires secretary health_and_human_services license biological product information submitted application sufficient biological product biosimilar interchangeable reference product allows products determined interchangeable biological product biosimilar reference product expected produce clinical result reference product given patient risk terms safety diminished efficacy switching use biological product reference product greater risk reference product switch prohibits biological product evaluated reference product prohibits secretary determining second subsequent biological product interchangeable reference product condition use specified periods based marketing presence status litigation involving biosimilar biological product deemed interchangeable reference product prohibits approval application act effective years reference product licensed authorizes secretary issue guidance respect licensure biological product public comment requires secretary establish process public provide secretary input priorities issuing guidance sets forth requirements product class specific guidance issued secretary including guidance include description criteria secretary use determine biological product highly similar interchangeable reference product product class allows secretary indicate guidance document science experience respect product product class allow approval application license act sets forth provisions governing exchange confidential information related patents biological products requires confidential information sole exclusive purpose determining claim patent infringement reasonably brought biosimilar biological product deems disclosure confidential information violation act cause applicant suffer irreparable harm adequate legal remedy requires good faith negotiations reference product sponsor applicant act sets forth provisions patent infringement lawsuits including time frame reference product sponsor bring action patent infringement requires secretary develop recommendations respect goals review process biosimilar biological product applications collect evaluate data cost reviewing applications determine alter user fee applicable applications establishes treasury funded savings federal government result enactment act expended activities authorized public_health_service_act directs comptroller general study report congress extent pediatric studies biological products required cosmetic act pediatric needs met existing authority extends time frame sponsor market exclusivity biological product designated rare disease condition


Summary: Preserving Access to Laboratory Services Act of 2007 - Amends title XVIII (Medicare) of the Social Security Act to repeal the mandate for a Medicare Competitive Bidding Demonstration Project for Clinical Laboratory Services.

preserving access laboratory services act amends title xviii medicare social security act repeal mandate medicare competitive bidding demonstration project clinical laboratory services


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

community pharmacy fairness act entitles independent pharmacies negotiating contract terms health plan provision health care items services treatment antitrust laws treatment bargaining units recognized national_labor_relations_act entitled treats pharmacy employee engaged concerted activities connection negotiations exempts actions taken good faith reliance act subject criminal sanctions civil penalties actual damages incurred prohibits exempting antitrust laws agreement unlawful conspiracy excludes limits participation reimbursement limits scope services provided independent pharmacy group independent pharmacies respect performance services scope practice defined permitted relevant law regulation applying act negotiations independent pharmacies health plans pertaining federal health benefits


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

transparency medical device pricing act amends title xviii medicare social security act require manufacturers implantable medical devices report annually secretary health_and_human_services sales prices related data devices


Summary: Non-Prescription Drug Modernization Act of 2007 - Amends the Federal Food, Drug, and Cosmetic Act to authorize: (1) the amendment or repeal of an over-the-counter drug monograph without notice and public procedure if there is a finding by the Secretary of Health and Human Services that a category of drugs or a specific drug is associated with a significant risk or that such drugs lack evidence of effectiveness; and (2) the Food and Drug Administration (FDA) to regulate over-the-counter drug advertisements.Directs the Commissioner of Food and Drugs to identify over-the-counter drug monographs that may require amendment or repeal and to report the findings to Congress.

amends cosmetic act authorize amendment repeal counter drug notice public procedure finding secretary health_and_human_services category drugs specific drug associated significant risk drugs lack evidence effectiveness food_and_drug_administration fda regulate counter drug advertisements directs commissioner food drugs identify counter drug require amendment repeal report findings congress


Summary: 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).

prevention affordable access act amends title xix medicaid social security act revise requirements best price component formula determination medicaid rebate covered single source outpatient drug covered innovator multiple source outpatient drug current law best prices shall account prices merely nominal revises list entities sales manufacturer covered outpatient drugs nominal prices shall considered sales nominal price merely nominal excluded computation best price drugs adds list entity operated health center institution higher education primarily students university based clinic public private nonprofit entity provides family planning services public_health_service_act safety net clinic


Summary: 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.

directs secretary health_and_human_services establish demonstration project evaluate new approaches coding payment medicare program title xviii social security act ssa clinical diagnostic laboratory tests appoint standing panel determine tests included project recommendations derived project results secretary health_and_human_services amends ssa title xviii respect correction erroneous determinations changes fee schedule national limitation amounts clinical diagnostic laboratory tests issuance regulations gap filling methodology determining medicare fee schedule tests increased transparency process determining fee schedule amounts new tests mandatory advance notice clinical diagnostic laboratory test amounts considered adjustment inherent reasonableness authority


Summary: 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.

cosmetic act require secretary health_and_human_services publish federal_register postmarket surveillance plans medical devices information exempted freedom information act subjects medical device manufacturers fail comply postmarket surveillance requirements civil monetary penalties requires secretary consideration manufacturer making efforts correcting violation determining civil penalty authorizes secretary order notification health personnel relevant persons violation postmarket surveillance requirements device presents unreasonable risk substantial harm public health notification necessary eliminate risk practicable means available eliminate risk


Summary: 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.

access care access act amends federal food drug cosmetic act require secretary health_and_human_services permit investigational drug biological product device available expanded access treatment investigational new drug application treatment investigational device exemption specified compassionate investigational access requirements met gives immunity manufacturer distributor administrator sponsor physician suit liability relating products approved act establishes procedure accelerated approval investigational drug biological product device reasonably likely predict clinical benefit patient suffering life threatening condition requires secretary establish new program expand access investigational treatments individuals life threatening conditions diseases demonstration project medicare program pay drugs biological products devices approved act amends title xviii medicare social security act revise definition medically accepted indication provide coverage covered drug based sponsor organization determination drug medically accepted indication requires secretary consider clinical judgment risks patient disease condition evaluating safety effectiveness drugs biological products devices treat life threatening diseases conditions including evaluation information requires committee evaluating investigational drugs devices biological product applications patient representatives voting members


Summary: 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.

requires automobiles manufactured sold united_states beginning model year equipped real time average fuel economy display visible driver


Summary: 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.

medicare dmepos competitive acquisition reform act amends title xviii medicare social security act delay generally implementation medicare competitive acquisition program purchase durable medical equipment dme prosthetics orthotics supplies program dividing implementation rounds specifying covered item updates requirements application accreditation implementing quality standards requires suppliers disclose subcontractors directs secretary health_and_human_services provide competitive acquisition ombudsman respond complaints inquiries suppliers individuals specifies topics comptroller_general required study report congress impact competitive acquisition dme suppliers manufacturers patients sets forth special rule competitive acquisition program diabetic testing strips


Summary: 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.

amends cosmetic act require priority review vouchers given secretary health_and_human_services sponsor tropical disease product application transferable sponsors human drug applications approval new drug biological product prohibits vouchers redeemed affect review pending human drug application


Summary: Independent Drug Education and Outreach Act of 2008 - 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.

amends public_health_service_act require secretary health_and_human_services acting director agency healthcare_research quality award grants contracts development production educational materials concerning evidence available relative safety effectiveness cost prescription drugs nonprescription drugs interventions treating selected conditions distributed presented health care providers prescribe drugs patients development implementation program appropriately train deploy health professionals distribute materials educate physicians drug prescribers concerning drugs interventions requires grantees receive support entity manufactures products treat medical conditions discussed


Summary: 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.

medical device safety act amends cosmetic act provide provisions preempting state local requirements medical devices intended human use shall construed modify affect action damages liability person state law makes act effective included medical device amendments applicable civil action pending filed date enactment act


Summary: 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.

drug device accountability act amends cosmetic act ffdca deem drug device misbranded certain conditions related registration establishments identification prior transactions labeling country manufacture provision required information importation met includes definition drug precursor ingredient repeals registration exemption manufacturers harmless inactive ingredients components drugs expands information required included registration establishments deems drug adulterated certain conditions related verification identity purity identification establishments consistency current manufacturing technologies conformity good distribution import practices met sets forth provisions governing importation drug sets forth required actions including cessation distribution reasonable probability drug intended human use cause adverse health consequences death establishes actions manufacturers defective drug sets forth additional required certifications submissions related drugs devices accuracy information submitted personal knowledge information establishes whistleblower protection employees providing information drug biological product device directs secretary health_and_human_services establish maintain corps inspectors dedicated inspections foreign establishments foreign facilities authorizes secretary conduct investigations subpoena witnesses compel attendance witnesses necessary carry authority ffdca provisions governing regulation biological products requires reports secretary certain civil actions involving regulated product


Summary: 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.

organ transplant authorization act amends public_health_service_act increase maximum funds provided establishment operation fiscal year


Summary: 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.

transparency drug labeling act amends cosmetic act deem drug misbranded labeling drug lists identity country manufacture active ingredient inactive ingredient drug listed descending order based percentage number ingredients final dosage form manufactured countries


Summary: 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.

pharmaceutical market access drug safety act amends cosmetic act ffdca revise provisions governing importation prescription drugs waives limitation importation prescription drugs exported united_states prohibits importation qualifying drug drug imported registered importer individual personal use establishes registration conditions importers exporters requires secretary inspect places business verify chains custody inspect facilities determine compliance registration conditions sets forth provisions governing importation qualifying drugs different label drugs including standards judging differences prohibits manufacturers discriminating registered exporters importers causing difference prescription drug distributed united_states distributed permitted country engaging actions restrict prohibit delay importation qualifying drug engaging action federal_trade_commission ftc determines discriminates person engages attempts engage importation qualifying drug states resale united_states prescription drugs properly sold abroad patent infringement requires secretary educate consumers prescription drug importation sets forth provisions governing sale prescription drugs internet site includes dispensing selling prescription drug violation act prohibited act ffdca prohibits introduction restricted transactions unregistered foreign pharmacies payment system completion transactions payment system


Summary: 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.

amends cosmetic act exempt prescription drugs shipped directly state restrictions importation exported drugs


Summary: 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.

prescription drug affordability act amends internal revenue code allow nonrefundable tax credit percent paid prescribed drug taxable year compensated insurance taxpayer attained social security retirement age amends cosmetic act ffdca repeal provisions restricting importation prescription drugs allows person meets applicable legal requirements importer prescription drugs application secretary health_and_human_services requires secretary approve application drug meets ffdca requirements admission united_states including drug approved food_and_drug_administration fda adulterated misbranded prohibits secretary taking action persons involved interstate sale prescription drug internet site sale compliance ffdca controlled substances act applicable state laws accurate information compliance laws posted internet site


Summary: 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).


Summary: 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.

integrity act amends public_health_service_act expand drug discount program allow participation covered entity certain children hospitals critical access hospitals entities providing maternal child health services community mental health services treatment services substance abuse medicare dependent small rural hospitals sole community hospitals rural referral centers prohibits enrolled hospitals obtaining covered outpatient drugs group purchasing arrangement requires secretary health_and_human_services establish reasonable exceptions requirements including drugs unavailable program facilitate generic substitution generic covered drug available lower price expands program include drug connection inpatient outpatient service enrolled hospitals currently outpatient drugs covered hospitals enrolled 340b drug discount program provide state credit estimated annual costs hospital single source innovator multiple source drugs multiple source drugs provided medicaid recipients inpatient use sets forth formula calculating credit allows hospital avoid paying credits certain circumstances requires secretary carry activities improve compliance manufacturers covered entities requirements drug discount program establish administrative process resolving claims covered entities manufacturers violations requirements requires manufacturers offer covered entity covered drugs purchase applicable ceiling price drug available purchaser price


Summary: 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.

amends cosmetic act prohibit holder new approved drug application commencing manufacture market sell distribute generic version drug time receipt notice generic manufacturer abbreviated new drug application submitted approval expiration forfeiture exclusivity period granted generic manufacturer


Summary: 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.

amends cosmetic act ffdca set forth provisions governing food safety including requiring food facility hazard analysis facilities manufacture process pack transport hold food consumption united_states identification implementation preventive controls written food safety plan requires secretary health_and_human_services issue science based performance standards significantly minimize prevent eliminate occurrence hazards establish science based minimum standards safe production harvesting fruits vegetables necessary establish risk based inspection schedule establish program expedite movement certified food importation process provides accreditation system food facilities certification laboratories conduct sampling testing food requires secretary acting director centers_for_disease_control_and_prevention cdc establish active surveillance system food sets forth provisions governing drug device safety including providing risk based inspection schedules requiring quality risk management plans establishments requiring country origin labeling providing recall drugs sets forth provisions governing cosmetic safety including requiring cosmetic establishments submit secretary cosmetic ingredient statement cosmetic report unexpected adverse event united_states associated use cosmetic conform good manufacturing practices sets forth provisions governing food_and_drug_administration fda including provisions reorganization fda authorizing commissioner food drugs issue subpoenas proceeding violation ffdca


Summary: 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.

prohibits federal department agency court taking action administrative civil criminal prohibit interfere regulate restrict interstate traffic milk milk product unpasteurized packaged direct human consumption solely basis milk milk product unpasteurized adulterated misbranded violation federal law


Summary: 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.

protect consumers act requires secretary health_and_human_services determination necessary implement mandatory recall product regulated food_and_drug_administration fda issue order requiring appropriate person immediately cease distribution manufacture sale product immediately provide notice individuals subject risks associated use product implement immediate recall product directs order shall provide informal hearing days treats failure obey order prohibited act cosmetic act requires secretary study implement new procedures voluntary mandatory recalls


Summary: 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.

prevention act amends supplementary_medical_insurance title xviii medicare social security act provide coverage vaccine administration


Summary: 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.

safe drug disposal act amends controlled substances act direct attorney general promulgate regulations authorize ultimate user care person responsible taking care individuals animals dispose controlled substance accordance prescribed state program include model state programs providing disposal delivery designated facility allow state work attorney general devise alternative disposal program consistent act requires program require state enact legislation prerequisite adoption implementation protect public safety allow disposal controlled substances persons law enforcement personnel incorporate environmentally sound practices disposal cost effective include convenient options urban rural locations restrict funding state use implement allows program apply similarly drug biological product controlled substance directs comptroller general collect data state disposal programs periodically report congress amends cosmetic act direct secretary health_and_human_services approving drug applications licensing biological products ensure drug product labeling include recommendation direction dispose drug means wastewater treatment system toilet review labeling existing drugs products order revision labeling includes recommendation direction deems drug product labeling violation order misbranded


Summary: 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.

community pharmacy fairness act entitles independent pharmacies negotiating contract terms health plan provision health care items services treatment antitrust laws treatment bargaining units recognized national_labor_relations_act entitled treats pharmacy employee engaged concerted activities connection negotiations exempts actions taken good faith reliance act subject criminal sanctions civil penalties actual damages incurred provides act exempt application antitrust laws agreement unlawful conspiracy effect independent pharmacy exclude limit participation reimbursement limit scope services provided independent pharmacy group independent pharmacies respect performance services scope practice defined permitted relevant law regulation allocates market competitors unlawfully ties sale purchase product service sale purchase product service attempts market requires comptroller general study impact act years provides act preclude federal_trade_commission ftc department_of_justice doj overseeing conduct independent pharmacies covered act


Summary: 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.

amends cosmetic act deem adulterated unfinished dextromethorphan possessed received distributed violation act prohibits person possessing receiving unfinished dextromethorphan person registered secretary health_and_human_services producer drug device registered licensed approved pursuant federal state law engage practice pharmacy pharmaceutical production manufacture distribution drug ingredients distributing unfinished dextromethorphan person registered authorized person excludes prohibitions common carriers possess receive distribute unfinished dextromethorphan purposes distributing registered licensed approved persons


Summary: 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.

pharmaceutical market access drug safety act amends cosmetic act ffdca revise provisions governing importation prescription drugs waives limitation importation prescription drugs exported united_states prohibits importation qualifying drug drug imported registered importer individual personal use establishes registration conditions importers exporters requires secretary health_and_human_services inspect places business verify chains custody inspect facilities determine compliance registration conditions sets forth provisions governing importation qualifying drugs different label drugs including standards judging differences prohibits manufacturers discriminating registered exporters importers causing difference prescription drug distributed united_states distributed permitted country engaging actions restrict prohibit delay importation qualifying drug engaging action federal_trade_commission ftc determines discriminates person engages attempts engage importation qualifying drug states resale united_states prescription drugs properly sold abroad patent infringement requires secretary educate consumers prescription drug importation sets forth provisions governing sale prescription drugs internet site includes dispensing selling prescription drug violation act prohibited act ffdca prohibits introduction restricted transactions unregistered foreign pharmacies payment system completion transactions payment system


Summary: 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.

secure responsible drug disposal act amends controlled substances act allow ultimate user lawfully obtained controlled substance deliver substance person registered purpose disposal person receiving substance authorized engage activity disposal takes place accordance regulations issued attorney general prevent diversion controlled substances permits attorney general authorize long term care facilities dispose controlled substances behalf ultimate users manner provide effective controls diversion consistent public health safety


Summary: 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.

promoting innovation access life saving medicine act amends public_health_service_act provide licensing biosimilar interchangeable biological products defines biosimilar purposes act allows person file abbreviated biological product application secretary health_and_human_services requires applications include information demonstrating high degree similarity biological product licensed biological product reference product requires secretary approve application issue license biosimilar product secretary finds informs applicant information application fails demonstrate biological product reference product safety purity biological product establish requirements efficient review approval suspension revocation abbreviated biological product applications allows applicant request secretary determination product reference product based product expected produce clinical result reference product given patient grants market exclusivity biological product determined interchangeable specified period sets forth provisions governing patent infringement claims involving comparable biological products legal remedies expedite adjudication patent infringement disputes extends period approval biological products allow studies use new biological products pediatric population


Summary: 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.

amends cosmetic act establish criminal penalties fine imprisonment years person commits prohibited act relating counterfeiting knowing conduct concerns rendering drug counterfeit drug conduct cause drug counterfeit drug drug held sold dispensed counterfeit drug increases term imprisonment term years life use counterfeit drug proximate cause consumer death modifies provisions pertaining criminal fines committing certain prohibited acts involving food drugs devices cosmetics


Summary: 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.

pathway act amends public_health_service_act allow person submit application licensure biological product based similarity licensed biological product reference secretary health_and_human_services approve application biological product biosimilar reference product respect condition use reference product approved applicant consents inspection facility subject application sets forth requirements determination secretary biological product interchangeable reference product prohibits biological product evaluated reference product prohibits licensure act biological product containing specified agents toxins schedule controlled substance secretary determines increased risk security health public licensing biological product prohibits secretary making approval application act effective date reference product licensed provides confidentiality information received pursuant act sets forth provisions governing patent infringement actions related act deems patent infringement submission statement act applicant setting forth reasons making use sale biosimilar product infringe patent patent invalid unenforceable purpose submission obtain approval engage commercial manufacture use sale expiration patent


Summary: 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.

preservation_of_antibiotics_for_medical_treatment_act amends cosmetic act require secretary health_and_human_services deny application new animal drug critical antimicrobial animal drug applicant demonstrates reasonably certainty harm human health development antimicrobial resistance attributable nontherapeutic use drug defines critical antimicrobial animal drug drug intended use food producing animals contains specified antibiotics drugs humans treat prevent disease infection caused microorganisms requires secretary withdraw approval nontherapeutic use drugs food producing animals years date enactment act certain safety requirements met directs specified congressional committees hold hearings implementation withdrawal approval


Summary: 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.

hearing aid assistance tax credit act amends internal revenue code allow nonrefundable income tax credit purchase qualified hearing aid individual age older claimed dependent taxpayer denies tax credit taxpayer modified adjusted gross income exceeds


Summary: 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.

protecting consumer access generic drugs act prohibits unfair deceptive act practice unfair method competition affecting interstate commerce person party agreement resolving settling patent infringement claim abbreviated new drug generic application filer receives value filer agrees research develop manufacture market sell generic drug excludes resolution settlement includes right market generic drug expiration patent exclusivity period waiver patent infringement claim damages authorizes federal_trade_commission ftc exempt agreements furtherance market competition benefit consumers amends cosmetic act provide generic drug applicant market exclusivity failing market drug days court declaratory judgment action lack subject matter jurisdiction applicant files secretary health_and_human_services covenant patent owner sue applicant patent infringement deems applicant forfeited market exclusivity applicant enters agreement violates act amends medicare_prescription_drug improvement modernization act revise reporting requirements related agreements generic drug applicant brand drug company include description subject matter agreements parties certification materials filed represent complete final exclusive agreement parties


Summary: 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.

plan act amends title xix medicaid social security act require drug manufacturers pay rebates state prescription drug discount programs condition participating medicaid rebate agreement outpatient prescription drugs state elected establish optional state prescription drug discount program


Summary: 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.

amends voluntary prescription drug benefit program title xviii medicare social security act limit medicare prescription drug plan pdp cost increases social_security cost living increase direct secretary health_and_human_services negotiate pharmaceutical manufacturers prices charged pdp sponsors medicareadvantage organizations covered drugs eligible individuals enrolled pdp ma-prescription_drug ma-pd plan


Summary: 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.

amends public_health_service_act require secretary health_and_human_services acting director agency healthcare_research quality award grants contracts development production educational materials concerning evidence available relative safety effectiveness cost prescription drugs nonprescription drugs interventions treating selected conditions distributed presented health care providers prescribe drugs patients development implementation program appropriately train deploy health professionals distribute materials educate physicians drug prescribers concerning drugs interventions requires grantees receive support entity manufactures products treat medical conditions discussed


Summary: 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.

promoting wellness individuals disabilities act amends rehabilitation act require architectural_and_transportation_barriers_compliance_board issue periodically review standards setting forth minimum technical criteria medical diagnostic equipment medical settings ensure equipment accessible usable individuals disabilities allows independent entry use exit equipment individuals maximum extent possible applies standards examination tables chairs weight scales mammography equipment ray machines radiological equipment commonly diagnostic purposes health professionals sets forth interim standards equipment amends public_health_service_act allow secretary health_and_human_services grants programs promote good health disease prevention wellness individuals disabilities prevent secondary conditions individuals requires secretary establish set priorities carry programs review grant proposals recommendations funding annually evaluate progress programs implementing priorities provides training programs improve competency clinical skills providing health care communicating patients disabilities training integrated core curriculum patient interaction community based settings


Summary: 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.)

preserve patient access reputable dmepos providers act amends title xviii medicare social security act declare surety bond requirement medicare program suppliers durable medical equipment prosthetics orthotics supplies dmepos shall apply state licensed retail pharmacy final adverse action subject administrative judicial appeal taken pharmacy year period preceding issuance renewal provider number involved exempts surety bond requirement state licensed retail pharmacy subject adverse action years adverse actions refer medicare imposed revocation medicare billing privileges suspension revocation license provide health care state licensing authority revocation suspension accreditation organization conviction federal state felony offense years preceding enrollment enrollment exclusion debarment participation federal state health care program


Summary: 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.

medicare_orthotics prosthetics improvement act amends title xviii medicare social security act respect recognized independent accreditation organizations apply quality standards suppliers items services relating prosthetic devices orthotics prosthetics directs secretary health_and_human_services hhs designate approve independent accreditation organization purposes program secretary determines accreditation approval standards essentially equivalent board requires organization satisfy applicable criteria provider qualification designation specified categories prosthetics orthotics requires application prosthetic devices orthotics prosthetics generally existing accreditation licensure requirements certain custom fabricated prosthetics custom fabricated orthotics categorized custom fitted high custom fitted low modifies medicare payment methodology prosthetic devices orthotics prosthetics require secretary payment purposes account practitioner qualifications complexity care directs secretary report congress steps taken ensure licensure accreditation requirements enforced effect requirements act occurrence fraud abuse medicare program respect prosthetic devices orthotics prosthetics


Summary: 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.

amends cosmetic act deem banned mercury containing vaccine adulterated amends public_health_service_act provide vaccine banned mercury containing vaccine dose vaccine contains micrograms mercury form authorizes secretary health_and_human_services hhs declare actual potential incident public health emergency makes administration vaccines advisable specified period requires secretary prohibit distribution banned mercury containing influenza vaccines approved biological products child age years old effective july pregnant women vaccine contains effective july child age effective july requires secretary revise vaccine information included mercury containing vaccines include statement indicates presence mercury vaccine information availability mercury free mercury reduced alternative vaccine instructions obtain alternative vaccine recommendation administration mercury containing vaccine pregnant woman expresses sense congress centers_for_disease_control_and_prevention cdc disseminate vaccine related information recommendation administration containing vaccine pregnant woman


Summary: 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.

assurance act amends public_health_service_act establish agency vaccine safety evaluation office_of_the_secretary health_and_human_services hhs requires director conduct support safety research monitor licensed vaccines develop vaccine safety research agenda evaluate means promote compliance federal adverse reaction reporting requirements provide clearinghouse vaccine studies ensure functions relating vaccine monitoring research adverse reactions carried conflict interest oversee resolve conflicts interest related international agreements partnerships activities allows director establish program awarding fellowships research vaccine safety requires commissioner food drugs provide director request complete access vaccine related information submitted food_and_drug_administration fda vaccine manufacturers requires director require vaccine manufacturers provide surveillance clinical testing acute chronic adverse reactions associated vaccine register qualified public registry clinical trial conducted supported manufacturer respect vaccine transfers cdc responsibilities post licensure vaccine safety monitoring activities requires secretary establish advisory council agency


Summary: Prescription Coverage for Now Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to direct the Commissioner of Social Security, through certain information requests to the Secretary of the Treasury, to provide for the identification of individuals potentially eligible for low-income subsidies (LIS) and transmit them low-income subsidy applications if they are also part D eligible. Requires the Secretary of Health and Human Services, jointly with the Commissioner, to develop a model, simplified low-income subsidy application and process. Amends the Internal Revenue Code to require the Secretary of the Treasury, upon the Commissioner's request, to disclose tax return information to facilitate identification of individuals likely to be eligible for Medicare prescription drug program low-income subsidies. Entitles low-income subsidy beneficiaries to retroactive reimbursement for previously incurred covered drug costs. Prescribes requirements for enhanced oversight and enforcement relating to such reimbursements. Establishes an asset standard for LIS eligibility for 2011 of $27,500 (or $55,000 in the case of the combined value of the individual's assets or resources and the assets or resources of the individual's spouse), increased in subsequent years by the annual percentage increase in the consumer price index. Exempts retirement benefits from resources under the LIS programs. Increases the income eligibility to 150% of the federal poverty level (FPL) for full benefits and 200% of the FPL for partial benefits under the LIS program. Authorizes indexing of deductible and cost-sharing above the annual out-of-pocket threshold for individuals with incomes below 200% of FPL. Prohibits the treating of LIS premium and cost-sharing subsidies as benefits, or otherwise taking them into account, in determining an individual's eligibility for, or amount of benefits under, any other federal program. Requires individuals eligible for Medicare Savings Programs to be deemed subsidy eligible individuals under LIS. Establishes a special enrollment period for subsidy eligible individuals under LIS.

prescription coverage act amends voluntary prescription drug benefit program title xviii medicare social security act ssa direct commissioner social_security certain information requests secretary treasury provide identification individuals potentially eligible low income subsidies lis transmit low income subsidy applications eligible requires secretary health_and_human_services jointly commissioner develop model simplified low income subsidy application process amends internal revenue code require secretary treasury commissioner request disclose tax return information facilitate identification individuals likely eligible medicare prescription drug program low income subsidies entitles low income subsidy beneficiaries retroactive reimbursement previously incurred covered drug costs prescribes requirements enhanced oversight enforcement relating reimbursements establishes asset standard lis eligibility case combined value individual assets resources assets resources individual spouse increased subsequent years annual percentage increase consumer price index exempts retirement benefits resources lis programs increases income eligibility federal poverty level fpl benefits fpl partial benefits lis program authorizes indexing deductible cost sharing annual pocket threshold individuals incomes fpl prohibits treating lis premium cost sharing subsidies benefits taking account determining individual eligibility benefits federal program requires individuals eligible deemed subsidy eligible individuals lis establishes special enrollment period subsidy eligible individuals lis