Summary: Tim Fagan's Law or the Counterfeit Drug Enforcement Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to establish a criminal fine and/or imprisonment for a person who: (1) knowingly causes a prescription drug to be adulterated, misbranded, or misrepresented as an approved prescription drug and sells or trades the drug; or (2) purchases or trades for such drug knowing or having reason to know that the drug was knowingly adulterated, misbranded, or misrepresented. Requires a manufacturer of a drug to notify the Secretary of Health and Human Services (HHS) within 48 hours after first receiving or becoming aware of information that reasonably suggests that such a violation may have occurred. Deems a drug to be misbranded if it is not manufactured in accordance with the use of technologies that the Secretary determines are technically feasible and will assist in preventing such violations. Requires the Secretary to establish alternative requirements to the extent that such requirements provide greater certainty on the chain of custody and are technically feasible. Increases funding for Food and Drug Administration (FDA) inspections, examinations, and investigations. Requires the Secretary to educate the public and health care professionals on counterfeit drugs. Directs the Secretary: (1) upon a finding of reasonable probability that a drug intended for human use would cause serious health consequences or death, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering or prescribing the drug; and (2) amend the order to include a recall if necessary.

amends cosmetic act establish criminal fine imprisonment person knowingly causes prescription drug adulterated misbranded misrepresented approved prescription drug sells trades drug purchases trades drug knowing having reason know drug knowingly adulterated misbranded misrepresented requires manufacturer drug notify secretary health_and_human_services hhs hours receiving aware information reasonably suggests violation occurred deems drug misbranded manufactured accordance use technologies secretary determines technically feasible assist preventing violations requires secretary establish alternative requirements extent requirements provide greater certainty chain custody technically feasible increases funding food_and_drug_administration fda inspections examinations investigations requires secretary educate public health care professionals counterfeit drugs directs secretary finding reasonable probability drug intended human use cause health consequences death issue order requiring appropriate person including manufacturers importers distributors retailers drug cease distribution drug notify instruct health professionals cease administering prescribing drug amend order include recall necessary


Summary: Living Organ Donor Job Security Act - Amends the Family and Medical Leave Act of 1993 (FMLA) to entitle employees covered by FMLA to leave to provide a living organ donation, including for time spent for: (1) tests to determine medical suitability of the employee for donation; (2) physical, psychological, and social evaluations of the donor; (3) pretransplant outpatient services; (4) postoperative inpatient and outpatient transplantation services; (5) travel in connection with such tests, evaluations, and services; and (6) recuperation. Amends federal civil service law to entitle civilian federal employees the same leave allowance.

living organ donor job security act amends family medical leave act fmla entitle employees covered fmla leave provide living organ donation including time spent tests determine medical suitability employee donation physical psychological social evaluations donor outpatient services inpatient outpatient transplantation services travel connection tests evaluations services recuperation amends federal civil service law entitle civilian federal employees leave allowance


Summary: Amends the Internal Revenue Code to deny a tax deduction for advertising and related expenses to promote the sale or use of any prescription drug.

amends internal revenue code deny tax deduction advertising related expenses promote sale use prescription drug


Summary: Amends title XVIII (Medicare) of the Social Security Act to permit a Medicare beneficiary to elect to take, or decline to take, ownership of a Group 3 Support Surface item of complex durable medical equipment (DME) after the 13-month capped rental period ends.

amends title xviii medicare social security act permit medicare beneficiary elect decline ownership group support surface item complex durable medical equipment dme month capped rental period ends


Summary: Say No to Drug Ads Act - Amends the Internal Revenue Code to deny a tax deduction for the cost of direct-to-consumer advertisement of a prescription drug.

drug ads act amends internal revenue code deny tax deduction cost direct consumer advertisement prescription drug


Summary: Medicare Safe Needle Disposal Coverage Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to cover as a part D drug any devices approved for home use by the Food and Drug Administration (FDA) for the safe and effective containment, removal, decontamination, and disposal of home-generated needles, syringes, and other sharps through a sharps container, decontamination/destructive device, or sharps-by-mail program or similar program.

medicare_safe_needle_disposal_coverage_act amends voluntary prescription drug benefit program title xviii medicare social security act cover drug devices approved home use food_and_drug_administration fda safe effective containment removal decontamination disposal home generated needles syringes sharps sharps container decontamination destructive device sharps mail program similar program


Summary: Amends the Internal Revenue Code to exclude from gross income gain from the sale of certain residential leased-fee interests to a holder of the leasehold right if such holder is: (1) an association of apartment owners of a multi-family residential leasehold property; or (2) a cooperative housing corporation for a residential leasehold property. Terminates such exclusion after 2014.

amends internal revenue code exclude gross income gain sale certain residential leased fee interests holder leasehold right holder association apartment owners multi family residential leasehold property cooperative housing corporation residential leasehold property terminates exclusion


Summary: Access to Medical Treatment Act - Gives an individual the right to be treated by a health care practitioner with any medical treatment that the individual desires, including a treatment that is not approved, certified, or licensed by the Secretary of Health and Human Services (HHS), if: (1) the practitioner has personally examined the individual and agrees to treat the individual; and (2) the administration of such treatment does not violate licensing laws. Authorizes health care practitioners to provide any method of treatment to such an individual if certain requirements are met, including that: (1) there is no reason to conclude that such treatment will cause danger to the individual; and (2) the patient is informed in writing that such treatment has not been approved, certified, or licensed by the Secretary. Requires a practitioner to report: (1) administering such treatment and discovering it to be a danger to an individual; and (2) the positive effects of an unconventional medical treatment for a life-threatening medical condition. Allows an individual to introduce or deliver into interstate commerce, or to produce, transport, receive, or hold, a food, drug, device, or equipment solely for use in accordance with this Act if there have been no advertising claims made by the manufacturer, distributor, or seller with respect to a medical treatment. States that nothing in this Act shall in any way adversely affect the distribution or sale of dietary supplements.

individual right treated health care practitioner medical treatment individual desires including treatment approved certified licensed secretary health_and_human_services hhs practitioner personally examined individual agrees treat individual administration treatment violate licensing laws authorizes health care practitioners provide method treatment individual certain requirements met including reason conclude treatment cause danger individual patient informed writing treatment approved certified licensed secretary requires practitioner report administering treatment discovering danger individual positive effects unconventional medical treatment life threatening medical condition allows individual introduce deliver interstate commerce produce transport receive hold food drug device equipment solely use accordance act advertising claims manufacturer distributor seller respect medical treatment states act shall way adversely affect distribution sale dietary supplements


Summary: Tax Equity for Meal Replacements and Supplements Act of 2009 - Amends the Internal Revenue Code to treat as medical care certain dietary supplements and meal replacement products evaluated by the Food and Drug Administration (FDA) for purposes of the tax exclusion for employer reimbursements of employee medical care expenses.

tax equity meal replacements supplements act amends internal revenue code treat medical care certain dietary supplements meal replacement products evaluated food_and_drug_administration fda purposes tax exclusion employer reimbursements employee medical care expenses


Summary: Medicare Prescription Drug Cost Equalization Act - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require application to specialty tier drugs (very high cost and unique items) of the process for exception from the tiered cost-sharing for drugs included within a formulary. (Under an exception, a nonpreferred drug could be covered under the terms applicable for preferred drugs if the prescribing physician determines that the preferred drug for treatment of the same condition either would not be as effective for the individual, or would have adverse effects for the individual, or both.)

voluntary prescription drug benefit program title xviii medicare social security act require application specialty tier drugs high cost unique items process exception tiered cost sharing drugs included formulary exception drug covered terms applicable preferred drugs prescribing physician determines preferred drug treatment condition effective individual adverse effects individual


Summary: Consistency, Accuracy, Responsibility, and Excellence in Medical Imaging and Radiation Therapy Act of 2009 - Amends the Public Health Service Act to require personnel who perform or plan the technical component of either medical imaging examinations or radiation therapy procedures for medical purposes to possess, effective January 1, 2013: (1) certification in each medical imaging or radiation therapy modality and service provided from a certification organization designated by the Secretary of Health and Human Services (HHS); or (2) state licensure or certification where such services and modalities are within the scope of practice as defined by the state for such profession and where the requirements for licensure, certification, or registration meet or exceed the standards established by the Secretary. Exempts physicians, nurse practitioners, and physician assistants. Directs the Secretary to: (1) establish minimum standards for personnel who perform, plan, evaluate, or verify patient dose for medical imaging examinations or radiation therapy procedures; (2) establish a program for designating certification organizations after consideration of specified criteria; (3) provide a method for the recognition of individuals whose training or experience are determined to be equal to, or in excess of, those of a graduate of an accredited educational program in that specialty; and (4) approve and publish a list of accrediting bodies for such certification organizations. Authorizes the Secretary to develop alternative standards for rural or health professional shortage areas as appropriate to assure access to quality medical imaging. Amends the Social Security Act to allow Medicare payment for medical imaging and radiation therapy services furnished on or after January 1, 2013, only if the examination or procedure is planned or performed by an individual who meets this Act's requirements.

consistency accuracy responsibility excellence medical imaging radiation therapy act amends public_health_service_act require personnel perform plan technical component medical imaging examinations radiation therapy procedures medical purposes possess effective january certification medical imaging radiation therapy modality service provided certification organization designated secretary health_and_human_services hhs state licensure certification services modalities scope practice defined state profession requirements licensure certification registration meet exceed standards established secretary exempts physicians nurse practitioners physician assistants directs secretary establish minimum standards personnel perform plan evaluate verify patient dose medical imaging examinations radiation therapy procedures establish program designating certification organizations consideration specified criteria provide method recognition individuals training experience determined equal excess graduate accredited educational program specialty approve publish list accrediting bodies certification organizations authorizes secretary develop alternative standards rural health professional shortage areas appropriate assure access quality medical imaging amends social security act allow medicare payment medical imaging radiation therapy services furnished january examination procedure planned performed individual meets act requirements


Summary: (This measure has not been amended since it was introduced. The summary of that version is repeated here.) Amends title XVIII (Medicare) of the Social Security Act to postpone until January 1, 2010, the effective date of the requirement that pharmacies, as suppliers of Medicare items and services (including durable medical equipment [DME]), must be accredited by an independent accreditation organization approved by the Secretary of Health and Human Services (HHS). Declares that nothing in this Act shall be construed to affect the application of an accreditation requirement for pharmacies to qualify for bidding in a competitive acquisition area.

measure amended introduced summary version repeated amends title xviii medicare social security act postpone january effective date requirement pharmacies suppliers medicare items services including durable medical equipment dme accredited independent accreditation organization approved secretary health_and_human_services hhs declares act shall construed affect application accreditation requirement pharmacies qualify bidding competitive acquisition area


Summary: Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.

drug price competition act amends cosmetic act expand definition applicant act allow generic drug manufacturer currently considered applicant subsequent brand manufacturer day exclusivity period qualify applicant purposes filing abbreviated application new drug requires applicant submit substantially complete application contains lawfully maintains certification drug


Summary: Strengthening of FDA Integrity Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to apply debarment provisions currently applicable to abbreviated new drugs to any drug products, including new drugs, animal drugs, exported drugs, biological products, and medical devices. Expands the conditions under which persons (i.e., partnerships, corporations, and associations) are subject to mandatory and permissive debarment preventing such persons from submitting an application for approval of a drug product. Requires the Secretary of Health and Human Services (HHS), in determining the appropriateness and the period of debarment, to consider whether debarment will affect the public health because sufficient quantities of the drug would not be available. Requires the Secretary to annually report to Congress on the implementation of debarment provisions.

strengthening amends cosmetic act apply debarment provisions currently applicable abbreviated new drugs drug products including new drugs animal drugs exported drugs biological products medical devices expands conditions persons partnerships corporations associations subject mandatory debarment preventing persons submitting application approval drug product requires secretary health_and_human_services hhs determining appropriateness period debarment consider debarment affect public health sufficient quantities drug available requires secretary annually report congress implementation debarment provisions


Summary: Protecting Americans from Drug Marketing Act - Amends the Internal Revenue Code to deny a business expense tax deduction for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals.

protecting americans deny business expense tax deduction expenses relating advertising promoting sale use prescription pharmaceuticals


Summary: Establishes a six-month grace period following enactment of this Act during which otherwise qualifying durable medical equipment (DME) suppliers that do not yet meet Medicare accreditation and surety bond requirements must meet them. Requires such suppliers to be treated as having met the requirements between the effective date of the requirements and the date on which they first meet them, so long as they actually do meet them within six months after enactment of this Act.

establishes month grace period following enactment act qualifying durable medical equipment dme suppliers meet medicare accreditation surety bond requirements meet requires suppliers treated having met requirements effective date requirements date meet long actually meet months enactment act


Summary: Compassionate Access Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) 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. 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.

compassionate access act amends cosmetic act require secretary health_and_human_services hhs 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 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: Amends the McCarran-Ferguson Act to restore application of the Clayton Act and other antitrust laws to insurers. Prohibits premium variation except by geographic premium rating area and by family enrollment. Requires each health benefits plan issuer that offers health insurance coverage in the individual or group market in a state to accept every employer and individual in the state that applies for such coverage. Places restrictions on federal funding of abortion, except in cases of certain physical conditions, rape, or incest. Limits a health benefits plan to selling health insurance coverage to U.S. citizens and lawful resident aliens. Amends title XVIII (Medicare) and title XIX (Medicaid) of the Social Security Act to revise requirements for: (1) Medicare Advantage, with respect to the blended benchmark amount and elimination of the MA Regional Plan Stabilization Fund; (2) an increase in the physician fee schedule practice expense geographic adjustment; (3) establishment of a Medicare operated prescription drug plan option; and (4) pharmacy reimbursement. Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise requirements for the importation of prescription drugs. Requires the registration of importers and exporters. Prescribes requirements for: (1) the disposition of certain drugs denied admission into the United States; (2) alternative identification of the chain of custody of certain prescription drugs, including through the use of standardized anti-counterfeiting or track-and-trace technologies; and (3) the sale of prescription drugs through an Internet site. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system. Amends the Internal Revenue Code to disallow a deduction from income for advertising and promotional expenses for prescription pharmaceuticals. Requires a pharmacy benefit manager with a contract with a health benefits plan to comply with fiduciary standards established by the Secretary of Health and Human Services (HHS). Amends SSA title XIX (Medicaid) to require any drug manufacturer with a rebate agreement concerning covered outpatient drugs to report to the HHS Secretary following a rebate period the total number of units used to calculate the monthly average manufacturer price for each covered outpatient drug.

amends mccarran ferguson act restore application clayton act antitrust laws insurers prohibits premium variation geographic premium rating area family enrollment requires health benefits plan issuer offers health insurance coverage individual group market state accept employer individual state applies coverage places restrictions federal funding abortion cases certain physical conditions rape incest limits health benefits plan selling health insurance coverage citizens lawful resident aliens amends title xviii medicare title xix medicaid social security act revise requirements medicare_advantage respect blended benchmark elimination regional plan stabilization fund increase physician fee schedule practice expense geographic adjustment establishment medicare operated prescription drug plan option pharmacy reimbursement amends cosmetic act ffdca revise requirements importation prescription drugs requires registration importers exporters prescribes requirements disposition certain drugs denied admission united_states alternative identification chain custody certain prescription drugs including use standardized anti counterfeiting track trace technologies sale prescription drugs internet site prohibits introduction restricted transactions unregistered foreign pharmacies payment system completion transactions payment system amends internal revenue code disallow deduction income advertising promotional expenses prescription pharmaceuticals requires pharmacy benefit manager contract health benefits plan comply fiduciary standards established secretary health_and_human_services hhs amends ssa title xix medicaid require drug manufacturer rebate agreement concerning covered outpatient drugs report hhs secretary following rebate period total number units calculate monthly average manufacturer price covered outpatient drug


Summary: Food and Drug Administration Improvement Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that all fees collected for the review of applications for human drugs, devices, animal drugs, or generic animal drugs be deposited in the general fund of the Treasury. Makes available amounts necessary for the Secretary of Health and Human Services (HHS) to review such applications. Prohibits the Secretary from entering into agreements with persons from whom such fees are collected and terminates any existing agreements. Requires the Secretary to: (1) establish the Center for Postmarket Drug, Device, and Biologic Safety and Effectiveness within the Food and Drug Administration (FDA) to regulate approved drugs; and (2) transfer to the Center all responsibilities for such regulation from the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, or the Center for Devices and Radiological Health Organization. Requires a statement regarding the reporting of negative side effects of prescription drugs in televised direct-to-consumer drug advertisements (currently required in published advertisements). Requires the Commissioner of Food and Drugs to: (1) complete a review of the FDA's regulations and guidance pertaining to the labeling of drugs and biological products; and (2) post on the FDA's website all clinical trial adverse events included in the registry and results data bank of the National Institutes of Health (NIH). Requires payment of a fee to the Secretary for the advertisement of drugs and devices. Requires doctors to inform patients and obtain consent to prescribe an approved drug for a purpose that has not been approved by the FDA.

amends cosmetic act ffdca require fees collected review applications human drugs devices animal drugs generic animal drugs deposited general fund treasury makes available amounts necessary secretary health_and_human_services hhs review applications prohibits secretary entering agreements persons fees collected terminates existing agreements requires secretary establish device food_and_drug_administration fda regulate approved drugs transfer center responsibilities regulation center_for_drug_evaluation_and_research center_for_biologics_evaluation_and_research requires statement reporting negative effects prescription drugs direct consumer drug advertisements currently required published advertisements requires commissioner food drugs complete review fda regulations guidance pertaining labeling drugs biological products post fda website clinical trial adverse events included registry results data bank national_institutes_of_health nih requires payment fee secretary advertisement drugs devices requires doctors inform patients obtain consent prescribe approved drug purpose approved fda


Summary: Stop Oxy Abuse Act of 2010 - Directs the Commissioner of Food and Drugs (FDA), within 90 days, to take such actions as may be necessary to modify the approval of, and limit any subsequent approval of, any drug containing controlled-release oxycodone hychloride to use for the relief of severe-only pain instead of moderate-to-severe pain. Applies any such modification to drugs introduced into interstate commerce 180 days after enactment of this Act.

stop abuse act directs commissioner food drugs fda days actions necessary modify approval limit subsequent approval drug containing controlled release use relief severe pain instead moderate severe pain applies modification drugs introduced interstate commerce days enactment act


Summary: Protect Medical Innovation Act - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers (established by the Patient Protection and Affordable Care Act [PPACA]).

protect medical innovation act amends internal revenue code repeal excise tax medical device manufacturers importers established patient_protection affordable care act ppaca


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, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; 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 pharmacies ordinarily stock contraceptives normal course business 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: Repeals the excise tax on medical devices enacted by the Health Care and Education Reconciliation Act of 2010. Rescinds the unobligated balance of the discretionary appropriations made available by the American Recovery and Reinvestment Act of 2009.

repeals excise tax medical devices enacted health_care_and_education reconciliation act rescinds unobligated balance discretionary appropriations available american_recovery_and_reinvestment_act


Summary: Amends the Federal Food, Drug, and Cosmetic Act to require any registered producer of a drug or device to notify the Secretary of Health and Human Services (HHS), as soon as practicable, of the identity and location of a drug, if such person has reason to believe: (1) that such drug is adulterated or misbranded; and (2) there is a reasonable probability that the use or consumption of, or exposure to, the drug will cause a threat of serious adverse health consequences or death to humans or animals. Authorizes the Secretary to: (1) request that any person who distributes a drug that the Secretary has reason to believe is adulterated, misbranded, or otherwise in violation of the FFDCA voluntarily recall such drug; (2) issue an order requiring any person who distributes a drug that may cause serious adverse health consequences or death to humans or animals to immediately cease distribution of such drug; (3) amend the order to cease distribution to include a recall of the drug after an opportunity for an informal hearing; and (4) issue an order requiring an immediate recall of a drug if the Secretary has credible evidence or information that a drug subject to a cease distribution or recall order presents an imminent threat of serious adverse health consequences or death to humans or animals. Provides for notice to affected persons. Prohibits the failure to comply with the notification requirements of, or orders issued pursuant to, this Act. Requires the Secretary to provide notice of a recall order to consumers to whom the drug was, or may have been, distributed and to appropriate state and local health officials, as necessary.

amends cosmetic act require registered producer drug device notify secretary health_and_human_services hhs soon practicable identity location drug person reason believe drug adulterated misbranded reasonable probability use consumption exposure drug cause threat adverse health consequences death humans animals authorizes secretary request person distributes drug secretary reason believe adulterated misbranded violation ffdca voluntarily recall drug issue order requiring person distributes drug cause adverse health consequences death humans animals immediately cease distribution drug amend order cease distribution include recall drug opportunity informal hearing issue order requiring immediate recall drug secretary credible evidence information drug subject cease distribution recall order presents imminent threat adverse health consequences death humans animals provides notice affected persons prohibits failure comply notification requirements orders issued pursuant act requires secretary provide notice recall order consumers drug distributed appropriate state local health officials necessary


Summary: America Rx Act of 2010 - Requires the Secretary of Health and Human Services (HHS) to establish the America Rx program to provide qualified residents with access to discounted prices for outpatient prescription drugs through rebate agreements that the Secretary negotiates with prescription drug manufacturers. Makes eligible only those residents that are not covered under any public or private program that provides substantial benefits towards the purchase of outpatient prescription drugs. Requires rebates to be payable to the Secretary at least quarterly and to be paid, directly or through states, to participating pharmacies that provide discounts to qualified residents. Denies manufacturers who do not participate in the rebate program a tax deduction for advertising and marketing expenses of drugs.

america act requires secretary health_and_human_services hhs establish america program provide qualified residents access discounted prices outpatient prescription drugs rebate agreements secretary prescription drug manufacturers makes eligible residents covered public private program provides substantial benefits purchase outpatient prescription drugs requires rebates payable secretary quarterly paid directly states participating pharmacies provide discounts qualified residents denies manufacturers participate rebate program tax deduction advertising marketing expenses drugs


Summary: Safe Prescription Drug Disposal and Education Act - Amends the Controlled Substances Act to permit, for purposes of carrying out the grant program established by this Act for drug disposal units: (1) an ultimate user (or an authorized agent of the ultimate user) who has lawfully obtained a controlled substance to deliver such substance, without being registered, to another person for disposal; and (2) such person to receive such substance for disposal, without being registered. Authorizes the Attorney General to make grants to an eligible entity (i.e., a state, local government, local educational agency, Indian tribe, a federal, state, or local governmental agency, corporation, community coalition, or any combination of such entities) to: (1) establish and operate prescription drug disposal units for disposal of unneeded or expired prescription drugs; and (2) design and implement educational programs on the abuse of prescription drugs and on household items that may be used to cause perception, emotion, or behavior similar to that caused by the use of psychotropic drugs. Directs the Director of National Drug Control Policy to carry out a public education and outreach campaign to increase awareness of how ultimate users may lawfully and safely dispose of prescription drugs, including controlled substances, through drug take-back programs.

safe prescription drug disposal education act amends controlled substances act permit purposes carrying grant program established act drug disposal units ultimate user authorized agent ultimate user lawfully obtained controlled substance deliver substance registered person disposal person receive substance disposal registered authorizes attorney general grants eligible entity state local government local educational agency indian tribe federal state local governmental agency corporation community coalition combination entities establish operate prescription drug disposal units disposal expired prescription drugs design implement educational programs abuse prescription drugs household items cause perception behavior similar caused use psychotropic drugs directs director national_drug_control_policy carry public education outreach campaign increase awareness ultimate users lawfully safely dispose prescription drugs including controlled substances drug programs


Summary: Amends title XVIII (Medicare) of the Social Security Act to exempt qualified hospital-related durable medical equipment (DME) entities from programs for competitive acquisition of items and services. Defines a qualified hospital-related DME entity as a DME supplier that: (1) owns and controls, is owned and controlled by, or is under common ownership and control with one or more hospitals or one or more hospitals and a university; and (2) meets the applicable quality and financial standards. Declares that in the case of certain DME and medical supplies furnished by a qualified hospital-related DME entity in a competitive acquisition area for which a contract is in effect: (1) the competitive acquisition programs shall not apply; and (2) payment shall be made to the entity without regard to whether it submitted a bid or was awarded such a contract, and in the amount payable for such equipment and supplies under the contract for the area and period involved. Limits the application of this Act to items and services furnished by a qualified hospital-related DME entity that: (1) has provided satisfactory assurances that a substantial majority of its patients who are enrolled under Medicare part B (Supplementary Medical Insurance) are patients of a hospital that owns and controls, or is owned and controlled by, the entity or any provider of services affiliated with the hospital; and (2) was either furnishing items and services of such type on or before April 1, 2010, or owns and controls, is owned and controlled by, or is under common ownership and control with, a hospital (or one or more hospitals and a university) that was furnishing such items or services of such type on or before such date.

amends title xviii medicare social security act exempt qualified hospital related durable medical equipment dme entities programs competitive acquisition items services defines qualified hospital related dme entity dme supplier owns controls owned controlled common ownership control hospitals hospitals university meets applicable quality financial standards declares case certain dme medical supplies furnished qualified hospital related dme entity competitive acquisition area contract effect competitive acquisition programs shall apply payment shall entity regard submitted bid awarded contract payable equipment supplies contract area period involved limits application act items services furnished qualified hospital related dme entity provided satisfactory assurances substantial majority patients enrolled medicare supplementary_medical_insurance patients hospital owns controls owned controlled entity provider services affiliated hospital furnishing items services type april owns controls owned controlled common ownership control hospital hospitals university furnishing items services type date


Summary: Amends title XVIII (Medicare) of the Social Security Act to treat as a physician, for Medicare purposes, a clinical psychologist acting within the scope of a psychologist's license (or other state law authorization), but only with respect to the furnishing of clinical psychologists services which the psychologist is legally authorized to perform by the state.

amends title xviii medicare social security act treat physician medicare purposes clinical psychologist acting scope psychologist license state law authorization respect furnishing clinical psychologists services psychologist legally authorized perform state


Summary: Amends the Public Health Service Act (PHSA) to revise provisions of the 340B drug discount program (a program limiting the cost of covered outpatient drugs to certain federal grantees) to permit a covered entity receiving assistance under title XXVI of the PHSA (popularly known as the Ryan White Care Act) to resell or transfer a drug to an individual with HIV/AIDS in connection with medication regimen adherence services being provided to the individual by a licensed health care professional of the entity. Excludes certain entities, including state and local governments.

amends public_health_service_act phsa revise provisions 340b drug discount program program limiting cost covered outpatient drugs certain federal grantees permit covered entity receiving assistance title xxvi phsa popularly known white care act resell transfer drug individual hiv aids connection medication regimen adherence services provided individual licensed health care professional entity excludes certain entities including state local governments


Summary: Requires a mail-order pharmacy to inform a customer to whom it dispenses a prescription brand name drug when a generic drug that is the pharmaceutical equivalent becomes available. Permits a mail-order pharmacy to substitute a generic drug for a brand name drug or a brand name drug for a generic drug if the mail order pharmacy: (1) notifies the customer that the pharmacy will request that the prescriber provide an authorization to make such a substitution; and (2) after providing such notification, obtains the express written authorization of the prescriber of the drug to make such a substitution. Requires the prescriber to provide notice to the customer of an authorization. Permits the Secretary of Health and Human Services (HHS) to assess civil penalties against a mail-order pharmacy for violations of this Act. Declares that this Act preempts state laws to the extent any are inconsistent with this Act.

requires mail order pharmacy inform customer dispenses prescription brand drug generic drug pharmaceutical equivalent available permits mail order pharmacy substitute generic drug brand drug brand drug generic drug mail order pharmacy notifies customer pharmacy request prescriber provide authorization substitution providing notification obtains express written authorization prescriber drug substitution requires prescriber provide notice customer authorization permits secretary health_and_human_services hhs assess civil penalties mail order pharmacy violations act declares act preempts state laws extent inconsistent act


Summary: Amends the Internal Revenue Code to exempt a qualified emergency medical device from the excise tax on medical devices. Defines "qualified emergency medical device" as a medical device furnished by first responders or ambulance services in providing out-of-hospital or pre-hospital care, or transport to a medical care facility, for individuals with illnesses, injuries, or other medical emergencies or in need of medical transport, extrication, or evacuation.

amends internal revenue code exempt qualified emergency medical device excise tax medical devices defines qualified emergency medical device medical device furnished responders ambulance services providing hospital pre hospital care transport medical care facility individuals illnesses injuries medical emergencies need medical transport evacuation


Summary: Drug Safety Enhancement Act of 2011 - Amends the Federal Food, Drug, and Cosmetic Act to expand safety and inspection requirements for the manufacture and importation of drugs by: (1) expanding registration requirements for foreign and domestic drug producers; (2) requiring drug manufacturers to have in effect and implement an effective quality system; (3) expanding and equalizing inspection requirements for foreign and domestic drug producers; (4) imposing additional requirements relating to the notification, nondistribution, and recall of adulterated or misbranded drugs; (5) permitting the detention of drugs found to be in violation of drug safety requirements; (6) allowing for the destruction of drugs that pose a significant adverse health effect; (7) providing enhanced civil and criminal penalties and forfeiture for violations of drug safety requirements and enhanced subpoena authority for investigating violations; (8) prohibiting the importation of drugs into the United States lacking documentation of safety; (9) requiring unique identification numbers for drug establishments and importers; and (10) expanding protections for whistleblowers who refuse to violate, or who disclose violations of, this Act.

drug safety enhancement act amends cosmetic act expand safety inspection requirements manufacture importation drugs expanding registration requirements foreign domestic drug producers requiring drug manufacturers effect implement effective quality system expanding equalizing inspection requirements foreign domestic drug producers imposing additional requirements relating notification recall adulterated misbranded drugs permitting detention drugs found violation drug safety requirements allowing destruction drugs pose significant adverse health effect providing enhanced civil criminal penalties forfeiture violations drug safety requirements enhanced subpoena authority investigating violations prohibiting importation drugs united_states lacking documentation safety requiring unique identification numbers drug establishments importers expanding protections whistleblowers refuse violate disclose violations act


Summary: Generics First Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to exclude from coverage under the Medicare part D prescription drug program all nongeneric (brand name) drugs unless no generic drug has been approved, and the brand name drug is determined to be medically necessary.

amends voluntary prescription drug benefit program title xviii medicare social security act exclude coverage medicare prescription drug program brand drugs generic drug approved brand drug determined medically necessary


Summary: Pharmaceutical Market Access Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to promulgate regulations permitting pharmacists, pharmacies, and wholesalers to import qualifying drugs from certain countries into the United States. Sets forth registration requirements for exporters. Requires the Secretary to: (1) educate consumers with regard to the availability of qualifying drugs for import for personal use; (2) inspect the facilities and records of importers and registered exporters to ensure compliance with this Act; and (3) establish a registration fee program to collect an annual fee from registered exporters. Deems a prescription drug to be misbranded unless the packaging of such drug complies with the requirements for counterfeit-resistant technologies. Prohibits: (1) failing to register in accordance with this Act; and (2) importing or offering to import a prescription drug in violation of a suspension order. Declares that selling or importing a patented drug in the United States that was first sold abroad by or under authority of the owner or licensee of the patent is not patent infringement. Prohibits drug manufacturers from discriminating against a person that engages in the importation of a prescription drug, including by charging higher prices or denying supplies of the drug. Allows the Secretary to suspend or terminate the registration of an exporter for failing to maintain substantial compliance with all registration conditions.

pharmaceutical market access act amends cosmetic act require secretary health_and_human_services promulgate regulations permitting pharmacists pharmacies wholesalers import qualifying drugs certain countries united_states sets forth registration requirements exporters requires secretary educate consumers regard availability qualifying drugs import personal use inspect facilities records importers registered exporters ensure compliance act establish registration fee program collect annual fee registered exporters deems prescription drug misbranded packaging drug complies requirements counterfeit resistant technologies prohibits failing register accordance act importing offering import prescription drug violation suspension order declares selling importing patented drug united_states sold abroad authority owner licensee patent patent infringement prohibits drug manufacturers discriminating person engages importation prescription drug including charging higher prices denying supplies drug allows secretary suspend terminate registration exporter failing maintain substantial compliance registration conditions


Summary: Physician Payments Sunshine Act of 2009 - Amends part A (General Provisions) of title XI of the Social Security Act to provide for transparency in the relationship between physicians and applicable manufacturers with respect to payments and other transfers of value and physician ownership or investment interests in manufacturers. Requires any manufacturer of a covered drug, device, biological, or medical supply that makes a payment or another transfer of value to a physician, a physician medical practice, or a physician group practice to report annually, in electronic form, specified information on such transactions to the Secretary of Health and Human Services. Requires any such manufacturer, or related group purchasing organization, also to report annually to the Secretary, in electronic form, certain information regarding any ownership or investment interest (other than in a publicly traded security and mutual fund) held by a physician (or an immediate family member) in the manufacturer or group purchasing organization during the preceding year. Prescribes administrative penalties for failure to comply with these requirements. Requires report submission procedures to ensure public availability of required information on a website.

physician payments sunshine act amends general provisions title social security act provide transparency relationship physicians applicable manufacturers respect payments transfers value physician ownership investment interests manufacturers requires manufacturer covered drug device biological medical supply makes payment transfer value physician physician medical practice physician group practice report annually electronic form specified information transactions secretary health_and_human_services requires manufacturer related group purchasing organization report annually secretary electronic form certain information ownership investment interest publicly traded security mutual fund held physician immediate family member manufacturer group purchasing organization preceding year prescribes administrative penalties failure comply requirements requires report submission procedures ensure public availability required information website


Summary: Preserve Access to Affordable Generics Act - Declares as the purposes of this Act to: (1) enhance competition in the pharmaceutical market by stopping anticompetitive agreements between brand name and generic drug manufacturers; and (2) support the purpose and intent of antitrust laws by prohibiting anticompetitive practices in the pharmaceutical industry that harm consumers. Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug product. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the drug product for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the procompetitive benefits of the agreement outweigh the anticompetitive effects. Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by a new drug application holder to a filer of an abbreviated new drug application is the right to market the drug product in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right that would prevent the marketing of such drug, a payment for reasonable litigation expenses not exceeding $7.5 million, and a covenant not to sue on any claim that the filer infringes a U.S. patent. Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act. Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to set forth additional filing requirements related to agreements between a brand name drug company and a generic drug applicant. Requires the Chief Executive Officer or the company official responsible for negotiating any agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive. Amends the Federal Food, Drug, and Cosmetic Act to provide that forfeiture of the 180-day exclusivity period for the marketing of a generic drug occurs if there is a final decision of the FTC or a court that an agreement has violated this Act. Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

preserve access affordable generics act declares purposes act enhance competition pharmaceutical market stopping anticompetitive agreements brand generic drug manufacturers support purpose intent antitrust laws prohibiting anticompetitive practices pharmaceutical industry harm consumers amends federal_trade_commission act authorize federal_trade_commission ftc initiate proceeding parties agreement resolving settling final interim basis patent infringement claim connection sale drug product establishes presumption agreement anticompetitive effects unlawful filer abbreviated new drug application receives value agrees limit forego research development manufacturing marketing sales drug product period time allows exception presumption parties agreement demonstrate clear convincing evidence based specified competitive factors benefits agreement outweigh anticompetitive effects exempts restrictions act resolution settlement patent infringement claim consideration granted new drug application holder filer abbreviated new drug application right market drug product united_states prior expiration patent basis patent infringement claim patent right prevent marketing drug payment reasonable litigation expenses exceeding million covenant sue claim filer infringes patent allows review ftc enforcement orders act federal court imposes civil penalties violations act amends medicare_prescription_drug improvement modernization act set forth additional filing requirements related agreements brand drug company generic drug applicant requires chief executive officer company official responsible negotiating agreement file certification materials filed respect agreement complete final exclusive amends cosmetic act provide forfeiture day exclusivity period marketing generic drug occurs final decision ftc court agreement violated act grants ftc exclusive authority litigate matters relating anticompetitive practices connection sale generic brand drugs establishes year limitation period bringing ftc enforcement actions cease desist requests act


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

fair prescription drug competition act 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: 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: Medical Device Safety Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit specified provisions preempting state and local requirements for medical devices intended for human use from being 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 prohibit specified provisions preempting state local requirements medical devices intended human use 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: Prohibits the use of funds by the Food and Drug Administration (FDA) to process a biologics license application for any biologic product that is, bears, or contains an agent or toxin listed in federal regulations as dangerous to life, property, or the environment and that has been marketed, sold, or distributed to the Islamic Republic of Iran by an entity under investigation for potential violations of the Iran Sanctions Act of 1996.

prohibits use funds food_and_drug_administration fda process biologics license application biologic product bears contains agent toxin listed federal regulations dangerous life property environment marketed sold distributed islamic_republic_of_iran entity investigation potential violations iran sanctions act


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.

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


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: Amends title XVIII (Medicare) of the Social Security Act to permit a Medicare beneficiary to elect to take, or decline to take, ownership of a Group 3 Support Surface item of complex durable medical equipment (DME) after the 13-month capped rental period ends.

amends title xviii medicare social security act permit medicare beneficiary elect decline ownership group support surface item complex durable medical equipment dme month capped rental period ends


Summary: Drug and Device Accountability Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise provisions regarding the registration of drug and device establishments, including to: (1) expand the information required to be included in a registration; and (2) provide for risk-based inspections. Includes in the definition of "drug" a precursor ingredient. Requires the Secretary of Health and Human Services (HHS) to assess the registration exemption for manufacturers of harmless inactive ingredients that become components of drugs. 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. Deems a drug or device to be misbranded unless certain conditions related to labeling for country of manufacture and provision of required information on importation are met. Sets forth provisions governing importation of a drug and its components. 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 and personal knowledge of information submitted. Establishes whistleblower protection for employees providing information regarding a drug, biological product, or device. Requires the Secretary to contract with the Institute of Medicine to evaluate: (1) the organizational structure and operations of the Food and Drug Administration (FDA) with respect to the review of medical devices for clearance and for premarket approval under FFDCA; and (2) the analytical and methodological tools used to conduct such reviews. Directs the Secretary to establish a corps of inspectors dedicated to inspections of foreign establishments and facilities. Sets forth enforcement provisions.

drug device accountability act amends cosmetic act ffdca revise provisions registration drug device establishments including expand information required included registration provide risk based inspections includes definition drug precursor ingredient requires secretary health_and_human_services hhs assess registration exemption manufacturers harmless inactive ingredients components drugs deems drug adulterated certain conditions related verification identity purity identification establishments consistency current manufacturing technologies conformity good distribution import practices met deems drug device misbranded certain conditions related labeling country manufacture provision required information importation met sets forth provisions governing importation drug components 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 personal knowledge information submitted establishes whistleblower protection employees providing information drug biological product device requires secretary contract institute_of_medicine evaluate organizational structure operations food_and_drug_administration fda respect review medical devices clearance premarket approval ffdca analytical tools conduct reviews directs secretary establish corps inspectors dedicated inspections foreign establishments facilities sets forth enforcement provisions


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: Sunscreen Labeling Protection Act of 2009 or the SUN Act - Requires the proposed rule issued by the Commissioner of Food and Drugs (FDA) pertaining to over-the-counter sunscreen drug products to take effect 180 days after enactment of this Act, unless the Commissioner issues a final rule that includes formulation, labeling, and testing requirements for both ultraviolet B (UVB) and ultraviolet A (UVA) radiation protection before such time.

sunscreen labeling protection act sun act requires proposed rule issued fda pertaining counter sunscreen drug products effect days enactment act commissioner issues final rule includes formulation labeling testing requirements ultraviolet ultraviolet radiation protection time


Summary: Drug Price Competition Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to expand the definition of "first applicant" under such Act to allow a generic drug manufacturer that is currently considered an applicant subsequent to a brand-name manufacturer's 180-day exclusivity period to qualify as a first applicant for purposes of filing an abbreviated application for a new drug. Requires such applicant to submit a substantially complete application that contains and lawfully maintains a certification for such drug.

drug price competition act amends cosmetic act expand definition applicant act allow generic drug manufacturer currently considered applicant subsequent brand manufacturer day exclusivity period qualify applicant purposes filing abbreviated application new drug requires applicant submit substantially complete application contains lawfully maintains certification drug


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: Amends the Internal Revenue Code to exempt fixed-wing aircraft used to provide acute care emergency medical services from certain restrictions on tax-exempt bond financing.

amends internal revenue code exempt fixed wing aircraft provide acute care emergency medical services certain restrictions tax exempt bond financing


Summary: Protecting Americans from Drug Marketing Act - Amends the Internal Revenue Code to deny a business expense tax deduction for expenses relating to advertising or promoting the sale and use of prescription pharmaceuticals.

protecting americans deny business expense tax deduction expenses relating advertising promoting sale use prescription pharmaceuticals


Summary: Access to Affordable Medicines Act - Amends the Federal Food, Drug, and Cosmetic Act to provide that an application for a generic drug the proposed labeling of which is different from the labeling at the time the Secretary of Health and Human Services (HHS) evaluates the application shall be eligible for approval (and such drug shall not be considered misbranded) if: (1) the revision has been approved by the Secretary within 60 days of the expiration of the patent or exclusivity period for the drug; (2) the Secretary has not determined the applicable labeling text when such period expires; (3) the labeling revision does not include a change to the warnings section; (4) the Secretary does not deem that the continued presence in commerce of the labeling before the revision adversely impacts the safe use of the drug; and (5) the sponsor of the application agrees to submit revised labeling not later than 60 days after the notification of any changes required by the Secretary.

access affordable medicines act amends cosmetic act provide application generic drug proposed labeling different labeling time secretary health_and_human_services hhs evaluates application shall eligible approval drug shall considered misbranded revision approved secretary days expiration patent exclusivity period drug secretary determined applicable labeling text period expires labeling revision include change warnings section secretary deem continued presence commerce labeling revision adversely impacts safe use drug sponsor application agrees submit revised labeling later days notification changes required secretary


Summary: Amends the Harmonized Tariff Schedule of the United States to reduce temporarily the duty no frames and mountings for spectacles, goggles, or the like, the foregoing of plastics.

amends harmonized_tariff schedule united_states reduce temporarily duty frames mountings spectacles goggles like foregoing plastics


Summary: Nanotechnology Safety Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to establish within the Food and Drug Administration (FDA) a program for the scientific investigation of nanoscale materials included or intended for inclusion in FDA-regulated products to address: (1) the potential toxicology of such materials; (2) the effects of such materials on biological systems; and (3) the interaction of such materials with biological systems.

nanotechnology safety act amends cosmetic act require secretary health_and_human_services hhs establish food_and_drug_administration fda program scientific investigation nanoscale materials included intended inclusion fda regulated products address potential toxicology materials effects materials biological systems interaction materials biological systems


Summary: Amends the Controlled Substances Act to revise the definition of "dispense" to include the delivery of a controlled substance through the use of an intrathecal pump by a practitioner acting in the usual course of professional practice.

amends controlled substances act revise definition dispense include delivery controlled substance use pump practitioner acting usual course professional practice


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, except for pharmacies that do not ordinarily stock contraceptives in the normal course of business; 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 pharmacies ordinarily stock contraceptives normal course business 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: Dietary Supplement Full Implementation and Enforcement Act of 2010 - Authorizes appropriations for FY2011-FY2014 to carry out the Dietary Supplement Health and Education Act of 1994 (DSHEA) and other provisions under the Federal Food, Drug, and Cosmetic Act (FFDCA) that apply to dietary supplements. Requires the allocation of funds appropriated to the Food and Drug Administration (FDA) for FY2010 for the purpose of enhancing food safety to be expended to effectively and fully implement and enforce DSHEA and other FFDCA provisions that apply to dietary supplements. Authorizes appropriations for FY2010-FY2014 for expanded research and development of consumer information on dietary supplements by the Office of Dietary Supplements at the National Institutes of Health (NIH). Requires the Secretary of Health and Human Services (HHS) to report to Congress annually on the implementation and enforcement of DSHEA and its amendments. Amends the FFDCA to require the Secretary to publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with safety information, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient. Requires the Secretary to notify the Drug Enforcement Agency (DEA) if information in a new dietary ingredient notification is inadequate to establish that a dietary supplement containing such ingredient will reasonably be expected to be safe because the ingredient may be, or may contain, an anabolic steroid or an analogue of an anabolic steroid.

dietary supplement implementation enforcement act authorizes appropriations fy2011 fy2014 carry provisions cosmetic act ffdca apply dietary supplements requires allocation funds appropriated food_and_drug_administration fda fy2010 purpose enhancing food safety expended effectively fully implement enforce ffdca provisions apply dietary supplements authorizes appropriations fy2010 fy2014 expanded research development consumer information dietary supplements national_institutes_of_health nih requires secretary health_and_human_services hhs report congress annually implementation enforcement amendments amends ffdca require secretary publish guidance clarifies dietary supplement ingredient new dietary ingredient manufacturer distributor dietary ingredient dietary supplement provide secretary safety information evidence needed document safety new dietary ingredients appropriate methods establishing identity new dietary ingredient requires secretary notify dea information new dietary ingredient notification inadequate establish dietary supplement containing ingredient reasonably expected safe ingredient contain anabolic steroid analogue anabolic steroid


Summary: Fair Pricing for Prescription Drugs Act - Pharmaceutical Market Access and Drug Safety Act of 2010 - 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 (HHS) to inspect places of business, verify chains of custody, inspect facilities, and determine compliance with registration conditions. Sets forth provisions governing the importation of qualifying drugs that are different from U.S. label drugs, including standards for judging such differences. Prohibits manufacturers from: (1) discriminating against registered exporters or importers; (2) causing there to be a difference in a prescription drug distributed in the United States and one distributed in a permitted country; (3) engaging in actions to restrict, prohibit, or delay the importation of a qualifying drug; or (4) engaging in any action that the Federal Trade Commission (FTC) determines discriminates against a person that engages or attempts to engage in the importation of a qualifying drug. States that the resale in the United States of prescription drugs that were properly sold abroad is not patent infringement. Requires the Secretary to educate consumers regarding prescription drug importation. Sets forth provisions governing the sale of prescription drugs through an Internet site. Includes the dispensing or selling of a prescription drug in violation of this Act as a prohibited act under FFDCA. Prohibits the introduction of restricted transactions with unregistered foreign pharmacies into a payment system or the completion of such transactions using a payment system. Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct the Secretary to negotiate with pharmaceutical manufacturers the prices that may be charged to Medicare part D prescription drug plan (PDP) sponsors and MedicareAdvantage (MA) organizations for covered part D drugs for part D eligible individuals who are enrolled under a PDP or an MA-Prescription Drug plan.

fair pricing prescription drugs act 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 hhs 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 amends voluntary prescription drug benefit program title xviii medicare social security act direct secretary negotiate pharmaceutical manufacturers prices charged medicare prescription drug plan pdp sponsors medicareadvantage organizations covered drugs eligible individuals enrolled pdp ma-prescription_drug plan


Summary: Drug Safety and Accountability Act of 2010 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require each registered drug producer to have in effect and implement a quality management plan to ensure the quality and safety of: (1) each drug; (2) each active and inactive ingredient of each drug; and (3) materials used in the manufacture of each active ingredient. Authorizes the Secretary of Health and Human Services (HHS) to order an establishment to promptly revise its quality management plan in response to a significant threat to public health. Requires each registered drug producer to report on each producer, manufacturer, distributor, and shipper involved in the production of a drug or the production or transport of the active ingredients of a drug. Requires the Secretary to develop and maintain information systems to track and assess every establishment that is involved in the manufacturing, preparation, propagation, compounding, or processing of a drug or active ingredient of a drug. Deems a drug to be adulterated if it was produced in an establishment that does not comply with the requirements of this Act. Gives the Secretary authority to: (1) order an immediate cessation of distribution, or a recall, of a drug; and (2) administer oaths and issue subpoenas. Revises provisions regarding civil penalties for FFDCA violations related to drugs for human use, including to consider each day a violation continues to be a separate violation. Authorizes the Secretary to share information subject to a trade secret exemption with: (1) other federal, state, or local agencies, foreign government agencies, and relevant international organizations; and (2) the public, as necessary to protect the public health. Sets forth whistleblower protection provisions.

drug safety accountability act amends cosmetic act ffdca require registered drug producer effect implement quality management plan ensure quality safety drug active inactive ingredient drug materials manufacture active ingredient authorizes secretary health_and_human_services hhs order establishment promptly revise quality management plan response significant threat public health requires registered drug producer report producer manufacturer distributor shipper involved production drug production transport active ingredients drug requires secretary develop maintain information systems track assess establishment involved manufacturing preparation propagation compounding processing drug active ingredient drug deems drug adulterated produced establishment comply requirements act gives secretary authority order immediate cessation distribution recall drug administer oaths issue subpoenas revises provisions civil penalties ffdca violations related drugs human use including consider day violation continues separate violation authorizes secretary share information subject trade secret exemption federal state local agencies foreign government agencies relevant international organizations public necessary protect public health sets forth whistleblower protection provisions