zli12321/Bills huggingface dataset:
Prescription Coverage for Now Act of 2009 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act (SSA) to direct the Commissioner of Social Security, through certain information requests to the Secretary of the Treasury, to provide for the identification of individuals potentially eligible for low-income subsidies (LIS) and transmit them low-income subsidy applications if they are also part D eligible. Requires the Secretary of Health and Human Services, jointly with the Commissioner, to develop a model, simplified low-income subsidy application and process. Amends the Internal Revenue Code to require the Secretary of the Treasury, upon the Commissioner's request, to disclose tax return information to facilitate identification of individuals likely to be eligible for Medicare prescription drug program low-income subsidies. Entitles low-income subsidy beneficiaries to retroactive reimbursement for previously incurred covered drug costs. Prescribes requirements for enhanced oversight and enforcement relating to such reimbursements. Establishes an asset standard for LIS eligibility for 2011 of $27,500 (or $55,000 in the case of the combined value of the individual's assets or resources and the assets or resources of the individual's spouse), increased in subsequent years by the annual percentage increase in the consumer price index. Exempts retirement benefits from resources under the LIS programs. Increases the income eligibility to 150% of the federal poverty level (FPL) for full benefits and 200% of the FPL for partial benefits under the LIS program. Authorizes indexing of deductible and cost-sharing above the annual out-of-pocket threshold for individuals with incomes below 200% of FPL. Prohibits the treating of LIS premium and cost-sharing subsidies as benefits, or otherwise taking them into account, in determining an individual's eligibility for, or amount of benefits under, any other federal program. Requires individuals eligible for Medicare Savings Programs to be deemed subsidy eligible individuals under LIS. Establishes a special enrollment period for subsidy eligible individuals under LIS.

Date: 2009-06-04
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-06-04
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-06-09
Topic: Health (Drug Industry)
Subject: Labor and employment
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.

Date: 2009-06-17
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2009-06-18
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-06-19
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2009-06-19
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-07-14
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2009-07-20
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-07-30
Topic: Health (Drug Industry)
Subject: Taxation
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.)

Date: 2009-07-30
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-09-25
Topic: Health (Drug Industry)
Subject: Health
(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.

Date: 2009-09-29
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-10-08
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-10-27
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-11-02
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2009-12-08
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-03-02
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-03-10
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-03-10
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-03-25
Topic: Health (Drug Industry)
Subject: Health
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]).

Date: 2010-04-21
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2010-05-13
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-06-28
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2010-07-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-07-27
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-07-29
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-08-10
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-09-16
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-09-22
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2010-09-29
Topic: Health (Drug Industry)
Subject: Commerce
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.

Date: 2010-09-29
Topic: Health (Drug Industry)
Subject: Taxation
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.

Date: 2010-12-17
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-01-06
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-01-06
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-01-22
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-02-03
Topic: Health (Drug Industry)
Subject: Commerce
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.

Date: 2009-02-26
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-03-05
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-03-17
Topic: Health (Drug Industry)
Subject: Health
Preservation of Antibiotics for Medical Treatment Act of 2009 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to deny an application for a new animal drug that is a critical antimicrobial animal drug unless the applicant demonstrates that there is a reasonably certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Defines "critical antimicrobial animal drug" as a drug intended for use in food-producing animals that contains specified antibiotics or other drugs used in humans to treat or prevent disease or infection caused by microorganisms. Requires the Secretary to withdraw approval of a nontherapeutic use of such drugs in food-producing animals two years after the date of enactment of this Act unless certain safety requirements are met.

Date: 2009-03-17
Topic: Health (Drug Industry)
Subject: Health
Promoting Innovation and Access to Life-Saving Medicine Act - Amends the Public Health Service Act to provide for the licensing of biosimilar and interchangeable biological products. Defines "biosimilar" and "interchangeability" for purposes of this Act. Allows any person to file an abbreviated biological product application with the Secretary of Health and Human Services. Requires such applications to include information demonstrating a high degree of similarity or interchangeability between the biological product and the licensed biological product (reference product). Requires the Secretary to: (1) approve an application and issue a license for a biosimilar product unless the Secretary finds and informs the applicant that the information in the application fails to demonstrate biosimilarity between the biological product and the reference product or the safety, purity, and potency of the biological product; and (2) establish requirements for the efficient review, approval, suspension, and revocation of abbreviated biological product applications. Allows an applicant to request the Secretary to make a determination as to the interchangeability of a product and its reference product based on whether a product can be expected to produce the same clinical result as the reference product in any given patient. Grants market exclusivity to any biological product that is determined to be interchangeable for a specified period. Sets forth provisions governing patent infringement claims involving comparable biological products and legal remedies to expedite the adjudication of patent infringement disputes. Extends the period for approval of biological products to allow for studies of the use of new biological products in the pediatric population.

Date: 2009-03-26
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-04-23
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-04-23
Topic: Health (Drug Industry)
Subject: Health
Preserve Patient Access to Reputable DMEPOS Providers Act of 2009 - Amends title XVIII (Medicare) of the Social Security Act to declare that the surety bond requirement under the Medicare program for suppliers of durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) shall apply only to a state-licensed retail pharmacy if there has been a final adverse action that is not subject to administrative or judicial appeal taken against such pharmacy during the 10-year period preceding the issuance (or renewal) of the provider number involved. (Thus exempts from the surety bond requirement any state-licensed retail pharmacy that has not been subject to such an adverse action for at least 10 years. Such adverse actions refer to: (1) a Medicare-imposed revocation of any Medicare billing privileges; (2) suspension or revocation of a license to provide health care by any state licensing authority; (3) revocation or suspension by an accreditation organization; (4) conviction of a federal or state felony offense within the last 10 years preceding enrollment, revalidation, or re-enrollment; or (5) an exclusion or debarment from participation in a federal or state health care program.)

Date: 2009-05-01
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2009-05-20
Topic: Health (Drug Industry)
Subject: Health