zli12321/Bills huggingface dataset:
Sensible Oversight for Technology which Advances Regulatory Efficiency Act of 2013 or the SOFTWARE Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FDCA) to apply it to medical software to the same extent and in the same manner as it applies to devices. Defines "medical software" as software that is intended to be marketed:

 to directly change the structure or any function of the body of man or other animals; or for use by consumers and makes recommendations for clinical action that includes the use of a drug, device, or procedure to cure or treat a disease or other condition without requiring the involvement of a health care provider and which, if followed, would change the structure or any function of the body of man or other animals. Excludes from such definition software whose primary purpose is integral to the functioning of a drug or device and is not a component of a device. Excludes clinical software and health software (defined as follows) from FDCA regulation.

Defines "clinical software" as software that: (1) captures, analyzes, changes, or presents patient or population clinical data or information and may recommend courses of clinical action, but does not directly change the structure or any function of the body of man or other animals; and (2) is intended for use only by a health care provider in a health care setting.

Defines "health software" as software that is not medical software or clinical software and that: (1) captures, analyzes, changes, or presents patient or population clinical data or information or supports administrative or operational aspects of health care and is not used in the direct delivery of care; or (2) has as its primary purpose to act as a platform for a secondary software, to run or act as a mechanism for connectivity, or to store data.

Expresses the sense of Congress concerning the value of clinical software and health software to health care quality and efficacy and the need for legislation that establishes a risk-based regulatory framework that reduces regulatory burdens, promotes patient safety, and fosters innovation.

Excludes medical software, clinical software, and health software from the FDCA definition of "device."

Date: 2013-10-22
Topic: Health (Drug Industry)
Subject: Health
Small Manufacturer Protection Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to grant the owner of a human generic drug facility a waiver from, or reduction of, one or more human generic drug fees if the Secretary finds that the assessment of the fee would present a significant barrier to market entry because of the owner's limited resources or other circumstances.

Requires an owner seeking such fee waiver or reduction to submit a written request no later than 180 days after the fee is due.

Prohibits the Secretary, in determining whether to grant such waiver or reduction, from considering anything other than the circumstances and assets of the owner and any affiliate of the owner.

Makes these provisions applicable to fees authorized to be assessed and collected for FY2014-FY2017.

Date: 2013-12-02
Topic: Health (Drug Industry)
Subject: Health
Protecting Consumer Access to Generic Drugs Act of 2013 - Prohibits, as an unfair and deceptive act or practice and an unfair method of competition in or affecting interstate commerce, any person from being a party to any agreement resolving or settling a patent infringement claim in which: (1) an abbreviated new drug (generic) application filer receives anything of value; and (2) such filer agrees not to research, develop, manufacture, market or sell the generic drug. Excludes a resolution or settlement that includes no more than: (1) the right to market the generic drug before the expiration of the patent or other exclusivity period, or (2) the waiver of a patent infringement claim for damages.

Authorizes the Federal Trade Commission (FTC) to exempt agreements in furtherance of market competition and for the benefit of consumers.

Amends the Federal Food, Drug, and Cosmetic Act to deem an applicant to have forfeited market exclusivity if the applicant enters into an agreement that violates this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to revise reporting requirements related to agreements between a generic drug applicant and a brand name drug company to include: (1) a description of the subject matter of other agreements between the parties; and (2) a certification that the materials filed represent the complete, final, and exclusive agreement between the parties.

Date: 2013-12-11
Topic: Health (Drug Industry)
Subject: Commerce
Servicemembers and Veterans Prescription Drug Safety Act of 2013 - Directs the Secretary of Defense (Secretary) and the Attorney General (AG) to jointly carry out a program under which a member of the Armed Forces (member), an individual receiving or entitled to military retired or retainer pay, a dependent-beneficiary of a member, or any person lawfully entitled to dispose of the property of any of such individuals may deliver a personal-use controlled substance (the prescription medication of a deceased individual) for disposal at a facility to be specified by the Secretary and the AG. Requires the Secretary and AG, in implementing the program, to develop appropriate guidelines and procedures to prevent the diversion, misuse, theft, or loss of such delivered substances.

Directs the Secretary and the AG to jointly carry out a program under which a veteran, a veteran's spouse or dependent, a person in receipt of medical services at a Department of Veterans Affairs (VA) facility, or any person lawfully entitled to dispose of the property of any of such individuals may deliver such a controlled substance for disposal at a specified facility, subject to the same guidelines and procedures with respect to such delivered substances.

Date: 2013-12-12
Topic: Health (Drug Industry)
Subject: Armed forces and national security
Personal Drug Importation Fairness Act of 2013 - Allows a drug to be imported into the United States, and re-imported into the United States by a person other than the drug's manufacturer, if the drug: (1) has the same active ingredients, route of administration, and strength as a prescription drug approved under provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) regarding adulterated drugs; (2) may be lawfully marketed in, and is imported or reimported from, a qualified country; (3) is dispensed by a licensed pharmacist; (4) is shipped directly to, or is imported by, the ultimate consumer from the qualified country; (5) is shipped or imported in quantities that do not exceed a 90-day supply; and (6) is accompanied by a copy of a valid prescription.

Defines: (1) "drug" for purposes of this Act as excluding any controlled substance; and (2) "qualified country" to mean any of specified countries (Australia, Canada, Israel, Japan, New Zealand, Switzerland, South Africa, a member-state of the European Union, or a country in the European Economic Area) that is determined by the Commissioner of Food and Drugs (FDA) to have standards for ensuring drug safety and effectiveness that are at least as protective as U.S. standards.

Date: 2013-12-12
Topic: Health (Drug Industry)
Subject: Health
Antibiotic Development to Advance Patient Treatment Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to authorize the Secretary of Health and Human Services (HHS) to approve the use of an antibacterial or antifungal drug that is intended for treatment of a serious or life-threatening disease or condition to treat a limited population of patients for which there is an unmet medical need.

Requires the labeling of such drugs to prominently include in the prescribing information the statement that the drug is indicated for use in a limited and specific population of patients.

Amends the Public Health Service Act to authorize the Secretary to license those antibacterial or antifungal drugs as biological products.

Requires the Secretary, acting through the Director of the Centers for Disease Control and Prevention (CDC), to: (1) monitor the use of antibacterial and antifungal drugs, (2) monitor changes in bacterial and fungal resistance to drugs, and (3) make the information derived from such monitoring available to the public.

Amends the FFDCA to direct the Secretary: (1) to identify upon approval, and subsequently update, susceptibility test interpretive criteria for antibacterial drugs by relying upon preclinical and clinical data, Bayesian and pharmacometric statistical methodologies, and such other confirmatory evidence the Secretary deems necessary; (2) on a quarterly basis, to evaluate new or updated criteria published by a nationally or internationally recognized standard development organization; and (3) to publish on the Food and Drug Administration's (FDA's) website a notice adopting, declining to adopt, or partially adopting such new or updated criteria.

Date: 2013-12-12
Topic: Health (Drug Industry)
Subject: Health
Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to revise the Medicare durable medical equipment face-to-face encounter documentation requirement.

Date: 2014-01-09
Topic: Health (Drug Industry)
Subject: Health
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2014 or DISARM Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services (HHS) to: (1) recognize the costs of new antimicrobial drugs under the Medicare payment system for the inpatient services of subsection (d) hospitals, (2) provide for additional payment with respect to discharges involving such drugs, (3) publish in the Federal Register a list of the new antimicrobial drugs, and (4) further reduce each of the average standardized payment amounts in a specified manner to maintain budget neutrality in a fiscal year beginning with FY2015.

(Generally, a subsection [d] hospital is an acute care hospital, particularly one that receives payments under Medicare's inpatient prospective payment system [IPPS] when providing covered inpatient services to eligible beneficiaries.)

Directs the Comptroller General (GAO) to study the barriers that prevent the development of new antimicrobial drugs and develop recommendations for actions to be taken in order to overcome such barriers.

Date: 2014-03-11
Topic: Health (Drug Industry)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act to cover pharmacist services.

Date: 2014-03-11
Topic: Health (Drug Industry)
Subject: Health
Act to Ban Zohydro - Ends the sale and distribution of pure hydrocodone bitartrate extended-release capsules (marketed as Zohydro ER) within 45 days by withdrawing approval for its new drug application. Prohibits the Commissioner of Food and Drugs (FDA) from approving any new drug application for the capsules unless they are formulated to prevent abuse.

Date: 2014-03-13
Topic: Health (Drug Industry)
Subject: Health
Independent Innovator and Repurposing Act - Establishes procedures under which the term of an unexpired patent claiming a method of using a biological product shall be extended for five years from its original expiration date.

 Requires an application for such an extension to demonstrate that: (1) the patent was issued to an independent innovator, and (2) the owner of record is the independent innovator or a small business (with fewer than 500 employees and which is not affiliated with the holder of the marketing application approved under licensing requirements of the Public Health Service Act for the commercial marketing of such biological product) in which the independent innovator has an ownership interest.

Defines "independent innovator" as a person or entity that obtains a method of use patent for a biological product and is not, at the time of invention or patent filing, affiliated with the holder of an approved application for the commercial marketing of the product.

Date: 2014-03-24
Topic: Health (Drug Industry)
Subject: Commerce
Improving Regulatory Transparency for New Medical Therapies Act - Amends the Controlled Substances Act to require any proceedings for the issuance, amendment, or repeal of a rule of the Attorney General for the classification of a controlled substance that are initiated at the request of the Secretary of Health and Human Services (HHS) to control a drug or other substance not previously scheduled, where the Secretary has recommended the drug or other substance be placed in schedule II, III, IV, or V, to be commenced not later than 120 days after receipt of written recommendations from the Secretary. Requires the final rule to be issued not later than 60 days after the date on which both the public comment period has closed and the new drug is the subject of an approved new drug application, unless a hearing on the proposed rule is granted by the Attorney General.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule III, IV, or V for use only in a clinical trial, to register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, not later than 180 days after receiving an application and all information necessary to make a determination about whether the issuance of such registration is inconsistent with the public interest.

Directs the Attorney General, for the purposes of registration to manufacture a controlled substance in schedule I or II for use only in a clinical trial, to: (1) issue a notice of application not later than 90 days after receipt of an application and all necessary information to issue such notice; and (2) register an applicant, or serve upon the applicant an order to show cause why registration should not be denied, revoked, or suspended, within 180 days following the close of the comment period and receipt of all information necessary to make a determination about whether the issuance of such registration is consistent with the public interest and with U.S. obligations under international treaties in effect on May 1, 1971, unless a hearing on the application has been granted pursuant to a provision of the Controlled Substances Import and Export Act regarding emergency situations.

Date: 2014-03-26
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Compassionate Freedom of Choice Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

Prohibits the FDA Commissioner from requiring the disclosure, collection, or reporting of certain information concerning such drugs or devices, except that the sponsor of a clinical trial may voluntarily disclose, collect, or report such information to the FDA.

Declares that, except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device shall not be liable in any action under state or federal law for loss, damage, or injury arising out of, relating to, or resulting from: (1) the design, development, clinical testing and investigation, manufacturing, labeling, distribution, sale, purchase, donation, dispensing, prescription, administration, or use of such drugs or devices; or (2) their safety or effectiveness.

Date: 2014-04-10
Topic: Health (Drug Industry)
Subject: Health
Ensuring Seniors Access to Local Pharmacies Act of 2014 - Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to direct any prescription drug plan that has in its network one or more pharmacies located in a health professional shortage area, in a medically underserved area, or among a medically underserved population, and that provides a reduction in coinsurance or copayments for covered part D drugs, to extend to any pharmacy located in that area, or among that population, the option to be an in-network pharmacy under terms and conditions comparable to those the plan has agreed upon with other in-network pharmacies located in the area or among that population.

Date: 2014-05-06
Topic: Health (Drug Industry)
Subject: Health
Research for All Act of 2014 - Directs the Food and Drug Administration (FDA) to review and develop policies to ensure that the design and size of clinical trials for products granted expedited approval to treat a serious or life-threatening disease or condition are sufficient to determine the safety and effectiveness of the products for men and women using subgroup analysis.

Amends the Federal Food, Drug, and Cosmetic Act to require FDA, at the request of the sponsor of a new drug, to facilitate the development and expedite its review if the drug is:

 intended to avoid serious adverse events or to treat a serious or life-threatening disease or condition, intended for safer or more effective treatment for either men or women than a currently available product approved to treat the general population or the other sex, and supported by results of clinical trials that include and separately examine outcomes for men and women. Amends the Public Health Service Act to require the Director of the National Institutes of Health (NIH) to determine when it is appropriate for projects of basic research involving cells, tissues, or animals to include both male and female cells, tissues, or animals. Requires, in such cases, disaggregation of results according to sex. Provides guidelines for ensuring that sex differences are examined and analyzed.

Authorizes the Secretary of Health and Human Services (HHS) to support the continued operation and expansion of Special Centers of Research on Sex Differences.

Requires the Comptroller General (GAO) to provide to Congress updated versions of the reports entitled “Women's Health: NIH Has Increased Its Efforts To Include Women in Research” and “Women's Health: Women Sufficiently Represented in New Drug Testing, But FDA Oversight Needs Improvement,” including in the reports examination of:

 the inclusion of women, female animals, and female-derived cells and tissues in federally funded research over the past decade; federal reporting and analysis of subgroup information and the translation of differences to the medical community and patients; the effect of inclusion rates in research on the quality of women’s health care; and current efforts within government agencies to encourage the sharing of research data on sex differences and mechanisms to improve such sharing.

Date: 2014-06-17
Topic: Health (Drug Industry)
Subject: Health
Speeding Access to Already Approved Pharmaceuticals Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), under procedures for expedited approval of products to treat a serious or life-threatening disease or condition, to facilitate the development and expedite the review of new drugs or devices approved for marketing in the European Union.

Date: 2014-06-19
Topic: Health (Drug Industry)
Subject: Health
Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to require state licensure and a bid and surety bond of at least $50,000 for each area for bidding entities under the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

Date: 2014-06-19
Topic: Health (Drug Industry)
Subject: Health
Everson Walls and Ron Springs Gift for Life Act of 2014 - Amends the Public Health Service Act to require the Administrator of the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

Requires the Center to: (1) advance the development, expansion, and evaluation of state organ donor registries; (2) facilitate timely exchange of donor information between state registries; and (3) maintain a clearinghouse for information on registry best practices.

Directs the Secretary of Health and Human Services (HHS) to award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. Requires a state registry that receives a grant to be accessible to individual donors and the Center.

Eliminates civil liability for a person taking an individual's organs as long as the person verified the individual's consent with a state organ donor registry.

Requires the Comptroller General (GAO) to study the feasibility of establishing a database to track the health effects of living organ donation.

Date: 2014-07-28
Topic: Health (Drug Industry)
Subject: Health
Living Donor Protection Act of 2014 - Prohibits discrimination based on a person's status as a living organ donor in the offering, issuance, cancellation, coverage, price, or any other condition of a life insurance policy, disability insurance policy, or long-term care insurance policy.

Revises the Family and Medical Leave Act of 1993 to specifically include living organ donation as a serious health condition that entitles a covered employee to leave under that Act.

Requires the Secretary of Health and Human Services (HHS) to update public service announcements, websites, and other media regarding live organ donation to educate the public on the benefits of live organ donation and access to insurance for living organ donors.

Date: 2014-07-30
Topic: Health (Drug Industry)
Subject: Health
Label and Transport Tissues Safely Act of 2014 or the LATTS Act of 2014 - Sets forth guidelines for handling human tissue specimens.

Prohibits sale of human tissue for research or education unless the seller has a non-transplant tissue bank license and each package of tissue is labeled with specified information.

Directs the Secretary of Health and Human Services (HHS) to establish a process for the approval, suspension, and revocation of non-transplant tissue bank licenses.

Prohibits falsely labeling packages of human tissue.

Allows HHS or any accrediting body authorized by HHS to enter and inspect any establishment engaged in the preparation of any human tissue specimen.

Requires HHS to recall any human tissue specimen that is an imminent or substantial hazard to public health.

Date: 2014-07-31
Topic: Health (Drug Industry)
Subject: Health
Protecting Our Kids' Medicine Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. Allows the Secretary of Health and Human Services (HHS) to waive the requirement for metric units if that requirement would not benefit public health.

Prohibits the sale of over-the-counter liquid drugs labeled for pediatric use that do not have a flow restrictor or another mechanism to reduce accidental ingestion.

Date: 2014-09-18
Topic: Health (Drug Industry)
Subject: Health
Fair Access for Safe and Timely Generics Act of 2014 or the FAST Generics Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug from restricting availability of the drug for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with any aspect of a risk evaluation and mitigation strategy (REMS).

Directs the Secretary to authorize product developers to obtain approved drugs for testing if the product developer is a license holder of an approved drug or the Secretary determines the product developer can comply with laws applicable to drug development.

Requires the Secretary to authorize a product developer to conduct human clinical trials with an approved drug if the product developer's clinical trial protocol includes protections comparable to the distribution restrictions on the approved drug.

Establishes a process for a product developer to obtain reasonable quantities of an approved drug when those quantities are not available commercially.

Allows the Secretary to prohibit or limit transfer of an approved drug to a product developer if the transfer poses an imminent hazard to public health.

Eliminates license holder liability for claims arising from a product developer's testing of an approved drug.

Requires the FDA and the Federal Trade Commission (FTC) to report on noncompliance with this Act.

Allows the Secretary to waive the requirement that a drug use a single, shared system of elements to assure safe use with a comparable approved drug if the developer of the drug is unable to finalize terms for a shared system with the license holder of the approved drug.

Date: 2014-09-18
Topic: Health (Drug Industry)
Subject: Health
Medicaid Generic Drug Price Fairness Act of 2014 - Amends title XIX (Medicaid) of the Social Security Act to extend to manufacturers of generic drugs the requirement that drug manufacturers in certain circumstances pay an additional rebate to state Medicaid programs.

Date: 2014-11-20
Topic: Health (Drug Industry)
Subject: Health
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to extend by six months the exclusivity period for a drug or biological product approved by the Food and Drug Administration (FDA) when the product is additionally approved to prevent, diagnose, or treat a new indication that is a rare disease or condition (also known as an “orphan disease”).

Allows the Secretary to revoke an extension if the application submitted to the FDA for the new indication contained an untrue material statement.

Requires the sponsor of a product receiving an extension to notify HHS one year prior to discontinuing production for commercial reasons.

Requires the Secretary to notify the public of products that receive this extension.

Limits a product to one extension under this Act. Sets forth that extensions under this Act are in addition to other extensions.

Applies only to products approved after enactment of this Act for a new indication that is a rare disease or condition.

Date: 2014-11-20
Topic: Health (Drug Industry)
Subject: Health
Andrea Sloan Compassionate Use Reform and Enhancement Act or the Andrea Sloan CURE Act - Amends the Federal Food, Drug, and Cosmetic Act to require the sponsor of a “breakthrough drug” (which is a drug that qualifies for expedited approval, is an infectious disease product, or qualifies the sponsor for a priority review voucher) to submit to the Secretary of Health and Human Services (HHS) and make available to the public a policy on requests for access to the drug for compassionate use, including the minimum criteria for consideration or approval of requests and the time needed to make a decision.

Requires a breakthrough drug sponsor to explain a denied request for compassionate use to the person who made the request.

Directs HHS to establish an Expanded Access Task Force. Requires the Task Force and the Government Accountability Office (GAO) to evaluate patient access to investigational drugs and make recommendations for improving access.

Directs HHS to finalize the draft guidance entitled “Expanded Access to Investigational Drugs for Treatment Use--Qs & As,” taking into account reports from the Task Force and GAO.

Date: 2014-12-08
Topic: Health (Drug Industry)
Subject: Health
Protecting Access to Diabetes Supplies Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act to revise the special competitive acquisition program rule applied to diabetic testing strips to require the volume for such types of products to be determined through the use of multiple sources of data that measure consumption and utilization of such strips among individuals in the United States.

Directs the Secretary of Health and Human Services to reject any bid submitted by an entity under the competitive acquisition program that does not demonstrate that it can furnish the types of strips included in its bid.

Requires an entity to furnish to an individual the brand of strips compatible with the individual's home blood glucose monitor.

Prohibits an entity from attempting to influence or incentivize an individual to switch the brand of glucose monitor or testing strips selected.

Prohibits an entity from communicating directly to such an individual until it has given the individual verbally standardized information about the individual's rights with respect to the entity.

Directs the Secretary to establish a process under which an individual furnished with diabetic testing strips under a competitive acquisition program may reject them by notifying the supplier and the Secretary. Permits the individual to obtain different strips from another supplier and have a new claim processed.

Date: 2014-12-08
Topic: Health (Drug Industry)
Subject: Health
Medicare DMEPOS Competitive Bidding Improvement Act of 2014 - Amends title XVIII (Medicare) of the Social Security Act with respect to the Medicare durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) competitive acquisition program.

Prohibits the Secretary of Health and Human Services (HHS) from accepting a bid from an entity for an area unless it: (1) meets state licensure requirements for the area for all items in the submitted bid for a product category, and (2) has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Prescribes requirements for the treatment of losing bidders and successful bidders that do not accept a contract.

Date: 2014-12-08
Topic: Health (Drug Industry)
Subject: Health
Amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act shall prevent or restrict, and the Food and Drug Administration (FDA) shall not implement or enforce any law to prevent or restrict, the importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

Date: 2014-12-11
Topic: Health (Drug Industry)
Subject: Health
Tim Fagan's Law or Counterfeit Drug Enforcement Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) 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 a 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 Department 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 using technologies that HHS determines are technically feasible and assist in preventing such violations.

Authorizes additional appropriations for Food and Drug Administration (FDA) inspections, examinations, and investigations.

Requires HHS to educate the public and health care professionals on counterfeit drugs.

Directs HHS, upon a finding that a drug intended for human use may constitute a threat to the public health, to issue an order requiring the appropriate person (including the manufacturers, importers, distributors, or retailers of the drug) to cease distribution of the drug and to notify and instruct health professionals to cease administering, distributing, selling, or prescribing the drug. Requires HHS, after providing the person with an opportunity for an informal hearing, to amend the order to include a recall, if appropriate.

Requires HHS and the Attorney General to establish a procedure through which the FDA is authorized to issue subpoenas.

Date: 2014-12-11
Topic: Health (Drug Industry)
Subject: Health
Preserve Access to Affordable Generics Act - Amends the Federal Trade Commission Act to authorize the Federal Trade Commission (FTC) to initiate a proceeding against parties to any agreement resolving or settling, on a final or interim basis, a patent infringement claim, in connection with the sale of a drug. Establishes a presumption that any such agreement has anticompetitive effects and is unlawful if the filer of an abbreviated new drug (generic) application receives anything of value and agrees to limit or forego research, development, manufacturing, marketing, or sales of the generic drug for any period of time. Allows an exception to such presumption if the parties to the agreement demonstrate by clear and convincing evidence, based on specified competitive factors, that the pro-competitive benefits of the agreement outweigh the anticompetitive effects.

Exempts from the restrictions of this Act a resolution or settlement of a patent infringement claim if the only consideration granted by the brand name manufacturer to the generic manufacturer is: (1) the right to market the generic drug in the United States prior to the expiration of any patent that is the basis for the patent infringement claim or any patent right or other statutory exclusivity that would prevent the marketing of such drug, (2) a payment for reasonable litigation expenses not exceeding $7.5 million, and (3) a covenant not to sue on any claim that the generic drug infringes a U.S. patent.

Allows review of FTC enforcement orders under this Act in federal court. Imposes civil penalties for violations of this Act.

Amends the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 to require a brand name manufacturer and generic manufacturer to submit to the FTC any other agreements the parties enter into within 30 days of entering into an agreement related to the manufacturing, marketing, or sale of the brand name or generic drug or the exclusivity period. Requires the Chief Executive Officer or the company official responsible for negotiating any such agreement to file a certification that materials filed with respect to such agreement are complete, final, and exclusive.

Amends the Federal Food, Drug, and Cosmetic Act to forfeit the 180-day exclusivity period for the marketing of a generic drug if there is a final decision of the FTC or a court that an agreement has violated this Act.

Grants the FTC exclusive authority to litigate matters relating to anticompetitive practices in connection with the sale of generic brand drugs. Establishes a three-year limitation period for bringing FTC enforcement actions (other than cease and desist requests) under this Act.

Date: 2013-02-04
Topic: Health (Drug Industry)
Subject: Commerce
Medical Device Access and Innovation Protection Act - Amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

Date: 2013-02-07
Topic: Health (Drug Industry)
Subject: Taxation
Comprehensive Immunosuppressive Drug Coverage for Kidney Transplant Patients Act of 2013 - Amends title II (Old Age, Survivors and Disability Benefits) (OASDI) of the Social Security Act (SSA) to extend the months of coverage of immunosuppressive drugs for kidney transplant patients.

Amends SSA title XVIII (Medicare) to make eligible for enrollment in Medicare part B (Supplementary Medical Insurance), solely for the purpose of such drug coverage, every individual whose insurance benefits under Medicare part A (Hospital Insurance) have ended by reason of a kidney transplant or the end of any requirement for a regular course of dialysis.

Directs the Secretary of Health and Human Services (HHS) to determine a monthly premium rate for such individuals equal to 35% of the monthly actuarial rate for enrollees age 65 and over. Prescribes a formula for detemination of a government contribution to such a premium.

Date: 2013-02-13
Topic: Health (Drug Industry)
Subject: Health
Amends the Internal Revenue Code to add vaccines against seasonal influenza to the list of those vaccines subject to the excise tax on taxable vaccines.

Date: 2013-02-27
Topic: Health (Drug Industry)
Subject: Taxation
Fair And Immediate Release of Generic Drugs Act or FAIR Generics Act - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to revise the definition of “first applicant” for purposes of the 180-day exclusivity period given to first applicants to file an abbreviated new drug application (generic drug). Makes applicants for a generic drug eligible for the exclusivity period only if they have not entered into a disqualifying agreement (an agreement between a generic drug applicant and the holder of the application for the listed drug [brand name drug] or the patent holder for the brand name drug whereby the generic drug applicant agrees not to seek approval of its generic drug or not to begin the commercial marketing of its generic drug until the expiration of the exclusivity period awarded to another generic applicant).

Expands the definition of “first applicant” to include an applicant that meets the following criteria: (1) the applicant is not the first generic applicant; (2) either no action for patent infringement was brought, such action was withdrawn or dismissed by a court without a decision that the patent was valid and infringed, or the court decided that the patent was invalid or not infringed; and (3) the applicant does not begin commercial marketing of such drug until 30 days after the first applicant began such commercial marketing.

Prohibits a party that enters an agreement to delay seeking approval of its generic drug application or to delay the commercial marketing of a generic drug from seeking approval of its application or beginning commercial marketing before the earlier of: (1) the latest date set forth in the agreement to seek approval or market the drug without regard to any earlier date under the agreement when commercial marketing could begin, or (2) 180 days after another first applicant begins commercial marketing of such drug.

Requires notice to the Secretary of the Health and Human Services (HHS) of the details of any agreement under this Act not later than ten business days after execution of the agreement.

Declares that the exclusive remedy for an infringement of a patent included within a new drug application shall be an action brought under the FFDCA within the 45-day period prescribed.

Date: 2013-03-07
Topic: Health (Drug Industry)
Subject: Health
Medical Innovation Prize Fund Act - Denies any person the exclusive right to manufacture, distribute, sell, or use in interstate commerce a drug, a biological product, or a drug or biological product manufacturing process, including the exclusive right to rely on health registration data or the 30-month stay-of-effectiveness period for Orange Book patents. Prescribes remuneration, in the form of prize payments from a Fund for Medical Innovation Prizes, in lieu of such market exclusivity.

Establishes: (1) the Fund for Medical Innovation Prizes; and (2) a Board of Trustees for such Fund, which shall award prize payments for medical innovation and establish independent expert advisory committees.

Directs the Board to award prize payments for medical innovation relating to a drug, a biological product, or a new manufacturing process for a drug or biological product to: (1) the first person to receive market clearance with respect to the drug or biological product; (2) the holder of the patent with respect to a manufacturing process; or (3) persons or communities that as an open source contribution openly shared knowledge, data, materials, and technology on a royalty-free and nondiscriminatory basis.

Requires the Board to establish and periodically modify minimum levels of funding for such awards for priority research and development, including global neglected diseases, orphan diseases, and global infectious diseases and other global public health priorities.

Allows the Board of Trustees to authorize multiple nonprofit intermediaries to reward projects for interim research and development of products or for open source dividend prizes.

Requires the Comptroller General (GAO) to conduct annual audits to determine the Board's effectiveness in bringing to market new drugs, vaccines, biological products, and manufacturing processes in a cost-effective manner and in addressing society's global medical needs.

Establishes an annual fee for health insurers to fund this Act.

Date: 2013-03-20
Topic: Health (Drug Industry)
Subject: Health
Cody Miller Initiative for Safer Prescriptions Act - Amends the Federal Food, Drug, and Cosmetic Act to direct the Secretary of Health and Human Services (HHS) to promulgate regulations regarding the authorship, content, format, and dissemination requirements for patient medication information (PMI) for prescription drugs.

Requires such regulations to require the PMI for such a drug: (1) to be scientifically accurate and to be based on the approved professional labeling and authoritative, peer-reviewed literature; and (2) to include plain language that is not promotional in tone or content. Requires that such language include: (1) the established name of the drug; (2) drug uses and clinical benefits; (3) general directions for proper use; (4) contraindications, common side effects, and the most serious risks of the drug; (5) measures patients may take to reduce the side effects and risks; (6) when a patient should contact his or her health care professional; (7) instructions not to share medications; (8) any key storage requirements; (9) recommendations relating to proper disposal of any unused portion of the drug; and (10) known clinically important interactions with other drugs and substances.

Requires such regulations to: (1) include standards related to performing timely updates of drug information, ensuring that common information is applied consistently and simultaneously across similar drug products and for drugs within classes of medications, and developing a process to assess the quality and effectiveness of PMI in promoting patient understanding and safe and effective use; and (2) provide for the development of a publicly accessible electronic repository for all PMI.

Requires the Secretary to publish on the Food and Drug Administration (FDA) website a link to the Daily Med website.

Date: 2013-04-17
Topic: Health (Drug Industry)
Subject: Health
Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers

Date: 2013-04-24
Topic: Health (Drug Industry)
Subject: Health
Antimicrobial Data Collection Act - Requires the Secretary of Health and Human Services (HHS), acting through the Commissioner of Food and Drugs (FDA), to develop a research program to study the relationship between the sales, distribution, and end-use practices of animal drugs containing an antimicrobial active ingredient in food-producing animals and antimicrobial resistance trends. Requires the Secretary to analyze data from the program to determine the data's contribution to studying antimicrobial resistance and establishing an antimicrobial data collection strategy.

Requires the Secretary to: (1) report to Congress on the program's research design and goals, including a needs assessment to improve the FDA's evaluation of antimicrobial resistance; and (2) report to Congress and the public within two years with the comprehensive results of the program and recommendations for developing an antimicrobial data collection strategy.

Amends the Federal Food, Drug, and Cosmetic Act to revise the requirements for the annual summaries of antimicrobial animal drug information, including by requiring the Secretary to maximize the quality, accuracy, detail, and specificity of the data made publicly available in the summaries. Requires the Secretary to conduct an annual evaluation of the effectiveness of and compliance with relevant FDA programs and policies regarding antimicrobial drug sales for food-producing animals, and the use of such drugs and antimicrobial resistance.

Directs the Secretary to publish a final version of voluntary guidance for drug sponsors on new animal drugs and new animal drug combination products administered in or on medicated feed or drinking water of food-producing animals.

Requires the Comptroller General (GAO) to evaluate the FDA's approaches to eliminate injudicious use of antimicrobial drugs in food-producing animals and the effectiveness of the FDA's data collection activities regarding antimicrobial resistance.

Date: 2013-05-08
Topic: Health (Drug Industry)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act to authorize direct payment under part B (Supplementary Medical Insurance Benefits for the Aged and Disabled) to a pharmacy for certain covered compound drugs prepared by the pharmacy for a specific beneficiary for the effective use of an implanted infusion pump.

Date: 2013-05-09
Topic: Health (Drug Industry)
Subject: Health
Preventing Antibiotic Resistance Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act to require an applicant for approval of a new animal drug that is a medically important antimicrobial to demonstrate that there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the nontherapeutic use of the drug. Requires the Secretary of Health and Human Services (HHS) to refuse approval if the applicant fails to make such a demonstration.

Defines “medically important antimicrobial” as a drug intended for use in food-producing animals and composed wholly or partly of: (1) any kind of specified antibiotics, including penicillin and tetracycline; or (2) a drug from an antimicrobial class that is listed on the World Health Organization’s list of critically important antimicrobials.

Requires the Secretary to withdraw approval for the nontherapeutic use in food-producing animals of a medically important antimicrobial marketed for human use unless the Secretary makes a final written determination that, based on either the application holder's demonstration or an HHS risk analysis, there is a reasonable certainty of no harm to human health due to the development of antimicrobial resistance attributable to the drug's nontherapeutic use.

Requires the Secretary to rescind approval of an exemption for investigational use of, or of approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in a food-producing animal two years after the exemption is granted or the application for approval is submitted. Exempts from this requirement any drugs for which there has been found a reasonable certainty of no harm to human health.

Prohibits the administration of a medically important antimicrobial (including by means of animal feed) to a food-producing animal for nonroutine disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the food-producing animal. Requires the administration of the antimicrobial to be: (1) necessary to prevent or reduce the risk of transmission; (2) for the shortest duration possible to prevent or reduce the risk of transmission; and (3) at a scale no greater than the barn, house, or pen level and to the fewest animals possible to prevent or reduce the risk of transmission.

Date: 2013-06-27
Topic: Health (Drug Industry)
Subject: Health