zli12321/Bills huggingface dataset:
Dietary Supplement Labeling Act of 2013 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the registration requirements for a dietary supplement manufacturing or processing facility to: (1) require the submission of a description, ingredient list, and label and labeling for each dietary supplement product manufactured or processed; and (2) require a manufacturer to update its registration for new, reformulated, or discontinued products within 30 days.

Requires the Secretary of Health and Human Services (HHS) to compile a list of dietary supplement ingredients and proprietary blends of ingredients that could cause potentially serious adverse events, drug interactions, contraindications, or potential risks to subgroups such as children and pregnant or breastfeeding women.

Directs the Secretary to enter into a contract with the Institute of Medicine to: (1) evaluate the safety of dietary supplement ingredients and proprietary blends of ingredients that the Institute determines could cause potentially serious adverse events, drug interations, contraindications, or potential risks to subgroups; and (2) identify proprietary blends of ingredients for which the weight per serving of the ingredient in the proprietary blend should be provided on the label.

Deems a dietary supplement that does not meet the requirements of this Act to be misbranded.

Requires the Secretary to establish a definition for the term “conventional food” for purposes of the FFDCA, taking in account foods marketed as dietary supplements.

Date: 2013-08-01
Topic: Health (Drug Industry)
Subject: Agriculture and food
Restoring Access to Medication Act - Repeals provisions of the Patient Protection and Affordable Care Act that restrict payments from health savings accounts, medical savings accounts, and health flexible spending arrangements for medications to prescription drugs and insulin only (thus allowing payments for over-the-counter medications).

Date: 2013-11-05
Topic: Health (Drug Industry)
Subject: Health
Safe and Affordable Drugs from Canada Act of 2014 - Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Secretary of Health and Human Services (HHS) to promulgate regulations permitting individuals to safely import into the United States, with exceptions, a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Provides criteria for approval of a Canadian pharmacy.

Requires HHS to publish a list of approved Canadian pharmacies, including their website address, from which individuals may purchase prescription drugs in accordance with this Act.

Date: 2014-06-26
Topic: Health (Drug Industry)
Subject: Health
Medicaid Generic Drug Price Fairness Act - 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
Promise for Antibiotics and Therapeutics for Health Act or the PATH Act - Amends the Federal Food, Drug, and Cosmetic Act to require the Department of Health and Human Services (HHS) to establish a program to approve an antibacterial drug intended to treat a serious medical condition and address an unmet medical need within an identifiable limited population as a limited population antibacterial drug.

Requires the sponsor of a drug eligible for approval as a limited population antibacterial drug to demonstrate the safety and effectiveness of the drug for its intended use.

Requires an HHS determination of the safety and effectiveness of a limited population antibacterial drug to reflect the drug's benefit-risk profile in the intended limited population. Prohibits a lack of evidence of a favorable benefit-risk profile in a broader population from resulting in a denial of approval.

Directs HHS to require: (1) the labeling of a limited population antibacterial drug to indicate that the drug has been approved for use only in a limited population, and (2) submission of promotional materials related to the drug prior to dissemination.

Directs HHS to describe considerations for demonstrating the safety and effectiveness of limited population antibacterial drugs and how the limited population pathway can be expanded to other therapeutic areas.

Requires HHS to conduct postapproval monitoring programs to study how antibacterial drugs approved through the limited population pathway are used and to monitor changes in bacterial drug resistance.

Allows HHS to remove the labeling, marketing, and postapproval monitoring requirements of a limited population antibacterial drug if the drug is approved for broader use.

Allows the limited population pathway to be expanded to other drugs intended to treat serious illness beginning October 1, 2016.

Date: 2014-12-10
Topic: Health (Drug Industry)
Subject: Health
Protect Medical Innovation Act of 2015

(Sec. 2) This bill amends the Internal Revenue Code to repeal the excise tax on medical device manufacturers and importers.

This repeal applies to sales in calendar quarters beginning after the enactment of this Act.

(Sec. 3) Prohibits the budgetary effects of this Act from being entered on either PAYGO scorecard under the Statutory Pay-As-You-Go Act of 2010.

Date: 2015-01-06
Topic: Health (Drug Industry)
Subject: Taxation
Medicare DMEPOS Competitive Bidding Improvement Act of 2015

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 an entity from submitting a bid for a competitive acquisition area, during calendar 2017-2019, unless it has obtained a bid surety bond of between $50,000 and $100,000 for each such area.

Requires the forfeit of any bid bond submitted for a competitive acquisition area if the bidding entity does not accept a contract offered for any product category when its composite bid was at or below the median composite bid rate for all bidding entities included in the calculation of the single payment amounts for the product category and the area. Requires the Secretary of Health and Human Services to collect on the forfeited bond.

Requires return of a bid bond within a specified 90-day period to a bidding entity that does not meet such bid forfeiture conditions.

Prohibits the Secretary from awarding a contract to any entity that does not meet state licensure requirements.

Directs the Government Accountability Office to study the effect of this bid surety bond requirement on the participation of small suppliers in the Medicare DMEPOS competitive acquisition program.

Date: 2015-01-12
Topic: Health (Drug Industry)
Subject: Health
Medical Testing Availability Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit a product labeled for research use only from being deemed adulterated or misbranded on the basis that its manufacturer or distributor: (1) sells the product to an end user who uses the product for a purpose other than research, or (2) engages in business communications with an end user regarding the product.

Date: 2015-01-13
Topic: Health (Drug Industry)
Subject: Health
Combination Drug Development Incentive Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to provide a five-year marketing exclusivity period to a new drug approved by the Food and Drug Administration that is a novel combination of active ingredients. The application for the combination drug must contain reports of new clinical investigations that are essential to approval and were conducted or sponsored by the applicant. Currently, a new drug that includes an active ingredient that has already been approved is provided a three-year marketing exclusivity period.

Date: 2015-01-20
Topic: Health (Drug Industry)
Subject: Health
Developing an Innovative Strategy for Antimicrobial Resistant Microorganisms Act of 2015 or the DISARM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to: (1) recognize the costs of DISARM 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 DISARM antimicrobial drugs, and (4) make a proportional adjustment in standardized payment amounts to assure that the requirements of this Act do not result in aggregate payments greater or less than those that would otherwise be made for a fiscal year.

(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.)

Defines a "DISARM antimicrobial drug" as one approved or licensed by the Food and Drug Administration on or after January 1, 2015, which, among other things, is intended to treat an infection:

 caused by, or likely to be caused by, a qualifying pathogen; associated with high rates of mortality or significant patient morbidity; and for which there is an unmet medical need. Requires that the mechanism established by the Secretary to recognize the costs of new medical services and technologies that are not DISARM antimicrobial drugs under the Medicare payment system is applicable to new medical services or technology if the service or technology is not a DISARM antimicrobial drug.

Directs the Comptroller General to study the barriers that prevent the development of DISARM antimicrobial drugs and develop recommendations for actions to be taken in order to overcome those barriers.

Date: 2015-01-22
Topic: Health (Drug Industry)
Subject: Health
First Responder Medical Device Tax Relief Act

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: 2015-01-22
Topic: Health (Drug Industry)
Subject: Taxation
Pharmacy and Medically Underserved Areas Enhancement Act

Amends title XVIII (Medicare) of the Social Security Act to cover pharmacist services.

Date: 2015-01-28
Topic: Health (Drug Industry)
Subject: Health
Clinical Trial Cancer Mission 2020 Act

Amends the Public Health Service Act to revise clinical trial registry data bank provisions to specify that a device or drug clinical trial must be included in the clinical trial registry data bank regardless of whether it results in a positive or negative outcome.

Requires the responsible party of any clinical trials funded in whole or in part by the Department of Defense (DOD) to certify in all required grant or progress forms that the required submissions to the clinical trial registry data bank have been made. Requires DOD to verify that the clinical trial information has been submitted before releasing any remaining grant funds or funding future grants.

Makes a clinical trial grantee of the Department of Health and Human Services or DOD who fails to submit the required information to the data bank ineligible for the remaining grant funds or future funds. Makes the grantee liable for repayment of grant amounts already provided.

Date: 2015-01-28
Topic: Health (Drug Industry)
Subject: Health
(This measure has not been amended since it was passed by the Senate on October 26, 2015. The summary of that version is repeated here.)

Improving Regulatory Transparency for New Medical Therapies Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act to delay the effective date of approval of a drug, biological product, or animal drug for which the Food and Drug Administration (FDA) recommends controls under the Controlled Substances Act until the Department of Justice (DOJ) issues a final interim rule for the drug. This delay also applies to conditional approval and indexing of animal drugs.

This bill amends the Controlled Substances Act to require the DOJ to issue a final interim rule for a drug product recommended for controls by the FDA not later than 90 days after DOJ receives a recommendation for controls or the FDA approves the drug. The final interim rule is effective immediately.

For purposes of submitting an application to extend a patent, a drug product recommended for controls is considered to be approved and have permission for commercial marketing and use on the date of FDA approval or the date an interim final rule is issued, whichever is later.

(Sec. 3) Timelines are established for DOJ to either register an applicant to manufacture a controlled substance for a clinical trial or serve an order to show cause upon the applicant.

(Sec. 4) This bill amends the Controlled Substances Import and Export Act to allow exported controlled substances to be re-exported within the European Economic Area.

Date: 2015-02-02
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
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: 2015-02-03
Topic: Health (Drug Industry)
Subject: Health
Protecting Access to Diabetes Supplies Act of 2015

 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: 2015-02-05
Topic: Health (Drug Industry)
Subject: Health
Compassionate Freedom of Choice Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that nothing in it or in the Public Health Service Act prevents or restricts, and the Food and Drug Administration (FDA) must not prevent or restrict, the manufacture, importation, distribution, or sale of investigational drugs or devices for terminally ill patients.

The FDA is prohibited 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.

Except in cases of gross negligence or willful misconduct, any person who manufactures, imports, distributes, prescribes, or administers an investigational drug or device is not liable under state or federal law for loss, damage, or injury from: (1) the development, testing, production, acquisition, or use of such drugs or devices; or (2) their safety or effectiveness.

Date: 2015-02-05
Topic: Health (Drug Industry)
Subject: Health
Ensuring Seniors Access to Local Pharmacies Act of 2015 

 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: 2015-02-05
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 an “investigational drug” (which is a drug that is designated as a breakthrough therapy, fast track product, infectious disease product, or drug for a rare disease or condition) to submit to the Food and Drug Administration (FDA) and make available to the public the sponsor's policy on requests for expanded access to the unapproved drug, including the minimum criteria for considering or approving requests and the time needed to make a decision.

Requires an investigational drug sponsor to explain a denied request for expanded access to the person who made the request.

Directs the Department of Health and Human Services 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 the FDA 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: 2015-02-12
Topic: Health (Drug Industry)
Subject: Health
Helping Effective Antibiotics Last Act of 2015 or the HEAL Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to approve an antibacterial drug or biological product that is intended to treat a serious or life-threatening condition only for treating a well-defined population of patients. To be approved, the antibacterial product must produce superior outcomes over available therapies in the well-defined patient population.

A product approved by this pathway must include in its prescribing information the population of patients expected to benefit from using the product and the method for identifying members of that population. The FDA must require each product to have a risk evaluation and mitigation strategy.

The Centers for Disease Control and Prevention must monitor changes to bacterial drug resistance and changes to patient outcomes caused by bacterial drug resistance.

Upon approval of antibacterial products, the FDA must identify susceptibility test interpretive criteria (the drug concentrations where a type of bacteria is categorized as susceptible, intermediate, or resistant) and update the criteria as needed based upon evidence of changes in patient outcomes.

To be eligible for an exclusivity period extension, a qualified infectious disease product must be demonstrated to produce superior outcomes over available therapies.

The FDA must issue guidance on the development of target product profiles for antibacterial drugs.

Date: 2015-02-12
Topic: Health (Drug Industry)
Subject: Health
Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to extend by six months the exclusivity period for an approved drug or biological product 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 FDA to revoke an extension if the application for the new indication contained an untrue material statement.

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

Requires the FDA to notify the public of products that receive this extension and patents related to those products.

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: 2015-02-13
Topic: Health (Drug Industry)
Subject: Health
Clinical Trials Modernization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to allow sponsors of applications for new drugs, biological products, and medical devices to propose incorporation of alternative statistical methods, including adaptive trial design and Bayesian methods, into clinical trial protocols and marketing applications.

The FDA is required to issue guidance that establishes or clarifies standards for using alternative statistical methods in clinical trials.

The FDA must establish a process under which a post-approval study or clinical trial required by the FDA is periodically evaluated to determine whether the trial or study is no longer scientifically warranted or whether the design should be renegotiated because of changes in medical practice or the standard of care.

Date: 2015-02-25
Topic: Health (Drug Industry)
Subject: Health
Promoting Access for Treatments Ideal in Enhancing New Therapies Act of 2015 or the PATIENT Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to extend to five years the three-year marketing exclusivity period provided to certain new drugs that include an active ingredient that was already approved by the Food and Drug Administration.

A drug is provided this extended exclusivity period if it is approved for a new indication or use, or the drug has been reformulated or redesigned to:

 promote greater patient adherence to an approved treatment regime, reduce the public health risks associated with the drug, reduce side effects or adverse events, provide benefits to the health-care system, or provide other comparable patient benefits.

Date: 2015-03-13
Topic: Health (Drug Industry)
Subject: Health
Patient Choice Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to authorize provisional approval of fast track products determined by the Department of Health and Human Services (HHS) to be adequately safe. Treats provisional approval in the same manner as approval of a drug, except that provisional approval is subject to requirements related to informed consent and continued pursuit of safety and efficacy data for purposes of gaining approval for the drug.

Defines the term “adequately safe” to mean that: (1) for at least one population, the risk of death or morbidity of the drug is unlikely to be greater than the combined risks of death or morbidity of the disease and existing therapies; or (2) the drug has had a valid marketing authorization for at least four years in one of the countries specified and data adequate for the approval of that marketing authorization has been submitted to HHS.

Prohibits HHS from imposing any requirements for safety studies or data in addition to, or different than, the requirements for studies to establish safety for purposes of Phase 1 (initial introduction of an investigational new drug into humans) or Phase 2 (controlled clinical studies to evaluate the effectiveness of the drug for a particular indication in patients with the disease or condition under study and to determine the common short-term side effects and risks associated with the drug).

Applies the provisional approval only to the indication for which the drug was: (1) designated as a fast track product, and (2) demonstrated to be adequately safe.

Prescribes requirements for termination of provisional approval, withdrawal of provisional approval, and application of market exclusivity to fast-track approval products.

Date: 2015-03-16
Topic: Health (Drug Industry)
Subject: Health
Speeding Access to Already Approved Pharmaceuticals Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to facilitate the development and expedite the review of a new drug, biological product, or device that has been approved in the European Union.

Date: 2015-03-18
Topic: Health (Drug Industry)
Subject: Health
Medical Device Tax Elimination Act

This bill amends the Internal Revenue Code to repeal the excise tax on medical devices and offsets the cost of such repeal by: (1) eliminating the tax deduction for income attributable to oil, natural gas, or primary products thereof for major integrated oil companies (companies that have an average daily worldwide annual production of crude oil of at least 500,000 barrels and annual gross receipts in excess of $1 billion); (2) prohibiting the use of the last-in, first-out (LIFO) accounting method by major integrated oil companies; and (3) denying the foreign tax credit to major integrated oil companies that are dual taxpayers (companies that receive an economic benefit from a foreign country or a possession of the United States that does not impose a generally applicable income tax).

Date: 2015-03-23
Topic: Health (Drug Industry)
Subject: Taxation
Preservation of Antibiotics for Medical Treatment Act of 2015

This bill 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 from antimicrobial resistance attributable to the nontherapeutic use of the drug.

Medically important antimicrobials are drugs intended for use in food-producing animals that contain: (1) specified antibiotics, or (2) certain drugs on the World Health Organization’s list of critically important antimicrobials.

 Two years after enactment of this Act, the Food and Drug Administration (FDA) must withdraw approval of a drug's nontherapeutic use in food-producing animals unless the FDA makes a determination that, based on the application holder's demonstration or an FDA risk analysis, there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

 The FDA must rescind an exemption for investigational use of, or approval of a new drug application for, a medically important antimicrobial for its nontherapeutic use in food-producing animals two years after the exemption is granted or the application for approval is submitted unless there is a reasonable certainty of no harm to human health from antimicrobial resistance attributable to nontherapeutic use.

A medically important antimicrobial cannot be administered (including through animal feed) to a food-producing animal for disease control unless there is a significant risk that a disease or infection present on the premises will be transmitted to the animal.

Date: 2015-03-23
Topic: Health (Drug Industry)
Subject: Health
Generic Complex Drugs Safety and Effectiveness for Patients Act of 2015

This bill requires the Government Accountability Office (GAO) to study whether generic versions of certain complex drugs or certain biological drugs face significantly different challenges in meeting the approval standards of the Food and Drug Administration (FDA) than generic versions of small-molecule drugs. (Complex drugs and biological drugs can be composed of large molecules that are more difficult to fully characterize than small molecules, so it can be more difficult to demonstrate that generic versions of these drugs are the same as the brand name versions.)

If the GAO determines that these generic drugs face significantly different challenges, then the GAO must also determine: (1) the evidence that should be required to demonstrate that one of these generic drugs is sufficiently similar to the brand name drug in safety, composition, and activity; (2) whether the Federal Food, Drug, and Cosmetic Act should be amended to address the approval of these generic drugs; and (3) whether the FDA should develop a policy document on the evidence that is necessary to obtain approval of these generic drugs.

Date: 2015-03-24
Topic: Health (Drug Industry)
Subject: Health
Diagnostic Imaging Services Access Protection Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to prohibit the Secretary of Health and Human Services from applying a multiple procedure payment reduction policy to the professional component of imaging services furnished: (1) after a specified date in the year this Act is enacted; or (2) in any subsequent year before the Secretary conducts and publishes, as part of the Medicare Physician Fee Schedule for a year, an analysis of the Resource-Based Relative Value Scale Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.

Date: 2015-04-28
Topic: Health (Drug Industry)
Subject: Health
Safe and Affordable Drugs from Canada Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require the Department of Health and Human Services (HHS) to promulgate regulations within 180 days permitting individuals to import a prescription drug purchased from an approved Canadian pharmacy that:

 is dispensed by a pharmacist licensed in Canada; is purchased for personal use in quantities not greater than a 90-day supply; is filled using a valid prescription issued by a physician licensed to practice in the United States; and has the same active ingredient or ingredients, route of administration, dosage form, and strength as a prescription drug approved under the FFDCA. Sets forth exceptions, including for controlled substances and biological products.

 Establishes a certification process for approving Canadian pharmacies. Requires HHS to publish a list of approved Canadian pharmacies.

Date: 2015-05-01
Topic: Health (Drug Industry)
Subject: Health
This bill amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services to provide for a pharmaceutical and technology ombudsman within the Centers for Medicare and Medicaid Services.

Date: 2015-05-14
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices.

Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation.

To expedite the development and review of designated medical devices, the FDA must:

 assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.

Date: 2015-05-14
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.)

Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals.

Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration to describe the responsibilities of each agency center charged with reviewing drugs, medical devices, or biological products when reviewing a product that is a combination of drug, medical device, or biological product.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
Amends title XVIII (Medicare) of the Social Security Act to direct the Secretary of Health and Human Services to begin the process to develop and implement a prior authorization process for certain durable medical equipment, prosthetics, orthotics, and supplies.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill requires the Food and Drug Administration to issue guidance that addresses using alternative statistical methods, including adaptive trial design and Bayesian methods, in clinical trials and in the development and review of drugs and biological products.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill authorizes the Commissioner of Food and Drugs to award grants to institutions of higher education and nonprofit organizations to study and recommend improvements to the process of continuous manufacturing of drugs and biological products and similar innovative monitoring and control techniques.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to define "precision drug or biological product." (Precision medications are commonly understood to be treatments for those patients who are likely to respond to the medication based on a biomarker, which is a biological characteristic such as a genetic factor.)

The FDA must issue and periodically update guidance that addresses the development and use of biomarkers to identify the subset of patients that are likely to respond to a medication.

The FDA may rely upon data previously submitted for a different approved medication or indication to expedite the clinical development of a precision medication that has been designated for the treatment of a serious or rare condition.

Date: 2015-05-19
Topic: Health (Drug Industry)
Subject: Health
Everson Walls and Ron Springs Gift for Life Act of 2015

This bill amends the Public Health Service Act to require the Health Resources and Services Administration to establish a National Organ and Tissue Donor Registry Resource Center.

The Center must: (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.

The Department of Health and Human Services must award grants to states in order to develop, expand, or maintain state organ donor registries and establish benchmarks for improvement in organ donation. A state registry that receives a grant must be accessible to individual donors and the Center.

A person taking an individual's organs is not civilly liable as long as the person verified the individual's consent with a state organ donor registry.

The Government Accountability Office must study the feasibility of establishing a database to track the health effects of living organ donation.

Date: 2015-05-20
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Federal Food, Drug, and Cosmetic Act to direct the Department of Health and Human Services (HHS) to review each regulation and guidance that applies to the dissemination by means of the Internet of information about medical products and to propose revisions to such regulations and guidance that:

 facilitate meaningful use of the Internet by product sponsors for dissemination of truthful, non-misleading information about medical products; recognize that such sponsors may use the Internet to disseminate, in character-limited applications, truthful, introductory information about medical products and to provide additional information about the safety and effectiveness of the medical products using information that is hyperlinked to such introductory information; and treat such hyperlinked information as if it appeared in such introductory information, for regulatory purposes. HHS is required, after providing notice and an opportunity for public comment, to: (1) publish final regulations and guidance addressing such matters within 18 months after publication of proposed regulations and guidance; and (2) review and update such regulations and guidance periodically.

Date: 2015-05-20
Topic: Health (Drug Industry)
Subject: Health
Surrogate Endpoint Improvement and Utilization Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the sponsor of a drug that is eligible for accelerated approval to request that the Food and Drug Administration (FDA) agree to an accelerated approval development plan that includes a surrogate endpoint for the study of the drug and a magnitude of drug effect that is sufficient to claim the drug is effective. (Accelerated approval is an FDA process for approving a new drug for a serious medical condition at a point in the study of the drug that is reasonably likely to predict a clinical benefit instead of at a later point when a clinical benefit can be confirmed.)

The FDA may require the sponsor to modify or terminate an agreed upon plan if additional information indicates that the plan is no longer sufficient to demonstrate the safety and effectiveness of the drug or the drug is no longer eligible for accelerated approval.

Date: 2015-05-21
Topic: Health (Drug Industry)
Subject: Health
Medical Imaging Modernization Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to make a special rule reducing by 20% the payment under the physician fee schedule and the hospital outpatient prospective payment system for the technical component of imaging services that are x-rays taken using film.

Imaging services that are x-rays taken using computed radiography technology shall have the technical component payment: (1) for services furnished from 2018 through 2022 reduced by 7%; and (2) for services furnished during 2023 or a subsequent year reduced by 10%.

Reduced expenditures attributable to incentives to transition to digital radiography under the physician fee schedule are exempt from budget-neutrality calculation.

The Department of Health and Human Services may not apply a multiple procedure payment reduction to the professional component of imaging services furnished before it publishes, as part of the Medicare Physician Fee Schedule Proposed Rule for a year, a empirical analysis of the Resource-Based Relative Value Scale (commonly known as the "RBRVS") Data Manager information used to determine what, if any, efficiencies exist within the professional component of imaging services when two or more studies are performed on the same patient on the same day.

These payment reductions under the hospital outpatient prospective payment system for the transition from traditional x-ray imaging to digital radiography shall apply without regard to budget neutrality.

Date: 2015-05-21
Topic: Health (Drug Industry)
Subject: Health
Accelerating Innovation in Medicine Act of 2015 or the AIM Act of 2015

 Amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services (HHS) to develop an accelerating innovation in medicine (AIM) list of medical devices for which, because of their inclusion on the list, insurance benefits and payments are prohibited under Medicare (either directly or on a capitated basis), with the result that no Medicare claim may be submitted and an individual who consents to receive such a device is responsible for paying for it and for any related services.

Directs the Secretary to post on a public HHS website or other publicly accessible media an updated list of the medical devices on the AIM list.

Date: 2015-06-01
Topic: Health (Drug Industry)
Subject: Health
Part D Beneficiary Appeals Fairness Act

 Amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act, with respect to a prescription drug plan (PDP) that provides for any tiered cost-sharing within a formulary (including a structure that provides for different co-payment or coinsurance amounts for drugs in different tiers included within the formulary), to authorize a Medicare part D eligible individual enrolled in the plan to request an exception to the tiered cost-sharing structure.

States that in no case may the Secretary of Health and Human Services allow a PDP sponsor to make any formulary tier of the tiered cost-sharing structure (including a formulary tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.

Date: 2015-06-03
Topic: Health (Drug Industry)
Subject: Health
Antibiotic Development to Advance Patient Treatment Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow the Food and Drug Administration (FDA) to agree with the sponsor of an applicable medication on a process for approving the medication for use in a limited population of patients. Applicable medications are antibacterial or antifungal drugs or biological products for the treatment of a serious infection. The FDA may rely on alternate study endpoints, limited data sets, and additional data, including preclinical evidence, in approving such a medication.

A medication approved for use in a limited population must be labeled accordingly.

The Public Health Service Act is amended to require the Department of Health and Human Services to monitor the use of antibacterial and antifungal medications and monitor antibacterial and antifungal resistance. (An individual infected by a strain of bacteria or fungi that is resistant to a medication cannot be treated with that medication. Resistance can develop naturally with the use of a medication.)

The FDA must identify and publish susceptibility test interpretive criteria for antimicrobial medications. (These criteria are used to characterize the resistance of microbes to antimicrobial medications. "Microbes" or "microorganisms" include bacteria, some fungi, and other organisms.)

Every six months, the FDA must evaluate any new or updated susceptibility test interpretive criteria established by a standard development organization and recognize new criteria or withdraw recognition of criteria, as appropriate.

The FDA may allow marketing of medical devices that use these criteria without premarket approval.

Date: 2015-06-03
Topic: Health (Drug Industry)
Subject: Health
Fair Access for Safe and Timely Generics Act of 2015 or the FAST Generics Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the license holder of a Food and Drug Administration (FDA)-approved drug or biological product from restricting availability of the medication for testing by a product developer seeking to develop a drug, generic drug, or biosimilar, including restricting availability with a risk evaluation and mitigation strategy (REMS).

Upon request, the license holder of a medication that is not subject to a REMS must provide a product developer with the medication for testing.

For a medication subject to a REMS, a product developer must have FDA authorization to obtain the medication before the license holder must provide it. The FDA may authorize a product developer to conduct testing and clinical trials with the medication.

A wholesaler or specialty distributor who receives a request from a product developer for a medication for testing may not disclose to the license holder the identity of the product developer. The FDA may prohibit or limit transfer of a medication to a product developer if the transfer poses an imminent hazard to public health.

License holders are not liable for claims arising from a product developer testing the medication.

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

Date: 2015-06-18
Topic: Health (Drug Industry)
Subject: Health
Right to Try Act of 2015

Bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, dispensing, possession, or use of an experimental drug, biological product, or device that is: (1) intended to treat a patient who has been diagnosed with a terminal illness; and (2) authorized by, and in accordance with, state law.

Defines an "experimental drug, biological product, or device" as one that: (1) has successfully completed a phase 1 clinical investigation; (2) remains under investigation in a clinical trial approved by the Food and Drug Administration; and (3) is not approved, licensed, or cleared for commercial distribution under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.

Date: 2015-07-09
Topic: Health (Drug Industry)
Subject: Health