jiayi-li23/proxann_data huggingface dataset:
Topic: Health — Drug Industry
Subject: Health
Date: 2015-04-15 00:00:00

FDA Accountability for Public Safety Act

This bill requires the Commissioner of Food and Drugs to ensure that an advisory committee of the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) evaluates each new drug application for an opioid (a drug with effects similar to opium, such as morphine) and issues a recommendation regarding approval of the drug. If the decision to approve the drug is inconsistent with the committee's recommendation, the Commissioner must make the final decision on approval.

If the committee recommends a drug not be approved but the Commissioner decides to approve the drug, the Commissioner must: (1) submit a report to Congress that includes the evidence regarding patient safety that supports the Commissioner's decision and a disclosure of any potential conflicts of interest of FDA officials involved in the decision to approve the drug; and (2) testify before Congress regarding the decision, upon request. Such a drug cannot be sold until the Commissioner has submitted the required report.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-04-23 00:00:00

Advancing Breakthrough Devices for Patients Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise requirements regarding priority review of breakthrough medical devices.

Upon a sponsor's request, the Food and Drug Administration (FDA) must determine whether a device meets the criteria for designation as a breakthrough device. 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 and timely 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 and flexible as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to a decision that a substantial scientific issue essential to determining the safety or effectiveness of the device exists.

The FDA must issue guidance and report on this priority review process.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-07 00:00:00

Patient Access to Disposable Medical Technology Act of 2015

(Sec. 2) This bill amends title XVIII (Medicare) of the Social Security Act to direct the Department of Health and Human Services to make a separate payment, calculated according to a specified formula, to a home health agency for an applicable disposable device when furnished on or after January 1, 2017 to an individual who receives home health services for which payment is made under Medicare.

 An "applicable disposable device" is one that is:

 a disposable negative pressure wound therapy device that is an integrated system composed of a non-manual vacuum pump, a receptacle for collecting exudate, and dressings for the purposes of wound therapy; and a substitute for, and used in lieu of, a negative pressure wound therapy durable medical equipment item that is an integrated system of a negative pressure vacuum pump, a separate exudate collection canister, and dressings that would otherwise be covered for individuals for such wound therapy. The Government Accountability Office shall study:

 the value of disposable devices to the Medicare program and Medicare beneficiaries as well as the role of disposable devices as substitutes for durable medical equipment, and the impact of the payment under this Act for applicable disposable devices.
Topic: Health — Drug Industry
Subject: Crime and law enforcement
Date: 2015-05-20 00:00:00

Safer Prescribing of Controlled Substances Act

Amends the Controlled Substances Act to direct the Attorney General, as a condition of granting or renewing the registration of a covered practitioner to dispense, or conduct research with, controlled substances in schedule II, III, IV, or V, to require such covered practitioner to complete training that the Department of Health and Human Services (HHS) determines meets the requirements of this Act. Defines a "covered practitioner" as a practitioner that is not a hospital, pharmacy, or veterinarian.

Requires such training to expose covered practitioners to:

 best practices for pain management, including alternatives to prescribing controlled substances; responsible prescribing of pain medications; methods for diagnosing, treating, and managing a substance use disorder, including evidence-based nonpharmacological therapies; ways of linking patients to evidence-based treatment for substance use disorders; and tools to manage adherence and diversion of controlled substances. Directs the Substance Abuse and Mental Health Services Administration to establish or support the establishment of at least one free, online training module that meets such requirements to be provided to any covered practitioner registered or applying for registration.

Requires HHS: (1) to establish, maintain, and periodically update a publicly available database providing information on such training modules; and (2) within five years after enactment of this Act, to evaluate and make publicly available a report describing how exposure to training required by this Act has changed prescribing patterns of controlled substances.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-20 00:00:00

Saving Access to Compounded Medications for Special Needs Patients Act

This bill amends the Federal Food, Drug, and Cosmetic Act to allow drugs to be compounded (manufactured at a small scale) and distributed to practitioners for treatment of, or administration to, patients of that practitioner. Currently, drugs may be compounded only for identified individual patients. (Compounded drugs do not need to meet certain requirements for drugs regarding manufacturing, labeling, or FDA approval.)

Compounded drugs must comply with United States Pharmacopeia standards.

A memorandum of understanding (MOU) between the FDA and a state regarding compounded drugs no longer must address interstate distribution of inordinate amounts of compounded drugs. Such an MOU must not create an unfunded mandate on a state. (Compounders in states that do not have an MOU with the FDA may not distribute more than 5% of their orders out of state.)
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-21 00:00:00

Orphan Product Extensions Now Accelerating Cures and Treatments Act of 2015

Amends the Federal Food, Drug, and Cosmetic Act to require the Department 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 HHS 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 HHS 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.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-05-21 00:00:00

Organ Donation Awareness and Promotion Act of 2015

This bill expresses the sense of Congress that: (1) the federal government should carry out programs to educate the public with respect to organ donation, and (2) organ and tissue donors should be honored.

The bill amends the Public Health Service Act to authorize the appropriation of specified amounts for FY2015-FY2019 for: (1) the Organ Donation Public Awareness Program; (2) studies and demonstration projects to increase organ donation and recovery rates; (3) grants to assist states in carrying out organ donor awareness, public education, and outreach activities and programs designed to increase the number of organ donors within the state; and (4) support for the development and dissemination of educational materials to inform health care and other appropriate professionals in issues surrounding organ, tissue, and eye donation.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-03 00:00:00

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 element of the tiered cost-sharing structure (including a tier used for very high cost or unique items) ineligible for lower-cost sharing through an exception.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-17 00:00:00

Patient-Focused Impact Assessment Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), after approving an application for a new medication, to publish a brief statement on any patient experience data or related information that was part of the application. Patient experience data is information about the impact of a medical condition or a related therapy on a patient's life and the patient's preferences for treatment.

(Sec. 3) The FDA must issue guidance on the collection of patient experience data and the use of that data in drug development.

(Sec. 4) The Paperwork Reduction Act does not apply to voluntary collection of patient experience data.

(Sec. 5) The FDA must report on its review of patient experience data as part of approving applications for new medications.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-06-18 00:00:00

FDA Device Accountability Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to eliminate the requirement for the Institutional Review Board supervising the clinical testing of an investigational or humanitarian medical device to be local.

(Sec. 3) The Food and Drug Administration (FDA) must revise the guidance entitled “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”

(Sec. 4) The FDA must ensure that employees who review premarket submissions of medical devices receive training on least burdensome means requirements. (Currently, the FDA is required to consider the least burdensome appropriate means for a sponsor to demonstrate the effectiveness of a medical device or demonstrate a device’s substantial equivalence to an approved medical device.) The FDA must periodically assess the implementation of those requirements. The ombudsman for any applicable unit of the FDA must audit and report on the training.

The FDA must consider the least burdensome appropriate means necessary to demonstrate medical device safety and effectiveness when requesting additional information from a device sponsor to support a premarket approval application, including the role of postmarket information in such a demonstration.

The FDA’s documented rationale for a significant decision regarding a medical device must include a statement regarding how the least burdensome requirements were considered and applied.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-07-14 00:00:00

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 (or for any items or services related to furnishing such 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 (or related items or services) is responsible for paying for it and any related items and 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.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-07-15 00:00:00

Combination Product Regulatory Fairness Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding products that are a combination of a drug, medical device, or biological product.

The primary mode of action of a combination product must be the mode of action that makes the greatest contribution to the product's therapeutic effect. (Combination products are regulated based on their primary mode of action.) The FDA is prohibited from determining that a combination product is a drug or biological product solely because the product has a chemical action. If the sponsor of a combination product disagrees with the FDA's determination of the primary mode of action of the product, the FDA must provide the rationale for its determination and the sponsor and the FDA may agree to studies to inform a reevaluation of the product.

After the primary mode of action of a product is determined, the sponsor and the FDA may agree to a combination product review plan that may address the standards and requirements applicable to the product's review, postmarket modification, or manufacturing. The plan must remain in effect unless the sponsor and the FDA agree otherwise or an issue essential to determining the safety or effectiveness of the product is identified.

The FDA may require the sponsor of a combination product that contains an approved constituent part to submit to the FDA only information that is necessary to assess the safety and effectiveness of the combination product, taking into account prior findings regarding the approved constituent part. If the approved constituent part is a drug, the application for the combination product must comply with specified requirements for drug applications.

The FDA Office of Combination Products must coordinate reviews of combination products and oversee feedback regarding such reviews. The office must review FDA agreements, guidance, and practices regarding combination products.

The FDA must: (1) issue guidance that describes the process and best practices for review of combination products, and (2) propose that certain types of combination products may adopt good manufacturing practices that vary from requirements in regulations.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-07-30 00:00:00

Orphan Drug Fairness Act

This bill amends the Patient Protection and Affordable Care Act (PPACA) to exclude sales of any drug or biological product approved by the Food and Drug Administration solely for rare diseases or conditions (orphan drug) from the calculation of the annual fee on manufacturers or importers with branded prescription drug sales exceeding $5 million.

This Act is effective as if included in PPACA.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-10-21 00:00:00

Rare Disease Innovation Act

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.

The FDA must report every five years on the effect of this expansion of the humanitarian device exception.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-11-16 00:00:00

Stem Cell Therapeutic and Research Reauthorization Act of 2015

This bill amends the Public Health Service Act and the Stem Cell Therapeutic and Research Act of 2005 to revise and extend through FY2020 the C.W. Bill Young Cell Transplantation Program and the National Cord Blood Inventory program. (These programs help match patients in need of a transplant with unrelated bone marrow and cord blood donors.)

The Department of Health and Human Services (HHS) must review the state of the science of using adult stem cells and birthing tissues to develop new therapies and consider the inclusion of new therapies in the C.W. Bill Young Cell Transplantation Program. Requirements for HHS contracts under the Stem Cell Therapeutic and Research Act of 2005 are revised.

HHS must determine whether to include peripheral blood stem cells and umbilical cord blood in the definition of human organ.
Topic: Health — Drug Industry
Subject: Health
Date: 2015-11-19 00:00:00

DME Access and Stabilization Act of 2015

This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to modify provisions relating to payment for durable medical equipment (DME) under the Medicare and Medicaid programs. (DME includes certain medically necessary equipment such as walkers, wheelchairs, and hospital beds.)

With respect to DME furnished in areas that are not competitive acquisition areas, current regulations require the Centers for Medicare & Medicaid (CMS) to phase in, over a two-year period, Medicare payment adjustments using information from competitive acquisition programs. (Through such programs, payment amounts for each area are determined based on competitive bids submitted by suppliers, rather than according to an established fee schedule.) The bill codifies this requirement and specifies that CMS shall adjust fee schedule amounts to the lesser of: (1) a specified percentage of the regional amount; and (2) the amount that would otherwise be determined according to the fee schedule, with specified adjustments.

In determining Medicare payment adjustments for areas that are not competitive acquisition areas, CMS shall solicit stakeholder input and take into account several specified factors.

CMS may not establish a ceiling on competitive bids submitted for DME that is less than the amount that would otherwise be paid under Medicare.

The Medicare Beneficiary Ombudsman shall evaluate the impact of the competitive acquisition program on beneficiary health status and health outcomes.

The bill limits federal Medicaid reimbursement rates to states for DME to the rates that would be paid for such items under Medicare.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-02-04 00:00:00

Preventing Superbugs and Protecting Patients Act

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization.

(Sec. 3) The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-17 00:00:00

Patient Access to Durable Medical Equipment Act of 2016

(Sec. 2) This bill amends title XVIII (Medicare) of the Social Security Act to delay by one year the full implementation of new Medicare payment rates for durable medical equipment (such as wheelchairs).

(Sec. 3) In addition, the bill specifies that the bid ceiling for durable medical equipment items under Medicare's competitive acquisition program (through which rates are set according to a bidding process rather than by an established fee schedule) shall not be less than the fee schedule amount that would otherwise be determined for those items.

(Sec. 4) Under current law, the Centers for Medicare & Medicaid Services (CMS) must use payment information from competitive acquisition programs to make payment adjustments for durable medical equipment items furnished in areas outside of such programs. Current law also allows, but does not require, CMS to make such adjustments with respect to certain orthotics (such as splints and braces) and parenteral and enteral nutrients, equipment, and supplies (such as feeding tubes). The bill requires CMS, in making these adjustments, to account for stakeholder input. In addition, CMS must account for a comparison of competitive acquisition areas and other areas with respect to the following factors:

 average travel distance and cost associated with furnishing items and services, barriers to access, average delivery time, average volume of items and services furnished by suppliers, and number of suppliers. (Sec. 5) In four quarterly reports, CMS must publish on its website the results of the monitoring of health outcomes and Medicare beneficiaries' access to durable medical equipment.

(Sec. 6) The bill accelerates the applicability, from January 1, 2019, to October 1, 2018, of provisions of current law that limit federal Medicaid reimbursement to states for durable medical equipment to Medicare payment rates.
Topic: Health — Drug Industry
Subject: Health
Date: 2016-03-17 00:00:00

Improving Medical Device Innovation Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions related to medical device performance standards, reporting requirements, and classification panels.

A person may request that the Food and Drug Administration (FDA) recognize a performance standard established by a recognized standards organization as a standard to which a medical device may conform in order to meet an FDA requirement. When a request to recognize a standard is received, the FDA must determine whether to recognize all, part, or none of the standard and publish the rationale for that determination. (Currently, the FDA recognizes certain performance standards, but it is not required to respond to requests or publish rationales.)

The FDA must:

 train employees who review premarket submissions for medical devices on recognized standards; review its published principles for recognizing standards; identify types of medical devices for which a premarket report is no longer needed to provide reasonable assurance of safety and effectiveness; ensure that adequate expertise is represented on medical device classification panels; provide an opportunity for a person whose premarket submission is subject to review by a classification panel to recommend expertise needed on the panel; and provide opportunities for patients, patient representatives, and medical device sponsors to recommend individuals for positions on classification panels. The FDA, in coordination with medical device manufacturers, must establish pilot projects to evaluate alternative methods of compliance with reporting requirements for certain medical devices. The Government Accountability Office must report on these pilot projects.