zli12321/Bills huggingface dataset:
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.

Date: 2015-04-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-04-23
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-05-07
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-05-20
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
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.)

Date: 2015-05-20
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 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.

Date: 2015-05-21
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-05-21
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 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.

Date: 2015-06-03
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-06-17
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-06-18
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 (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.

Date: 2015-07-14
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-07-15
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-07-30
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-10-21
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-11-16
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2015-11-19
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2016-02-04
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2016-03-17
Topic: Health (Drug Industry)
Subject: Health
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.

Date: 2016-03-17
Topic: Health (Drug Industry)
Subject: Health
Prescription Drug and Health Improvement Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services (CMS) to negotiate lower prices on behalf of Medicare and Medicare Advantage (MA) beneficiaries for covered prescription drugs that CMS deems appropriate for negotiation based on: (1) program and per-beneficiary spending, (2) unit cost increases over the preceding years, (3) initial launch price, and (4) any other criteria determined by CMS.

CMS may negotiate lower prices on behalf of Medicare and MA beneficiaries for other covered prescription drugs, as well.

Date: 2016-04-27
Topic: Health (Drug Industry)
Subject: Health
Trickett Wendler Right to Try Act of 2016

This bill bars the federal government from prohibiting or restricting the production, manufacture, distribution, prescribing, or dispensing 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. The federal government may not restrict the possession or use of such a treatment by a patient certified by a physician as having exhausted all other treatment options.

A producer, manufacturer, distributor, prescriber, dispenser, possessor, or user of such a treatment has no liability regarding the treatment.

The outcome of production, manufacture, distribution, prescribing, dispensing, possession, or use of such a treatment may not be used by a federal agency to adversely impact review or approval of the treatment.

The treatment must: (1) have successfully completed a phase 1 (initial, small scale) clinical trial; (2) remain under investigation in a clinical trial approved by the Food and Drug Administration (FDA); and (3) not be approved, licensed, or cleared for sale under the Federal Food, Drug, or Cosmetic Act or the Public Health Service Act.

Not later than 30 days after enactment of this bill, and every 30 days thereafter until implementation is complete, the FDA must report on its progress in implementing a streamlined application process for compassionate use of experimental drugs and biological products.

Date: 2016-05-10
Topic: Health (Drug Industry)
Subject: Health
Budgeting for Opioid Addiction Treatment Act 

This bill amends the Internal Revenue Code to impose a one cent per milligram excise tax on the sale of active opioids by the manufacturer, producer, or importer. The tax excludes prescription drugs used exclusively for the treatment of opioid addiction as part of a medically assisted treatment effort.

The Department of Health and Human Services (HHS) must establish a program to provide rebates or discounts to cancer and hospice patients to ensure that they do not pay the tax.

The bill amends the Public Health Service Act to require any increase in federal revenues from the tax after rebates and discounts are subtracted to be distributed to states under the Substance Abuse Prevention and Treatment Block Grant program to be used exclusively for substance abuse (including opioid abuse) efforts in the states, including specified treatment programs.

HHS must report to Congress on the impact of this bill on the retail cost of opioids and patient access to opioid medication, the effectiveness of the discount or rebate for cancer and hospice patients, how the funds are being used to improve substance abuse treatment efforts, and suggestions for improving access to opioids for cancer and hospice patients and substance abuse treatment efforts.

Date: 2016-05-24
Topic: Health (Drug Industry)
Subject: Health
This bill amends titles XVIII (Medicare) and XIX (Medicaid) of the Social Security Act to add standards for drug compendia used by physicians with respect to payment for certain drugs under the Medicare and Medicaid programs.

Specifically, such compendia shall include compendia that, as determined by the Centers for Medicare & Medicaid Services: (1) are used by health care providers and utilized nationwide by the health insurance industry; (2) have a publicly available policy on disclosures of conflicts of interest; (3) use an international, widely recognized standard to evaluate clinical evidence for inclusion; and (4) are accepted by at least one state board of pharmacy or equivalent licensing body.

Date: 2016-05-25
Topic: Health (Drug Industry)
Subject: Health
DXM Abuse Prevention Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of a drug containing dextromethorphan (DXM) to an individual under age 18 unless the individual has a prescription or is actively enrolled in the military. Civil monetary penalties that escalate upon repeated violation are imposed.

To possess or receive unfinished DXM, a person must be registered with the Department of Health and Human Services as a producer of a drug or medical device or otherwise allowed to engage in the practice of pharmacy, pharmaceutical production, or manufacture or distribution of drug ingredients. Unfinished DXM may be distributed only to these authorized persons. Common carriers distributing unfinished DXM between authorized persons are exempted. Civil monetary penalties are imposed for possession and distribution violations.

Date: 2016-05-26
Topic: Health (Drug Industry)
Subject: Health
Creating and Restoring Equal Access to Equivalent Samples Act of 2016 or the CREATES Act of 2016

This bill permits the developer of a drug or biological product to bring a civil action against the license holder of an approved medication alleging that the license holder: (1) declined to make available sufficient quantities of the approved medication for the developer's testing; or (2) failed to agree on, or refused to allow the developer to join, a single, shared system of elements to assure safe use (ETASU) of the medication. (Under current law, a generic version of a medication with ETASU must join the brand name medication's system of ETASU unless the developer of the generic has a waiver from the Food and Drug Administration.) The bill does not apply to medications for which there is a shortage, unless the shortage will not be promptly resolved.

In a civil action regarding the availability of sufficient quantities of a medication, it is an affirmative defense that the license holder: (1) is not manufacturing or marketing the medication and does not have access to a supply of the medication to make available, or (2) sells the medication without restrictions through other entities and the developer can purchase sufficient quantities of the medication from those entities.

Date: 2016-06-14
Topic: Health (Drug Industry)
Subject: Health
Addiction Prevention and Responsible Opioid Practices Act

This bill addresses prescription opioid misuse.

 The Food and Drug Administration (FDA) must: (1) seek recommendations concerning opioid drugs from an FDA advisory committee relating to the approval of a new drug that is an opioid, and the labeling of opioid drugs for pediatric prescriptions; (2) develop recommendations for education programs for prescribers of opioids; and (3) issue guidance for labeling that deters opioid abuse.

The bill amends the Federal Food, Drug, and Cosmetic Act by requiring manufacturers of opioid drugs to ensure that certain information about the risk factors associated with opioid drugs are included on the drug labels.

The bill amends the Controlled Substances Act by: (1) addressing annual narcotic manufacturing quotas with respect to fentanyl, oxycodone, hydrocodone, oxymorphone, and hydromorphone; and (2) directing the Department of Justice (DOJ) to require medical practitioners to complete a training program on prescribing opioids for chronic pain before they are certified to prescribe controlled substances in schedule II, III, or IV.

The bill establishes requirements for prescription drug monitoring systems to prevent over-prescribing controlled substances.

The Department of Health and Human Services must: (1) submit a plan of action for addressing outliers in opioid prescribing practices and ensuring an adequate response to protect the public health, and (2) study the expansion of Medicare coverage for alternatives to opioid treatments.

The bill amends the Internal Revenue Code to impose an excise tax on manufacturers or producers of opioid pain relievers. A portion of the amount generated from the tax must be used for substance abuse treatment programs.

DOJ must establish a take-back program for the safe and environmentally responsible disposal of controlled substances.

Date: 2016-06-16
Topic: Health (Drug Industry)
Subject: Health
Prescription Drug Monitoring Act of 2016

This bill requires a state that receives grant funds under the prescription drug monitoring program (PDMP) or the controlled substance monitoring program to comply with specified requirements. The Department of Justice (DOJ) or Department of Health and Human Services may withhold grant funds from a state that fails to comply.

Additionally, the bill requires a state to share its PDMP data with other states through a data-sharing hub established by DOJ.

Date: 2016-07-13
Topic: Health (Drug Industry)
Subject: Health
Carl's Law

This bill amends the Federal Food, Drug, and Cosmetic Act to require the label of a drug containing an opioid to prominently state that the drug contains an opioid and addiction to the drug is possible. (Opioids are drugs with effects similar to opium, such as certain pain medications.)

Date: 2016-09-07
Topic: Health (Drug Industry)
Subject: Health
Fair Accountability and Innovative Research Drug Pricing Act of 2016

This bill amends the Public Health Service Act to require manufacturers of certain drugs and biological products to report to the Department of Health and Human Services (HHS) price increases that result in a 10% or more increase in the price of a drug over a 12-month period. Reports are required for prescription drugs and drugs commonly administered in hospitals, except vaccines, drugs for rare conditions, and drugs with annual sales for Medicare and Medicaid enrollees of less than $1.

Manufacturers that do not submit a required report are subject to a civil penalty. The Inspector General of HHS must review drug price information to determine compliance. Collected penalty funds must be used to carry out activities related to this reporting requirement and to improve consumer and provider information about drug value and drug price transparency.

HHS must publish manufacturer reports, a summary of those reports, and supporting analyses.

Date: 2016-09-15
Topic: Health (Drug Industry)
Subject: Health
Safely Advancing Valuable and Inexpensive New Generic Solutions Act or the SAVINGS Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to prioritize the review of certain generic drug applications and act on them within 150 days. This generic fast track review applies to applications for drugs: (1) that are not under patent or for which patents will expire soon, (2) for which there is no marketing exclusivity in effect, and (3) for which a generic has not recently been introduced to the market by more than one manufacturer.

The FDA must report on applications subject to generic fast track review and provide an annual accounting of how it has spent generic drug user fees.

Date: 2016-09-22
Topic: Health (Drug Industry)
Subject: Health
This bill amends the Public Health Service Act to require the Department of Health and Human Services to research and report on medication adherence with respect to federal health care programs. ("Medication adherence" refers to the extent to which patients take their medications as prescribed.)

In addition, the bill amends titles XI (General Provisions) and XVIII (Medicare) of the Social Security Act to require the Centers for Medicare & Medicaid Services to:

 upon request by a prescription drug plan (PDP) sponsor, provide the plan with Medicare enrollee claims data to provide context for an enrollee's medication regimen; in calculating the minimum medical loss ratio with respect to PDPs, include medication management as an activity that improves health care quality; and through the Center for Medicare and Medicaid Innovation, test a model for enhanced medication therapy management for PDPs under Medicare Advantage.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Health
Pharmaceutical Supply and Value Enhancement Act or the Pharmaceutical SAVE Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to authorize importation of life-saving drugs for which there is, or is likely to be, a shortage. For a drug to be imported, the drug's manufacturer must intend to seek FDA approval of the drug as a generic drug. The FDA may deny importation of a drug for reasons related to safety or effectiveness.

Drugs in noncompetitive markets must be treated as being in a shortage for purposes of this bill and for purposes of expedited inspections and review. A drug is in a noncompetitive market if: (1) there are fewer than five holders of approved applications for commercially available brand name or generic versions of the drug, (2) the drug has been approved for at least 10 years, and (3) patents on the active ingredient of the drug have expired.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Health
Accelerating New Pharmaceutical Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to permit brand name drug applications to rely upon investigations conducted in certain foreign countries if the drug has been approved in the foreign country where the investigations were conducted. The Food and Drug Administration (FDA) has 90 days to act on these applications.

The bill revises a provision regarding the effective date of the approval of a generic drug that is subject to a patent infringement action.

The FDA must prioritize the review of, and act within 150 days on, generic drug applications or supplements to generic drug applications for drugs: (1) for which there is a shortage, or (2) that have not been recently introduced to the market by more than one manufacturer and for which tentative approval has not been granted to more than two applications.

Date: 2016-09-29
Topic: Health (Drug Industry)
Subject: Health
Disability Benefit Fairness Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act (SSA) to eliminate: (1) the five-month waiting period for an individual (including a disabled widow or widower) to be eligible for benefits based on disability; and (2) any intervening reconsideration from the review process governing decisions on benefit entitlement.

Date: 2007-01-04
Topic: Social Welfare (Disabled Assistance)
Subject: Social welfare
Social Security and Medicare Improved Burn Injury Treatment Access Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to direct the Commissioner of Social Security to waive the application of the five-month Social Security disability waiting period in cases of individuals with disabling burn injuries. Eliminates the 24-month Medicare disability waiting period in cases of individuals with disabling burn injuries.

Date: 2007-01-24
Topic: Social Welfare (Disabled Assistance)
Subject: Social welfare
Financial Security Accounts for Individuals with Disabilities Act of 2007 - Amends the Internal Revenue Code to establish tax-exempt financial security accounts for individuals with disabilities to pay certain expenses of such individuals, including expenses for education, medical care, and employment training.

Date: 2007-05-17
Topic: Social Welfare (Disabled Assistance)
Subject: Taxation
Danielle's Act - Amends title XIX (Medicaid) of the Social Security Act to require state Medicaid plans to require staff working with persons with a developmental disability or traumatic brain injury to call emergency services in the event of a life-threatening situation.

Date: 2007-05-17
Topic: Social Welfare (Disabled Assistance)
Subject: Health
Amends the Developmental Disabilities Assistance and Bill of Rights Act of 2000 to require states, in order to receive allotments under provisions relating to state councils on developmental disabilities or provisions relating to the protection and advocacy of individual rights, to obtain the authorization of the individual with a developmental disability or the individual's legal representative before pursuing any legal or other remedy on behalf of the individual.

Date: 2007-06-22
Topic: Social Welfare (Disabled Assistance)
Subject: Civil rights and liberties, minority issues
Claire Collier Social Security Disability Insurance Fairness Act - Amends title II (Old Age, Survivors and Disability Insurance) of the Social Security Act to provide that the eligibility requirement for disability insurance benefits under which an individual must have 20 quarters of Social Security coverage in the 40 quarters preceding a disability shall not apply in the case of a disabled individual suffering from a covered terminal disease.

Date: 2007-06-28
Topic: Social Welfare (Disabled Assistance)
Subject: Social welfare
ADA Amendments Act of 2008 - (Sec. 4) Amends the Americans with Disabilities Act of 1990 (ADA) to redefine the term "disability," including by defining "major life activities" and "being regarded as having such an impairment."Sets forth rules of construction regarding the definition of "disability," including that: (1) such term shall be construed in favor of broad coverage of individuals under the Act; (2) an impairment that substantially limits one major life activity need not limit other major life activities in order to be a disability; (3) an impairment that is episodic or in remission is a disability if it would substantially limit a major life activity when active; and (4) the determination of whether an impairment substantially limits a major life activity shall be made without regard to the ameliorative effects of specified mitigating measures.Defines the term "auxiliary aids and services."(Sec. 5) Prohibits employment discrimination against a qualified individual on the basis of disability. (Current law prohibits employment discrimination against a qualified individual with a disability because of the disability.)Prohibits the use of qualification standards, employment tests, or other selection criteria based on an individual's uncorrected vision unless the standard, test, or other selection criteria, as used by the covered entity, is shown to be related to the position and is consistent with business necessity.(Sec. 6) Declares that nothing in the Act: (1) alters the standards for determining eligibility for benefits under state worker's compensation laws or under state and federal disability benefit programs; (2) alters the requirement to make reasonable modifications in policies or procedures, unless such modifications would fundamentally alter the nature of the goods, services, facilities, or accommodations involved; or (3) provides the basis for a claim by a person without a disability that he or she was subject to discrimination because of the lack of disability.Declares that the authority of the Equal Employment Opportunity Commission (EEOC), the Attorney General, and the Secretary of Transportation to issue regulations includes the authority to issue regulations implementing the definitions of this Act.(Sec. 7) Makes conforming amendments to the Rehabilitation Act of 1973.

Date: 2007-07-26
Topic: Social Welfare (Disabled Assistance)
Subject: Civil rights and liberties, minority issues
ADA Notification Act of 2007 - Amends the Americans with Disabilities Act of 1990 to deny jurisdiction to a court in a civil action for remedies for disability discrimination in public accommodations and certain services provided by private entities unless: (1) the plaintiff notified the defendant in writing of the alleged violations prior to filing the complaint; (2) the notice identified the specific facts that constitute the alleged violation; (3) 90 or more days has elapsed after the date on which the notice was provided; (4) the notice informed the defendant that the civil action could not be commenced for 90 days; and (5) the complaint states that the defendant has not corrected the alleged violation. Excludes civil actions seeking preliminary injunctive relief or temporary restraining orders from such notification requirements.

Date: 2007-09-05
Topic: Social Welfare (Disabled Assistance)
Subject: Civil rights and liberties, minority issues
Blind Persons Earnings Fairness Act of 2007 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to increase, by specified increments over five years, the level of earnings demonstrating the ability of a blind person to engage in substantial gainful activity for purposes of determining disability insurance benefit payments.

Date: 2007-10-15
Topic: Social Welfare (Disabled Assistance)
Subject: Social welfare
Prohibits any entity that receives funds from the federal government from using them to file a class action lawsuit against an intermediate care facility for the mentally retarded on behalf of any facility resident unless the resident (or the resident's legal representative), after receiving notice of the proposed class action lawsuit, has the opportunity to elect not to have the action apply to the resident.

Date: 2007-10-30
Topic: Social Welfare (Disabled Assistance)
Subject: Law
Inclusive Home Design Act of 2007 - Requires, with exceptions, newly constructed, federally assisted single family houses and town houses to include at least one level that complies with the following accessibility features for persons with disabilities: (1) accessible entrance; (2) accessible interior doors; (3) accessible environmental controls; and (4) accessible habitable space and an accessible bathroom. Requires: (1) each applicant for federal financial assistance to submit compliance assurances to the relevant federal agency; and (2) each person who arranges for design or construction of a covered dwelling to submit architectural and construction plans for state or local approval. Prohibits federal financial assistance to a state or local government unit unless the recipient is taking certain enforcement actions with regard to covered dwellings. Permits: (1) private civil actions in a U.S. District Court or state court for violations under this Act; and (2) the Attorney General to commence civil actions or intervene in civil actions under this Act.

Date: 2007-11-15
Topic: Social Welfare (Disabled Assistance)
Subject: Housing and community development
Social Security Disability Insurance Demonstration Authority Act of 2008 - Amends title II (Old Age, Survivors and Disability Insurance) (OASDI) of the Social Security Act to reestablish the Social Security Administration's disability insurance demonstration project authority.

Date: 2008-07-31
Topic: Social Welfare (Disabled Assistance)
Subject: Social welfare
Amends the Internal Revenue Code to make permanent the suspension of the taxable income limitation on percentage depletion for oil and natural gas produced from marginal properties.

Date: 2007-03-15
Topic: Social Welfare (Disabled Assistance)
Subject: Taxation
Veterans' Housing Benefits Enhancement Act of 2007 - Authorizes the Secretary of Veterans Affairs, in the case of a member of the Armed Forces determined to have a total disability permanent in nature which was incurred or aggravated in the line of active duty, to furnish home improvements and structural alterations for the member for the disability while the member is hospitalized or receiving outpatient care, medical services, or treatment, if the Secretary determines that the member is likely to be discharged or released from the Armed Forces for such disability. Authorizes the provision of specially adapted housing assistance for: (1) disabled veterans whose disability is due to a severe burn injury; and (2) disabled members residing temporarily in housing owned by a family member. Makes veterans and members with a severe burn disability eligible for automobile and automotive adaptive equipment assistance.

Date: 2007-04-12
Topic: Social Welfare (Disabled Assistance)
Subject: Armed forces and national security