zli12321/Bills huggingface dataset:
Veterans Access to Orthotic and Prosthetic Care Act

This bill directs the Department of Veterans Affairs (VA) to ensure that: (1) each VA prosthetist and orthotist and each VA employee who provides prosthetic or orthotic services meets all current certification and licensing requirements, and (2) each VA orthotic or prosthetic facility and laboratory that provides prosthetic and orthotic services is certified by one of the nationally recognized accrediting bodies.

Date: 2015-07-29
Topic: Health (Drug Industry)
Subject: Armed forces and national security
Reinvigorating Antibiotic and Diagnostic Innovation Act of 2015

This bill amends the Internal Revenue Code to allow tax credits for 50% of the clinical testing expenses for: (1) infectious disease products that are intended to treat a serious or life-threatening infection, including one caused by an antibacterial or antifungal resistant pathogen or a qualifying pathogen listed by the Department of Health and Human Services as having the potential to pose a serious threat to public health; and (2) in-vitro diagnostic devices that identify in less than four hours the presence, concentration, or characteristics of a serious or life-threatening infection.

Date: 2015-09-17
Topic: Health (Drug Industry)
Subject: Taxation
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: 2015-09-25
Topic: Health (Drug Industry)
Subject: Health
Gluten in Medicine Disclosure Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of any drug intended for human use that contains an ingredient other than a polyol that constitutes or is derived from a grain or starch-containing ingredient and whose label does not include a parenthetical statement identifying the source of that ingredient.

Date: 2015-09-29
Topic: Health (Drug Industry)
Subject: Health
Preserving Access to Orphan Drugs Act of 2015

This bill amends the Patient Protection and Affordable Care Act to expand the definition of orphan drug for purposes of the annual fee paid by brand name prescription drug manufacturers and importers to include medications for rare conditions that were, prior to 2011, approved or in clinical trials. (Drug manufacturers and importers pay an annual fee based on their sales of brand name prescription drugs, excluding sales of orphan drugs.) Currently, only medications for rare conditions for which a tax credit for clinical trials was allowed are considered orphan drugs.

This Act applies to fees paid after 2014.

Date: 2015-10-01
Topic: Health (Drug Industry)
Subject: Health
Strategy To Oppose Predatory Organ Trafficking Act or the STOP Organ Trafficking Act

 (Sec. 3) This bill expresses the sense of Congress that:

 kidnapping or coercion of individuals to extract their organs for profit contradicts the standards for ethical behavior upon which the United States has based its laws; illegal harvesting of organs from children is a violation of the chid's human rights and a breach of international medical ethical standards; illegal harvesting and trafficking of human organs violates the Universal Declaration of Human Rights; and establishing efficient national organ donation systems with strong enforcement mechanisms is the most effective way to combat trafficking of persons for the removal of their organs. (Sec. 4) It shall be U.S. policy to: (1) combat trafficking of persons for the removal of their organs, (2) promote the establishment of voluntary organ donation systems with effective enforcement mechanisms, and (3) promote the dignity and security of human life.

(Sec. 5) The Passport Act of 1926 is amended to authorize the Department of State to refuse to issue a passport to, and revoke a previously issued passport from, a person convicted of trafficking in human organs who used a passport or otherwise crossed an international border in committing such offense.

(Sec. 6) The Trafficking Victims Protection Act of 2000 is amended to define "trafficking of persons for the removal of their organs" as the recruitment, transportation, transfer, harboring, or receipt of a person, either living or dead, for the purpose of removing one or more of the person's organs by:

 coercion, abduction, deception, fraud, abuse of power, or transfer of payments or benefits to achieve the consent of an individual having control over such person for the purpose of removing the person's organs. "Organ" means the human (including fetal) kidney, liver, heart, lung, pancreas, bone marrow, cornea, eye, bone, and skin or any subpart thereof and any other human organ specified by the Department of Health and Human Services.

Trafficking of persons for the removal of their organs is included in the definition of "severe forms of trafficking in persons."

 The Interagency Task Force To Monitor and Combat Trafficking is tasked with collecting and organizing data from human rights officers at U.S. embassies on host country's laws against trafficking of persons for the removal of their organs and any instances of violations of such laws.

(Sec. 7) The State Department shall report annually through 2024 to Congress regarding: (1) the trafficking of persons for the removal of their organs, and (2) preventive activities undertaken by the State Department and other countries.

Date: 2015-10-06
Topic: Health (Drug Industry)
Subject: International affairs
E-Free Act

This bill requires the Food and Drug Administration to withdraw approval for Essure, a medical device for permanent, non-surgical female sterilization.

Date: 2015-11-04
Topic: Health (Drug Industry)
Subject: Health
Meaningful Use Hardship Relief Act of 2015

This bill amends title XVIII (Medicare) of the Social Security Act to create a blanket exception for providers from the application of certain negative payment adjustments for failing to comply, during the 2015 reporting period, with requirements related to the meaningful use of electronic health records. Under current law, providers may be exempted due to significant hardship on a case-by-case basis.

Date: 2015-11-05
Topic: Health (Drug Industry)
Subject: Health
Cardiac Arrest Survival Act of 2015

This bill amends the Public Health Service Act to expand immunity from civil liability related to automated external defibrillator devices (AEDs), including by giving immunity to: (1) a person who owns, occupies, or manages the premises from which an AED is taken or at which an AED is used; and (2) the owner of an AED for any harm resulting from the use of the AED, unless the harm was caused by the failure of the owner to properly maintain the AED.

This immunity applies regardless of whether: (1) the AED is marked with cautionary signage or registered with any government; or (2) the person who used the AED complied with signage, had received training on use of the AED, or was assisted or supervised, including by a licensed physician.

Date: 2015-12-02
Topic: Health (Drug Industry)
Subject: Health
Protecting Access through Competitive-pricing Transition Act of 2015 or the PACT 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 accept a bid under the competitive acquisition program unless the bidder: (1) meets applicable state licensure requirements; and (2) has submitted a cash deposit as a bond, as specified by the bill.

CMS must establish a six-year market pricing demonstration project, under which auctions are conducted in eligible areas for the furnishing of market-priced DME items and services. The bill establishes project requirements related to auction design, contract terms, transparency, and monitoring.

Date: 2015-12-08
Topic: Health (Drug Industry)
Subject: Health
Responsibility in Drug Advertising Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit direct-to-consumer advertising of a drug in the first three years after the drug's approval. The Food and Drug Administration may: (1) waive the third year of this prohibition for a drug if direct-to-consumer advertising of the drug would have an affirmative value to public health, or (2) extend the prohibition if the drug has significant adverse health effects.

Date: 2016-02-12
Topic: Health (Drug Industry)
Subject: Health
(This measure has not been amended since it was reported to the House on May 10, 2016. The summary of that version is repeated here.)

Lali's Law

(Sec. 2) This bill amends the Public Health Service Act to permit the Department of Health and Human Services to make grants to states that allow standing orders (documents that allow a person to acquire, dispense, or administer a prescription medication without a person-specific prescription) for opioid overdose reversal medication (e.g., naloxone). (Opioids are drugs with effects similar to opium, such as heroin and certain pain medications.)

Grants may be used for:

 developing standing orders for opioid overdose reversal medication for pharmacies; encouraging pharmacies to dispense medication pursuant to such a standing order; implementing best practices for prescribing opioids, prescribing opioid overdose reversal medication with opioids, and discussing opioid overdose reversal medication with patients; developing training for prescribers to use in educating the public on administration of opioid overdose reversal medication; and educating the public on the availability and public health benefits of opioid overdose reversal medication. States must report on pharmacies that dispense opioid overdose reversal medication under a standing order and the number of pharmacists trained in educating the public on administration of opioid overdose reversal medication.

(Sec. 3) As an offset, this bill reduces the authorization of appropriations for Centers for Disease Control and Prevention facilities.

Date: 2016-02-23
Topic: Health (Drug Industry)
Subject: Health
Advancing Standards in Regenerative Medicine Act

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to facilitate the establishment of a public-private Standards Coordinating Body in Regenerative Medicine and Advanced Therapies. The FDA must work with this body to develop standards to support the development and review of regenerative medicine products.

Date: 2016-03-02
Topic: Health (Drug Industry)
Subject: Health
Removing Barriers to Clinical Research Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to expand Medicare coverage of costs associated with clinical trials. Under current law, Medicare covers routine costs of care furnished to a beneficiary enrolled in a category A (experimental) clinical trial of a medical device intended for use in the diagnosis, monitoring, or treatment of an immediately life-threatening disease or condition. The bill requires Medicare to also cover, with respect to a beneficiary enrolled in a category B (non-experimental) clinical trial, routine costs of care as well as the cost of the device under investigation.

A trial of a medical device shall, for purposes of Medicare coverage, be deemed to meet the definition of a category A or category B clinical trial, as the case may be, if the trial is conducted under the Federal Food, Drug, and Cosmetic Act's investigational use exemption.

Date: 2016-03-03
Topic: Health (Drug Industry)
Subject: Health
Reliable and Effective Growth for Regenerative Health Options that Improve Wellness or the REGROW Act

This bill amends the Public Health Service Act to require the Food and Drug Administration (FDA) to conditionally approve certain cellular therapeutic products without initiation of large-scale clinical trials. A conditionally approved cellular therapy may be marketed if certain conditions are met, including conditions on the source, processing, and function of the cells in the product. The sponsor of a conditionally approved cellular therapy must apply for approval of the product as a biological product within five years. Unless the FDA has decided not to approve the product, the product may be marketed during this five-year period and the FDA may permit continued marketing while the application is being reviewed.

An individual administering a conditionally approved cellular therapy must inform the recipient regarding conditional approval.

The premarket report for a medical device used for cellular therapy must include specified information regarding the preparation or delivery of the cellular therapy.

The approval of a medical device that is a cellular therapy must be based on laboratory performance testing and not clinical trials.

A medical device used for cellular therapy is subject to medical device classification. The FDA must not limit the use of these devices to only specific cell types unless unique to the use of the device.

The Center for Biologics Evaluation and Research has primary jurisdiction for premarket review of combination products that act primarily through cellular components.

The Department of Health and Human Services must work with stakeholders to promote the development of standards for regenerative medicine products.

Date: 2016-03-16
Topic: Health (Drug Industry)
Subject: Health
Lower Drug Costs through Competition Act

This bill amends the Federal Food, Drug, and Cosmetic Act to revise provisions regarding review and approval of 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.

The Food and Drug Administration (FDA) must prioritize the review of such submissions and act on them within 180 days. The FDA may expedite the inspection of a facility proposed to manufacture such a drug.

Beginning FY2018, the FDA must award a transferrable generic drug priority review voucher to the sponsor of such an application once the drug has a sustained market presence. A voucher may be used to have the FDA review and take action upon a generic drug application within 180 days of submission. The FDA must establish an additional user fee for applications subject to a voucher. This voucher program is terminated at the end of FY2021.

The FDA must periodically report on generic drug applications filed before FY2017 that are still pending.

For a new drug application to be eligible for a priority review voucher as a tropical disease product application, the application must include new, essential clinical investigations.

The Government Accountability Office must study the FDA's program for drug risk evaluation and mitigation strategies.

Date: 2016-03-17
Topic: Health (Drug Industry)
Subject: Health
Prevent Abuse By Using Interstate Exchange Act of 2016 or the Prevent ABUSE Act of 2016

This bill requires a state that receives a prescription drug monitoring program implementation and enhancement grant to set aside at least 20% of grant funds to facilitate interstate electronic information sharing about prescriptions for controlled substances.

Date: 2016-03-23
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
This bill requires the Centers for Disease Control and Prevention to issue guidance for the safe prescribing of opioids for the treatment of acute pain. (Opioids are drugs with effects similar to opium, such as certain pain medications.)

Date: 2016-04-12
Topic: Health (Drug Industry)
Subject: Health
Pharmaceutical Stewardship Act of 2016

This bill requires the Drug Enforcement Administration to establish and implement a national pharmaceutical stewardship program to collect and dispose of prescription medications.

Date: 2016-04-13
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Disclosure; and Encouragement of Verification, Innovation, Cleaning, and Efficiency Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring a manufacturer of a medical device to give the Food and Drug Administration (FDA) premarket notification of changes to the design or reprocessing instructions of its device.

Medical device manufacturers must also notify the FDA within five days of widely disseminating to health care providers in a foreign country communications relating to a change to the recommended reprocessing protocols, if any, for their device, or a safety concern about the device.

The bill bans the devices if the manufacturers violate the notification requirements concerning those design or reprocessing changes or communications to foreign health care providers.

The FDA must publish a list of the types of rapid assessment tests of reusable devices for which premarket notification must include proposed labeling, including validated instructions regarding sanitizing reusable devices.

Date: 2016-04-15
Topic: Health (Drug Industry)
Subject: Health
Preventing Superbugs and Protecting Patients Act

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.

The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.

Date: 2016-04-15
Topic: Health (Drug Industry)
Subject: Health
(This measure has not been amended since it was introduced. The expanded summary of the House reported version is repeated here.)

Opioid Review Modernization Act of 2016

(Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to refer new drug applications for opioids (drugs with effects similar to opium, such as certain pain medications) to an advisory committee before approval, unless the FDA finds that such a referral is scientifically unnecessary and not in the interest of protecting and promoting public health and the FDA notifies Congress of its rationale.

The FDA must convene an advisory committee on labeling opioids for pediatric use before approving any such labeling.

(Sec. 3) As part of its evaluation of the Extended-Release/Long-Acting Opioid Analgesics Risk Evaluation and Mitigation Strategy, the FDA must develop recommendations regarding education programs for prescribers of opioids.

(Sec. 4) The FDA must finalize the draft guidance entitled "General Principals for Evaluating the Abuse Deterrence of Generic Solid Oral Opioid Drug Products."

Date: 2016-04-18
Topic: Health (Drug Industry)
Subject: Health
Curb Opioid Misuse By Advancing Technology Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to extend the marketing exclusivity period for certain brand name drugs that the Food and Drug Administration approves: (1) on the basis of new clinical abuse potential studies, and (2) with labeling that characterizes the drug's abuse-deterrent properties. This extension does not apply to the marketing exclusivity period for new chemical entities.

The bill also extends the marketing exclusivity period for generics of these drugs.

Date: 2016-04-29
Topic: Health (Drug Industry)
Subject: Health
Safe Drug Disposal Tax Credit Act of 2016 

This bill amends the Internal Revenue Code to establish a tax credit for 30% of the program costs of an entity to establish or maintain a drug disposal site where individuals can deposit drugs to be disposed of legally at no cost to the individual. The credit includes the costs of materials for the site, outreach and training about the use of the site, and the safe disposal of drugs collected at the site.

Date: 2016-05-11
Topic: Health (Drug Industry)
Subject: Taxation
Empowering Pharmacists in the Fight Against Opioid Abuse Act

This bill requires the Drug Enforcement Administration (DEA) to develop and disseminate training programs and materials on: (1) the circumstances under which a pharmacist may refuse to fill a controlled substance prescription suspected to be fraudulent, forged, or indicative of abuse or diversion; and (2) federal requirements related to such refusal.

The DEA must seek input from relevant stakeholders.

Date: 2016-05-24
Topic: Health (Drug Industry)
Subject: Crime and law enforcement
Organ Donation Clarification Act of 2016

This bill allows the exchange of human organs for valuable consideration (anything of value) under pilot programs approved by the Department of Health and Human Services to measure the effect of removing disincentives or providing a noncash benefit that may increase organ availability. (Currently, exchanging human organs for valuable consideration is prohibited by the National Organ Transplant Act.)

In addition to reimbursements permitted in the National Organ Transplant Act, this bill declares that valuable consideration does not include:

 dependent care needs related to organ donation, medical expenses related to donation and all related follow-up care including preventive follow-up care and medication, paperwork or legal costs related to donation, or an insurance policy against the risk of death or disability as a result of donating an organ or the longer-term health effects of having donated an organ.

Date: 2016-05-26
Topic: Health (Drug Industry)
Subject: Health
Alzheimer's Breakthrough Sunshine Act 

This bill amends the Internal Revenue Code to exclude from gross income for seven years amounts received from the sale of certain drugs for treating Alzheimer's disease and related dementias.

The exclusion applies to the sale of a drug approved or licensed as a disease-modifying treatment for Alzheimer's disease and that has been designated as a breakthrough therapy under the Federal Food, Drug, and Cosmetic Act. The drug must be sold through an arm's length transaction by a holder of the approved application for the drug.

Date: 2016-05-26
Topic: Health (Drug Industry)
Subject: Taxation
Ariel Grace's Law

This bill amends the Federal Food, Drug, and Cosmetic Act to declare that an action for damages or a person's liability under state law is not affected by the federal prohibition on state or local requirements regarding medical devices. This bill is retroactively effective and applies to pending civil actions.

Date: 2016-06-08
Topic: Health (Drug Industry)
Subject: Health
Medical Device Guardians Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act by requiring physicians to report to the Food and Drug Administration about significant adverse experiences caused by medical devices.

Date: 2016-06-08
Topic: Health (Drug Industry)
Subject: Health
Deliver for Our Nation At Times of Emergency Act of 2016

This bill requires the Department of Health and Human Services to provide for increased flexibility in blood donor screening, while maintaining a safe blood donor pool, during times of national or local need.

Date: 2016-06-16
Topic: Health (Drug Industry)
Subject: Health
Price Relief, Innovation, and Competition for Essential Drugs Act or the PRICED Act

This bill amends the Public Health Service Act to allow biosimilars to be marketed seven years after the reference brand name biological product is licensed. Currently, brand name biological products are provided a 12-year marketing exclusivity period.

This shortened marketing exclusivity period applies only to biological products licensed by the Food and Drug Administration after enactment of this bill.

Date: 2016-06-23
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: 2016-06-28
Topic: Health (Drug Industry)
Subject: Health
Veterans Transplant Coverage Act of 2016

This bill authorizes the Department of Veterans Affairs (VA) to: (1) provide for an operation on a live donor to carry out a transplant procedure for an eligible veteran notwithstanding that the live donor may not be eligible for VA health care, and (2) provide for such an operation at a VA or a non-VA facility.

The VA shall furnish to such a donor any care or services that may be required before and after conducting with such procedure.

Date: 2016-07-12
Topic: Health (Drug Industry)
Subject: Armed forces and national security
Prostate Cancer Misdiagnosis Elimination Act of 2016

This bill specifies that, unless the physician ordering a DNA Specimen Provenance Assay (DSPA) test recommends otherwise, a DSPA test furnished with respect to a positive prostate cancer biopsy shall be deemed to be medically necessary for purposes of Medicare.

Date: 2016-07-13
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: 2016-07-14
Topic: Health (Drug Industry)
Subject: Health
Research to Accelerate Cures and Equity for Children Act or the RACE for Children Act

This bill amends the Federal Food, Drug, and Cosmetic Act to expand requirements for assessing the use of medications in pediatric populations.

Applications and supplements to applications for certain drugs and biological products, including orphan drugs, that could be used to treat pediatric cancer must include an assessment of pediatric use. Upon request, the Food and Drug Administration (FDA) must meet with the sponsor of such a medication to discuss the plan for pediatric studies.

The FDA may require the sponsor of an approved medication that could be used to treat pediatric cancer to complete a pediatric assessment if: (1) the medication is used for a substantial number of pediatric cancer patients, or (2) there is reason to believe the medication would have a meaningful therapeutic benefit over existing therapies for pediatric cancer patients.

The bill limits waivers of pediatric assessment requirements for certain medications that could be used to treat a pediatric cancer for which there is a need for additional treatment options.

The FDA must meet with medication sponsors to discuss a deferral or waiver of the pediatric assessment requirement.

Date: 2016-07-14
Topic: Health (Drug Industry)
Subject: Health
Accurate Labeling of Menstrual Products Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require menstrual cups, menstrual pads, tampons, and therapeutic vaginal douche apparatuses to include a list of ingredients on the label.

Date: 2016-07-18
Topic: Health (Drug Industry)
Subject: Health
Menstrual Products Tax Credit Act of 2016 

This bill amends the Internal Revenue Code to provide taxpayers with a refundable tax credit of $120 for each individual: (1) for whom a taxpayer is allowed a deduction for a personal exemption, and (2) who uses menstrual products. The credit must be adjusted for inflation after 2017 and is limited to taxpayers with modified adjusted gross incomes below specified amounts.

The Department of Health and Human Services must determine and provide the Internal Revenue Service with a definition for "menstrual products," which must include tampons, pads, liners, cups, and similar products used by women with respect to menstruation.

Date: 2016-07-18
Topic: Health (Drug Industry)
Subject: Taxation
Contact Lens Consumer Health Protection Act of 2016

This bill amends the Fairness to Contact Lens Consumers Act to require contact lens sellers to provide a toll-free telephone number and email address that prescribers can use to ask questions about a seller's prescription verification request.

Under current law, a prescription is considered verified if the prescriber fails to communicate with the seller within eight business hours after receiving the seller-provided verification information. The bill requires the prescription to be considered unverified until the seller obtains affirmative confirmation of the accuracy of the prescription from the prescriber in cases where a prescriber communicates a question or concern about the accuracy or verification of the prescription to a seller through the toll-free telephone service or email address before the end of that eight-hour period.

The bill removes the Federal Trade Commission's authority to adjust the eight-hour period.

If a prescriber communicates a question or concern about the accuracy of a prescription before the deadline: (1) the seller shall not fill the prescription, and (2) the prescriber shall provide the seller with an accurate prescription.

Sellers must offer prescribers different communication methods that the prescribers may select as their preferred method for verification requests.

The bill allows a seller to alter a prescription only if: (1) a private label contact lens is included on the prescription and the same contact lens is manufactured by the same company and sold under multiple labels to individual providers; and (2) the seller fills the prescription with a contact lens of exactly the same material, design, and power as manufactured by that company under another label.

Sellers must maintain a database of the issuance and expiration dates of each prescription they receive. The bill prohibits advertisements representing that a contact lens prescription may be filled after the prescription expires.

Sellers violating certain prescriber verification requirements are subject to increased penalties of up to $40,000 per violation. Such requirements apply to all contact lens sales in the United States, notwithstanding where the seller is located.

The Centers for Disease Control and Prevention must examine the potentially adverse effects of seller violations on consumers.

Date: 2016-09-22
Topic: Health (Drug Industry)
Subject: Commerce
Closing Loopholes for Orphan Drugs Act

This bill amends the Public Health Service Act to revise the 340B Drug Pricing Program, which currently requires drug manufacturers to discount orphan drugs (drugs for rare conditions) for certain entities covered by the program. The bill discounts orphan drugs that are not being used to treat rare conditions for all entities covered by the program.

Date: 2016-09-27
Topic: Health (Drug Industry)
Subject: Health
Reciprocity Ensures Streamlined Use of Lifesaving Treatments Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to establish a reciprocal marketing approval process that allows for the sale of a drug, biological product, or medical device that has not been approved by the Food and Drug Administration (FDA) if the product is approved for sale in another country.

For a product to be granted reciprocal marketing approval, the product's sponsor must submit a request to the FDA that demonstrates: (1) the product may be sold in at least one country from a specified list of countries, (2) the FDA and listed countries have not withdrawn approval of the product because of safety or effectiveness concerns, and (3) there is a public health or unmet medical need for the product.

The FDA may: (1) require postmarket studies of a product granted reciprocal marketing approval, or (2) decline to approve a product that is not safe and effective.

The FDA must grant or decline reciprocal marketing approval not later than 30 days after receiving a request. During that period, the FDA and product sponsor must negotiate and finalize product labeling and, for a medical device, classify the device.

Congress may pass a joint resolution to grant reciprocal marketing approval to a product that the FDA declines to approve through this process.

User fees apply to requests for reciprocal marketing approval.

The FDA must encourage the sponsors of potentially eligible products to request reciprocal marketing approval.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Health
Protecting Our Kids' Medicine Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the sale of liquid formulations of over-the-counter drugs that are not packaged with a dosage delivery device, such as a calibrated cup or spoon, and that do not have measurements on the label and on the dosage delivery device exclusively in metric units. The Food and Drug Administration may waive the requirement for metric units if that requirement would not benefit public health.

Over-the-counter liquid drugs labeled for pediatric use may not be sold without a flow restrictor or another mechanism to reduce accidental ingestion.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Health
Eliminate Price Increases Act of 2016 or the EPI Act

This bill amends the Federal Food, Drug, and Cosmetic Act to prohibit the manufacturer of a brand name drug from authorizing or commencing the manufacturing, marketing, selling, or distributing of a generic version of the drug from the time the manufacturer is notified by a generic manufacturer that a generic drug application has been submitted until the expiration or forfeiture of the 180-day exclusivity period granted to the generic manufacturer.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Health
Making Online Banking Initiation Legal and Easy Act of 2016 or the MOBILE Act of 2016

This bill authorizes a financial institution, with an individual's consent, to record personal information from a swipe or copy of an individual's driver's license or personal identification card and store the information electronically for the purpose of verifying the authenticity of the driver's license or identification card, verifying the identity of the individual, or complying with legal requirements.

Financial institutions must not sell, rent, transfer, or make the personal information available to another person, other than an affiliate.

Date: 2016-09-28
Topic: Health (Drug Industry)
Subject: Finance and financial sector
Patient Safety and Toxicology Modernization Act of 2016

This bill requires the Food and Drug Administration to issue and periodically update guidance on: (1) novel tools for testing the toxicology and efficacy of medications, and (2) three-dimensional human tissue models.

Date: 2016-12-07
Topic: Health (Drug Industry)
Subject: Health
Protecting Access to Diabetes Supplies Act of 2016

This bill amends title XVIII (Medicare) of the Social Security Act to modify provisions relating to Medicare's competitive acquisition program (through which rates are set through a competitive bidding program rather than by an established fee schedule) with respect to diabetic testing strips. Specifically, the bill requires the Centers for Medicare & Medicaid Services (CMS) to:

 use specified data to determine whether a bid satisfies certain requirements related to volume of coverage with respect to such products, reject a bid if the bidder does not demonstrate its ability to furnish such products in a manner consistent with its bid, and establish a process to monitor the extent to which an entity continues to cover the product types included in its bid. CMS may terminate a contract if it determines that an entity, for reasons other than product discontinuation or market-wide shortage, fails to maintain ready access to such products included its bid.

In addition, the bill specifies that an entity furnishing such products to beneficiaries under the program: (1) must furnish to each beneficiary a brand of strips that is compatible with the beneficiary's home blood glucose monitor, (2) may not attempt to influence or incentivize a beneficiary to switch the brand of either type of product, and (3) must contact and receive a request from a beneficiary no more than 14 days prior to dispensing a refill to the beneficiary.

Date: 2016-11-16
Topic: Health (Drug Industry)
Subject: Health
Over-the-Counter Hearing Aid Act of 2016

This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids. The regulations for over-the-counter hearing aids must provide reasonable assurances of safety and efficacy and describe requirements for the sale of hearing aids in-person, by mail, or online, without a prescription.

State and local governments may not establish or continue in effect requirements for over-the-counter hearing aids that are not identical to FDA requirements.

Until the FDA updates its draft guidance regarding hearing aids, previous draft guidance is in effect.

Date: 2016-12-01
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: 2015-01-08
Topic: Health (Drug Industry)
Subject: Health
Fair And Immediate Release of Generic Drugs Act or the FAIR Generics Act

This bill amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to disqualify from being a “first applicant” an applicant submitting an abbreviated new drug application (for a generic drug) to the Food and Drug Administration that has entered into a specified agreement. Currently, any generic drug applicant submitting an application on the first day an application is submitted for that drug is a “first applicant” and is granted a 180-day marketing exclusivity period.

An agreement that disqualifies a generic drug applicant from being a first applicant is an agreement between the applicant and the holder of the application or a patent for the brand name drug whereby the applicant agrees not to seek approval or begin marketing the generic drug until the expiration of the exclusivity period awarded to another applicant.

“First applicant” is expanded to include applicants that did not submit an application on the first day an application was submitted. These first applicants must not have a patent infringement action pending against them and must not have been found to have infringed a patent. If an applicant that submitted an application on the first day an application was submitted has begun marketing the drug, a first applicant that submitted after the first day cannot begin marketing until 30 days after the first day applicant began marketing.

A first applicant that has entered into an agreement not to seek approval of an application or begin marketing at the earliest possible date cannot seek approval or begin marketing until the earlier of: (1) the latest date set forth in the agreement, or (2) 180 days after a first day applicant begins marketing.

An action for infringement of a drug patent must be brought within the 45-day period described in FFDCA.

Date: 2015-01-08
Topic: Health (Drug Industry)
Subject: Health
Medical Device Access and Innovation Protection Act

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

Date: 2015-01-13
Topic: Health (Drug Industry)
Subject: Taxation
No Obamacare Mandate Act 

This bill repeals provisions of the Patient Protection and Affordable Care Act that impose: (1) an excise tax on medical devices, (2) a requirement that individuals obtain minimum essential health care coverage, and (3) a penalty on large employers who fail to offer health care coverage to their eligible employees.

Date: 2015-01-13
Topic: Health (Drug Industry)
Subject: Health
Promise for Antibiotics and Therapeutics for Health Act or the PATH Act

(Sec. 2) This bill amends the Public Health Service Act to require the Department of Health and Human Services (HHS) to encourage the health care facilities of the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service to report on antibacterial drug use, bacterial resistance to antibacterial drugs, and antibiotic stewardship programs.

HHS must: (1) annually publish information on antibacterial resistance and antibiotic stewardship; (2) disseminate guidance and materials regarding antibiotic stewardship; (3) continue working with state and local public health departments on antibacterial resistance programs; and (4) collect, evaluate, and publish data from the antibiotic stewardship activities of health care facilities.

(Sec. 3) This bill amends the Federal Food, Drug, and Cosmetic Act to permit the Food and Drug Administration (FDA), at the request of the drug sponsor, to approve an antibiotic drug for use in a limited population if the drug is intended to treat a serious infection in a limited population of patients with unmet medical needs. The FDA must issue guidance on demonstrating the safety and effectiveness of such drugs. The FDA's determination of the safety and effectiveness of such a drug must reflect the drug's use in the intended limited population.

The label and prescribing information of such a drug must indicate that the drug has been approved for use only in a limited population. The sponsor of such a drug must submit promotional materials for the drug to the FDA prior to dissemination. The FDA may remove these requirements for such a drug that is approved for broader use.

The FDA must report the number of requests for approval and the number of approvals of such drugs. The Government Accountability Office must report on activities to combat antimicrobial resistance and the limited population drug approval process established by this bill.

Date: 2015-01-16
Topic: Health (Drug Industry)
Subject: Health
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: 2015-02-12
Topic: Health (Drug Industry)
Subject: Health
Amends part B (Supplementary Medical Insurance) of title XVIII (Medicare) of the Social Security Act to exclude from the average sales price in calculating Medicare payments for drugs and biologicals any customary prompt pay discounts from manufacturers to wholesalers.

Date: 2015-02-12
Topic: Health (Drug Industry)
Subject: Health
Medicare Formulary Improvement Act of 2015

This bill amends part D (Voluntary Prescription Drug Benefit Program) of title XVIII (Medicare) of the Social Security Act to require a sponsor offering a prescription drug plan (PDP) to include all covered part D drugs in the following categories and classes of drugs in the formulary: (1) anticonvulsants, (2) antidepressants, (3) antineoplastics, (4) antipsychotics, (5) antiretrovirals, and (6) immunosuppressants for the treatment of transplant rejection. Currently the Secretary of Health and Human Services is required to identify categories and classes of drugs of clinical concern.

The Secretary is required, however, to establish any exceptions that permit a PDP sponsor to exclude from its formulary a particular covered part D drug only through promulgation of a regulation, including a public notice and comment period.

Date: 2015-03-04
Topic: Health (Drug Industry)
Subject: Health
This bill repeals the excise tax on medical devices and offsets the cost of such repeal by prohibiting: (1) major integrated oil companies from using the last-in, first-out (LIFO) accounting method; and (2) the issuance of new oil or natural gas production leases in the Gulf of Mexico under the Outer Continental Shelf Lands Act to any person who does not renegotiate their existing leases to generate payment of royalties from such leases.

Date: 2015-03-24
Topic: Health (Drug Industry)
Subject: Taxation