Summary:
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.

pharmaceutical stewardship act bill requires drug_enforcement_administration establish implement national pharmaceutical stewardship program collect dispose prescription medications


Summary:
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.

disclosure innovation cleaning efficiency act bill amends cosmetic act requiring manufacturer medical device food_and_drug_administration fda premarket notification changes design reprocessing instructions device medical device manufacturers notify fda days widely disseminating health care providers foreign country communications relating change recommended reprocessing protocols device safety concern device bill bans devices manufacturers violate notification requirements concerning design reprocessing changes communications foreign health care providers fda publish list types rapid assessment tests reusable devices premarket notification include proposed labeling including validated instructions reusable devices


Summary:
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.

act bill amends cosmetic act require food_and_drug_administration fda identify types medical devices premarket notification include proposed labeling including validated instructions cleaning disinfection sterilization fda issue final guidance premarket notification required modification medical device


Summary:
(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."

measure amended introduced expanded summary house reported version repeated opioid review modernization act sec bill amends cosmetic act require food_and_drug_administration fda refer new drug applications opioids drugs effects similar opium certain pain medications advisory committee approval fda finds referral scientifically unnecessary interest protecting promoting public health fda notifies congress rationale fda convene advisory committee labeling opioids pediatric use approving labeling sec evaluation fda develop recommendations education programs prescribers opioids sec fda finalize draft guidance entitled general principals evaluating abuse deterrence generic solid oral opioid drug products


Summary:
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.

curb opioid misuse advancing technology act bill amends cosmetic act extend marketing exclusivity period certain brand drugs food_and_drug_administration approves basis new clinical abuse potential studies labeling drug abuse deterrent properties extension apply marketing exclusivity period new chemical entities bill extends marketing exclusivity period generics drugs


Summary:
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.

safe drug disposal tax credit act bill amends internal_revenue_code establish tax credit program costs entity establish maintain drug disposal site individuals deposit drugs disposed legally cost individual credit includes costs materials site outreach training use site safe disposal drugs collected site


Summary:
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.

empowering pharmacists bill requires drug_enforcement_administration dea develop disseminate training programs materials circumstances pharmacist refuse fill controlled substance prescription suspected fraudulent forged abuse diversion federal requirements related refusal dea seek input relevant stakeholders


Summary:
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.

organ donation clarification act bill allows exchange human organs valuable consideration value pilot programs approved department_of_health_and_human_services measure effect removing disincentives providing benefit increase organ availability currently exchanging human organs valuable consideration prohibited national_organ_transplant_act addition reimbursements permitted national_organ_transplant_act bill declares valuable consideration include dependent care needs related organ donation medical expenses related donation related follow care including preventive follow care medication paperwork legal costs related donation insurance policy risk death disability result donating organ longer term health effects having donated organ


Summary:
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.

alzheimer breakthrough sunshine act bill amends internal_revenue_code exclude gross income seven years amounts received sale certain drugs treating alzheimer disease related dementias exclusion applies sale drug approved licensed disease modifying treatment alzheimer disease designated breakthrough therapy cosmetic act drug sold arm length transaction holder approved application drug


Summary:
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.

law bill amends cosmetic act declare action damages person liability state law affected federal prohibition state local requirements medical devices bill retroactively effective applies pending civil actions


Summary:
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.

medical device guardians act bill amends cosmetic act requiring physicians report food_and_drug_administration significant adverse experiences caused medical devices


Summary:
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.

deliver nation times emergency act bill requires department_of_health_and_human_services provide increased flexibility blood donor screening maintaining safe blood donor pool times national local need


Summary:
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.

price relief innovation competition essential drugs act priced act bill amends public_health_service_act allow marketed seven years reference brand biological product licensed currently brand biological products provided year marketing exclusivity period marketing exclusivity period applies biological products licensed food_and_drug_administration enactment bill


Summary:
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.)

carl law bill amends cosmetic act require label drug containing opioid prominently state drug contains opioid addiction drug possible opioids drugs effects similar opium certain pain medications


Summary:
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.

veterans transplant coverage act bill authorizes department_of_veterans_affairs provide operation live donor carry transplant procedure eligible veteran notwithstanding live donor eligible health care provide operation non-va facility shall furnish donor care services required conducting procedure


Summary:
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.

prostate cancer elimination act bill specifies physician ordering dna specimen assay test recommends test furnished respect positive prostate cancer shall deemed medically necessary purposes medicare


Summary:
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.

budgeting opioid addiction treatment act bill amends internal_revenue_code impose cent excise tax sale active opioids manufacturer producer importer tax excludes prescription drugs exclusively treatment opioid addiction medically assisted treatment effort department_of_health_and_human_services hhs establish program provide rebates discounts cancer hospice patients ensure pay tax bill amends public_health_service_act require increase federal revenues tax rebates discounts distributed states program exclusively substance abuse including opioid abuse efforts states including specified treatment programs hhs report congress impact bill retail cost opioids patient access opioid medication effectiveness discount rebate cancer hospice patients funds improve substance abuse treatment efforts suggestions improving access opioids cancer hospice patients substance abuse treatment efforts


Summary:
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.

research accelerate cures equity children act race children act bill amends cosmetic act expand requirements assessing use medications pediatric populations applications supplements applications certain drugs biological products including orphan drugs treat pediatric cancer include assessment pediatric use request food_and_drug_administration fda meet sponsor medication discuss plan pediatric studies fda require sponsor approved medication treat pediatric cancer complete pediatric assessment medication substantial number pediatric cancer patients reason believe medication meaningful therapeutic benefit existing therapies pediatric cancer patients bill limits waivers pediatric assessment requirements certain medications treat pediatric cancer need additional treatment options fda meet medication sponsors discuss deferral waiver pediatric assessment requirement


Summary:
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.

accurate labeling products act bill amends cosmetic act require pads therapeutic include list ingredients label


Summary:
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.

bill amends internal_revenue_code provide taxpayers refundable tax credit individual taxpayer allowed deduction personal exemption uses products credit adjusted inflation limited taxpayers modified adjusted gross incomes specified amounts department_of_health_and_human_services determine provide internal_revenue_service definition products include pads similar products women respect


Summary:
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.

contact lens consumer health protection act bill amends fairness contact lens consumers act require contact lens sellers provide toll free telephone number email address prescribers use ask questions seller prescription verification request current law prescription considered verified prescriber fails communicate seller business hours receiving seller provided verification information bill requires prescription considered unverified seller obtains affirmative confirmation accuracy prescription prescriber cases prescriber communicates question concern accuracy verification prescription seller toll free telephone service email address end hour period bill removes federal_trade_commission authority adjust hour period prescriber communicates question concern accuracy prescription deadline seller shall fill prescription prescriber shall provide seller accurate prescription sellers offer prescribers different communication methods prescribers select preferred method verification requests bill allows seller alter prescription private label contact lens included prescription contact lens manufactured company sold multiple labels individual providers seller fills prescription contact lens exactly material design power manufactured company label sellers maintain database issuance expiration dates prescription receive bill prohibits advertisements representing contact lens prescription filled prescription expires sellers violating certain prescriber verification requirements subject increased penalties violation requirements apply contact lens sales united_states notwithstanding seller located centers_for_disease_control_and_prevention examine potentially adverse effects seller violations consumers


Summary:
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.

orphan drugs act bill amends public_health_service_act revise 340b drug pricing program currently requires drug manufacturers discount orphan drugs drugs rare conditions certain entities covered program bill discounts orphan drugs treat rare conditions entities covered program


Summary:
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.

reciprocity ensures streamlined use lifesaving treatments act bill amends cosmetic act establish reciprocal marketing approval process allows sale drug biological product medical device approved food_and_drug_administration fda product approved sale country product granted reciprocal marketing approval product sponsor submit request fda demonstrates product sold country specified list countries fda listed countries withdrawn approval product safety effectiveness concerns public health unmet medical need product fda require postmarket studies product granted reciprocal marketing approval decline approve product safe effective fda grant decline reciprocal marketing approval later days receiving request period fda product sponsor negotiate finalize product labeling medical device classify device congress pass joint resolution grant reciprocal marketing approval product fda declines approve process user fees apply requests reciprocal marketing approval fda encourage sponsors potentially eligible products request reciprocal marketing approval


Summary:
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.

protecting kids medicine act bill amends cosmetic act prohibit sale liquid formulations counter drugs packaged dosage delivery device cup measurements label dosage delivery device exclusively metric units food_and_drug_administration waive requirement metric units requirement benefit public health counter liquid drugs labeled pediatric use sold flow mechanism reduce accidental ingestion


Summary:
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.

eliminate price increases act act bill amends cosmetic act prohibit manufacturer brand drug authorizing commencing manufacturing marketing selling distributing generic version drug time manufacturer notified generic manufacturer generic drug application submitted expiration forfeiture day exclusivity period granted generic manufacturer


Summary:
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.

making online banking initiation legal easy act mobile act bill authorizes financial institution individual consent record personal information copy individual driver license personal identification card store information electronically purpose verifying driver license identification card verifying identity individual complying legal requirements financial institutions sell rent transfer personal information available person affiliate


Summary:
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.

patient safety toxicology modernization act bill requires food_and_drug_administration issue periodically update guidance novel tools testing toxicology efficacy medications human tissue models


Summary:
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.

bill amends title xviii medicare social security act modify provisions relating medicare competitive acquisition program rates set competitive bidding program established fee schedule respect diabetic testing strips specifically bill requires centers cms use specified data determine bid satisfies certain requirements related volume coverage respect products reject bid bidder demonstrate ability furnish products manner consistent bid establish process monitor extent entity continues cover product types included bid cms terminate contract determines entity reasons product market wide shortage fails maintain ready access products included bid addition bill specifies entity furnishing products beneficiaries program furnish beneficiary brand strips compatible beneficiary home blood glucose monitor attempt influence incentivize beneficiary switch brand type product contact receive request beneficiary days prior dispensing beneficiary


Summary:
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.

counter hearing aid act bill amends cosmetic act require food_and_drug_administration fda categorize certain hearing aids counter hearing aids issue regulations hearing aids regulations counter hearing aids provide reasonable assurances safety efficacy describe requirements sale hearing aids person mail online prescription state local governments establish continue effect requirements counter hearing aids identical fda requirements fda updates draft guidance hearing aids previous draft guidance effect


Summary:
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.

safe affordable drugs canada act amends cosmetic act ffdca require department_of_health_and_human_services hhs promulgate regulations days permitting individuals import prescription drug purchased approved canadian pharmacy dispensed pharmacist licensed canada purchased personal use quantities greater day supply filled valid prescription issued physician licensed practice united_states active ingredient ingredients route administration dosage form strength prescription drug approved ffdca sets forth exceptions including controlled substances biological products establishes certification process approving canadian pharmacies publish list approved canadian pharmacies


Summary:
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.

fair immediate release generic drugs act fair generics act bill amends cosmetic act ffdca disqualify applicant applicant submitting abbreviated new drug application generic drug food_and_drug_administration entered specified agreement currently generic drug applicant submitting application day application submitted drug applicant granted day marketing exclusivity period agreement disqualifies generic drug applicant applicant agreement applicant holder application patent brand drug applicant agrees seek approval begin marketing generic drug expiration exclusivity period awarded applicant applicant expanded include applicants submit application day application submitted applicants patent infringement action pending found infringed patent applicant submitted application day application submitted begun marketing drug applicant submitted day begin marketing days day applicant began marketing applicant entered agreement seek approval application begin marketing earliest possible date seek approval begin marketing earlier latest date set forth agreement days day applicant begins marketing action infringement drug patent brought day period described ffdca


Summary:
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.

medical device access innovation protection act bill amends internal_revenue_code repeal excise tax medical device manufacturers importers


Summary:
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.

obamacare mandate act bill repeals provisions patient_protection affordable care act impose excise tax medical devices requirement individuals obtain minimum essential health care coverage penalty large employers fail offer health care coverage eligible employees


Summary:
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.

promise antibiotics path act sec bill amends public_health_service_act require department_of_health_and_human_services hhs encourage health care facilities department_of_defense department_of_veterans_affairs indian_health_service report antibacterial drug use bacterial resistance antibacterial drugs antibiotic stewardship programs hhs annually publish information antibacterial resistance antibiotic stewardship disseminate guidance materials antibiotic stewardship continue working state local public health departments antibacterial resistance programs collect evaluate publish data antibiotic stewardship activities health care facilities sec bill amends cosmetic act permit food_and_drug_administration fda request drug sponsor approve antibiotic drug use limited population drug intended treat infection limited population patients unmet medical needs fda issue guidance demonstrating safety effectiveness drugs fda determination safety effectiveness drug reflect drug use intended limited population label prescribing information drug indicate drug approved use limited population sponsor drug submit promotional materials drug fda prior dissemination fda remove requirements drug approved broader use fda report number requests approval number approvals drugs government_accountability_office report activities combat antimicrobial resistance limited population drug approval process established bill


Summary:
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.

improving regulatory transparency new medical therapies act sec bill amends cosmetic act public_health_service_act delay effective date approval drug biological product animal drug food_and_drug_administration fda recommends controls controlled substances act department_of_justice doj issues final interim rule drug delay applies conditional approval indexing animal drugs bill amends controlled substances act require doj issue final interim rule drug product recommended controls fda later days doj receives recommendation controls fda approves drug final interim rule effective immediately purposes submitting application extend patent drug product recommended controls considered approved permission commercial marketing use date fda approval date interim final rule issued whichever later sec timelines established doj register applicant manufacture controlled substance clinical trial serve order cause applicant sec bill amends controlled_substances_import_and_export_act allow exported controlled substances exported


Summary: 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.

amends supplementary_medical_insurance title xviii medicare social security act exclude average sales price calculating medicare payments drugs biologicals customary prompt pay discounts manufacturers wholesalers


Summary:
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.

bill amends voluntary prescription drug benefit program title xviii medicare social security act require sponsor offering prescription drug plan pdp include covered drugs following categories classes drugs formulary antidepressants treatment transplant rejection currently secretary health_and_human_services required identify categories classes drugs clinical concern secretary required establish exceptions permit pdp sponsor exclude formulary particular covered drug promulgation regulation including public notice comment period


Summary: 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.

bill repeals excise tax medical devices offsets cost repeal prohibiting major integrated oil companies lifo accounting method issuance new oil natural gas production leases gulf_of_mexico outer_continental_shelf_lands_act person renegotiate existing leases generate payment royalties leases


Summary:
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.

bill requires commissioner food drugs ensure advisory committee center_for_drug_evaluation_and_research food_and_drug_administration fda evaluates new drug application opioid drug effects similar opium issues recommendation approval drug decision approve drug inconsistent committee recommendation commissioner final decision approval committee recommends drug approved commissioner decides approve drug commissioner submit report congress includes evidence patient safety supports commissioner decision disclosure potential conflicts interest fda officials involved decision approve drug testify congress decision request drug sold commissioner submitted required report


Summary:
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.

sec bill amends cosmetic act revise requirements priority review breakthrough medical devices sponsor request food_and_drug_administration fda determine device meets criteria designation breakthrough device expedite development review designated medical devices fda assign team staff device adopt efficient process dispute resolution provide interactive timely communication device sponsor expedite review manufacturing quality systems compliance disclose sponsor advance topics consultation fda external experts advisory committee provide sponsor opportunity recommend external experts assign staff address questions institutional review committees concerning investigational use device fda coordinate sponsor early agreement data development plan steps ensure design clinical trials efficient flexible practicable utilize timely postmarket data collection agree clinical protocols subject decision substantial scientific issue essential determining safety effectiveness device exists fda issue guidance report priority review process


Summary:
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.

patient access disposable medical technology act sec bill amends title xviii medicare social security act direct department_of_health_and_human_services separate payment calculated according specified formula home health agency applicable disposable device furnished january individual receives home health services payment medicare applicable disposable device disposable negative pressure wound therapy device integrated system composed non manual vacuum pump collecting purposes wound therapy substitute lieu negative pressure wound therapy durable medical equipment item integrated system negative pressure vacuum pump separate collection covered individuals wound therapy government_accountability_office shall study value disposable devices medicare program medicare beneficiaries role disposable devices substitutes durable medical equipment impact payment act applicable disposable devices


Summary:
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.

safer prescribing controlled substances act amends controlled substances act direct attorney general condition granting renewing registration covered practitioner dispense conduct research controlled substances schedule iii require covered practitioner complete training department_of_health_and_human_services hhs determines meets requirements act defines covered practitioner practitioner hospital pharmacy veterinarian requires training expose covered practitioners best practices pain management including alternatives prescribing controlled substances responsible prescribing pain medications methods diagnosing treating managing substance use disorder including evidence based therapies ways linking patients evidence based treatment substance use disorders tools manage adherence diversion controlled substances directs substance_abuse_and_mental_health_services_administration establish support establishment free online training module meets requirements provided covered practitioner registered applying registration requires hhs establish maintain periodically update publicly available database providing information training modules years enactment act evaluate publicly available report describing exposure training required act changed prescribing patterns controlled substances


Summary:
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.)

saving access compounded medications special needs patients act bill amends cosmetic act allow drugs compounded manufactured small scale distributed practitioners treatment administration patients practitioner currently drugs compounded identified individual patients compounded drugs need meet certain requirements drugs manufacturing labeling fda approval compounded drugs comply standards memorandum understanding mou fda state compounded drugs longer address interstate distribution amounts compounded drugs mou create unfunded mandate state states mou fda distribute orders state


Summary:
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.

accelerating cures treatments act amends cosmetic act require department_of_health_and_human_services hhs extend months exclusivity period drug biological product approved food_and_drug_administration fda product additionally approved prevent diagnose treat new indication rare disease condition known orphan disease revoke extension application submitted fda new indication contained untrue material statement requires sponsor product receiving extension notify hhs year prior discontinuing production commercial reasons requires hhs notify public products receive extension patents related products limits product extension act sets forth extensions act addition extensions applies products approved enactment act new indication rare disease condition


Summary:
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.

promotion act bill expresses sense congress federal government carry programs educate public respect organ donation organ tissue donors honored bill amends public_health_service_act authorize appropriation specified amounts fy2015 fy2019 studies demonstration projects increase organ donation recovery rates grants assist states carrying organ donor awareness public education outreach activities programs designed increase number organ donors state support development dissemination educational materials inform health care appropriate professionals issues surrounding organ tissue eye donation


Summary:
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.

beneficiary appeals fairness act amends voluntary prescription drug benefit program title xviii medicare social security act respect prescription drug plan pdp provides tiered cost sharing formulary including structure provides different payment coinsurance amounts drugs different tiers included formulary authorize medicare eligible individual enrolled plan request exception tiered cost sharing structure states case secretary health_and_human_services allow pdp sponsor element tiered cost sharing structure including tier high cost unique items ineligible lower cost sharing exception


Summary:
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.

patient focused impact assessment act sec bill amends cosmetic act require food_and_drug_administration fda approving application new medication publish brief statement patient experience data related information application patient experience data information impact medical condition related therapy patient life patient preferences treatment sec fda issue guidance collection patient experience data use data drug development sec paperwork reduction act apply voluntary collection patient experience data sec fda report review patient experience data approving applications new medications


Summary:
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.

fda device accountability act sec bill amends cosmetic act eliminate requirement supervising clinical testing investigational humanitarian medical device local sec food_and_drug_administration fda revise guidance entitled recommendations clinical laboratory improvement amendments waiver applications manufacturers vitro diagnostic devices sec fda ensure employees review premarket submissions medical devices receive training burdensome means requirements currently fda required consider burdensome appropriate means sponsor demonstrate effectiveness medical device demonstrate device substantial equivalence approved medical device fda periodically assess implementation requirements ombudsman applicable unit fda audit report training fda consider burdensome appropriate means necessary demonstrate medical device safety effectiveness requesting additional information device sponsor support premarket approval application including role postmarket information demonstration fda documented rationale significant decision medical device include statement burdensome requirements considered applied


Summary:
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.

accelerating innovation medicine act aim act amends title xviii medicare social security act direct department_of_health_and_human_services hhs develop accelerating innovation medicine aim list medical devices items services related furnishing devices inclusion list insurance benefits payments prohibited medicare directly capitated basis result medicare claim submitted individual consents receive device related items services responsible paying related items services directs secretary post public hhs website publicly accessible media updated list medical devices aim list


Summary:
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.

combination product regulatory fairness act sec bill amends cosmetic act revise provisions products combination drug medical device biological product primary mode action combination product mode action makes greatest contribution product therapeutic effect combination products regulated based primary mode action fda prohibited determining combination product drug biological product solely product chemical action sponsor combination product disagrees fda determination primary mode action product fda provide rationale determination sponsor fda agree studies inform reevaluation product primary mode action product determined sponsor fda agree combination product review plan address standards requirements applicable product review postmarket modification manufacturing plan remain effect sponsor fda agree issue essential determining safety effectiveness product identified fda require sponsor combination product contains approved constituent submit fda information necessary assess safety effectiveness combination product taking account prior findings approved constituent approved constituent drug application combination product comply specified requirements drug applications coordinate reviews combination products oversee feedback reviews office review fda agreements guidance practices combination products fda issue guidance describes process best practices review combination products propose certain types combination products adopt good manufacturing practices vary requirements regulations


Summary:
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.

fairness act bill amends patient_protection affordable care act ppaca exclude sales drug biological product approved food_and_drug_administration solely rare diseases conditions orphan drug calculation annual fee manufacturers importers branded prescription drug sales exceeding million act effective included ppaca


Summary:
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.

rare disease innovation act bill amends cosmetic act expand humanitarian device exemption authorize food_and_drug_administration fda exempt effectiveness requirements certain medical devices intended benefit fewer individuals currently fda exempt devices intended benefit fewer individuals months enactment act fda define probable benefit devices fda report years effect expansion humanitarian device exception


Summary:
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.

stem cell therapeutic research reauthorization act bill amends public_health_service_act revise extend fy2020 bill young cell transplantation program program programs help match patients need transplant unrelated bone marrow cord blood donors department_of_health_and_human_services hhs review state science adult stem cells tissues develop new therapies consider inclusion new therapies bill young cell transplantation program requirements hhs contracts revised hhs determine include peripheral blood stem cells umbilical cord blood definition human organ


Summary:
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.

stabilization act bill amends titles xviii medicare xix medicaid social security act modify provisions relating payment durable medical equipment dme medicare medicaid programs dme includes certain medically necessary equipment wheelchairs hospital beds respect dme furnished areas competitive acquisition areas current regulations require centers cms phase year period medicare payment adjustments information competitive acquisition programs programs payment amounts area determined based competitive bids submitted suppliers according established fee schedule bill codifies requirement specifies cms shall adjust fee schedule amounts lesser specified percentage regional determined according fee schedule specified adjustments determining medicare payment adjustments areas competitive acquisition areas cms shall solicit stakeholder input account specified factors cms establish ceiling competitive bids submitted dme paid medicare medicare beneficiary ombudsman shall evaluate impact competitive acquisition program beneficiary health status health outcomes bill limits federal medicaid reimbursement rates states dme rates paid items medicare


Summary:
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.

act sec bill amends cosmetic act require food_and_drug_administration fda identify types medical devices premarket notification include proposed labeling including validated instructions cleaning disinfection sterilization sec fda issue final guidance premarket notification required modification medical device


Summary:
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.

reliable effective growth health options improve wellness act bill amends public_health_service_act require food_and_drug_administration fda conditionally approve certain cellular therapeutic products initiation large scale clinical trials conditionally approved cellular therapy marketed certain conditions met including conditions source processing function cells product sponsor conditionally approved cellular therapy apply approval product biological product years fda decided approve product product marketed year period fda permit continued marketing application reviewed individual administering conditionally approved cellular therapy inform recipient conditional approval premarket report medical device cellular therapy include specified information preparation delivery cellular therapy approval medical device cellular therapy based laboratory performance testing clinical trials medical device cellular therapy subject medical device classification fda limit use devices specific cell types unique use device center biologics evaluation research primary jurisdiction premarket review combination products act primarily cellular components department_of_health_and_human_services work stakeholders promote development standards medicine products


Summary:
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.

patient access durable medical equipment act sec bill amends title xviii medicare social security act delay year implementation new medicare payment rates durable medical equipment wheelchairs sec addition bill specifies bid ceiling durable medical equipment items medicare competitive acquisition program rates set according bidding process established fee schedule shall fee schedule determined items sec current law cms use payment information competitive acquisition programs payment adjustments durable medical equipment items furnished areas outside programs current law allows require cms adjustments respect certain orthotics nutrients equipment supplies feeding tubes bill requires cms making adjustments account stakeholder input addition cms account comparison competitive acquisition areas areas respect following factors average travel distance cost associated furnishing items services barriers access average delivery time average volume items services furnished suppliers number suppliers sec quarterly reports cms publish website results monitoring health outcomes medicare beneficiaries access durable medical equipment sec bill accelerates applicability january october provisions current law limit federal medicaid reimbursement states durable medical equipment medicare payment rates


Summary:
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.

improving medical device innovation act bill amends cosmetic act revise provisions related medical device performance standards reporting requirements classification panels person request food_and_drug_administration fda recognize performance standard established recognized standards organization standard medical device conform order meet fda requirement request recognize standard received fda determine recognize standard publish rationale determination currently fda recognizes certain performance standards required respond requests publish fda train employees review premarket submissions medical devices recognized standards review published principles recognizing standards identify types medical devices premarket report longer needed provide reasonable assurance safety effectiveness ensure adequate expertise represented medical device classification panels provide opportunity person premarket submission subject review classification panel recommend expertise needed panel provide opportunities patients patient representatives medical device sponsors recommend individuals positions classification panels fda coordination medical device manufacturers establish pilot projects evaluate alternative methods compliance reporting requirements certain medical devices government_accountability_office report pilot projects


Summary:
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.

prescription drug health improvement act bill amends title xviii medicare social security act require centers cms negotiate lower prices behalf medicare medicare_advantage beneficiaries covered prescription drugs cms deems appropriate negotiation based program beneficiary spending unit cost increases preceding years initial launch price criteria determined cms cms negotiate lower prices behalf medicare beneficiaries covered prescription drugs


Summary:
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.

right try act bill bars federal government prohibiting restricting production manufacture distribution prescribing dispensing experimental drug biological product device intended treat patient diagnosed terminal illness authorized accordance state law federal government restrict possession use treatment patient certified physician having exhausted treatment options producer manufacturer distributor prescriber dispenser user treatment liability treatment outcome production manufacture distribution prescribing dispensing possession use treatment federal agency adversely impact review approval treatment treatment successfully completed phase initial small scale clinical trial remain investigation clinical trial approved food_and_drug_administration fda approved licensed cleared sale cosmetic act public_health_service_act later days enactment bill days implementation complete fda report progress implementing streamlined application process compassionate use experimental drugs biological products


Summary:
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.

budgeting opioid addiction treatment act bill amends internal_revenue_code impose cent excise tax sale active opioids manufacturer producer importer tax excludes prescription drugs exclusively treatment opioid addiction medically assisted treatment effort department_of_health_and_human_services hhs establish program provide rebates discounts cancer hospice patients ensure pay tax bill amends public_health_service_act require increase federal revenues tax rebates discounts distributed states program exclusively substance abuse including opioid abuse efforts states including specified treatment programs hhs report congress impact bill retail cost opioids patient access opioid medication effectiveness discount rebate cancer hospice patients funds improve substance abuse treatment efforts suggestions improving access opioids cancer hospice patients substance abuse treatment efforts


Summary:
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.

bill amends titles xviii medicare xix medicaid social security act add standards drug physicians respect payment certain drugs medicare medicaid programs specifically shall include determined health care providers utilized nationwide health insurance industry publicly available policy disclosures conflicts interest use international widely recognized standard evaluate clinical evidence inclusion accepted state board pharmacy equivalent licensing body


Summary:
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.

abuse prevention act bill amends cosmetic act prohibit sale drug containing dextromethorphan individual age individual prescription actively enrolled military civil monetary penalties repeated violation imposed possess receive unfinished person registered department_of_health_and_human_services producer drug medical device allowed engage practice pharmacy pharmaceutical production manufacture distribution drug ingredients distributed authorized persons common carriers distributing unfinished authorized persons exempted civil monetary penalties imposed possession distribution violations