3.0.0 934 2023-01-11T13:36:21Z 2023-01-11T13:36:21Z Senate S 2017-04-25 115 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2017-05-11T20:10:38Z Markup by 2017-05-11T13:30:34Z Referred to 2017-04-25T18:56:09Z Making Pharmaceutical Markets More Competitive Act 115 1115 S 2017-05-11 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS FDA Reauthorization Act of 2017 115 2430 HR 2017-08-18 Signed by President. Related bill House Related bill CRS Medical Device Safety Monitoring Act 115 1069 S 2017-05-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Realizing Intended Safety for Certain Accessories Act of 2017 115 1070 S 2017-05-08 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Making Pharmaceutical Markets More Competitive Act 115 2562 HR 2017-05-26 Referred to the Subcommittee on Health. Related bill CRS Over-the-Counter Hearing Aid Act of 2017 115 1652 HR 2017-03-24 Referred to the Subcommittee on Health. Related bill CRS Over-the-Counter Hearing Aid Act of 2017 115 670 S 2017-03-21 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Opioid Addiction Risk Transparency Act 115 1049 S 2017-05-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Drug Diversion and Counterfeit Crackdown Act of 2017 115 2376 HR 2017-05-05 Referred to the Subcommittee on Health. Related bill CRS FDA Reporting Transparency and Accountability Act 115 1062 S 2017-05-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Enhanced Clinical Trial Design Act of 2017 115 1048 S 2017-05-04 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS Pediatric Device Development Act 115 1093 S 2017-05-10 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Related bill CRS 2017-05-11 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 76. Calendars 2017-05-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2017-05-11 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2017-05-11 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2017-04-25 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2017-04-25 Introduced in Senate IntroReferral 10000 9 Library of Congress A000360 Sen. Alexander, Lamar [R-TN] Lamar Alexander R TN N M001111 Sen. Murray, Patty [D-WA] Patty Murray D WA 2017-04-25 True 2017-06-15T21:10:44Z S. 934, FDA Reauthorization Act of 2017 https://www.cbo.gov/publication/52826 As reported by the Senate Committee on Health, Education, Labor, and Pensions on May 11, 2017 Health Administrative law and regulatory procedures Administrative remedies Alternative treatments Cancer Child health Computers and information technology Congressional oversight Department of Health and Human Services Drug safety, medical device, and laboratory regulation Drug therapy Executive agency funding and structure Food and Drug Administration (FDA) Fraud offenses and financial crimes Government buildings, facilities, and property Government information and archives Government studies and investigations Health information and medical records Health personnel Health technology, devices, supplies Hearing, speech, and vision care Infectious and parasitic diseases International organizations and cooperation Licensing and registrations Manufacturing Marketing and advertising Medical research Medical tests and diagnostic methods Performance measurement Prescription drugs Public contracts and procurement Public participation and lobbying Public-private cooperation Small business User charges and fees Health 00 2017-04-25 Introduced in Senate 2017-07-25T17:03:19Z FDA Reauthorization Act of 2017

Prescription Drug User Fee Amendments of 2017

This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.

Medical Device User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health.

The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards.

The bill revises the types of medical devices that the FDA may accredit third parties to review.

Generic Drug User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.

Biosimilar User Fee Amendments of 2017

The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees.

The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.]]> 01 2017-05-11 Reported to Senate with amendment(s) 2018-02-02T15:17:07Z FDA Reauthorization Act of 2017

TITLE I--FEES RELATING TO DRUGS

Prescription Drug User Fee Amendments of 2017

(Sec. 102) This bill amends the Federal Food, Drug, and Cosmetic Act to extend through FY2022 and revise Food and Drug Administration (FDA) user fees for new drug applications. User fees are eliminated for supplements to new drug applications and drug manufacturing facilities.

TITLE II--FEES RELATING TO DEVICES

Medical Device User Fee Amendments of 2017

(Sec. 203) The bill extends through FY2022 and revises FDA user fees for medical devices. A user fee is established for requests to classify devices that are not substantially equivalent to marketed devices. The FDA is no longer granted the discretion to waive or reduce fees in the interest of public health.

(Sec. 205) The FDA must establish a pilot program to accredit testing laboratories to determine whether medical devices conform to performance standards.

(Sec. 206) The bill revises the types of medical devices that the FDA may accredit third parties to review.

TITLE III--FEES RELATING TO GENERIC DRUGS

Generic Drug User Fee Amendments of 2017

(Sec. 303) The bill extends through FY2022 and revises FDA user fees for generic drugs. User fees are eliminated for supplements to generic drug applications. An annual fee is assessed on holders of approved generic drug applications.

TITLE IV--FEES RELATING TO BIOSIMILAR BIOLOGICAL PRODUCTS

Biosimilar User Fee Amendments of 2017

(Sec. 403) The bill extends through FY2022 and revises FDA user fees for biosimilars. (Biosimilars are biological products approved by the FDA based on their similarity to an already-approved biological product.) User fees are eliminated for supplements to biosimilar applications and biosimilar manufacturing facilities. An annual fee is assessed on holders of approved applications for biosimilars. The bill sets the annual amount of revenue that must be generated by fees.

TITLE V--PEDIATRIC DRUGS AND DEVICES

(Sec. 501) The bill revises requirements for the FDA to report on pediatric use of medical devices.

The bill extends and revises the authorization for certain medical devices for pediatric patients to be sold above cost under the humanitarian device exemption.

TITLE VI--REAUTHORIZATIONS AND IMPROVEMENTS RELATED TO DRUGS

(Sec. 601) The bill extends through FY2022 programs and policies including Critical Path Public-Private Partnerships and support for development of medical products for rare conditions.

(Sec. 604) Except in cases of a drug shortage or certain importation of drugs from Canada, prescription drugs manufactured outside the United States may only be imported if authorized by the manufacturer and appropriately labeled.

TITLE VII--DEVICE INSPECTION AND REGULATORY IMPROVEMENTS

(Sec. 701) The bill revises provisions regarding FDA inspections of establishments that manufacture or process medical devices.

(Sec. 703) The bill extends through FY2022 accreditation by the FDA of third parties to conduct inspections of medical device establishments.

(Sec. 704) The bill revises provisions regarding FDA certification of medical devices for export.

(Sec. 711) The FDA must categorize certain hearing aids as over-the-counter hearing aids and issue regulations regarding those hearing aids.

TITLE VIII--ADDITIONAL PROVISIONS

(Sec. 803) User fee performance reports must include an analysis of: (1) the number of product applications filed and approved, (2) whether the relevant FDA review office has met performance enhancement goals, and (3) circumstances affecting the ability of the FDA to meet review time and performance enhancement goals.

TITLE IX--GENERIC DRUG ACCESS

Subtitle A--Removing Regulatory Barriers to Competition

(Sec. 901) The FDA must prioritize the review of generic drug applications and supplements for drugs for which there are not more than three approved drugs or that are in a shortage.

Subtitle B--Incentivizing Competition

(Sec. 911) The FDA, upon request, must expedite the development and review of generic drug applications for drugs with three or fewer approved generic drug applications or that are in a shortage.

(Sec. 912) The holder of an approved drug application must notify the FDA within 180 days of withdrawing the drug from sale, withdrawing the application, or transferring the application.

The FDA must maintain a list of generic drugs with three or fewer holders of approved applications.

]]> FDA Reauthorization Act of 2017 Display Title FDA Reauthorization Act of 2017 Official Title as Introduced A bill to amend the Federal Food, Drug, and Cosmetic Act to revise and extend the user-fee programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. Introduced in Senate IS Short Titles as Introduced for portions of this bill Generic Drug User Fee Amendments of 2017 Short Titles as Introduced for portions of this bill Medical Device User Fee Amendments of 2017 Short Titles as Reported to Senate for portions of this bill Generic Drug User Fee Amendments of 2017 S Senate Short Titles as Introduced for portions of this bill Biosimilar User Fee Amendments of 2017 Short Titles as Reported to Senate for portions of this bill Medical Device User Fee Amendments of 2017 S Senate Short Titles as Reported to Senate for portions of this bill Prescription Drug User Fee Amendments of 2017 S Senate Short Titles as Reported to Senate for portions of this bill Biosimilar User Fee Amendments of 2017 S Senate Short Titles as Introduced FDA Reauthorization Act of 2017 Short Titles as Reported to Senate FDA Reauthorization Act of 2017 S Senate Short Titles as Introduced for portions of this bill Prescription Drug User Fee Amendments of 2017 Reported to Senate 2017-05-11T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s934rs/xml/BILLS-115s934rs.xml Introduced in Senate 2017-04-25T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-115s934is/xml/BILLS-115s934is.xml 2017-05-11 Placed on Senate Legislative Calendar under General Orders. Calendar No. 76. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.