3.0.0 320 2023-01-11T13:28:47Z 2023-01-11T13:28:47Z Senate S 2015-01-29 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Referred to 2015-01-29T22:16:29Z Medical Innovation Act of 2015 114 744 HR 2015-02-06 Referred to the Subcommittee on Health. Identical bill CRS 2015-01-29 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S657-658) IntroReferral 2015-01-29 Introduced in Senate IntroReferral 10000 9 Library of Congress W000817 Sen. Warren, Elizabeth [D-MA] Elizabeth Warren D MA A. N C000141 Sen. Cardin, Benjamin L. [D-MD] Ben Cardin D MD 2015-01-29 True B000944 Sen. Brown, Sherrod [D-OH] Sherrod Brown D OH 2015-01-29 True B001230 Sen. Baldwin, Tammy [D-WI] Tammy Baldwin D WI 2015-01-29 True F000457 Sen. Franken, Al [D-MN] Al Franken D MN 2015-05-05 False Health Appropriations Civil actions and liability Department of Health and Human Services Drug safety, medical device, and laboratory regulation Executive agency funding and structure Food and Drug Administration (FDA) Fraud offenses and financial crimes Health technology, devices, supplies Medical research National Institutes of Health (NIH) Prescription drugs Research administration and funding Health 00 2015-01-29 Introduced in Senate 2015-05-15T12:29:14Z Medical Innovation Act of 2015

This bill amends the Public Health Service Act to require certain drug manufacturers to make payments to fund research supported by the Food and Drug Administration (FDA) and the National Institutes of Health (NIH).

A drug manufacturer with over $1 billion in net income in a fiscal year that has entered into a settlement agreement in the previous five years with a federal agency regarding specified violations must pay 1% of its net income to the Department of Health and Human Services (HHS) for each of its covered blockbuster drugs. A covered blockbuster drug is a drug that has at least $1 billion in net sales in a year and was developed, in whole or in part, through federal investments in medical research, including a drug for which a patent contains information that relates to, or is based upon, federally-funded research.

Each fiscal year, HHS must publish a list of manufacturers that make payments, each manufacturer's covered blockbuster drugs, and payment amounts.

Payments are divided between the FDA and the NIH in proportion to the discretionary funding of those agencies, excluding FDA user fees. Payments are not disbursed if appropriations for the FDA or the NIH are lower than in the prior fiscal year.

The FDA's priority use for payments must include advancing regulatory science for medical products.

The NIH's priority use for payments must include supporting: (1) research that fosters radical innovation, (2) research that advances fundamental knowledge, (3) research related to diseases that disproportionately account for federal health care spending, and (4) early career scientists.

A covered blockbuster drug for which a manufacturer has not made a required payment is considered misbranded and cannot be sold until payment is made.]]> Medical Innovation Act of 2015 Display Title Medical Innovation Act of 2015 Official Title as Introduced A bill to authorize the collection of supplemental payments to increase congressional investments in medical research, and for other purposes. Introduced in Senate IS Short Titles as Introduced Medical Innovation Act of 2015 Introduced in Senate 2015-01-29T05:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s320is/xml/BILLS-114s320is.xml 2015-01-29 Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (Sponsor introductory remarks on measure: CR S657-658) 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.