H.R. 7667: Food and Drug Amendments of 2022

Bill · 117th Congress (2021–2022). Passed House, 8 Jun 2022. Introduced 6 May 2022.

Official title: 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.

Vote results

House, 8 Jun 2022: Passed, 392 Yea, 28 Nay, 0 Present, 7 Not voting. The House’s roll call
President: Not presented to the President.

How each member voted

House

Yea (392): Harold Rogers (R-KY-5); Christopher H. Smith (R-NJ-4); Marcy Kaptur (D-OH-9); Peter A. DeFazio (D-OR-4); Fred Upton (R-MI-6); Frank Pallone, Jr. (D-NJ-6); Richard E. Neal (D-MA-1); David E. Price (D-NC-4); Jim Cooper (D-TN-5); Rosa L. DeLauro (D-CT-3); Maxine Waters (D-CA-43); Jerrold Nadler (D-NY-10); Sanford D. Bishop, Jr. (D-GA-2); Ken Calvert (R-CA-42); James E. Clyburn (D-SC-6); Anna G. Eshoo (D-CA-18); Eddie Bernice Johnson (D-TX-30); Carolyn B. Maloney (D-NY-12); Lucille Roybal-Allard (D-CA-40); Bobby L. Rush (D-IL-1); Robert C. "Bobby" Scott (D-VA-3); Nydia M. Velázquez (D-NY-7); Bennie G. Thompson (D-MS-2); Frank D. Lucas (R-OK-3); Lloyd Doggett (D-TX-35); Sheila Jackson Lee (D-TX-18); Zoe Lofgren (D-CA-19); Earl Blumenauer (D-OR-3); Steve Chabot (R-OH-1); Robert B. Aderholt (R-AL-4); Kevin Brady (R-TX-8); Danny K. Davis (D-IL-7); Diana DeGette (D-CO-1); Kay Granger (R-TX-12); Ron Kind (D-WI-3); James P. McGovern (D-MA-2); Bill Pascrell, Jr. (D-NJ-9); Brad Sherman (D-CA-30); Adam Smith (D-WA-9); Gregory W. Meeks (D-NY-5); Barbara Lee (D-CA-13); John B. Larson (D-CT-1); Grace F. Napolitano (D-CA-32); Janice D. Schakowsky (D-IL-9); Michael K. Simpson (R-ID-2); Mike Thompson (D-CA-5); Pete Sessions (R-TX-17); Sam Graves (R-MO-6); James R. Langevin (D-RI-2); Rick Larsen (D-WA-2); Betty McCollum (D-MN-4); Adam B. Schiff (D-CA-28); Stephen F. Lynch (D-MA-8); Joe Wilson (R-SC-2); Michael C. Burgess (R-TX-26); John R. Carter (R-TX-31); Tom Cole (R-OK-4); Mario Diaz-Balart (R-FL-25); Raúl M. Grijalva (D-AZ-3); Mike Rogers (R-AL-3); C. A. Dutch Ruppersberger (D-MD-2); Tim Ryan (D-OH-13); David Scott (D-GA-13); Linda T. Sánchez (D-CA-38); Michael R. Turner (R-OH-10); Darrell Issa (R-CA-50); Emanuel Cleaver (D-MO-5); Jim Costa (D-CA-16); Henry Cuellar (D-TX-28); Virginia Foxx (R-NC-5); Al Green (D-TX-9); Brian Higgins (D-NY-26); Michael T. McCaul (R-TX-10); Patrick T. McHenry (R-NC-10); Cathy McMorris Rodgers (R-WA-5); Gwen Moore (D-WI-4); Debbie Wasserman Schultz (D-FL-23); Doris O. Matsui (D-CA-6); Albio Sires (D-NJ-8); Gus M. Bilirakis (R-FL-12); Vern Buchanan (R-FL-16); Kathy Castor (D-FL-14); Yvette D. Clarke (D-NY-9); Steve Cohen (D-TN-9); Joe Courtney (D-CT-2); Henry C. "Hank" Johnson, Jr. (D-GA-4); Jim Jordan (R-OH-4); Doug Lamborn (R-CO-5); Kevin McCarthy (R-CA-23); Jerry McNerney (D-CA-9); Ed Perlmutter (D-CO-7); John P. Sarbanes (D-MD-3); Adrian Smith (R-NE-3); Peter Welch (D-VT-AL); John A. Yarmuth (D-KY-3); Robert E. Latta (R-OH-5); Robert J. Wittman (R-VA-1); André Carson (D-IN-7); Jackie Speier (D-CA-14); Steve Scalise (R-LA-1); Tim Walberg (R-MI-7); Gerald E. Connolly (D-VA-11); Brett Guthrie (R-KY-2); James A. Himes (D-CT-4); Blaine Luetkemeyer (R-MO-3); Tom McClintock (R-CA-4); Chellie Pingree (D-ME-1); Bill Posey (R-FL-8); Glenn Thompson (R-PA-15); Paul Tonko (D-NY-20); Kurt Schrader (D-OR-5); Mike Quigley (D-IL-5); Judy Chu (D-CA-27); John Garamendi (D-CA-3); Bill Foster (D-IL-11); Karen Bass (D-CA-37); Larry Bucshon (R-IN-8); David N. Cicilline (D-RI-1); Eric A. "Rick" Crawford (R-AR-1); Scott DesJarlais (R-TN-4); Jeff Duncan (R-SC-3); Charles J. "Chuck" Fleischmann (R-TN-3); Bob Gibbs (R-OH-7); H. Morgan Griffith (R-VA-9); Vicky Hartzler (R-MO-4); Jaime Herrera Beutler (R-WA-3); Bill Huizenga (R-MI-2); Bill Johnson (R-OH-6); William R. Keating (D-MA-9); Mike Kelly (R-PA-16); Billy Long (R-MO-7); David B. McKinley (R-WV-1); Steven M. Palazzo (R-MS-4); David Schweikert (R-AZ-6); Austin Scott (R-GA-8); Terri A. Sewell (D-AL-7); Daniel Webster (R-FL-11); Frederica S. Wilson (D-FL-24); Steve Womack (R-AR-3); Dina Titus (D-NV-1); Kweisi Mfume (D-MD-7); Mark E. Amodei (R-NV-2); Suzanne Bonamici (D-OR-1); Suzan K. DelBene (D-WA-1); Donald M. Payne, Jr. (D-NJ-10); Andy Barr (R-KY-6); Joyce Beatty (D-OH-3); Ami Bera (D-CA-7); Julia Brownley (D-CA-26); Cheri Bustos (D-IL-17); Matt Cartwright (D-PA-8); Joaquin Castro (D-TX-20); Tony Cárdenas (D-CA-29); Rodney Davis (R-IL-13); Lois Frankel (D-FL-21); Richard Hudson (R-NC-8); Jared Huffman (D-CA-2); Hakeem S. Jeffries (D-NY-8); David P. Joyce (R-OH-14); Daniel T. Kildee (D-MI-5); Derek Kilmer (D-WA-6); Ann Kirkpatrick (D-AZ-2); Ann M. Kuster (D-NH-2); Doug LaMalfa (R-CA-1); Alan S. Lowenthal (D-CA-47); Sean Patrick Maloney (D-NY-18); Grace Meng (D-NY-6); Markwayne Mullin (R-OK-2); Scott H. Peters (D-CA-52); Mark Pocan (D-WI-2); Tom Rice (R-SC-7); Raul Ruiz (D-CA-36); Chris Stewart (R-UT-2); Eric Swalwell (D-CA-15); Mark Takano (D-CA-41); Juan Vargas (D-CA-51); Marc A. Veasey (D-TX-33); Ann Wagner (R-MO-2); Randy K. Weber, Sr. (R-TX-14); Brad R. Wenstrup (R-OH-2); Roger Williams (R-TX-25); Robin L. Kelly (D-IL-2); Jason Smith (R-MO-8); Katherine M. Clark (D-MA-5); Alma S. Adams (D-NC-12); Donald Norcross (D-NJ-1); Pete Aguilar (D-CA-31); Rick W. Allen (R-GA-12); Brian Babin (R-TX-36); Donald S. Beyer, Jr. (D-VA-8); Mike Bost (R-IL-12); Brendan F. Boyle (D-PA-2); Earl L. "Buddy" Carter (R-GA-1); Ed Case (D-HI-1); Mark DeSaulnier (D-CA-11); Debbie Dingell (D-MI-12); Tom Emmer (R-MN-6); Ruben Gallego (D-AZ-7); Garret Graves (R-LA-6); Glenn Grothman (R-WI-6); Jody B. Hice (R-GA-10); J. French Hill (R-AR-2); John Katko (R-NY-24); Brenda L. Lawrence (D-MI-14); Ted Lieu (D-CA-33); Barry Loudermilk (R-GA-11); John R. Moolenaar (R-MI-4); Seth Moulton (D-MA-6); Dan Newhouse (R-WA-4); Gary J. Palmer (R-AL-6); Kathleen M. Rice (D-NY-4); David Rouzer (R-NC-7); Elise M. Stefanik (R-NY-21); Norma J. Torres (D-CA-35); Bonnie Watson Coleman (D-NJ-12); Bruce Westerman (R-AR-4); Lee M. Zeldin (R-NY-1); Bradley Scott Schneider (D-IL-10); David G. Valadao (R-CA-21); Trent Kelly (R-MS-1); Darin LaHood (R-IL-18); James Comer (R-KY-1); Dwight Evans (D-PA-3); Jodey C. Arrington (R-TX-19); Don Bacon (R-NE-2); Jim Banks (R-IN-3); Nanette Diaz Barragán (D-CA-44); Jack Bergman (R-MI-1); Lisa Blunt Rochester (D-DE-AL); Anthony G. Brown (D-MD-4); Ted Budd (R-NC-13); Salud O. Carbajal (D-CA-24); J. Luis Correa (D-CA-46); Val Butler Demings (D-FL-10); Neal P. Dunn (R-FL-2); Adriano Espaillat (D-NY-13); A. Drew Ferguson IV (R-GA-3); Brian K. Fitzpatrick (R-PA-1); Mike Gallagher (R-WI-8); Vicente Gonzalez (D-TX-15); Josh Gottheimer (D-NJ-5); Steven Horsford (D-NV-4); Pramila Jayapal (D-WA-7); Mike Johnson (R-LA-4); Ro Khanna (D-CA-17); Raja Krishnamoorthi (D-IL-8); David Kustoff (R-TN-8); Al Lawson, Jr. (D-FL-5); Stephanie N. Murphy (D-FL-7); Tom O’Halleran (D-AZ-1); Jimmy Panetta (D-CA-20); Jamie Raskin (D-MD-8); John H. Rutherford (R-FL-4); Lloyd Smucker (R-PA-11); Darren Soto (D-FL-9); Thomas R. Suozzi (D-NY-3); Ron Estes (R-KS-4); Jimmy Gomez (D-CA-34); John R. Curtis (R-UT-3); Conor Lamb (D-PA-17); Debbie Lesko (R-AZ-8); Troy Balderson (R-OH-12); Kevin Hern (R-OK-1); Joseph D. Morelle (D-NY-25); Mary Gay Scanlon (D-PA-5); Susan Wild (D-PA-7); Colin Z. Allred (D-TX-32); Kelly Armstrong (R-ND-AL); Cynthia Axne (D-IA-3); James R. Baird (R-IN-4); Tim Burchett (R-TN-2); Sean Casten (D-IL-6); Ben Cline (R-VA-6); Angie Craig (D-MN-2); Dan Crenshaw (R-TX-2); Jason Crow (D-CO-6); Sharice Davids (D-KS-3); Madeleine Dean (D-PA-4); Veronica Escobar (D-TX-16); Lizzie Fletcher (D-TX-7); Russ Fulcher (R-ID-1); Sylvia R. Garcia (D-TX-29); Jesús G. "Chuy" García (D-IL-4); Jared F. Golden (D-ME-2); Anthony Gonzalez (R-OH-16); Mark E. Green (R-TN-7); Michael Guest (R-MS-3); Josh Harder (D-CA-10); Jahana Hayes (D-CT-5); Chrissy Houlahan (D-PA-6); Dusty Johnson (R-SD-AL); John Joyce (R-PA-13); Andy Kim (D-NJ-3); Susie Lee (D-NV-3); Andy Levin (D-MI-9); Mike Levin (D-CA-49); Elaine G. Luria (D-VA-2); Tom Malinowski (D-NJ-7); Lucy McBath (D-GA-6); Daniel Meuser (R-PA-9); Carol D. Miller (R-WV-3); Joe Neguse (D-CO-2); Alexandria Ocasio-Cortez (D-NY-14); Ilhan Omar (D-MN-5); Chris Pappas (D-NH-1); Greg Pence (R-IN-6); Dean Phillips (D-MN-3); Katie Porter (D-CA-45); Ayanna Pressley (D-MA-7); Guy Reschenthaler (R-PA-14); John W. Rose (R-TN-6); Kim Schrier (D-WA-8); Mikie Sherrill (D-NJ-11); Elissa Slotkin (D-MI-8); Abigail Davis Spanberger (D-VA-7); Greg Stanton (D-AZ-9); Pete Stauber (R-MN-8); Bryan Steil (R-WI-1); Haley M. Stevens (D-MI-11); William R. Timmons IV (R-SC-4); Rashida Tlaib (D-MI-13); Lori Trahan (D-MA-3); David J. Trone (D-MD-6); Lauren Underwood (D-IL-14); Jefferson Van Drew (R-NJ-2); Michael Waltz (R-FL-6); Jennifer Wexton (D-VA-10); Claudia Tenney (R-NY-22); Gregory F. Murphy (R-NC-3); Mike Garcia (R-CA-25); Chris Jacobs (R-NY-27); Jake Auchincloss (D-MA-4); Cliff Bentz (R-OR-2); Stephanie I. Bice (R-OK-5); Carolyn Bourdeaux (D-GA-7); Jamaal Bowman (D-NY-16); Cori Bush (D-MO-1); Kat Cammack (R-FL-3); Jerry L. Carl (R-AL-1); Andrew S. Clyde (R-GA-9); Pat Fallon (R-TX-4); Randy Feenstra (R-IA-4); Michelle Fischbach (R-MN-7); Scott Fitzgerald (R-WI-5); Scott Franklin (R-FL-15); Andrew R. Garbarino (R-NY-2); Carlos A. Gimenez (R-FL-26); Tony Gonzales (R-TX-23); Diana Harshbarger (R-TN-1); Yvette Herrell (R-NM-2); Ashley Hinson (R-IA-1); Ronny Jackson (R-TX-13); Sara Jacobs (D-CA-53); Mondaire Jones (D-NY-17); Kaiali’i Kahele (D-HI-2); Young Kim (R-CA-39); Jake LaTurner (R-KS-2); Teresa Leger Fernandez (D-NM-3); Nancy Mace (R-SC-1); Nicole Malliotakis (R-NY-11); Tracey Mann (R-KS-1); Kathy E. Manning (D-NC-6); Lisa C. McClain (R-MI-10); Peter Meijer (R-MI-3); Mariannette Miller-Meeks (R-IA-2); Barry Moore (R-AL-2); Blake D. Moore (R-UT-1); Frank J. Mrvan (D-IN-1); Troy E. Nehls (R-TX-22); Marie Newman (D-IL-3); Jay Obernolte (R-CA-8); Burgess Owens (R-UT-4); August Pfluger (R-TX-11); Deborah K. Ross (D-NC-2); Maria Elvira Salazar (R-FL-27); Victoria Spartz (R-IN-5); Michelle Steel (R-CA-48); Marilyn Strickland (D-WA-10); Ritchie Torres (D-NY-15); Beth Van Duyne (R-TX-24); Nikema Williams (D-GA-5); Julia Letlow (R-LA-5); Troy A. Carter (D-LA-2); Melanie A. Stansbury (D-NM-1); Jake Ellzey (R-TX-6); Shontel M. Brown (D-OH-11); Mike Carey (R-OH-15); Sheila Cherfilus-McCormick (D-FL-20); G. K. Butterfield (D-NC-1); Jackie Walorski (R-IN-2); A. Donald McEachin (D-VA-4); Charlie Crist (D-FL-13).

Nay (28): Louie Gohmert (R-TX-1); Mo Brooks (R-AL-5); Paul A. Gosar (R-AZ-4); Andy Harris (R-MD-1); Thomas Massie (R-KY-4); Scott Perry (R-PA-10); Ken Buck (R-CO-4); Alexander X. Mooney (R-WV-2); Warren Davidson (R-OH-8); Andy Biggs (R-AZ-5); Matt Gaetz (R-FL-1); Clay Higgins (R-LA-3); Brian J. Mast (R-FL-18); Ralph Norman (R-SC-5); Michael Cloud (R-TX-27); Lance Gooden (R-TX-5); Chip Roy (R-TX-21); W. Gregory Steube (R-FL-17); Van Taylor (R-TX-3); Dan Bishop (R-NC-9); Thomas P. Tiffany (R-WI-7); Lauren Boebert (R-CO-3); Madison Cawthorn (R-NC-11); Byron Donalds (R-FL-19); Bob Good (R-VA-5); Marjorie Taylor Greene (R-GA-14); Mary E. Miller (R-IL-15); Matthew M. Rosendale, Sr. (R-MT-AL).

Not voting (7): Steny H. Hoyer (D-MD-5); Adam Kinzinger (R-IL-16); Liz Cheney (R-WY-AL); Trey Hollingsworth (R-IN-9); Fred Keller (R-PA-12); Michael F. Doyle (D-PA-18); Theodore E. Deutch (D-FL-22).

Speaker, not listed (1): Nancy Pelosi (D-CA-12).

Not in office (21): Connie Conway (R-CA-22); Mayra Flores (R-TX-34); Mike Flood (R-NE-1); Brad Finstad (R-MN-1); Mary Sattler Peltola (D-AK-AL); Patrick Ryan (D-NY-19); Joseph Sempolinski (R-NY-23); Rudy Yakym III (R-IN-2); Don Young (R-AK-AL); Alcee L. Hastings (D-FL-20); Devin Nunes (R-CA-22); Jeff Fortenberry (R-NE-1); Marcia L. Fudge (D-OH-11); Tom Reed (R-NY-23); Steve Stivers (R-OH-15); Cedric L. Richmond (D-LA-2); Filemon Vela (D-TX-34); Antonio Delgado (D-NY-19); Jim Hagedorn (R-MN-1); Debra A. Haaland (D-NM-1); Ron Wright (R-TX-6).

Summary

Main subject: Renews through fiscal year 2027 the Food and Drug Administration's user-fee programs for prescription drugs, medical devices, generic drugs and biosimilar biological products, and makes other changes to the Federal Food, Drug, and Cosmetic Act. Title I, Title II, Title III, Title IV

Its core areas: Prescription drug user fees; Medical device user fees; Generic drug user fees; Biosimilar biological product user fees; Diversity action plans for clinical studies; FDA inspections of drug and device establishments; Accelerated approval of drugs; Medical device cybersecurity.

Unexpected Items: 38 provisions

These provisions fall outside the bill’s main subject or apply narrowly. This describes the text; it is not a judgment.

Not related to the bill’s main subject (35)

Sec. 205: Conformity assessment pilot program: Rewrites section 514(d) so the Secretary sets up a program in which testing laboratories can be accredited to conduct tests supporting device conformity assessments, with results accepted by the Secretary, and treats the earlier pilot as completed after September 30, 2023.
Sec. 206: Reauthorization of third-party review program: Extends the third-party review program for devices from 2022 to 2027 by changing the year in section 523(c); this is not a user-fee provision.
Sec. 505: Public meeting on clinical study flexibilities initiated in response to COVID–19 pandemic: Requires the Secretary to convene a public meeting after the COVID–19 emergency period ends on clinical study recommendations issued during that period, and to publish a report on the topics discussed.
Sec. 506: Decentralized clinical studies: Requires the Secretary to issue draft and final guidance on decentralized clinical studies, including digital health technology, telehealth, and recruitment and retention of participants.
Sec. 601: Increasing transparency in generic drug applications: Requires the Secretary, on request or during review, to tell a generic applicant whether a new drug is qualitatively and quantitatively the same as the listed drug, to identify the differing ingredients, and limits later changes to that determination.
Sec. 602: Enhancing access to affordable medicines: Replaces the conditions in section 505(j)(10)(A) for approving generic applications while listed drug labeling is being revised, including a condition that the labeling revision not change the Warnings section.
Sec. 701: Animal testing alternatives: Replaces references to animal tests in section 505 with "nonclinical tests" and defines the term to include in vitro, in silico, in chemico, and nonhuman in vivo tests.
Sec. 702: Emerging technology program: Creates an emerging technology program for innovative drug product design and manufacturing, with grants, guidance and reporting, and authorizes $20,000,000 for each fiscal year 2023 through 2027. ($20,000,000)
Sec. 703: Improving the treatment of rare diseases and conditions: Requires reports, a contracted study, public meetings and a Government Accountability Office study on drugs for rare diseases or conditions, and amends section 569(a)(2) to allow experts on small population studies.
Sec. 704: Antifungal research and development: Requires draft and final guidance on approval of antifungal therapies for coccidioidomycosis and a public workshop on preventive vaccines for fungal infections and coccidioidomycosis.
Sec. 705: Advancing qualified infectious disease product innovation: Amends the definition of a qualified infectious disease product and adds biological product applications under section 351(a) of the Public Health Service Act to the related incentive provisions and priority review.
Sec. 706: National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing: Rewrites the program for National Centers of Excellence in Advanced and Continuous Pharmaceutical Manufacturing, allowing up to 5 designated institutions of higher education, and authorizes $100,000,000 for fiscal years 2023 through 2027. ($100,000,000)
Sec. 707: Advanced manufacturing technologies designation pilot program: Creates a pilot program under which persons may request designation of a drug manufacturing method as an advanced manufacturing technology, with expedited review of applications that use it.
Sec. 708: Public workshop on cell therapies: Requires the Secretary to convene a public workshop within 3 years on generating scientific data for stem-cell and other cellular therapies.
Sec. 709: Reauthorization of best pharmaceuticals for children: Extends the Best Pharmaceuticals for Children provision in the Public Health Service Act from fiscal years 2018 through 2022 to 2023 through 2027.
Sec. 710: Reauthorization for humanitarian device exemption and demonstration grants for improving pediatric availability: Extends the humanitarian device exemption provision to 2027 and extends the Pediatric Medical Device Safety and Improvement Act period to fiscal years 2023 through 2027.
Sec. 711: Reauthorization of provision related to exclusivity of certain drugs containing single enantiomers: Changes the year in the provision on exclusivity of certain drugs containing single enantiomers from 2022 to 2027.
Sec. 712: Reauthorization of the critical path public-private partnership program: Changes the critical path public-private partnership authorization from $6,000,000 for each of fiscal years 2018 through 2022 to $10,000,000 for each of fiscal years 2023 through 2027. ($10,000,000)
Sec. 713: Reauthorization of orphan drug grants: Adds regulatory science for individualized medical products for rare diseases to the Orphan Drug Act grant purposes and extends the period to fiscal years 2023 through 2027.
Sec. 714: Research into pediatric uses of drugs; additional authorities of Food and Drug Administration regarding molecularly targeted cancer drugs: Revises pediatric study requirements for molecularly targeted cancer drugs, sets guidance and report deadlines, and applies to applications submitted 3 years after enactment.
Sec. 801: Prompt reports of marketing status by holders of approved applications for biological products: Extends the marketing status reporting requirements to holders of approved biological product applications and adds a one-time report and list updates for biological products.
Sec. 802: Encouraging blood donation: Exempts voluntary collection of information from blood donors or potential donors, and from patients, from the Paperwork Reduction Act chapter.
Sec. 803: Regulation of certain products as drugs: Provides that any contrast agent, radioactive drug, or OTC monograph drug is deemed a drug and not a device.
Sec. 805: Facilitating the use of real world evidence: Requires guidance on the use of real world data and real world evidence for drug and device regulatory decisions, and a report to Congress after the COVID-19 emergency determination ends.
Sec. 806: Dual Submission for Certain Devices: Allows the sponsor of an emergency-use device whose laboratory examination was deemed in a certain category to file a single submission for classification and categorization.
Sec. 807: Medical Devices Advisory Committee meetings: Requires the Secretary to convene Medical Devices Advisory Committee panels at least once a year on devices used in pandemic preparedness and response, ending October 1, 2027.
Sec. 809: Public docket on proposed changes to third-party vendors: Requires a public docket on factors for reviewing requests to change third-party vendors for risk evaluation and mitigation strategies, and a GAO report by December 31, 2026.
Sec. 810: Facilitating exchange of product information prior to approval: Provides that sharing certain product information about investigational drugs or devices with payors and formulary committees does not make a product misbranded, and requires a GAO study.
Sec. 811: Bans of devices for one or more intended uses: Allows devices to be banned for one or more intended uses and deems electrical stimulation devices applying a noxious stimulus to the skin to reduce self-injurious or aggressive behavior to be banned devices.
Sec. 812: Clarifying application of exclusive approval, certification, or licensure for drugs designated for rare diseases or conditions: Changes the scope of exclusive approval for rare disease designated drugs from the same disease or condition to the same approved indication or use, applying to drugs regardless of designation or approval date.
Sec. 813: GAO report on third-party review: Requires a GAO report by September 30, 2026 on the device third-party review program, including resources used and an audit of select accredited persons.
Sec. 814: Reporting on pending generic drug applications and priority review applications: Extends the reporting requirement on pending generic drug applications and priority review applications by changing 2022 to 2027.
Sec. 815: FDA Workforce Improvements: Broadens the FDA workforce provision to products regulated by the agency and requires an agency-wide strategic workforce plan and a report to Congress.
Sec. 902: Medicaid Improvement Fund: Changes an amount in the Social Security Act provision on the Medicaid Improvement Fund from $0 to $450,000,000. ($450,000,000)
Sec. 901: Determination of budgetary effects: Sets the budgetary effects of the Act for Statutory Pay-As-You-Go purposes by reference to a statement printed in the Congressional Record.

Exception or delay for a subset (3)

Sec. 102: Definitions: Amends the drug fee definitions so that allergenic extract products licensed before October 1, 2022 are left out of the definition of a human drug application, and defines skin-test diagnostic products.
Sec. 103: Authority to assess and use drug fees: Amends the prescription drug fee provisions so that a human drug application for a skin-test diagnostic product is not subject to the application fee, and skin-test diagnostic products are excluded from the program fee.
Sec. 808: Ensuring cybersecurity of medical devices: Adds cybersecurity requirements for medical devices that include software or can connect to the internet. It also lets the Secretary identify devices or types of devices that are exempt from those requirements and publish a list of them.

What it does

Sec. 103: Sets the annual base revenue for prescription drug fees for fiscal year 2023 at $1,151,522,958 and sets how fee revenue is adjusted for fiscal years 2023 through 2027.
Sec. 203: Sets total medical device fee revenue amounts from $312,606,000 for fiscal year 2023 to $418,343,000 for fiscal year 2027.
Sec. 302: Replaces $493,600,000 with $582,500,000 as the generic drug fee revenue amount for fiscal year 2023 and sets how that amount is adjusted for fiscal years 2024 through 2027.
Sec. 403: Sets the annual base revenue for biosimilar biological product fees for fiscal year 2023 at $43,376,922 and sets how fee revenue is adjusted for fiscal years 2023 through 2027.
Sec. 501: Requires sponsors of phase 3 or other pivotal drug studies, and of certain device studies, to submit a diversity action plan stating enrollment goals, the rationale for them, and how the sponsor intends to meet them, unless the Secretary waives the requirement.
Sec. 601: Requires the Secretary, on request or during review, to tell a generic drug applicant whether the drug is qualitatively and quantitatively the same as the listed drug, and to identify the ingredients that cause any difference.
Sec. 721: Authorizes the Secretary to inspect sites and facilities and the records related to studies and submissions supporting marketing authorization of drugs and devices, including clinical and nonclinical studies and postmarket safety activities.
Sec. 804: Allows the Secretary to require postapproval studies for drugs approved under accelerated approval, sets expedited procedures for withdrawing such approval, and requires specified labeling statements.
Sec. 808: Requires premarket submissions for cyber devices to include cybersecurity information, and requires manufacturers to have a postmarket vulnerability plan, provide updates and patches, and include a software bill of materials in labeling.
Sec. 902: Amends the Social Security Act to replace $0 with $450,000,000 in the Medicaid Improvement Fund provision.

Written automatically from the official text by Claude Sonnet 5.5, an AI model. Written 15 Oct 2026 and published after the automatic checks, without a person reading it first. Every line names the section it came from.