H.R. 1629: Fairness in Orphan Drug Exclusivity Act

Bill · 117th Congress (2021–2022). Passed House, 19 May 2021. Introduced 8 Mar 2021.

Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to limitations on exclusive approval or licensure of orphan drugs, and for other purposes.

Vote results

How each member voted

House

Yea (402): Harold Rogers (R-KY-5); Christopher H. Smith (R-NJ-4); Steny H. Hoyer (D-MD-5); 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); 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); 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); 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); 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); Charles J. "Chuck" Fleischmann (R-TN-3); Bob Gibbs (R-OH-7); Paul A. Gosar (R-AZ-4); 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); Adam Kinzinger (R-IL-16); 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); 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); Thomas Massie (R-KY-4); 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 Perry (R-PA-10); 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); 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); Ken Buck (R-CO-4); 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); Alexander X. Mooney (R-WV-2); 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); Warren Davidson (R-OH-8); 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); Salud O. Carbajal (D-CA-24); Liz Cheney (R-WY-AL); 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); Matt Gaetz (R-FL-1); Mike Gallagher (R-WI-8); Vicente Gonzalez (D-TX-15); Josh Gottheimer (D-NJ-5); Trey Hollingsworth (R-IN-9); 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); Brian J. Mast (R-FL-18); Stephanie N. Murphy (D-FL-7); Tom O’Halleran (D-AZ-1); Jimmy Panetta (D-CA-20); Jamie Raskin (D-MD-8); Lloyd Smucker (R-PA-11); Darren Soto (D-FL-9); Thomas R. Suozzi (D-NY-3); Ralph Norman (R-SC-5); Jimmy Gomez (D-CA-34); John R. Curtis (R-UT-3); Conor Lamb (D-PA-17); Debbie Lesko (R-AZ-8); Michael Cloud (R-TX-27); 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); Sylvia R. Garcia (D-TX-29); Jesús G. "Chuy" García (D-IL-4); Anthony Gonzalez (R-OH-16); Lance Gooden (R-TX-5); 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); 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); Van Taylor (R-TX-3); 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); Fred Keller (R-PA-12); Dan Bishop (R-NC-9); Gregory F. Murphy (R-NC-3); Mike Garcia (R-CA-25); Thomas P. Tiffany (R-WI-7); 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); Madison Cawthorn (R-NC-11); Andrew S. Clyde (R-GA-9); Byron Donalds (R-FL-19); 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); Mary E. Miller (R-IL-15); 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); Don Young (R-AK-AL); Michael F. Doyle (D-PA-18); Devin Nunes (R-CA-22); G. K. Butterfield (D-NC-1); Jeff Fortenberry (R-NE-1); Theodore E. Deutch (D-FL-22); Tom Reed (R-NY-23); Jackie Walorski (R-IN-2); Filemon Vela (D-TX-34); A. Donald McEachin (D-VA-4); Charlie Crist (D-FL-13); Antonio Delgado (D-NY-19); Jim Hagedorn (R-MN-1).

Nay (23): Virginia Foxx (R-NC-5); Louie Gohmert (R-TX-1); Jim Jordan (R-OH-4); Doug Lamborn (R-CO-5); Mo Brooks (R-AL-5); Jeff Duncan (R-SC-3); Andy Harris (R-MD-1); Billy Long (R-MO-7); Jason Smith (R-MO-8); Earl L. "Buddy" Carter (R-GA-1); Andy Biggs (R-AZ-5); Ted Budd (R-NC-13); Clay Higgins (R-LA-3); John H. Rutherford (R-FL-4); Ron Estes (R-KS-4); Russ Fulcher (R-ID-1); John W. Rose (R-TN-6); Chip Roy (R-TX-21); W. Gregory Steube (R-FL-17); Lauren Boebert (R-CO-3); Bob Good (R-VA-5); Marjorie Taylor Greene (R-GA-14); Matthew M. Rosendale, Sr. (R-MT-AL).

Not voting (4): Danny K. Davis (D-IL-7); John Garamendi (D-CA-3); Daniel Webster (R-FL-11); Jared F. Golden (D-ME-2).

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

Not in office (19): 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); 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); Alcee L. Hastings (D-FL-20); Marcia L. Fudge (D-OH-11); Steve Stivers (R-OH-15); Cedric L. Richmond (D-LA-2); Debra A. Haaland (D-NM-1); Ron Wright (R-TX-6).

Summary

Main subject: Amends the Federal Food, Drug, and Cosmetic Act so that an orphan drug designated because its development costs are not expected to be recovered from U.S. sales keeps exclusive approval or licensure only if its sponsor demonstrates that expectation, taking into account sales within 12 years of first marketing. Sec. 2

Its core areas: Orphan drug exclusive approval and licensure under section 527 of the Federal Food, Drug, and Cosmetic Act.

Unexpected Items: 0 provisions

What it does

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.

Sources