Bills to Watch

Introduced

H.R. 3610
Food and Drug Import Safety Act of 2007
Sponsors: Rep. Dingell (D-MI)
Introduced: 09/20/07
Cosponsors: 8 (Reps. Boyda, DeGette, Delahunt, Miller (CA), Pallone, Stupak, Sutton and Waxman)
Status: Referred to House Energy & Commerce Committee.  Health Subcommittee Hearing held on September 26.
Description: Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services to provide for research on the development of tests and sampling methodologies for use on imported food; Requires the Secretary to assess and collect fees on imported food and drugs; Directs the Secretary to restrict the importation of all food to metropolitan ports of entry with a Food and Drug Administration (FDA) laboratory for testing such food; Deems a food, drug, or device to be misbranded it its labeling fails to identify its country of origin.

S. 484
Enhancing Drug Safety and Innovation Act of 2007
Sponsors: Sens. Kennedy (D-MA) and Enzi (R-WY)
Cosponsors – None
Introduced: 02/01/07
Status: Hearings held on bill on March 14, 2007 in Senate Committee on Health, Education, Labor, and Pensions.
Description: Bill would amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight.

S. 1695
Kennedy-Clinton-Schumer-Enzi-Hatch Biogenerics Bill
Sponsor: Sen. Kennedy (D-MA)
Cosponsors: 4 (Sens. Clinton, Enzi, Hatch and Schumer)
Introduced: 6/27/2007
Status: Markup held on June 27.  Bill to be reported with an amendment in the nature of a substitute favorably to full Senate.
Description: Bill would establish a pathway for the licensure of biosimilar biological products, to promote innovation in the life sciences.

S. 623
Access to Life-Saving Medicine Act
Sponsor: Sen. Schumer (D-NY)
Cosponsors: 7 (Sens. Brown, Clinton, Coleman, Collins, Leahy, Stabenow, and Vitter)
Introduced: 02/15/07
Status: Referred to Senate Committee on Health, Education, Labor, and Pensions on February 15.  Many provisions incorporated into S. 1695 which was reported favorably on June 27.
Description: Bill would amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products.

HR 1038
Access to Life-Saving Medicine Act
Sponsor: Rep. Waxman (D-CA)
Cosponsors: 28 (Reps. Abercrombie, Allen, Clay, Cohen, Cooper, Conyers, Ellison, Emanuel, Emerson, Grijalva, Hirono, Hoekstra, Holden, Kildee, Kilpatrick, Loebsack, McCarthy, McCollum, Norton, Pallone, Pastor, Platts, Slaughter, Stark, Thornberry, Wamp, Wolf, and Woolsey)
Introduced: 02/14/07
Status: Joint referral to the House Committee on Energy and Commerce and to the House Committee on the Judiciary.  Hearing on issue held in Energy and Commerce Committee on March 26.
Description: Bill would amend the Public Health Service Act to provide for the licensing of comparable and interchangeable biological products.

HR 1956
Patient Protection and Innovative Biologic Medicines Act of 2007
Sponsor: Rep. Inslee (D-WA)
Cosponsors: 16 (Reps. Baldwin, Bishop, Butterfield, Crowley, Davis (AL), Green (TX), Hill, Hooley, Kind, Meeks, Melancon, Moran (VA), Richardson, Smith (WA) Tauscher, and Towns.)
Introduced: 04/19/07
Status: Referred to the House Committee on Energy and Commerce’s Health Subcommittee. 
Description: Amends the Public Health Service Act to allow any person to submit an application for approval of a biologics license for a biological product that is claimed to be similar to a qualified biological product (reference product) after 12 years have elapsed since the reference product was approved or licensed.

HR 5629
Pathway for Biologics Act of 2008
Sponsors: Rep. Eshoo (D-CA) and Barton (R-TX)
Cosponsors: 14 (Reps. Boucher, Buyer, Capuano, Ferguson, Hill, Lofgren, Lynch, McCarthy(CA), McGovern, T. Murphy(PA), Pitts, Rogers(MI), Upton and Wynn)
Introduced: 03/13/08
Status: Joint referral to the House Committee on Energy and Commerce’s Health Subcommittee and the House Judiciary Committee.
Description: Bill would amend the Public Health Service Act to establish a pathway for the licensure of biosimilar biological products

S. 1505
Affordable Biologics for Consumers Act
Sponsor: Sen. Gregg (R-NH)
Cosponsors: 2 (Sens. Burr and Coburn)
Introduced; 5/24/07
Status: Referred to the Committee on Health, Education, Labor, and Pensions
Description: Bill would amend the Public Health Service Act to provide for the approval of biosimilars (i.e. generic biologics)

S. 242
Pharmaceutical Market Access and Drug Safety Act of 2007
Sponsor: Sen. Dorgan (D-ND)
Cosponsors: 35 (Sens. Bingaman, Boxer, Brown, Casey, Clinton, Collins, Conrad, Durbin, Feingold, Feinstein, Grassley, Inouye, Johnson, Kennedy, Kerry, Kohl, Leahy, Levin, Lincoln, McCain, McCaskill, Nelson (FL), Obama, Pryor, Salazar, Sanders, Schumer, Snowe, Specter, Stabenow, Tester, Thune, Webb, Whitehouse and Wyden)
Introduced: 01/10/2007
Status:  Referred to Senate Committee on Health, Education, Labor, and Pensions.  Hearings held on March 7 in Senate Committee on Commerce, Science, and Transportation Subcommittee on Interstate Commerce, Trade, and Tourism.
Description: Bill to amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs that are “safe and effective” as determined by “adequate and well-controlled investigations, including clinical investigations, conducted by experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs.” 
Related bill introduced in House H.R. 380

S. 467
Fair Access to Clinical Trials (FACT) Act of 2007
Sponsor: Sen. Chris Dodd (D-CT)
Cosponsors: 7 (Sens. Bingaman, Collins, Durbin, Grassley, Harkin, Johnson and Wyden)
Introduced: 1/31/07
Status: Referred to the Senate Committee on Health, Education, Labor, and Pensions. No hearings held to date. 
Description:  Bill would (1) create a publicly accessible national data bank of clinical trial information comprised of a clinical trial registry and a clinical trial results database; (2) to foster transparency and accountability in health-related intervention research and development; (3) to maintain a clinical trial registry accessible to patients and health care practitioners seeking information related to ongoing clinical trials for serious or life-threatening diseases and conditions; and (4) to establish a clinical trials results database of all publicly and privately funded clinical trial results regardless of outcome, that is accessible to the scientific community, health care practitioners, and members of the public.

HR 1165
Swift Approval, Full Evaluation (SAFE) Drug Act
Sponsor: Rep. Markey (D-MA)
Cosponsors: 1 (Rep. Eshoo)
Introduced: 02/16/07
Status: Referred to the House Committee on Energy and Commerce.  No hearings held to date.
Description: Bill would amend the Federal Food, Drug, and Cosmetic Act to establish additional authorities to ensure the safe and effective use of drugs, to establish whistleblower protections for certain individuals.

H. Res. 248
Resolution Honoring the Contributions of Patient Participants in Clinical Trials
Sponsor: Rep. Boucher (D-VA)
Cosponsors: 9 (Reps. Broun, Cannon, DeGette, Frank, Gerlach, Markey, Towns, Upton and Wilson of NM)
Introduced: 03/15/07
Status: Referred to the House Committee on Energy and Commerce.  Added two cosponsors on January 17, 2008.
Description: Introduced resolution in the House of Representatives to honor the contributions of patients who participate in clinical trials.

HR 1561
Enhancing Drug Safety and Innovation Act of 2007
Sponsor: Rep. Waxman (D-CA)
Cosponsors: 12 (Reps. Abercrombie, Allen, Cohen, Eshoo, Filner, Gordon, Grijalva, Markey McCollum, McGovern, Miller and Murphy of CT)
Introduced: 03/19/07
Status: Referred to the House Committee on Energy and Commerce.  No hearings held to date.
Description: Bill would amend the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act to improve drug safety and oversight.

S.1507
Access to Medicare Data Act of 2007
Sponsor: Sen. Grassley (R-IA)
Cosponsors: 1 (Sen. Baucus)
Introduced: 05/24/07
Status: Referred to the Senate Committee on Finance.
Description: Bill would amend Title XVIII of the Social Security Act to provide for drug and health care claims data release.

S.251
Pharmaceutical Market Access Act of 2007
Sponsor: Sen. Vitter (R-LA)
Cosponsor: 2 (Sens. DeMint and Thune)
Introduced: 01/10/07
Status: Referred to the Senate Committee on Health, Education, Labor, and Pensions.
Description: Bill would amend the Federal Food, Drug, and Cosmetic Act with respect to the importation of prescription drugs.

S. 438
Fair Prescription Drug Competition Act
Sponsor: Sen. Rockefeller (D-WV)
Cosponsors: 4 (Sens. Kohl, Leahy, Schumer and Stabenow)
Introduced: 01/30/07
Status:  Referred to the Committee on Health, Education, Labor, and Pensions.
Description: Bill would amend the Federal Food, Drug, and Cosmetic Act to prohibit the marketing of “authorized generic drugs”
Related bill in House is H.R. 806.

H.R. 1902
Protecting Consumer Access to Generic Drugs Act of 2007
Sponsor: Rep. Rush (D-IL)
Cosponsors: 13 (Reps. Butterfield, DeGette, Dingell, Doyle, Gonzalez, Gordon. Markey, Marshall, Schakowsky, Stupak, Van Hollen. Waxman, and Wynn)
Introduced: 04/17/07
Status: Referred to the House Energy & Commerce Committee and House Judiciary Committee.
Description: Bill would prohibit brand name drug companies from compensating generic drug companies to delay the entry of a generic drug into the market.

S. 2029
Physician Payments Sunshine Act
Sponsor: Sen. Grassley (R-IA)
Introduced: 09/06/07
Cosponsors: 6 (Sens. Clinton, Kennedy, Klobuchar, Kohl, McCaskill & Schumer)
Status:  Introduced in Senate.
Description: Bill would create a process for drug and medical device manufacturers to report to the HHS Secretary all payments and gifts of value which they make to physicians.

Passed Senate

S. 30
Hope Offered through Principled and Ethical Stem Cell Research (HOPE) Act
Sponsors:  Sens. Coleman (R-MN) and Isakson (R-GA)
Cosponsors: 6 (Sens Burr, Chambliss, Coburn, Cornyn, Isakson and McConnell)
Introduced:  03/29/07
Status: April 12, 2007 – Passed Senate by a vote of 70-28 (Vote # 128).
Bill referred to the House Committee on Energy and Commerce on April 16.
Description: Bill would allow federal funding for stem cell research using methods that do not involve the destruction of embryos.