Drug Regulation Reform Act of 1978, Part 1, Hearings Before the Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce, House of Representatives, Ninety-Fifth Congress, Second Session, June 6, 12, 13, 14, 15, 19, 20, 21, 22, 23, and 27, 1978 [open pdf - 597MB]
This is the June 6, 12, 13, 14, 15, 19, 20, 21, 22, 23, and 27, 1978 hearing on "Drug Regulation Reform Act of 1978, Part 1," held before the U.S. House Subcommittee on Health and the Environment of the Committee on Interstate and Foreign Commerce. From the Opening Statement of Paul G. Rogers: "The subcommittee will come to order, please. This afternoon, the subcommittee begins its hearings on a bill that has the potential of becoming one of the most important pieces of legislation enacted in this decade: The Drug Regulation Reform Act of 1978. This legislation, sponsored by seven members of the subcommittee, including Dr. Carter, its ranking minority member and by Chairman Staggers of the full committee, has the potential of bringing the benefits of promising new drug therapies to the marketplace more rapidly, without compromising safety or effectiveness, and hopefully of reducing the cost of drugs. It promises a better informed citizenry about the proper use and intended effects of drugs. Properly implemented, it can result in much safer use of drugs than can be the case today. And, with a substantially more open decisionmaking process, the Commissioner of Food and Drugs will be better able to explain his actions to the American people." Statements, letters, and materials submitted for the record include those of the following: John G. Adams, Robert Anderson, Robert N. Anderson, William S. Apple, John C. Ballin, Robert L. Banse, Barry M. Bloom, Thomas Bloor, Robrt J. Bolger, Saul Boyarsky, Bruce Brennan, John J. Burns, Joseph A. Califano Jr., Sanford N. Cohen, William J. Colley, Richard M. Cooper, James D. Cope, J. Richard Crout, E. Richard Dorsey, Lawrence J. Dubow, Gertrude Engle, Sheldon W. Fantle, Edward G. Feldmann, James Ferrendelli, Diane J. Fisher, Joseph L. Garde, Elmer A. Garder, Raymond W. Gifford, Leon I. Goldberg, Henry G. Garbowski, Marcia D. Greenberger, Doris B. Haire, Authur Hayes Jr., William M. Heller, Earl B. Herr Jr., Harold B. Hubbard, John L. Huck, Peter Barton Hutt, Anita Johnson, Ty Kelley, Donald Kennedy, Louis Lasagna, Philip Lee, Irwin Lerner, Peter Libassi, Kathleen McGee, Daniel J. Manelli, James G. Martin, Kenneth L. Melmon, Thomas Miya, Louis A. Morris, Barbara Moulton, Rodney R. Munsey, Roger Nol, William D. Nordhaus Mark Novitch, John A. Owen Jr., Micharl Pertschuk, Joseph M. Pisani, Albert W. Pruitt, David L. Rabin, David P. Rall, Henry W. Riecken, Carl Robert, Christopher A. Rodowskas Jr., Ted H. Rowell, Jr., C.H. William Ruhe, Lewis N. Sarett, Richard T.F. Schmidt, Gene H. Schwach, Harry C. Shirkey, Milton Silverman, William J. Skinner, Micharl Sohn, Robert F. Steeves, C. Joseph Stetler ronald J. Streck, Steven D. Symms, Robert J. Temple, Herbert Thompson, Monroe E. Trout, P. Roy Vagelos, William W. Vodra, William M. Wardell, Peyton E. Weary, Fred Wegner, Bob Wilbur, and Sidney M. Wolfe.
Serial No. 95-169
U.S. Government Publishing Office: http://www.gpo.gov/