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53. Senate Committee on Labor and Human Resources, "The FDA

and the Future of American Biomedical and Food Industries,

Hearings of the Committee April 5 and 6, 1995."  (Washing-

ton: U.S. Government Printing Office, 1995), p. 97.

54. Ibid., pp. 119-121.

55. Ibid., pp. 11, 102.

56. Ibid., pp. 125, 126.

57. Senate Report 105-43, 1997, p. 22.

58. Author's conversation with Melpi Jeffries, Center for

Devices and Radiological Health, December 6, 1996.

59. For a discussion on how the FDA breaks statutory law by

delaying the approval process, see Higgs, pp. 8-10, where he

discusses the FDA's ignoring 1976 amendment requirements to

solicit PMA submissions on predicate Class III devices, and

to produce performance standards for Class II devices.  See

also Lydia Verheggen, "FDA Review Times: Not Making the

Grade," Issue Analysis no. 23, Citizens for a Sound Economy,

February 20, 1996.  Verheggen details the FDA's violation of

its statutory deadlines to approve drugs, devices, animal

drugs, and food additives.

60. David Masci with Steve Langdon, p. 888.

61. This term was used in Senate Report 105-43, p. 24.

62. From conversations with a company official, June 27,

1997.

63. See Senate Report 105-43, pp. 22-24.

64. Barry Meier, "Sparks Fly over Industry Safety Test," New

York Times, December 24, 1995, section 3, p. 1.

65. See Higgs, especially the text and notes 167-173.  See

also U.S. House of Representatives, Committee on Energy and

Commerce, Subcommittee on Oversight and Investigations, p.

237: "It is unclear why medical devices that have undergone

both regulatory scrutiny and actual market use in Europe,

Canada, and Japan are not also approved in the United States

within a similar time frame, particularly since U.S. medical

device firms generally seek to first market their products

in the United States.  There is no evidence which indicates