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Legislation News & Report (TM) TheWeekInCongress.com (TM) Managing America: Authorizations |
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TheWeekInCongress.com (TM) Week Ending May 4, 2006
S.1082 A bill to amend the Federal Food, Drug, and Cosmetic Act to reauthorize and amend the prescription drug user fee provisions, and for other purposes.
The Food and Drug Administration is authorized to increase fees for post-approval and pre-market testing of prescription drugs and medical devices, improve safety of drugs, and communicate to consumers potential adverse drug effects. Some fees taken in would be dedicated to expediting the drug development process for review of human applications and post market drug safety studies. Others would finance review of medical devices. The FDA may review direct to consumer prescription drug advertisements. Safety monitoring both pre- and post-acceptance is a significant part of the bill and a public / private organization is to be formed to oversee the drug safety process. The bill also establishes the Reagan-Udall foundation that will adapt the FDA mission to modernizing medicine, veterinary medicine, food ingredients, cosmetic products and product safety.
The advent of direct to consumer prescription drug advertisements has brought the need to study their impact and to review the ads under the advisory review programs. Ads must be under 2 minutes.
User fees, those fees paid by manufacturers, are expanded in this bill that adds a yearly 'establishment registration' fee paid by all manufacturers and an annual fee for periodic filing of devices. The fee would increase 8.5% in 2010 if the number of users fell below 12,500 in 2009. Devices for pediatric use and for humanitarian devices are exempt from testing fees.
Medical devices may be inspected by a third, non-public party certified by the FDA to do that work. A manufacturer can request a third party test rather than the FDA test and after two consecutive private sector tests the next test or the next device must be done by the FDA.
Drug safety would be improved through routine active monitoring by a public / private foundation to be created under the bill’s Risk Evaluation and Mitigation Strategy (REM). The partnership will oversee trials and surveys both post-market and when safety signals are triggered. Safety signals come from reports of adverse events experienced by drug users. The private side of the partnership will be an entity that has a ‘significant business presence’, research capabilities, drug development expertise and experience with drug development and risk balancing, has sufficient Internet technology to manage that data and survey adverse events and can provide data security to insure privacy. The partnership would look to adverse drug events that range from reactions to use, to the drug not being effective, and to serious adverse drug events ranging from death to inability to live a normal life. An amendment provided increased fines to drug companies that do not allow for safety testing of their products should the FDA request one.
Drug importation under the bill requires FDA investigation and certification of every drug imported must have a chain of custody and other identifying data that would allow for tracing the drug's journey, who handled it and how and when. Customs is authorized to seize and destroy unauthorized imports and confiscate funds paid to foreign exporters who are not legitimate sellers or manufacturers. Amendment activity in the area of drug safety included providing for regulation of Internet pharmacies and requiring counterfeit-resistant technologies.
Medical marijuana is addressed to require that State-legalized medical marijuana be subject to the full regulations for the FDA including a risk evaluation and mitigation strategy.
An amendment aiming to eliminate
conflict of interest on FDA advisory committees was defeated. The
amendment would have prohibited an advisory board member from serving if
the member had the potential for financial gain due to the outcome of a
committee ruling on a drug or device. Increasing the authority of FDA
scientists in regards to determining drug safety was also defeated. Sponsor: Senator Edward M. Kennedy (D-MA) Vote: the Senate succeeded to invoke Cloture and thereby limit debate on the amendment 63 to 28 May 3, 2007. (RV ). Cloture was invoked May 7, 2007 82 to 8 (RV152) Passed Senate 93 to 1 May 9, 2007 (RV 157) Cost to the taxpayers: “CBO estimates that gross spending in subsequent years would exceed the amounts collected from user fees (because some of that spending under the bill would not be offset by fees), and that the net cost of implementing the bill would amount to $547 million over the 2008-2012 period, assuming the appropriation of the necessary amounts” “CBO estimates that direct spending for Medicare, Medicaid, the Federal Employees Health Benefits (FEHB) program, and the TRICARE for Life program would increase by an estimated $5 million over the 2008-2012 period and $150 million over the 2008-2017.” “CBO estimates that the proposal would have a negligible effect on federal tax revenues over the 2008-2012 period and would reduce federal revenues by $32 million over the 2008-2017 period (see Table 2). Social Security payroll taxes, which are off-budget, would account for $11 million of that total.” Earmark Certification: ## All Rights Reserved. © 2007 TheWeekInCongress.com(TM) No reproduction, language translation or distribution without written permission from TheWeekInCongress.com.(TM)
MORE INFORMATION
AMENDMENTS Amendments For S.10821. S.AMDT.982 to S.1082 To strike provisions related to market
exclusivity. Failed 41 to 53 May 2, 2007 (RV 148) 2. S.AMDT.983 to S.1082
To require
counterfeit-resistant technologies for prescription drugs. 3. S.AMDT.984 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 4. S.AMDT.985 to S.1082
To establish
a priority drug review process to encourage treatments of tropical
diseases 5. S.AMDT.986 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 6. S.AMDT.987 to S.1082
To amend the
Head Start Act to require parental consent for nonemergency intrusive
physical examinations 7. S.AMDT.988 to S.1082
To protect
children and their parents from being coerced into administering a
controlled substance in order to attend school, and for other purposes.
8. S.AMDT.989 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 9. S.AMDT.990 to S.1082 To provide for the importation of
prescription drugs. Senate succeeded to invoke Cloture and thereby limit debate on the amendment 63 to 28 May 3, 2007. (RV 150) 5/7/2007 Senate amendment agreed to. Status: Amendment SA 990 agreed to in Senate by Voice Vote. 10. S.AMDT.991 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 11. S.AMDT.992 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 12. S.AMDT.993 to S.1082
To provide
for the regulation of Internet pharmacies. 13. S.AMDT.994 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 14. S.AMDT.995 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 15. S.AMDT.996 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 16. S.AMDT.997 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 17. S.AMDT.998 to S.1082
To provide
for the application of stronger civil penalties for violations of approved
risk evaluation and mitigation strategies. Passed Senate 64 to 30 May 9, 2007 (RV 155) 18. S.AMDT.999 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 19. S.AMDT.1000 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 20. S.AMDT.1001 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. Failed in the Senate 46 to 47 May 9, 2007 (RV 154) 21. S.AMDT.1002 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 22. S.AMDT.1003 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 23. S.AMDT.1004 to S.1082 To require the Food and Drug
Administration to permit the sale of baby turtles as pets so long as the
seller uses proven methods to effectively treat salmonella. 24. S.AMDT.1005 to S.1082
To require
the Food and Drug Administration to determine whether certain substances
create any health risks and mislead consumers.. 25. S.AMDT.1006 to S.1082
To modify
provisions relating to required experience or certification for
prescribing or dispensing certain drugs, and for other purposes. 26. S.AMDT.1008 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 27. S.AMDT.1009 to S.1082
To insert
provisions relating to antibiotic access and innovation and certain
enantiomer drugs. 28. S.AMDT.1010 to S.1082 To protect the health and safety of
the public. This bill would restate that the imported drug would be
certified as not harmful for human consumption and will not negatively
impact the market. 5/7/2007 Senate amendment agreed to. Status: Amendment SA 1010 agreed to in Senate by Yea-Nay Vote. 49 - 40. Record Vote Number: 151. 29. S.AMDT.1011 to S.1082 To insert provisions related to
citizens petitions. 30. S.AMDT.1012 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 31. S.AMDT.1013 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 32. S.AMDT.1014 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 33. S.AMDT.1015 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 34. S.AMDT.1016 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 35. S.AMDT.1017 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 36. S.AMDT.1018 to S.1082 To amend the notification provision
with respect to drugs deemed to have risk evaluation and mitigation
strategies. 37. S.AMDT.1019 to S.1082
To express
the sense of the Senate concerning orphan disease treatment in children.
38. S.AMDT.1020 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 39. S.AMDT.1021 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 40. S.AMDT.1022 to S.1082 To ensure the safety of human and pet
food. 41. S.AMDT.1023 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 42. S.AMDT.1024 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 43. S.AMDT.1025 to S.1082 To express the sense of the Senate
with respect to follow-on biologics. 44. S.AMDT.1026 to S.1082
To require
the Food and Drug Administration to publish certain annual reports.
. 45. S.AMDT.1027 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 46. S.AMDT.1028 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 47. S.AMDT.1029 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 48. S.AMDT.1030 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 49. S.AMDT.1031 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 50. S.AMDT.1032 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 51. S.AMDT.1033 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 52. S.AMDT.1034 to S.1082 To reduce financial conflict of
interest in FDA Advisory Panels. Failed 47 to 47 may 9, 2007 (RV 156) 53. S.AMDT.1035 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 54. S.AMDT.1036 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 55. S.AMDT.1037 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 56. S.AMDT.1038 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 57. S.AMDT.1039 to S.1082 To clarify the authority of the Office
of Surveillance and Epidemiology with respect to postmarket drug safety
pursuant to recommendations by the Institute of Medicine. 58. S.AMDT.1040 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 59. S.AMDT.1041 to S.1082 To improve the safety and efficacy of
genetic tests. 60. S.AMDT.1042 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 61. S.AMDT.1043 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 62. S.AMDT.1044 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 63. S.AMDT.1045 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 64. S.AMDT.1046 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 65. S.AMDT.1047 to S.1082 To modify provisions relating to
direct-to-consumer advertisements. 66. S.AMDT.1048 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 67. S.AMDT.1049 to S.1082 To modify provisions relating to user
fees, and for other purposes. 68. S.AMDT.1050 to S.1082 To provide for color certification
reports. 69. S.AMDT.1051 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 70. S.AMDT.1052 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 71. S.AMDT.1053 to S.1082 to modify provisions related to
pediatric testing and medical products. 72. S.AMDT.1054 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 73. S.AMDT.1055 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 74. S.AMDT.1056 to S.1082 To require the FDA to conduct consumer
testing to determine the appropriateness of the labeling requirements for
indoor tanning devices. 75. S.AMDT.1057 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 76. S.AMDT.1058 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 77. S.AMDT.1059 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 78. S.AMDT.1060 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 79. S.AMDT.1061 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 80. S.AMDT.1062 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 81. S.AMDT.1063 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. 82. S.AMDT.1064 to S.1082 Purpose will be available when the
amendment is proposed for consideration. See Congressional Record for
text. ## All Rights Reserved. © 2007 TheWeekInCongress.com.(TM) No reproduction, language translation or distribution without written permission from TheWeekInCongress.com.(TM)
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