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91_SR0335
SRS91SR0044DLsa
1 SENATE RESOLUTION
2 WHEREAS, The federal Food, Drug and Cosmetic (FDC) Act of
3 1938, for the first time, required a manufacturer to prove
4 the safety of a drug before it could be marketed; and
5 WHEREAS, The 1962 Kefauver-Harris Drug Amendments to the
6 Act tightened the federal Food and Drug Administration's
7 control over drugs by requiring drug manufacturers to prove
8 not only safety, but also effectiveness; and
9 WHEREAS, This requirement was applied retroactively to
10 1938, when the FDC Act was passed, and all US-marketed drugs
11 approved solely for safety were to be further evaluated by
12 the FDA for effectiveness; and
13 WHEREAS, The FDA now reviews generic drugs approved for
14 safety and efficacy to evaluate their bioequivalence and
15 therapeutic equivalence to reference innovator products and
16 publishes such evaluations in a listing commonly referred to
17 as the "Orange Book"; and
18 WHEREAS, Pre-1938 drugs were "grandfathered" - allowed to
19 be sold because they were generally recognized as safe and
20 effective, provided no evidence to the contrary developed;
21 and
22 WHEREAS, Certain drugs marketed between 1938 and 1962
23 have also been allowed to remain legally marketed in the US,
24 under the presumption of being generally recognized as safe
25 while further evidence of efficacy is developed, under the
26 provisions of the FDA's Drug Efficacy Implementation Study
27 (DESI); and
28 WHEREAS, Grandfathered drugs and DESI drugs are not
29 listed in the FDA's "Orange Book; and
30 WHEREAS, Concerned about rising costs of prescription
-2- SRS91SR0044DLsa
1 medications and the safety of generic medications, in 1977,
2 the Illinois General Assembly created the Technical Advisory
3 Council within the Department of Public Health to establish a
4 formulary of medications acceptable for substitution in
5 Illinois; and
6 WHEREAS, Today the General Assembly remains concerned
7 about the increasing price of prescription medications and
8 the safety of medication substitution; and
9 WHEREAS, The Illinois General Assembly believes that the
10 Technical Advisory Council, in keeping with its mission to
11 help reduce costs and ensure safety, has authority to review
12 and approve generic substitutions for pre-1938 and DESI
13 (non-"Orange Book") medications, and to issue rules and
14 regulations regarding such substitution; and
15 WHEREAS, The Technical Advisory Council has capably
16 demonstrated its ability to review non "Orange Book" drugs as
17 evidenced its inclusion of over forty generic drug entities
18 in the Illinois Formulary for pharmacists' substitution;
19 therefore be it
20 RESOLVED, BY THE SENATE OF THE NINETY-FIRST GENERAL
21 ASSEMBLY OF THE STATE OF ILLINOIS, That the Illinois State
22 Senate encourages the Illinois Department of Public Health
23 and the Technical Advisory Council to promulgate rules and
24 regulations regarding the substitution of prescriptions for
25 pre-1938 and DESI (non "Orange Book") medications; and be it
26 further
27 RESOLVED, That a suitable copy of this preamble and
28 resolution be presented to the Director of Public Health.