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1 | SENATE JOINT RESOLUTION
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2 | WHEREAS, With approximately $16 billion in biologic drug | ||||||
3 | patents set to expire next year, the average price of a | ||||||
4 | traditional drug is about $45, while the average cost of a | ||||||
5 | biologic can be about 4 times as much, and with Medicaid | ||||||
6 | accounting for about 19% of federal government drug | ||||||
7 | expenditures, the 110th United States Congress will be | ||||||
8 | considering legislation to authorize a regulatory pathway at | ||||||
9 | the federal Food and Drug Administration (FDA) for the approval | ||||||
10 | of therapeutically equivalent versions of biologic drugs; and
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11 | WHEREAS, Biologics are a major driver of increasing | ||||||
12 | prescription drug costs; for the first time, 5 of the 20 | ||||||
13 | top-selling drugs in 2005 were made by biotech companies; | ||||||
14 | generic competition for biotech pharmaceuticals has the | ||||||
15 | potential to offer consumers dramatic and substantial savings, | ||||||
16 | while also lowering America's healthcare bill; and
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17 | WHEREAS, Illinois spends nearly $200 million for 61 | ||||||
18 | biologics under its Medicaid pharmacy benefits and Part D wrap | ||||||
19 | around programs and an estimated 12% of its drug benefits on | ||||||
20 | biologics for State employees and retirees; and | ||||||
21 | WHEREAS, The science to create affordable generic biotech | ||||||
22 | drugs exists today; it is being done in other countries; raw |
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1 | materials are available today for many bio-generic products | ||||||
2 | including insulin, GCSF, epoetin, interferons, and others; in | ||||||
3 | many countries around the world, competitive biotech products | ||||||
4 | are already available to consumers; in these countries, | ||||||
5 | patients have access to safe biogenerics and receive | ||||||
6 | significant cost savings from competition provided by | ||||||
7 | biogenerics; and
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8 | WHEREAS, Significant investment is made by biotech drug | ||||||
9 | developers in intellectual property, and appropriate | ||||||
10 | intellectual property protection and the ability to recoup | ||||||
11 | their investment is needed; however, as has been proven under | ||||||
12 | the Drug Price Competition and Patent Restoration Act of 1984, | ||||||
13 | competition fuels innovation; timely generic competition will | ||||||
14 | ensure continued innovation in biotech drugs; it is critical to | ||||||
15 | preserve the incentives for innovation that drive the | ||||||
16 | development of new biologics, but it is now time to provide the | ||||||
17 | balance of competition to those drugs off-patent or so to lose | ||||||
18 | patent protection in order to keep this country's biotech | ||||||
19 | innovators strong and growing; and
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20 | WHEREAS, A Citizens Petition was submitted to the FDA in | ||||||
21 | August 2006 requesting that the FDA use its statutory and | ||||||
22 | regulatory authority to issue guidelines that will facilitate | ||||||
23 | the availability of more affordable, therapeutically | ||||||
24 | equivalent versions of insulin and human growth hormone (HGH); |
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1 | and
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2 | WHEREAS, American patients currently spend approximately | ||||||
3 | $1.5 billion on insulin products to treat diabetes and | ||||||
4 | approximately $433 million on HGH, which is used to treat a | ||||||
5 | variety of conditions, including growth deficiencies in | ||||||
6 | children and adults, chronic renal insufficiency, and AIDS | ||||||
7 | wasting syndrome; and | ||||||
8 | WHEREAS, The FDA has repeatedly and publicly indicated that | ||||||
9 | guidance on the approval process for insulin and HGH would be | ||||||
10 | forthcoming; this guidance would provide generic | ||||||
11 | pharmaceutical manufacturers with the criteria for | ||||||
12 | demonstrating equivalence of generic versions of insulin and | ||||||
13 | HGH; however, it appears that issuance of appropriate | ||||||
14 | regulatory requirements for these products has come to a | ||||||
15 | standstill resulting in our citizens and taxpayers to continue | ||||||
16 | to shoulder the burden for excessive costs because no generic | ||||||
17 | version of either of these products is available; insulin and | ||||||
18 | HGH have relatively simple biologic structures with a long | ||||||
19 | history of safe use and a wealth of data available about these | ||||||
20 | products; and | ||||||
21 | WHEREAS, While such guidance unnecessarily languishes in | ||||||
22 | the United States, the European Medicines Agency (EMEA) has | ||||||
23 | adopted final guidelines on quality, non-clinical and clinical |
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1 | issues regarding similar biological medicinal products in | ||||||
2 | December 2003 and a general regulatory guideline on such | ||||||
3 | products in September 2005; the EMEA also issued final | ||||||
4 | product-specific guidance documents on similar biologic | ||||||
5 | medicine products, including one for insulin, in February 2006; | ||||||
6 | and | ||||||
7 | WHEREAS, In 2004, national Medicaid expenditures for | ||||||
8 | insulin alone were approximately $500 million; insulin was | ||||||
9 | historically approved for sale in the United States under the | ||||||
10 | Federal Food Drug and Cosmetic Act; this fact should make it | ||||||
11 | eligible to generic competition under the Drug Price | ||||||
12 | Competition and Patent Restoration Act of 1984; diabetes is on | ||||||
13 | the rise, and, if current population and diagnosis rates | ||||||
14 | continue as projected, the number of people with diabetes could | ||||||
15 | reach 17.4 million by 2020 with attendant costs rising to an | ||||||
16 | estimated $192 billion; insulin is a relatively simple | ||||||
17 | biopharmaceutical product and many versions are no longer | ||||||
18 | patent protected; if the FDA were to issue guidance in a timely | ||||||
19 | manner, a lower cost generic form could rapidly begin | ||||||
20 | generating savings for patients; and | ||||||
21 | WHEREAS, On average, African-Americans are 2.4 times as | ||||||
22 | likely to have diabetes as Caucasians; the highest incidence of | ||||||
23 | diabetes in African-Americans occurs between 65 and 75 years of | ||||||
24 | age; African-American women are especially affected; when |
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1 | adjusted for age, African-American women are more likely to be | ||||||
2 | diagnosed with diabetes than non-Hispanic Caucasians, | ||||||
3 | African-American men, or Hispanics; African-Americans with | ||||||
4 | diabetes are more likely to experience complications of | ||||||
5 | diabetes; diabetic retinopathy, an eye disease, is 19% more | ||||||
6 | common in African-American men than Caucasian men; amputations | ||||||
7 | of lower extremities are also more common in African-Americans | ||||||
8 | with diabetes; and | ||||||
9 | WHEREAS, As of 2002, 2 million Hispanic adults age 20 years | ||||||
10 | and older and about 8.2% of the population have diabetes; | ||||||
11 | diabetes is more prevalent in older Hispanics with the highest | ||||||
12 | rates in Hispanics 65 and older; on average, Hispanics are 1.5 | ||||||
13 | times as likely to have diabetes as Caucasians; | ||||||
14 | Mexican-Americans, the largest Hispanic subgroup, are more | ||||||
15 | than twice as likely to have diagnosed diabetes than | ||||||
16 | non-Hispanic Caucasians; in 2002, the death rate from diabetes | ||||||
17 | in Hispanics was 60% higher than the death rate of non-Hispanic | ||||||
18 | Caucasians; in 2001, Hispanics of all races experienced more | ||||||
19 | age-adjusted years of potential life lost before age 75 years | ||||||
20 | than non-Hispanic Caucasians for diabetes; and | ||||||
21 | WHEREAS, HGH is one of the most expensive prescription | ||||||
22 | regimes, costing a patient upwards of $30,000 a year; HGH has | ||||||
23 | annual sales in the United States that are estimated to be more | ||||||
24 | than $700 million; HGH costs are increasing as the number of |
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1 | growth deficiency-related cases continues to rise and as the | ||||||
2 | FDA approves new uses for HGH; as usage and the subsequent | ||||||
3 | expenses increase, Illinois is paying high prices for a drug | ||||||
4 | product that has not been patent protected since 2003; and | ||||||
5 | WHEREAS, The financial impact of the availability of | ||||||
6 | generic, substitutable versions of insulin, HGH, and other | ||||||
7 | biologics would be dramatic to the State and its citizens; for | ||||||
8 | example, if only one-third of patients using insulin were | ||||||
9 | converted to a generic and it was priced at a modest 10% | ||||||
10 | discount, payers would save $17 million annually; a discount of | ||||||
11 | 30%, more typical of the generic market, with only one-third of | ||||||
12 | patients utilizing the generic, would result in savings of more | ||||||
13 | than $50 million annually; if all Medicaid patients were | ||||||
14 | converted to the generic, at a 30% discount to current brand | ||||||
15 | prices, the savings would exceed $150 million annually; and | ||||||
16 | WHEREAS, For more than 2 decades, generic pharmaceuticals | ||||||
17 | have offered our State with a mechanism to manage the high cost | ||||||
18 | of providing prescription drugs for State-funded and federally | ||||||
19 | mandated prescription drug programs; at the same time, generic | ||||||
20 | drugs have provided all of the citizens of Illinois with the | ||||||
21 | opportunity to lower their prescription drug costs; therefore, | ||||||
22 | be it
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23 | RESOLVED, BY THE SENATE OF THE NINETY-FIFTH GENERAL |
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1 | ASSEMBLY OF THE STATE OF ILLINOIS, THE HOUSE OF REPRESENTATIVES | ||||||
2 | CONCURRING HEREIN, that we urge the members of the 110th United | ||||||
3 | States Congress and the President of the United States to enact | ||||||
4 | legislation that establishes a regulatory pathway authorizing | ||||||
5 | the Secretary of Health and Human Services to approve | ||||||
6 | abbreviated applications for biological products that are | ||||||
7 | comparable to previously approved biological products; and be | ||||||
8 | it further
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9 | RESOLVED, That the FDA promptly issue guidance documents | ||||||
10 | outlining the specific approval requirements for forms of | ||||||
11 | insulin and HGH that are therapeutically equivalent to brand | ||||||
12 | products currently approved by the FDA; the issuance of these | ||||||
13 | guidance documents would open the door for significant savings | ||||||
14 | on these important therapies for consumers across our nation; | ||||||
15 | and be it further
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16 | RESOLVED, That the FDA also commit to working with drug | ||||||
17 | companies developing such products and to expediting the | ||||||
18 | application process so that these products may be approved and | ||||||
19 | made available to patients as quickly as possible; and be it | ||||||
20 | further | ||||||
21 | RESOLVED, That we strongly concur with those Governors who | ||||||
22 | filed the Citizens Petition or sent letters of support for the | ||||||
23 | Citizens Petition to the FDA on this issue; and be it further |
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1 | RESOLVED, That we and the Governor have a responsibility | ||||||
2 | for managing the costs that the State incurs for prescription | ||||||
3 | drugs in connection with our State Medicaid program, as well as | ||||||
4 | other State programs such as State employees and State retirees | ||||||
5 | that provide a drug benefit; we also are charged with ensuring | ||||||
6 | that high quality, affordable healthcare is available to all | ||||||
7 | citizens of our State; and be it further | ||||||
8 | RESOLVED, That suitable copies of this Resolution be | ||||||
9 | provided to the acting Commissioner of the FDA, the Speaker the | ||||||
10 | United States House of Representatives, the Minority Leader of | ||||||
11 | the United States House of Representatives, the Majority Leader | ||||||
12 | of the United States Senate, the Minority Leader of the United | ||||||
13 | States Senate, and each member of the Illinois congressional | ||||||
14 | delegation.
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