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1 | AMENDMENT TO SENATE JOINT RESOLUTION 48
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2 | AMENDMENT NO. ___. Amend Senate Joint Resolution 48 by | ||||||
3 | replacing everything after the heading with the following:
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4 | "WHEREAS, With approximately $16 billion in biologic drug | ||||||
5 | patents set to expire next year, the average price of a | ||||||
6 | traditional drug is about $45, while the average cost of a | ||||||
7 | biologic can be about 4 times as much, and with Medicaid | ||||||
8 | accounting for about 19% of federal government drug | ||||||
9 | expenditures, the 110th United States Congress will be | ||||||
10 | considering legislation to authorize a regulatory pathway at | ||||||
11 | the federal Food and Drug Administration (FDA) for the | ||||||
12 | determination and approval of safe comparable versions of | ||||||
13 | biologic drugs that are expected to produce the same clinical | ||||||
14 | results as the innovator product; and | ||||||
15 | WHEREAS, Biologics are a major driver of increasing | ||||||
16 | prescription drug costs; for the first time, 5 of the 20 |
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1 | top-selling drugs in 2005 were made by biotech companies; | ||||||
2 | additional competition for biotech pharmaceuticals has the | ||||||
3 | potential to offer consumers real savings, while also lowering | ||||||
4 | America's healthcare bill; and
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5 | WHEREAS, Illinois spends nearly $200 million for 61 | ||||||
6 | biologics under its Medicaid pharmacy benefits and Part D wrap | ||||||
7 | around programs and an estimated 12% of its drug benefits on | ||||||
8 | biologics for State employees and retirees; and | ||||||
9 | WHEREAS, The science to create safe comparable biotech | ||||||
10 | drugs exists today in other countries; raw materials are | ||||||
11 | available today for many comparable protein products including | ||||||
12 | insulin, GCSF, epoetin, interferons, and others; in many | ||||||
13 | countries around the world, competitive biotech products are | ||||||
14 | already available to consumers; in these countries, patients | ||||||
15 | have access to safe comparable biological products and receive | ||||||
16 | cost savings from additional competition; and
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17 | WHEREAS, Significant investment is made by biotech drug | ||||||
18 | developers in intellectual property, and appropriate | ||||||
19 | intellectual property protection and the ability to recoup | ||||||
20 | their investment and make a fair profit is needed; however, as | ||||||
21 | has been proven under the Drug Price Competition and Patent | ||||||
22 | Restoration Act of 1984, competition fuels innovation; | ||||||
23 | competition from safe comparable biologics will ensure |
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1 | continued innovation in biotech drugs; it is critical to | ||||||
2 | preserve the incentives for innovation that drive the | ||||||
3 | development of new biologics, recognizing that data | ||||||
4 | exclusivity and patents work together to create the environment | ||||||
5 | to support investments in discovering new biologics in order to | ||||||
6 | keep this country's biotech innovators strong and growing; and
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7 | WHEREAS, A Citizens Petition was submitted to the FDA in | ||||||
8 | August 2006 requesting that the FDA use its statutory and | ||||||
9 | regulatory authority to issue guidelines that will facilitate | ||||||
10 | the availability of more affordable versions of insulin and | ||||||
11 | human growth hormone (HGH); and
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12 | WHEREAS, American patients currently spend approximately | ||||||
13 | $1.5 billion on insulin products to treat diabetes and | ||||||
14 | approximately $433 million on HGH, which is used to treat a | ||||||
15 | variety of conditions, including growth deficiencies in | ||||||
16 | children and adults, chronic renal insufficiency, and AIDS | ||||||
17 | wasting syndrome; and | ||||||
18 | WHEREAS, The FDA has repeatedly and publicly indicated that | ||||||
19 | guidance on the approval process for insulin and HGH would be | ||||||
20 | forthcoming; this guidance would provide generic | ||||||
21 | pharmaceutical manufacturers with the criteria for | ||||||
22 | demonstrating safety and efficiency of comparable versions of | ||||||
23 | insulin and HGH; however, it appears that issuance of |
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1 | appropriate regulatory requirements for these products has | ||||||
2 | come to a standstill resulting in our citizens and taxpayers to | ||||||
3 | continue to shoulder the burden for costs because no comparable | ||||||
4 | version of either of these products is available; insulin and | ||||||
5 | HGH have less complex biologic structures with a long history | ||||||
6 | of safe use and a wealth of data available about the innovator | ||||||
7 | versions of those products; and | ||||||
8 | WHEREAS, While such guidance unnecessarily languishes in | ||||||
9 | the United States, the European Medicines Agency (EMEA) has | ||||||
10 | adopted final guidelines on quality, non-clinical and clinical | ||||||
11 | issues regarding similar biological medicinal products in | ||||||
12 | December 2003 and a general regulatory guideline on such | ||||||
13 | products in September 2005; the EMEA also issued final | ||||||
14 | product-specific guidance documents on similar biologic | ||||||
15 | medicine products, including one for insulin, in February 2006; | ||||||
16 | and | ||||||
17 | WHEREAS, In 2004, national Medicaid expenditures for | ||||||
18 | insulin alone were approximately $500 million; insulin was | ||||||
19 | historically approved for sale in the United States under the | ||||||
20 | Federal Food Drug and Cosmetic Act; this fact should make it | ||||||
21 | eligible to generic competition under the Drug Price | ||||||
22 | Competition and Patent Restoration Act of 1984; diabetes is on | ||||||
23 | the rise, and, if current population and diagnosis rates | ||||||
24 | continue as projected, the number of people with diabetes could |
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1 | reach 17.4 million by 2020 with attendant costs rising to an | ||||||
2 | estimated $192 billion; insulin is a less complex | ||||||
3 | biopharmaceutical product and many versions are no longer | ||||||
4 | patent protected; if the FDA were to issue guidance in a timely | ||||||
5 | manner and approve a lower cost, safe, comparable form of | ||||||
6 | insulin, patients could begin realizing savings; and | ||||||
7 | WHEREAS, On average, African-Americans are 2.4 times as | ||||||
8 | likely to have diabetes as Caucasians; the highest incidence of | ||||||
9 | diabetes in African-Americans occurs between 65 and 75 years of | ||||||
10 | age; African-American women are especially affected; when | ||||||
11 | adjusted for age, African-American women are more likely to be | ||||||
12 | diagnosed with diabetes than non-Hispanic Caucasians, | ||||||
13 | African-American men, or Hispanics; African-Americans with | ||||||
14 | diabetes are more likely to experience complications of | ||||||
15 | diabetes; diabetic retinopathy, an eye disease, is 19% more | ||||||
16 | common in African-American men than Caucasian men; amputations | ||||||
17 | of lower extremities are also more common in African-Americans | ||||||
18 | with diabetes; and | ||||||
19 | WHEREAS, As of 2002, 2 million Hispanic adults age 20 years | ||||||
20 | and older and about 8.2% of the population have diabetes; | ||||||
21 | diabetes is more prevalent in older Hispanics with the highest | ||||||
22 | rates in Hispanics 65 and older; on average, Hispanics are 1.5 | ||||||
23 | times as likely to have diabetes as Caucasians; | ||||||
24 | Mexican-Americans, the largest Hispanic subgroup, are more |
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1 | than twice as likely to have diagnosed diabetes than | ||||||
2 | non-Hispanic Caucasians; in 2002, the death rate from diabetes | ||||||
3 | in Hispanics was 60% higher than the death rate of non-Hispanic | ||||||
4 | Caucasians; in 2001, Hispanics of all races experienced more | ||||||
5 | age-adjusted years of potential life lost before age 75 years | ||||||
6 | than non-Hispanic Caucasians for diabetes; and | ||||||
7 | WHEREAS, HGH is one of the most expensive prescription | ||||||
8 | regimes, costing a patient upwards of $30,000 a year; HGH has | ||||||
9 | annual sales in the United States that are estimated to be more | ||||||
10 | than $700 million; HGH costs are increasing as the number of | ||||||
11 | growth deficiency-related cases continues to rise and as the | ||||||
12 | FDA approves new uses for HGH; as usage and the subsequent | ||||||
13 | expenses increase, Illinois is paying more for a drug product | ||||||
14 | that has not been patent protected since 2003; and | ||||||
15 | WHEREAS, With the availability of safe comparable versions | ||||||
16 | of insulin, HGH, and other biologics there will be savings to | ||||||
17 | the State and its citizens; for example, if only one-third of | ||||||
18 | patients using insulin were converted to a comparable insulin | ||||||
19 | product and it was priced at a modest 10% discount, payers | ||||||
20 | would save $17 million annually; a discount of 30%, more | ||||||
21 | typical of the small molecule generic market, with only | ||||||
22 | one-third of patients utilizing the small molecule generic, | ||||||
23 | would result in savings of more than $50 million annually; if | ||||||
24 | all Medicaid patients were converted to the small molecule |
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1 | generic, at a 30% discount to current brand prices, the savings | ||||||
2 | would exceed $150 million annually; and | ||||||
3 | WHEREAS, For more than 2 decades, generic pharmaceuticals | ||||||
4 | have offered our State with a mechanism to manage the high cost | ||||||
5 | of providing prescription drugs for State-funded and federally | ||||||
6 | mandated prescription drug programs; at the same time, generic | ||||||
7 | drugs have provided all of the citizens of Illinois with the | ||||||
8 | opportunity to lower their prescription drug costs; therefore, | ||||||
9 | be it
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10 | RESOLVED, BY THE SENATE OF THE NINETY-FIFTH GENERAL | ||||||
11 | ASSEMBLY OF THE STATE OF ILLINOIS, THE HOUSE OF REPRESENTATIVES | ||||||
12 | CONCURRING HEREIN, that we urge the members of the 110th United | ||||||
13 | States Congress and the President of the United States to enact | ||||||
14 | legislation that establishes a regulatory pathway authorizing | ||||||
15 | the FDA to approve, when appropriate, abbreviated applications | ||||||
16 | for comparable biological products that are expected to produce | ||||||
17 | the same clinical results as the innovator product and are | ||||||
18 | deemed by the FDA to be safe and effective; and be it further
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19 | RESOLVED, That the FDA be authorized to approve | ||||||
20 | applications for safe comparable biologics in a manner that is | ||||||
21 | determined to be in the best interests of patients; and be it | ||||||
22 | further |
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1 | RESOLVED, That the FDA promptly promulgate guidance for the | ||||||
2 | specific approval requirements for forms of insulin and HGH; | ||||||
3 | the issuance of these guidances would open the door for | ||||||
4 | potential savings on these important therapies for consumers | ||||||
5 | across our nation; and be it further
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6 | RESOLVED, That the FDA also commit to working with drug | ||||||
7 | companies developing such products and to expediting the | ||||||
8 | process so that these products may be approved and made | ||||||
9 | available to patients as quickly as possible; and be it further | ||||||
10 | RESOLVED, That any new regulatory pathway for safe | ||||||
11 | comparable protein products contain appropriate incentives for | ||||||
12 | new biological products; and be it further | ||||||
13 | RESOLVED, That we strongly concur with those Governors who | ||||||
14 | filed the Citizens Petition or sent letters of support for the | ||||||
15 | Citizens Petition to the FDA on this issue; and be it further | ||||||
16 | RESOLVED, That we also strongly support the twenty | ||||||
17 | Governors who have sent a letter encouraging Congress to | ||||||
18 | authorize the FDA to provide a pathway for safe comparable | ||||||
19 | biologics; and be it further | ||||||
20 | RESOLVED, That we and the Governor have a responsibility | ||||||
21 | for managing the costs that the State incurs for prescription |
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1 | drugs in connection with our State Medicaid program, as well as | ||||||
2 | other State programs such as State employees and State retirees | ||||||
3 | that provide a drug benefit; we are also charged with ensuring | ||||||
4 | that high quality, affordable healthcare that provides safe and | ||||||
5 | effective care is available to all citizens of our State; and | ||||||
6 | be it further | ||||||
7 | RESOLVED, That suitable copies of this Resolution be | ||||||
8 | provided to the Commissioner of the FDA, the Speaker the United | ||||||
9 | States House of Representatives, the Minority Leader of the | ||||||
10 | United States House of Representatives, the Majority Leader of | ||||||
11 | the United States Senate, the Minority Leader of the United | ||||||
12 | States Senate, and each member of the Illinois congressional | ||||||
13 | delegation.". |