Full Text of SJR0048 95th General Assembly
SJ0048 95TH GENERAL ASSEMBLY
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| SENATE JOINT RESOLUTION
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| 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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| 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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| 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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| 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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| 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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| 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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| and
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| 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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| 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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| 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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| 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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| RESOLVED, BY THE SENATE OF THE NINETY-FIFTH GENERAL |
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| 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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| 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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| 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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| 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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