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AMENDMENT TO SENATE JOINT RESOLUTION 48

2     AMENDMENT NO. ___. Amend Senate Joint Resolution 48 by
3 replacing everything after the heading with the following:
 
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 follow-on biologic drugs and
13 generic versions of innovator biologic products; and
 
14     WHEREAS, Biologics are a major driver of increasing
15 prescription drug costs; for the first time, 5 of the 20
16 top-selling drugs in 2005 were made by biotech companies;

 

 

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1 additional competition for biotech pharmaceuticals has the
2 potential to offer consumers real savings, while also lowering
3 America's healthcare bill; and
 
4     WHEREAS, Illinois spends nearly $200 million for 61
5 biologics under its Medicaid pharmacy benefits and Part D wrap
6 around programs and an estimated 12% of its drug benefits on
7 biologics for State employees and retirees; and
 
8     WHEREAS, The science to create some follow-on biotech drugs
9 exists today and will exist in the future for others; raw
10 materials are available today for many follow-on protein
11 products including insulin, GCSF, epoetin, interferons, and
12 others; in many countries around the world, competitive biotech
13 products are already available to consumers; in these
14 countries, patients have access to safe follow-on biological
15 products and receive significant cost savings from additional
16 competition; and
 
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 follow-on 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 and to support investments in
4 discovering new biologics in order to keep this country's
5 biotech innovators strong and growing; and
 
6     WHEREAS, A Citizens Petition was submitted to the FDA in
7 August 2006 requesting that the FDA use its statutory and
8 regulatory authority to issue guidelines that will facilitate
9 the availability of more affordable versions of insulin and
10 human growth hormone (HGH); and
 
11     WHEREAS, American patients currently spend approximately
12 $1.5 billion on insulin products to treat diabetes and
13 approximately $433 million on HGH, which is used to treat a
14 variety of conditions, including growth deficiencies in
15 children and adults, chronic renal insufficiency, and AIDS
16 wasting syndrome; and
 
17     WHEREAS, The FDA has repeatedly and publicly indicated that
18 guidance on the approval process for insulin and HGH would be
19 forthcoming; this guidance would provide generic
20 pharmaceutical manufacturers with the criteria for
21 demonstrating safety and efficiency of comparable versions of
22 insulin and HGH; however, it appears that issuance of
23 appropriate regulatory requirements for these products has

 

 

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1 come to a standstill resulting in our citizens and taxpayers to
2 continue to shoulder the burden for costs because no comparable
3 version of either of these products is available; insulin and
4 HGH have less complex biologic structures with a long history
5 of safe use and a wealth of data available about the innovator
6 versions of those products; and
 
7     WHEREAS, While such guidance unnecessarily languishes in
8 the United States, the European Medicines Agency (EMEA) has
9 adopted final guidelines on quality, non-clinical and clinical
10 issues regarding similar biological medicinal products in
11 December 2003 and a general regulatory guideline on such
12 products in September 2005; the EMEA also issued final
13 product-specific guidance documents on similar biologic
14 medicine products, including one for insulin, in February 2006;
15 and
 
16     WHEREAS, In 2004, national Medicaid expenditures for
17 insulin alone were approximately $500 million; insulin was
18 historically approved for sale in the United States under the
19 Federal Food Drug and Cosmetic Act; this fact should make it
20 eligible to generic competition under the Drug Price
21 Competition and Patent Restoration Act of 1984; diabetes is on
22 the rise, and, if current population and diagnosis rates
23 continue as projected, the number of people with diabetes could
24 reach 17.4 million by 2020 with attendant costs rising to an

 

 

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1 estimated $192 billion; insulin is a less complex
2 biopharmaceutical product and many versions are no longer
3 patent protected; if the FDA were to issue guidance in a timely
4 manner and approve a lower cost, safe, comparable form of
5 insulin, patients could begin realizing savings; and
 
6     WHEREAS, On average, African-Americans are 2.4 times as
7 likely to have diabetes as Caucasians; the highest incidence of
8 diabetes in African-Americans occurs between 65 and 75 years of
9 age; African-American women are especially affected; when
10 adjusted for age, African-American women are more likely to be
11 diagnosed with diabetes than non-Hispanic Caucasians,
12 African-American men, or Hispanics; African-Americans with
13 diabetes are more likely to experience complications of
14 diabetes; diabetic retinopathy, an eye disease, is 19% more
15 common in African-American men than Caucasian men; amputations
16 of lower extremities are also more common in African-Americans
17 with diabetes; and
 
18     WHEREAS, As of 2002, 2 million Hispanic adults age 20 years
19 and older and about 8.2% of the population have diabetes;
20 diabetes is more prevalent in older Hispanics with the highest
21 rates in Hispanics 65 and older; on average, Hispanics are 1.5
22 times as likely to have diabetes as Caucasians;
23 Mexican-Americans, the largest Hispanic subgroup, are more
24 than twice as likely to have diagnosed diabetes than

 

 

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1 non-Hispanic Caucasians; in 2002, the death rate from diabetes
2 in Hispanics was 60% higher than the death rate of non-Hispanic
3 Caucasians; in 2001, Hispanics of all races experienced more
4 age-adjusted years of potential life lost before age 75 years
5 than non-Hispanic Caucasians for diabetes; and
 
6     WHEREAS, HGH is one of the most expensive prescription
7 regimes, costing a patient upwards of $30,000 a year; HGH has
8 annual sales in the United States that are estimated to be more
9 than $700 million; HGH costs are increasing as the number of
10 growth deficiency-related cases continues to rise and as the
11 FDA approves new uses for HGH; as usage and the subsequent
12 expenses increase, Illinois is paying more for a drug product
13 that has not been patent protected since 2003; and
 
14     WHEREAS, With the availability of safe comparable versions
15 of insulin, HGH, and other follow-on biologics there will be
16 savings to the State and its citizens; for example, if only
17 one-third of patients using insulin were converted to a
18 comparable insulin product and it was priced at a modest 10%
19 discount, payers would save $17 million annually; a discount of
20 30%, more typical of the small molecule generic market, with
21 only one-third of patients utilizing the small molecule
22 generic, would result in savings of more than $50 million
23 annually; if all Medicaid patients were converted to the small
24 molecule generic, at a 30% discount to current brand prices,

 

 

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1 the savings would exceed $150 million annually; and
 
2     WHEREAS, For more than 2 decades, generic pharmaceuticals
3 have offered our State with a mechanism to manage the high cost
4 of providing prescription drugs for State-funded and federally
5 mandated prescription drug programs; at the same time, generic
6 drugs have provided all of the citizens of Illinois with the
7 opportunity to lower their prescription drug costs; therefore,
8 be it
 
9     RESOLVED, BY THE SENATE OF THE NINETY-FIFTH GENERAL
10 ASSEMBLY OF THE STATE OF ILLINOIS, THE HOUSE OF REPRESENTATIVES
11 CONCURRING HEREIN, that we urge the members of the 110th United
12 States Congress and the President of the United States to enact
13 legislation that establishes a regulatory pathway authorizing
14 the FDA to approve, when appropriate, abbreviated applications
15 for follow-on biological products that the FDA deems are
16 interchangeable if it has been demonstrated that the product is
17 therapeutically equivalent; and be it further
 
18     RESOLVED, That the FDA be authorized to approve
19 applications for safe follow-on biologics in a manner that is
20 determined to be in the best interests of patients; and be it
21 further
 
22     RESOLVED, That the FDA promptly promulgate guidance for the

 

 

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1 specific approval requirements for forms of insulin and HGH;
2 the issuance of these guidances would open the door for
3 potential savings on these important therapies for consumers
4 across our nation; and be it further
 
5     RESOLVED, That the FDA also commit to working with drug
6 companies developing such products and to expediting the
7 process so that these products may be approved and made
8 available to patients as quickly as possible; and be it further
 
9     RESOLVED, That Congress should determine in light of
10 current patents and patent extensions whether any additional
11 exclusivity is appropriate; any additional patent time or data
12 exclusivity should be sufficient to create an incentive for the
13 development of innovator biologics, but not greater than
14 necessary so that patient, states, and other payers can reap
15 the savings from follow-on and biogeneric products; and be it
16 further
 
17     RESOLVED, That we strongly concur with those Governors who
18 filed the Citizens Petition or sent letters of support for the
19 Citizens Petition to the FDA on this issue; and be it further
 
20     RESOLVED, That we also strongly support the twenty
21 Governors who have sent a letter encouraging Congress to
22 authorize the FDA to provide a pathway for safe follow-on

 

 

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1 biologics; and be it further
 
2     RESOLVED, That we and the Governor have a responsibility
3 for managing the costs that the State incurs for prescription
4 drugs in connection with our State Medicaid program, as well as
5 other State programs such as State employees and State retirees
6 that provide a drug benefit; we are also charged with ensuring
7 that high quality, affordable healthcare that provides safe and
8 effective care is available to all citizens of our State; and
9 be it further
 
10     RESOLVED, That suitable copies of this Resolution be
11 provided to the Commissioner of the FDA, the Speaker the United
12 States House of Representatives, the Minority Leader of the
13 United States House of Representatives, the Majority Leader of
14 the United States Senate, the Minority Leader of the United
15 States Senate, and each member of the Illinois congressional
16 delegation.".