Legislators in Congress have introduced
legislation (H.R. 1038, the "Access to Life-Saving Medicine Act of 2007") that would give the Food and Drug Administration (FDA) express legal authority to approve cheaper, generic versions of biotech drugs known as biologics, which include generic forms of human insulin.
Vaccines and most biotech drugs are governed under the Public Health Services Act, which would indeed have to be amended to allow for generics, but because insulin and human growth hormone were already on the market when the Drug Price Competition and Patent Term Restoration Act (better known as the "Hatch-Waxman" Act) was signed into law, therefore the law considers them "drugs" which are governed by the Federal Food, Drug & Cosmetic Act, therefore generics are already legally permitted. Furthermore, the patents for Eli Lilly & Company's Humulin insulin products expired in 2001, and Novo Nordisk's Novolin insulin products expired in 2002, so patent protection is not at issue. (Insulin analogs, however, enjoy continued patent protection until at least 2014) However, the FDA has refused to outline a procedure for generic manufacturers to obtain approvals from the agency, making it difficult to proceed even if generic manufacturers wanted to.
Its no secret generic pharmaceuticals usually cost significantly less than the branded versions of drugs, and the cost savings to patients and their healthcare providers has been enormous. According to figures released by the U.S. FDA, once a second generic version of a drug hits the market, the cost of a drug usually sells for about half the original's price and multiple copies often cost 80% less. Express Scripts Inc., the No. 3 U.S. ******** benefit manager, estimated that the potential savings from generics in 2006 alone would total nearly $24.7 billion. According to a recent
study undertaken by Express Scripts, some estimates of the potential savings generated by the pending bill now in Congress (H.R. 1038, the "Access to Life-Saving Medicine Act of 2007") on prescription insulin has been computed. Although the relative savings for generic insulin is comparatively small relative to other biologic medicines, it is still noteworthy at $797 million in the first year, and totaling in excess of $16 billion over 10 years.
Ultimately, the cost of regulatory inaction on this issue will be borne by patients with diabetes. Approximately 45 million people in the U.S. – 17% of the working-age population – are not covered by health care insurance. Given that roughly 6% of people in the U.S. have diabetes, of the approximately 45 million people with no healthcare cover, we can conservatively estimate that approximately 3 million people with diabetes in the U.S. lack healthcare insurance, and their prognosis isn’t good. Analysis of a study done in 2002 revealed that when compared to people who had health insurance, people without any form of health insurance received fewer preventive diabetes care interventions and showed generally less-desirable diabetes outcomes. Specifically, a higher percentage of uninsured people had HbA1c levels of 9% or higher; fewer had an annual blood lipid test and/or annual foot exam. Its hard to imagine, but on average, fully one-fourth (25%) of people with diabetes go without a checkup for two years if they have been without health insurance for a year or more vs. only 5% of diabetes patients with insurance. Obviously, the cost of prescription medicines, including insulin, is especially difficult for this segment of the population to pay out-of-pocket. For example, based on IMS Health data, excluding the effect of rebates, the typical cash customer pays nearly 15% more for the same medicines than do customers with third-party coverage. For a quarter of the most common drugs, the price difference between cash and third parties is even higher – over 20%.
I would urge everyone to write to their Congressional representatives and ask them to support this legislation. If you would like more details on this subject and specifically how it pertains to insulin, please see a detailed report I did on this subject back in January 2007 here.
Pending Legislation Would Permit FDA to Approve Generic Insulin 
Linear Mode
