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Medicaid patients with diabetes who are dependent on insulin analogs could find relief in medication prices from an unlikely ally: their state governor. Faced with growing costs—amounting to $500 million in 2005—governors from 11 states asked Congress and federal regulators in January to allow for a generic form of insulin to stem the burden associated with the disease.
Acknowledging an epidemic of patients being diagnosed with diabetes, the governors are hoping that by establishing a procedure to allow manufacturing of generic equivalents to insulin, known as biogenerics, they can decrease some of the costs associated with diabetes borne by state Medicaid programs.
The current U.S. insulin supply comes from three companies: Novo Nordisk, Eli Lilly and Company, and Sanofi-Aventis. Any regulatory change to allow biogenerics on the market would affect two insulin analogs, Humulin (Eli Lilly) and Novolin (Novo Nordisk), because they are no longer protected with patents. Both Eli Lilly and Novo Nordisk have stated that they oppose Food and Drug Administration (FDA) action on approval of generic insulin unless the generic manufacturers conduct clinical studies.
Generic drugs represent 56% of the total prescriptions dispensed in the U.S. annually, but account for 13.1% of total dollars spent on prescription drugs, according to the Generic Pharmaceutical Association (GPhA).
BIOLOGICS REGULATED DIFFERENTLY
The governors took their argument straight to the agency responsible for regulating generic drugs: the FDA. Because insulin is derived from living material, it falls under biologic regulations that chemically created replicas of brand-name medications do not have to follow. Back in 2001, the FDA announced it would develop guidelines for approving generic insulin and human growth hormone, another widely used biologic. The agency finally approved Omnitrope (Novartis) last May, a biogeneric equivalent to Genotropin (Pfizer), but only after a judge forced the agency to make an approval decision on the product.
States Seeking Generic Insulin
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The states could see health care expenditures decrease for insulin if congressional leaders succeed in passing new legislation. Rep. Henry Waxman (D-Calif.), who heads the House Oversight and Government Reform Committee, pledged to reintroduce legislation he sponsored in the last session of Congress: the Access to Life-Saving Medicine Act. The legislation would require the FDA to establish an approval process for biogenerics by offering guidelines for manufacturers.
The Commonwealth of Virginia, in a joint resolution this legislative session, is asking the Department of Medical Assistance Services to collect data on the cost of insulin. "The FDA has repeatedly and publicly indicated that guidance on the approval process for generic insulin would be forth-coming. However, it appears that issuance of appropriate regulatory requirements for these products has come to a standstill resulting in our citizens and taxpayers to continue to shoulder the burden for excessive costs since no generic version of the product is available," reads a portion of the joint resolution.1
The chorus of voices calling for regulatory guidelines is growing. "We look forward to working with Congress as it continues to examine this issue, along with obstacles to market entry for generics. We share many of Congress's concerns about ensuring that generics reach consumers in a timely manner," says Kathleen Jaeger, president and CEO of GPhA. Jaeger testified at a January 17 Senate Judiciary Committee hearing regarding a Federal Trade Commission (FTC) study, which concludes that manufacturers of brand-name medications "substantially increased payments" to generic manufacturers to abandon plans to develop generic products from expiring patents on existing drugs. "Such settlements restrict competition at the expense of consumers, whose access to lower-priced generic drugs is delayed, sometimes for many years," said FTC Commissioner Jon Leibowitz in his testimony to the Senate committee.
FDA will issue guidelines on developing biogeneric insulin by spring,
according to officials in the Center for Biological Evaluations and Research.
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| DOC News | Diabetes | Diabetes Care | Clinical Diabetes | Diabetes Spectrum |
