Governors, Lawmakers Seek Access to Generic Insulin
Some federal lawmakers and governors have been lobbying FDA to ease the way for the production and sale of generic insulin, which analysts say would reduce the cost of the treatment by 25%, the New York Times reports. Generic insulin could mean spending reductions for Medicaid programs -- which spent $500 million on the treatment in 2005 -- as well as for people with diabetes.
In addition, some observers say that the availability of generic insulin could ease development of other drugs in the class of biologics, which are medicines made from living organisms.
However, many scientists say duplication of such drugs could be difficult, as they are variable and could cause allergic reactions in patients.
The drug companies Novo Nordisk, Eli Lilly and Sanofi-Aventis "dominat[e]" the insulin market, the Times reports. Of the five insulin products sold in the U.S. in 2005, only Lilly's Humulin and Novo Nordisk's Novolin have lost their 20-year patent protection, while patents on other products "exten[d] into the next decade."
Generic manufacturers say the first step to creating a competitor drug would be for FDA to adopt guidelines explaining the testing and documentation required to approve a generic version of insulin.
In 2001, the agency announced it would develop guidelines for generic insulin and the human growth hormone, but those guidelines were never released, in part because of pressure from the Biotechnology Industry Organization, the Times reports. The group has said that some exemptions granted to conventional generic drugs that speed their market entry are not applicable for biologics.
FDA has said that it might be more appropriate to develop guidelines applying to all biologics rather than individual treatments. According to the Times, the agency has said it will release a scientific background paper on the issue this spring.
Sen. Orrin Hatch (R-Utah) and Rep. Henry Waxman (D-Calif.) last year said in a letter to FDA, "There is simply no excuse -- scientific, legal or otherwise -- for the FDA to delay the release of these guidelines."
Mississippi Gov. Haley Barbour (R), one of 11 governors who have asked FDA to speed approval of generic insulin, said, "To have a lower-cost solution for our very large diabetic population is in the interest of the state and the interest of these people" (Saul, New York Times, 1/11).