States petition US FDA on generic insulin, hormone

Four governors, looking to ease drug costs under state programs, petitioned the U.S. Food and Drug Administration on Thursday to provide guidelines for generic versions of insulin and human growth hormone.

The FDA has been developing regulatory advice for companies who want to make cheaper copycat versions of the injectable drugs since 2001, but recently delayed issuing final guidelines.

In their petition, the governors joined other critics in accusing the agency of dragging its feet.

“We have been informed that there are no scientific reasons for delaying the issuance of the guidance documents FDA already has drafted,” the bipartisan group of governors wrote the FDA.

Democratic Govs. Kathleen Sebelius of Kansas and Jim Doyle of Wisconsin joined Republicans Tim Pawlenty of Minnesota and James Douglas of Vermont in signing the petition.

“There is no legal or regulatory obstacle to the immediate issuance of these guidance documents,” they added.

Both insulin, used to treat diabetics, and growth hormone, used to treat growth disorder, are protein-based drugs known as biologics.

With a growing number of diabetics in the Unites States and tightening state budgets, the governors are eager for cheaper insulin alternatives.

“The FDA’s delay in informing manufacturers of the requirements for obtaining approval of therapeutically equivalent versions of insulin and HGH has cost the states and other health-care providers hundreds of millions of dollars,” the petition said.

About 7 percent of Americans, or nearly 21 million people, have diabetes, according to the National Institutes of Health. Growth disorders are more difficult to measure. Not all those diagnosed with either condition are treated.

Many states pay for prescription drugs through the joint federal-state Medicaid program for the poor as well as special insurance programs for children.

Because insulin and growth hormone were approved decades ago as regular drugs, supporters argue the FDA has the legal authority to approve generic versions.

The issue of cheaper alternatives to other biological drugs remains in limbo. Brand name companies say biologics are too complicated to copy.

In May, the agency approved a generic version of human growth hormone made by Novartis AG’s Sandoz unit called Omnitrope but said the decision did not set any precedent for other biologics.

The FDA did not have immediate comment on the petition.

The Generic Pharmaceutical Association supported the governors’ move as a way to force the FDA’s hand. The Biotechnology Industry Organization, which represents brand name makers, did not have immediate comment.