Drug company pushes to change regulatory barrier blocking generic insulin production

WASHINGTON — A pharmaceutical company said regulatory barriers are standing in the way of it developing a generic form of insulin.

Insulin prices have jumped 700 percent over the last decade leaving many people unable to afford the life-saving medicine.

"There are more and more stories of patients rationing their insulin,” Senior Vice President for AmbioPharm Inc. Robert Geiger said.

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He said the company is prepared to make a generic option of insulin to offer a cheaper alternative for patients.

“We have the technology ready to go” Geiger said. “We’ve scaled it up. We have the capacity and we could launch within two years a generic insulin product.”

But under the current FDA regulation, that’s not an option.

There will be a cheaper option of insulin that could be developed starting March 23 known as a biosimilar under the current regulation.

That’s not the same as a generic option and that difference is at the center of the push to change the regulation.

A bio-similar is highly similar to the name brand insulin and the FDA said it has the same effect on the body.

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A generic option has the exact same active ingredient.

“People say well why would that be important?,” Rep. Mike Kelly (R-Pennsylvania) said. “Well here’s why. A generic substitute is an exact replica of insulin.”

Kelly proposed legislation to make changes that would allow generic insulin.

It’s now pending in Congress.

“We’re not letting up on it,” Kelly said. “We have a lot of help out there. We’ve been briefing other staff members in the Congress, all the different committees that have jurisdiction.”

“The clock is running out,” Geiger said. “We have less than two months and we’re working on Capitol Hill to try to a pathway open.”

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