Senator Blunt (R-MO) specifically asked Commissioner Hamburg about the speed of drug approvals and the idea of imposing user fees for the first time on generic drug companies. The administration proposed adding $40 million in user fees for generic companies in its fiscal 2012 budget.
After the hearing, a reporter asked Hamburg for an update on the agency’s work in creating a new approval process for follow-on biologics that are similar to biologics already on the market. Biologics are treatments and vaccines made with live organisms.
Hamburg said agency action will happen “soon.””There are some real scientific challenges here but it’s a high priority for us to get this program up and going,” she said. “We know there are a lot of people waiting to be able to get access and a lot of products going off patent, too.”
Hamburg said that with generic versions of chemical drugs, the FDA starts the review process and does a tentative approval while the patent is still in place on the original drug. Then it fully approves a drug when the patent expires. She said she would “imagine there’ll be a mechanism similar to that but we’re still in the process of shaping” the procedures for the biologic drugs.
She added that companies are already starting to formally discuss potential applications with the agency.
“We’re talking to a lot of people already, getting a sense of what’s out there,” she said.
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