APPROVAL PATHWAY FOR BIOLOGICS UNLIKELY UNTIL 2008

Any legislative fix to the current FDA approval process for follow-on biologics is likely at least two years away because of other legislative priorities and the need for lawmakers to get up to speed on this issue, a Senate staffer says.

"I would look to 2008" for legislative proposals amending the Food, Drug and Cosmetic Act (FDCA) to ease approval of follow-on biologics, the staffer, who asked not to be named, told FDAnews. While lawmakers such as Senate Health, Education, Labor and Pensions Chairman Mike Enzi (R-Wyo.), ranking member Sen. Edward Kennedy (D-Mass.) and Sen. Orrin Hatch (R-Utah) support a change, there are a number of obstacles.

First, lawmakers are still formulating their positions on the issue, the source said. There are technical, scientific, legal and regulatory questions that need to be answered first, including when and how these products should be approved. "You don't build a house without a foundation," the source said. "Right now we don't have a foundation."

To develop this knowledge, lawmakers will need to have hearings, briefings and formal discussions with stakeholders. "We have to start an educational process," the source said, which could begin as soon as the fall.

Beyond the need to better acclimate themselves with the issue, other constraints will prevent legislative action before 2008, the source added. A bill in 2006 is unlikely because it is getting too close to the midterm elections for a new bill to make it through the legislative process. "I will say there will be no action this year," the source said.

Next year is also not realistic because of other competing legislative priorities. In 2007 Congress will have to reauthorize both the Prescription Drug User Fee Act and the Medical Device User Fee and Modernization Act. These bills are two of the top healthcare priorities for Congress, the source said. "They are absolutely must-do items. That's going to drive the schedule" next year. (http://www.fdanews.com/did/5_123/)