WASHINGTON — A streamlined process for getting Food and Drug Administration approval for new packaging is getting some funding from Congress, but apparently not as much as needed.
Congress is still writing its budgets for the next fiscal year, which begins Oct. 1, and both the House and the Senate appropriations subcommittees took the first steps in meetings June 9-11 to earmark funds for the pre-market notification program.
A House appropriations subcommittee has included $500,000 to begin development, about one-third of what was estimated to be needed in FDA restructuring legislation that passed in 1997, according to officials with the Washington-based Society of the Plastics Industry Inc.
The Senate has language encouraging FDA to pursue the program, SPI said.
Plastics industry officials caution that it is still early in the Congressional budget-writing process.
Advocates of the PMN program say it will cut approval time from several years to 120 days, unless the FDA formally objects to a new material.
The program was to be funded by user fees, but they were stripped out last year by House Commerce Committee Chairman Thomas Bliley, R-Va., forcing the fight in the appropriations committees.