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FDA pressed to 'repackage' 120-day approval program

Congress appears likely to provide at least part of the $6 million needed to get a new 120-day notification program off the ground by Oct. 1. But many manufacturers are concerned with how the FDA will administer the program.

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The 120-day notification option will help companies that want to use new packaging materials that are regarded as safe. Typically, suppliers submit a formal petition to the FDA containing reams of data on the materials that are used in the new package. It usually takes FDA a couple of years to evaluate the petition. But sometimes it's much longer, and those delays seriously affect both the packaging supplier and the manufacturer that wants to use the package.

The 120-day notification for packaging that employs safe materials would allow a company to use the new packaging 120 days after the supplier notifies FDA--unless the agency yells "stop!"

The Oct. 1 start-up date could be delayed, however, if Congress declines to provide a bare-bones $3 million in funding. It is already clear that Congress will not act this year on user-fee legislation, which would have raised the $6 million via payments assessed on packaging and chemical companies that submit 120-day notifications. For a number of reasons, both the industry and the FDA would prefer to fund the program through user fees, if an equitable fee structure can be worked out.

The sidetracking of user-fee legislation means Congress will have to appropriate $3 million for the FDA. The FDA Modernization Act (FDAMA), which authorized the 120-day program, said it could start with a budget of $3 million. But the FDA has said it needs $6 million to do a good job.

The Senate is expected to put $6 million for the indirect additives program in the FDA budget for fiscal 2000 (starts Oct. 1, 1999). But the House put zero in its FDA appropriations bill. So there will be a lot riding on the negotiations of the House-Senate conference committee on the FDA's fiscal 2000 appropriation.

Lew Freeman, vice president of government affairs for the Society of the Plastics Industry, says there is no telling whether the House will ultimately accept the $6 million figure approved by the Senate. But at a minimum, the Senate and House can be expected to split the difference; so at least $3 million would seem to be certain.

Mitchell Cheeseman, the FDA official in charge of getting the 120-day notification program off the ground, says it could start if Congress appropriates only $3 million. Because the FDA has not issued even a proposed rule, much less a final rule, setting the parameters of the program, Cheeseman says there will be guidance documents published prior to Oct. 1.

The shape of these guidance documents is also the subject of negotiation, but the back and forth is between FDA officials and members of industry. At a meeting March 12, FDA officials previewed what data they expected to receive from companies using the "fast track" notification system.

A number of prospective requirements proved controversial, though none of them were objectionable enough to cause the industry reps to pull out hairs. "None of the draft provisions are deal killers," says Ralph Simmons, who represents the SPI and packaging and resin suppliers via the law firm of Keller & Heckman.

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