WASHINGTON — Congress passed Food and Drug Administration reform legislation last week that dramatically shortens the time it takes to review new food packaging, but the measure still lacks one key component: money.
The plan — described by one lobbyist as the most significant overhaul of food packaging laws since 1957 — was stripped of user fees by House Commerce Committee Chairman Thomas Bliley, R-Va., and now must find money elsewhere before it can be enacted.
Legislators who crafted the compromise endorsed giving the FDA $1.5 million in 1999 to put it into place, and several industry observers hope the House and Senate Appropriations Committees will go along.
``We not only expect it to happen, but we are going to work diligently to see that it does happen,'' said Jerry Heckman, general counsel for the Society of the Plastics Industry Inc. in Washington. ``We consider this a major breakthrough.''
The packaging plan is a small part of the much larger FDA reform bill, which President Clinton is expected to sign.
The plan would let companies market new packaging materials, ranging from water bottles to plastic wrap, 120 days after asking the FDA, unless the agency objects. A normal review now takes two to four years, Heckman said.
``What we need to do is demonstrate our resolve to work with the FDA and the Congress to get the necessary funding,'' said Peter Molinaro, assistant director of government relations with Danbury, Conn.-based Union Carbide Corp.
The endorsement of key legislators who wrote the FDA bill will make it easier to get money, but the provision clearly must compete with other programs for funding, Molinaro said.
The delicately crafted plan, known as pre-market notification, had the support of the FDA because it contained fees, he said. The packaging industry, including SPI, supported fees to get FDA approval. FDA officials could not be reached to comment on the current version.
The provision calls for giving the FDA $1.5 million in 1999 and $3 million a year until 2003, when the program must be reauthorized. Industry officials wanted the program to be permanent, but recommended the reauthorization as a way to placate Bliley, who officials said supported the concept but not the user fees.
Assuming the money is allocated, the new regulations would take effect April 1, 1999.
The user fees had been opposed by groups such as the Grocery Manufacturers Association, which argued they were a hidden tax.
The packaging plan was a small part of a mammoth FDA overhaul, which included expanding a program for third-party approval of medical devices. More low-risk devices have been added to the third-party process, which allows companies to pay a private testing lab to review a device.
Some Senate Democrats had delayed the bill, in part over concerns about expanding such medical-device review programs, but the final version was praised by the Washington-based Medical Device Manufacturers Association because it said it will quicken device approval.
``This is by far the single-largest legislative victory the medical-device industry has ever achieved,'' said Jeffrey Kimbell, MDMA executive director.
