FDA, SPI WORK ON LESSENING RESTRICTIONS

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WASHINGTON — The Food and Drug Administration has proposed a restructuring of its medical device review process that is aimed at getting devices to market more quickly, as Congress prepares to unveil its own reforms next month.

While the medical device plan has drawn some praise from industry, food safety proposals — the other leg of FDA reform that affect plastics — look less clear.

The Society of the Plastics Industry Inc. in Washington and the FDA remain hopeful they can steer their joint plan to loosen restrictions on food packaging through Congress, but industry observers suggest that other aspects of food safety revamping, such as rewriting the Delaney Clause, may face a bumpier path.

FDA's medical device restructuring plan is a good sign, said James Benson, executive vice president for technology and regulatory affairs at the Health Industry Manufacturers Association.

FDA's tentative plan, proposed last month by its Center for Devices and Radiological Health, would shift agency resources to reviewing high-risk devices and try to quicken approval of low-risk devices, with steps such as allowing third-party review and exempting lower-risk devices from review.

FDA has not specified how much money will be shifted to high-risk devices or when it will have more details on the plan.

CDRH spokeswoman Marcia Meyer said, ``This is a real effort. Things will come out of this.''

It is difficult to tell if the FDA plan will quicken device approval, said Jeffrey Kimbell, executive director of the Medical Device Manufacturers Association. Progress has been made in low-risk devices, but the biggest backlogs are in new devices requiring pre-market approvals, where average approval time is 780 days, four times the 180 days set by Congress.

Benson said the internal reform may be less-effective if the agency's budget is cut, as the administration has proposed. The agency has proposed user fees to make up for budget cuts, but industry lobbyists have resisted such fees, arguing that device companies are small and would find fees prohibitive.

Largely bipartisan congressional proposals on FDA reform are expected in early May, Kimbell said.

Lawyer Jerome Heckman, SPI general counsel, said he and the FDA still are looking for a way to get Congress to pass its agreement allowing companies that make food packaging additives to market their products within 120 days of notifying the agency, rather than seeking FDA approval.

Because FDA currently supports it, the measure should not be controversial, he said.

Other aspects of food safety reform faced some questions on Capitol Hill at a hearing April 11.

Sen. Barbara Mikulski, D-Md., said Congress may need more time on food safety issues and should not be guided by ``cliches'' offered by either side on issues like the Delaney Clause, a provision that establishes a ``zero-risk'' threshold for carcinogens in food packaging and other areas. An industry official, speaking anonymously, said much of the food safety reform agenda may get stalled because it does not have much support outside the food industry.