HIMA Proposals For FDA Operations

Congress has been told by the US Health Industry Manufacturers Association that the Food and Drug Administration's mission should include assuring that Americans have prompt access to new technology, as well as the removal of unsafe medical devices from the market. The 700-member group urged that FDA reform be carried out by a combination of legislation, funding and oversight.

A report sent by the group to Congress said the reforms should force the agency to take quicker action in approving new devices, noting that applications for breakthrough technologies had decreased by 52% but the FDA's review time had increased by 250%. The associations plans to submit additional reports to Congress on other health care technology industry concerns, including product liability laws.

Review times for products similar to the 50,000-60,000 approved and already on the market have more than doubled since 1989, according to HIMA president Alan Magazine. Noting that FDA slowness was driving American manufacturers to Europe, where review time is faster, he proposed that the agency use government-accredited third-party private sector groups to review and approve new products.