Linda Kahan, Former FDA Executive, Dies at 64

A 1968 graduate of Vassar College who obtained her law degree from Georgetown University in 1985, Kahan joined FDA’s Office of Chief Counsel in 1989 after obtaining two master’s degrees in history from Columbia University, the Post reported. In OCC, she oversaw medical device cases and helped draft FDA’s mammography regulations.

In 1999, she was promoted to CDRH deputy director, and that year became an early advocate of device user fees. In an FDA presentation touting their implementation, she said they would provide “more rapid generation of income for companies” as well as quicker access to devices for patients. After reviewing reasons why industry had opposed user fees in the past, Kahan said the Center had streamlined and reengineered, leading to an improvement in review times and elimination of 510(k) backlogs. But, she wrote, an increasingly complex workload had exceeded allocated resources and it no longer was possible to shift additional resources without undermining other public health responsibilities.

Positioning the Clinton administration’s legislative proposal for device user fees, Kahan said the FDA Review Fee Act of 1999 would allow imposition of fees relating to medical devices, including $40,000 for a PMA, $4500 for a PMA supplement, and $1000 for a periodic PMA report. There would be no fee for a 510(k) application, her presentation said.

Since then, the fees have been enacted and currently stand at well over four times those amounts. In addition, 510(k) submissions have become subject to user fees of between $2359 and $4717.