Observers are recommending that Congress launch a clean-up of the Food and Drug Administration before confirming a new administrator. The agency, they say is nearly in ethical ruins.

Here is one case they cite as an example:

• Summit Technology Inc., a Massachusetts-based manufacturer of devicesused in laser eye surgery, collected nearly $500,000 in campaign contributions for Senator Edward Kennedy (D-Mass.), who later pressured the FDA to approve Summit's application for its laser surgery device.

• An FDA memo dated January 1, 1995 shows that the FDA helped Summit and Sen. Kennedy by promising that it would not seek criminal charges against the company for selling the product before FDA approval was granted.

• The memo also asserted that Summit would eventually get the FDA's approval.

Meanwhile the FDA continues to delay processing the applications for approval of other manufacturers' medical devices, say some analysts, showing that favoritism is at work.

Source: Robert Goldberg (American Enterprise Institute), "The Ethical Mess at the FDA," Wall Street Journal, January 16, 1997.

For Robert M. Goldberg's NCPA brief analysis on the FDA http://www.ncpa.org/ba/ba214.html