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As the vote on FDA reform bill draws near, a look at how Kennedy altered the legislation.

The recent Senate debate over reforming the Food and Drug Administration illustrates again why many say Sen. Edward Kennedy (D) of Massachusetts is one of the most effective legislators on Capitol Hill.

When the Democrats have held the Senate majority, Senator Kennedy has moved major pieces of legislation as a committee chairman. When Republicans have held power, he has found GOP allies or filibustered when necessary to force changes in bills on the Senate floor.

Kennedy's key to success? "He does it with a lot of preparation and persistence," says Sen. Joseph Lieberman (D) of Connecticut. "He studies the subject, learns it well.... He's prepared to negotiate. He's not unyielding. That's why he's successful in achieving so many of his goals."

Congress has been struggling for three years to reform the FDA, which regulates about one-third of all products on the market. But pressure to pass a bill this fall became overwhelming when the Prescription Drug-User Fee Act (PDUFA), which charges pharmaceutical companies fees that help fund the FDA, expired Oct. 1.

Reformers set out to lessen the amount of time it takes the agency to approve new prescription drugs and medical devices, bolster federal versus state authority over cosmetics, and increase patients' access to experimental drugs and treatment.

Kennedy's list

Kennedy had 20 objections to the bill as it emerged from committee. By the time it reached the first Senate floor vote, he and a small band of allies had got changes on all but two. One provision he opposed would have given the FDA authority to regulate cosmetics, superceding state regulation. He argued the FDA doesn't have the resources to regulate cosmetics and that, in effect, the bill would reduce oversight of the industry. The other provision would have limited the FDA's ability to review a medical device for purposes it was not designed and approved for.

Kennedy marched to the Senate floor with posters displaying graphic photos of victims of flawed cosmetics and unapproved medical devices. He spoke for hours, cleverly using the Senate rules to force a series of procedural votes that brought the already slow Senate to a crawl.

One of the Senate's best orators when he gets fired up, the senior senator from Massachusetts employed the rhetoric he is famous for. "To listen to some of the speeches we have heard on the floor during the course of this debate, you would think that the [FDA] was a regulatory dinosaur, mired in the past, cumbersome and bureaucratic, imposing unnecessary and costly regulatory burdens on industry," Kennedy thundered on the floor one day.

"That is a myth that those who want to destroy the FDA in the service of an extreme ideological agenda or in the interest of higher profits at the expense of patient health would have you believe," he said.

The tactics exasperated the bill's supporters. "No one on the committee is attempting to undermine the ... Food and Drug Administration," said Sen. Daniel Coats (R) of Indiana. "We have been open to negotiation. But every time we have met an objection, something new pops up."

Kennedy and others argued the agency must be able to protect the public against unapproved uses of medical devices, something he charged manufacturers sometimes promote.

De facto filibuster

While reform advocates easily had the votes to defeat Kennedy at each step, the bill would have taken weeks to pass unless he stopped his de facto filibuster. In the end, the two sides struck a compromise: States would keep their authority to regulate cosmetics unless the FDA had issued regulations - something it rarely does for cosmetics.

The bill finally passed the Senate 98 to 2, with Kennedy voting no. But he got even closer to what he wanted when the House worked out a compromise that, while not requiring testing of devices for alternative uses, allows the FDA to broaden testing if it finds "a reasonable likelihood" that the device would be used for a purpose that could cause harm.

House and Senate conferees are now negotiating a bill that extends the PDUFA program and sets up a "fast track" approval process for drugs and treatments used in life-threatening situations. It expands an FDA program that lets third parties review medical devices similar to those already on the market; and it allows manufacturers to put on their labels claims from federal scientific agencies other than FDA unless the FDA objects. The bill is expected to clear Congress soon and get presidential approval. In the end, Kennedy went 20 for 20.

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