FDA reform prospects "very good" in 105th Congress -- House Commerce staffer Holcombe.

FDA REFORM PROSPECTS "VERY GOOD" IN 105th CONGRESS, COMMERCE's HOLCOMBE said at the National Association of Pharmaceutical Manufacturers annual meeting Jan. 31 in Naples, Fla. "The prospects are very good for making responsible, careful, thoughtful changes in the FD&C Act" during this session of Congress "and for good bipartisan cooperation," House Commerce Committee minority staffer Kay Holcombe said.

"We have successful legislative initiatives that we can use as models of the process," she said. "We have a lot of bills, a lot of legislative language that's kind of sitting out there that's left over from the last time. We need to lay [it] out on the table [and] figure what's good, what's bad, what's indifferent, and we need to bring everybody to the table and start talking about it."

Holcombe advised FDA reform advocates to "be honest: exaggeration and hyperbole and cavalier off-hand pronouncements are extremely easy to refute, and in the last two years we heard many things said about FDA which simply were not accurate....It works counter to the goals of people who are saying it."

In the 1995-96 reform debate, FDA also "fell into that trap," Holcombe declared. "They began to argue that you couldn't change anything in the law...and that's not true either."

"We need to be careful on an individual policy argument basis to be honest about whether we believe the policy is wrong, whether we believe the policy isn't being implemented, or whether we believe it's just sort of a glitch in the system that we can fix very easily or [whether it has] only happened a few times, it's not really your routine thing," Holcombe said.

"Let's try to target solutions to meet actual problems," Holcombe stressed. "We need to think strategically...about what it is that the law and the agency are intended to do...and avoid thinking about the minutiae of the day-to-day operations of the agency....We cannot legislate based on anecdotes about what every company didn't like about what somebody at FDA told them."

Holcombe also recommended that parties set reform priorities, differentiate problems that can be solved administratively from those that need legislative changes and collaborate with everyone affected by FDA, including patient and consumer advocacy groups, the regulated industries and the agency itself.

Holcombe asked NAPM to be "supportive of FDA in the appropriations process," suggesting that a change in committee membership could affect the process.

"One of FDA's great champions on the House Appropriations Committee, Dick Durbin [D-Ill.], is...now in the Senate," Holcombe pointed out. "He won't be there as the champion and defender of FDA. So FDA needs you and I hope you'll help them."