FDA reform should be among first issues considered in 1997, Rep. Barton says.

FDA REFORM MARKUP IN COMMERCE COMMITTEE STILL LONG-SHOT POSSIBILITY before Congress adjourns at the end of September, Rep. Joe Barton (R-Tex.) said Sept. 16 at the National Electrical Manufacturers Association's Diagnostic Imaging and Therapy Systems Division annual meeting in Seattle. "I'm going to try at least one time" before the current session is over "to get [Commerce Committee] Chairman [Thomas] Bliley [R-Va.] to mark up" the medical device (HR 3201), drug (HR 3199) and food reform (HR 3200) bills, Barton said.

The Commerce/oversight subcommittee chairman added that the late-term mark-up is unlikely, however, estimating the odds at "one in five."

Acknowledging that FDA reform has no chance of passing in the final days of the current congressional session, Barton said: "We don't have the time to go to conference [with the Senate] and all of that...but it would still be an accomplishment if we could get a strong vote in committee on a bipartisan basis, which would make it much easier to move the bill early in the next Congress."

Despite the failure of FDA reform in the 104th Congress, Barton continues to predict passage of a consolidated bill early in the next session of Congress. "There's no reason we couldn't [re-introduce] this bill in early January, do hearings on it, do final negotiations, move it in the April-May time period, go to conference with the Senate and have a bill on the President's desk...before the July Fourth break," he said. "That's my plan to try to expedite this bill in the 105th Congress."

Barton asserted that the Commerce Committee, whether marking up the legislation this session or next, should consider either the original FDA reform bills introduced in March or revised versions unveiled in July. Barton said he would not support consideration of an Aug. 2 staff-level "working draft" of medical device reform legislation negotiated with the Clinton Administration during the summer recess.

"I'm all for compromise to make [the legislation] better," the Texas lawmaker said. "I'm all for compromise to make it realistic and acceptable. But I'm not for compromising on something just so we can have a bill that the President can sign."

Barton gave several reasons for the failure of FDA reform to make it through Congress, including: the relatively low priority of the issue in Congress; the "newness" of the issue for the American public; and the distraction caused by FDA's regulations on cigarettes and smokeless tobacco.

Barton added that Commerce/health subcommittee Ranking Minority member Henry Waxman (D-Calif.) was instrumental in slowing FDA reform legislation this session. Calling the California Democrat "as smart a guy [and] as dedicated a guy as there is in this Congress," Barton said: "I don't think Henry Waxman wanted FDA reform or at least he didn't want FDA reform like we structured it."

Alluding in part to FDA Deputy Commissioner for Policy William Schultz, who served on the staff of the Commerce/health subcommittee when it was chaired by Waxman, Barton added that "many of the people that we had to negotiate with at the FDA are former [Waxman] staff members...And I think that was a real constraint."

"I believe Congressman Waxman would accept some kind of FDA reform," he continued. "I don't think he's in the camp that says it doesn't need to be reformed at all." However, Republicans "will have to work to convince" Waxman to accept a third-party review provision, Barton said.

Barton conceded that retiring Senate Labor Committee Chair Nancy Kassebaum's (R-Kan.) absence in the 105th Congress is "going to hurt" the overall FDA reform effort. "We're going to miss Nancy Kassebaum because she had credibility on both sides of the aisle, she had studied the issue and she was a very good coalition builder," he said.

Asked to compare Labor Committee Ranking Minority Member Edward Kennedy's (D-Mass.) role in derailing FDA reform in the Senate to that of Waxman in the House, Barton said Kennedy is "less encouraging, that's for sure." However, he added: "I'm very confident that we...can work with Sen. Kennedy...when the time comes."