HOUSE GOVERNMENT REFORM COMMITTEE COULD TAKE INCREASED INTEREST IN FDA UNDER BURTON AND WAXMAN; COMMERCE MEMBER McCARTHY IS EX-MARION CONSULTANT

The new chairman of the House Government Reform & Oversight Committee, Indiana Republican Dan Burton, is a co-sponsor of FDA reform legislation and critic of FDA's MedGuide regulation.

Burton is replacing Rep. Clinger (R-Penn.), who is retiring. Burton's suburban Indianapolis district suggests that he will be receptive to the interests of Lilly, which is a major employer in the region. He was first elected to Congress in 1982 and has served previously as chairman of the International Relations/Western Hemisphere Subcommittee.

Rep. Waxman (D-Calif.) will be the new ranking Democrat on the Government Reform Committee. Waxman's long-standing interest in FDA issues and support for the agency's regulatory mission could balance Burton's pharmaceutical industry constituency. The presence of both congressmen could herald greater activity by the Government Reform Committee on FDA issues.

Waxman is succeeding retiring Rep. Collins (D-Ill.). Waxman has long been one of FDA's strongest allies in the House as chairman and then ranking Democrat on the Commerce/Health Subcommittee. Under House rules, Waxman will relinquish his ranking position on the Health Subcommittee; he will continue to serve as a member of the full Commerce Committee.

If FDA issues do arise in the Government Reform Committee, moderate Republican Rep. Morella (Md.) could be put in the role of a mediator between the conservative Burton and the liberal Waxman. Morella's district includes FDA's Rockville offices. Morella plans to maintain her current committee seats; she also sits on the House Science Committee, where she chairs the subcommittee on technology.

Another key member of the Government Reform Committee, Regulatory Affairs Subcommittee Chairman McIntosh, is also an Indiana Republican and an FDA reform advocate. While the Republican Indiana delegation is developing into a potential force to question FDA actions in the 105th Congress, the recent publicity surrounding Lilly's use of homeless people in its Phase I research may undercut that potential. Direct efforts to reduce FDA regulatory authority may be discounted as a constituent favor.

House Government Reform/Human Resources Chairman Shays (R-Ct.) plans to continue his oversight of FDA and NIH in the 105th Congress. Shays' subcommittee has also been examining the effectiveness of HHS' orphan products board, which held its first meeting since 1994 on Nov. 21. A subcommittee report on Shays' supplemental approval process hearing is due out at the beginning of the session; the congressman has expressed particular concern over the effectiveness of the supplemental approval process for oncology drugs, orphan products and pediatric indications.

Waxman's likely successor as ranking Democrat on the Commerce/Health Subcommittee is moderate Rep. Hall (D-Tex.). Hall is a member of the conservative Democratic "Blue Dog" Coalition, where he chairs the task force on health care issues. He was also a co-sponsor of the House FDA reform bills.

Hall said Nov. 20 that he does not anticipate any challenge to his taking the ranking spot, claiming support from Commerce Committee Democrats, including Ranking Democrat Dingell (D-Mich.). While Hall would have to relinquish his current ranking member position on the Science/Space and Aeronautics Subcommittee, he said Nov. 20 that "I would lean towards Health." Hall explained that he could continue to work towards his primary goal with the space subpanel -- maintaining bioreactors in spacecraft -- through the health panel.

Hall's ascension assumes that the subcommittee structure will remain the same. Republicans indicated earlier this year that they will split the telecommunications and finance subcommittee to accommodate both Reps. Oxley (Ohio) and Tauzin (La.) as chairmen. "I presume they're going to keep" the health subpanel "as it is," Hall said.

By his own account, Hall is a "contrast 180 degrees" with Waxman, stating that "I'm trying to pull the Democrats to the middle, where they belong." He maintains that "Billy Tauzin and I killed" the Administration's health care reform package in Commerce in 1994.

Hall contends that if he becomes ranking minority member, it would indicate an enhancement of moderates' influence in the House. Noting the Nov. 20 election of conservative Democratic Rep. Spratt (S.C.) 106-83 over liberal Democrat Slaughter (N.Y.) as ranking member of the House Budget Committee, Hall said that "I don't think the Democrats want to knock us around too much."

Hall was one of the original co-sponsors of the FDA reform package proposed by the House Commerce Committee last session. His office indicates that he still hopes to negotiate an FDA reform measure that can be enacted. On other industry-related legislation, Hall opposed a proposed amendment to the FY 1997 HHS Appropriations bill that would have required any drug company using data from HHS or NIH research to enter into a reasonable pricing agreement. Hall is one of the most conservative Democrats in the House; his voting record for the past session indicates support for the Republican Contract with America, including product liability reform.

Among the new Democratic Commerce Committee members chosen during the Nov. 21 caucus is Rep. Karen McCarthy (D-Mo.). McCarthy, who is representing Kansas City, Mo. for a second term, was a government affairs consultant for Marion Merrell Dow between 1986 and 1994.

One of McCarthy's legislative priorities is a restructuring of Medicare; she plans to reintroduce legislation from last session establishing a bipartisan commission to preserve Medicare on the first day of the 105th Congress. McCarthy is a co-chair of the Democratic Caucus task force on health care.

The four other Democrats who will join the Commerce Committee next session are Reps. Ted Strickland (Ohio), Diana DeGette (Colo.), Albert Wynn (Md.) and Gene Green (Tex.). Strickland and DeGette are both newly-elected members. Strickland, a psychologist, represented the sixth district of Ohio from 1992 to 1994. DeGette, who replaces retiring Rep. Schroeder (D-Colo.), is a first-time freshman.

Maryland Democrat Wynn represents a predominantly African-American district that includes most of the Washington, D.C. suburbs of Prince George's County. Wynn, who was first elected in 1992, participated in congressional investigations of allegations of racial bias at the National Institutes of Health. Green has represented his Houston district since 1992.

On the House Appropriations Committee, six open Democratic slots enable the reappointment of Reps. Pastor (Ariz.), Meek (Fla.), Moran (Va.), DeLauro (Conn.) and Olver (Mass.), all of whom lost their spots on the committee after the GOP took over the majority in the House in 1994. Pastor and DeLauro previously sat on the Agriculture Subcommittee, which has jurisdiction over FDA appropriations. Also gaining a spot is Rep. Price (N.C.), a committee member until he lost his congressional seat in 1994. If Democrats are given another seat on the committee, it will be filled by Rep. Edwards (Tex.).