FDA REFORM BILL FOCUSING ON THIRD PARTY REVIEW PLANNED BY HOUSE "BLUE DOGS"; OVERSIGHT SUBCMTE. HEARING ON COMMISSIONER's OFFICE PLANNED FOR FEBRUARY

An FDA reform proposal under development by the House Democratic "Blue Dog" coalition is understood to be focusing on third-party reviews.The coalition bill likely would avoid controversial elements such as permitting off-label information dissemination and imposing "hammers" if the agency failed to meet performance goals.

An options paper for a bill is being readied for Blue Dog members as part of the process of developing a legislative agenda and budget. While specific initiatives such as medical device user fees could be included in a budget plan, the overall proposal appears as yet largely conceptual.

The Blue Dogs hope to refine existing Republican FDA reform proposals. The group has met with most of the major industry players and plans to meet with FDA soon, at the agency's request.

Rep. Condit (D-Calif.) is leading the centrist coalition's effort towards a single pharmaceuticals/ devices/food bill. Besides Condit, key health voices within the 20-odd member Coalition are Reps. Stenholm (Tex.), Tanner (Tenn.), Hall (Tex.), and John (La.). Hall could be pivotal in the effort. He is in line to become the ranking Democrat on the House Commerce/Health & Environment Subcommittee, succeeding Rep. Waxman (D-Calif.). However, Hall is said to be considering the ranking position on the Commerce/Energy subcommittee.

If Hall moves to the energy panel, Rep. Pallone (D-N.J.) could become the ranking member on the Health Subcommittee. Pallone is not currently on the Commerce Committee, but is expected to return to fill the seat vacated by Rep. Richardson (D-N.M.), President Clinton's choice as ambassador to the United Nations. While not a member of the Blue Dog coalition, Pallone is likely to be sympathetic to FDA reform efforts on behalf of his home state pharmaceutical industry constituents. Virginia Democrat Boucher is also a possible contender for the position. The Democrats plan to fill the ranking minority slot Jan. 21.

Rep. Burr (R-N.C.), who sponsored drugs and biologics FDA reform legislation in 1996, indicated at a Jan. 16 Health Care Marketing Council meeting in New York City that he hopes to see a bill in the Commerce Committee by the end of the first quarter of 1997. He suggested that the bill will pick up from the points of agreement between the committee and HHS last summer.

As of mid-July, the House FDA reform bill (HR 3199) permitted FDA to request outside review of all or part of an NDA with permission of a sponsor, and said the agency could pay outsider reviewers with user fee funds. Generic drug applications could also be reviewed by third parties under the bill ("The Pink Sheet" July 15, 1996, p. 11).

The Commerce/Oversight Subcommittee is mentioning the possibility of a hearing on the operation of the FDA commissioner's office on Feb. 27.

On the Senate side, Sen. Jeffords (R-Vt.) has tapped former Health Industry Manufacturers Association Director of Government Affairs James Hawkins to work on FDA issues at the Senate Labor and Human Resources Committee beginning Jan. 27. Hawkins' predecessor, Jane Williams, also came from HIMA. During the 1980's Hawkins served two Democratic congressmen as a legislative assistant assigned to the Commerce Committee for Rep. Bates (D-Calif.), and later served as a legislative director responsible for FDA, Medicare and Medicaid for Rep. Bruce (D-Ill.).

FDA reform may not be an early priority of the Labor Committee. Jeffords has indicated that he favors delaying action on reform until a new commissioner is in place.