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ORPHAN DRUG AMENDMENT PASSES HOUSE COMMERCE/HEALTH SUBCOMMITTEE

Executive Summary

ORPHAN DRUG AMENDMENT PASSES HOUSE COMMERCE/HEALTH SUBCOMMITTEE by a voice vote at an Oct. 6 markup. The bill is expected to be considered by the Energy & Commerce Committee on Oct. 13, which puts it on track for consideration by the full House during this session of Congress. House Speaker Wright (D-Texas) has set an Oct. 15 deadline for 1987 legislation to be ready for a vote on the House floor. At the Oct. 6 markup, the subcommittee adopted a technical amendment by Chairman Waxman (D-Calif.), which stipulates that no more than one seven-year period of exclusivity may be granted for any orphan drug. In other words, if a second developer of an orphan drug receives full NDA approval during the exclusivity period granted to the first developer, all exclusivity for marketing the drug ends seven years after the approval date of the first NDA. The amendment was offered at the request of FDA. The subcommittee also rejected an amendment by Rep. Dannemeyer (R-Calif.) to freeze orphan product research grants at $4 mil. per year. The Waxman bill would increase such grants from $4 mil. in 1987 to $10 mil. in 1988, $12 mil. in 1989, and $14 mil. in 1990. Waxman introduced his orphan drug amendments (HR 3349) on Sept. 29, and reviewed the bill at an Oct. 1 Health Commerce/Health Subcommittee hearing ("The Pink Sheet" Oct. 5, p. 3). The legislation would limit exclusivity under the Orphan Drug Act to prevent competition from ANDA and paper NDA approvals only. Sponsors willing to duplicate studies conducted by the original sponsor and file a full NDA could no longer be excluded from the market.
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