II 110th CONGRESS 2d Session S. 3151 IN THE SENATE OF THE UNITED STATES June 18, 2008 Mr. Brown (for himself and Mr. Brownback) introduced the following bill; which was read twice and referred to the Committee on Health, Education, Labor, and Pensions A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to priority review vouchers.

1.

Amendments regarding priority review vouchers

Section 524(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360n(b)) is amended— (1)by amending paragraph (2) to read as follows: (2)

Transferability

Priority review vouchers shall be transferrable (including by sale). Entities eligible to participate in such transfers include sponsors of a human drug application under section 505(b)(1) or section 351 of the Public Health Service Act. ; and (2)in paragraph (3), by adding at the end the following: (C)

No effect on pending review

A priority review voucher may not be redeemed to affect the review of a pending human drug application under section 505(b)(1) or section 351 of the Public Health Service Act. .