SAFETY AND EFFECTIVENESS DATA.

SEC. 104. SAFETY AND EFFECTIVENESS DATA. Section 512 (as amended by section 101(b) of this title) is amended by adding at the end the following: “(p)(1) Safety and effectiveness data and information which has been submitted in an application filed under subsection (b)(1) for a drug and which has not previously been disclosed to the public shall be made available to the public, upon request, unless extraordinary circumstances are shown— “(A) if no work is being or will be undertaken to have the application approved, “(B) if the Secretary has determined that the application is not approvable and all legal appeals have been exhausted, “(C) if approval of the application under subsection (c) is withdrawn and all legal appeals have been exhausted, “(D) if the Secretary has determined that such drug is not a new drug, or “(E) upon the effective date of the approval of the first application filed under subsection (b)(2) which refers to such drug or upon the date upon which the approval of an application filed under subsection (b)(2) which refers to such drug could be made effective if such an application had been filed. “(2) Any request for data and information pursuant to paragraph (1) shall include a verified statement by the person making the 102 STAT. 3983request that any data or information received under such paragraph shall not be disclosed by such person to any other person— “(A) for the purpose of, or as part of a plan, scheme, or device for, obtaining the right to make, use, or market, or making, using, or marketing, outside the United States, the drug identified in the application filed under subsection (b)(1), and “(B) without obtaining from any person to whom the data and information are disclosed an identical verified statement, a copy of which is to be provided by such person to the Secretary, which meets the requirements of this paragraph.”.