S.Amdt. 2858

SA 2858. Mr. SANDERS submitted an amendment intended to be proposed
to amendment SA 2786 proposed by Mr. Reid (for Mr. Baucus. Mr. Dodd,
and Mr. Harkin) to the bill H.R. 3590, to amend the Internal Revenue
Code of 1986 to modify the first-time homebuyers credit in the case of
members of the Armed Forces and certain other Federal employees, and
for other purposes; which was ordered to lie on the table; as follows:

On page 1925, between lines 14 and 15, insert the
following:

Subtitle C--Ethical Pathway for Pharmaceutical Products

SEC. 7201. ETHICAL PATHWAY FOR THE APPROVAL AND LICENSURE OF
GENERIC PHARMACEUTICAL PRODUCTS.

(a) Definitions.--In this section--
(1) the term ``abbreviated new drug application'' means an
abbreviated application for a new drug submitted under
section 505(j) of the Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 355(j);
(2) the term ``Commissioner'' means the Commissioner of
Food and Drugs; and
(3) the term ``Secretary'' means the Secretary of Health
and Human Services.
(b) Ethical Pathway.--As soon as practicable after the date
of enactment of this Act, the Secretary, acting through the
Commissioner, shall establish a mechanism by which the filer
of an abbreviated new drug application for approval of a drug
or an application for licensure of a biological product under
section 351(k) of the Public Health Service Act may request a
cost-sharing arrangement described in subsection (c). Such a
filer may request such an arrangement if, but for the
arrangement, such filer would be required to conduct clinical
investigations involving human subjects that violate Article
20 of the Declaration of Helsinki on Ethical Principles for
Medical Research Involving Human Subjects in order to obtain
such approval or licensure from the Secretary.
(c) Cost-Sharing Arrangement.--The cost-sharing arrangement
described in this subsection is an arrangement in which--
(1) the filer of the abbreviated new drug application or
the application under section 351(k) of the Public Health
Service Act pays a fee to the Commissioner;
(2) notwithstanding any other provision of law, the
Commissioner provides such reports to such filer;
(3) such filer may, notwithstanding any provision of
chapter V of the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 351 et seq.) or of the Public Health Service Act (42
U.S.C. 301 et seq.), rely in such application on reports of
investigations, conducted by a holder of an approved
application under section 505(b) of the Federal Food, Drug,
and Cosmetic Act or a holder of a license under section
351(a) of the Public Health Service Act, which have been made
to show whether or not such drug or biological product is
safe for use and whether such drug or biological product is
effective in use; and
(4) the Commissioner remits the amount of such fee to the
holder of the approved application under such section 505(b)
or of the license under such section 351(a), as appropriate.
______