I 112th CONGRESS 1st Session H. R. 3206 IN THE HOUSE OF REPRESENTATIVES October 14, 2011 Mr. Burgess (for himself, Mr. Cassidy, Mr. Bilbray, Mr. Gingrey of Georgia, Mr. Paulsen, Mr. Guthrie, Mrs. Blackburn, Mr. Shimkus, and Mr. Latta) introduced the following bill; which was referred to the Committee on Energy and Commerce A BILL To amend the Federal Food, Drug, and Cosmetic Act with respect to appointments to advisory committees and conflicts of interest.

1.

Short title

This Act may be cited as the Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011.

2.

Conflicts of interest

(a)

Evaluation of individual appointments to advisory committees

Paragraph (2) of section 712(b) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–1(b)) is amended to read as follows: (2)

Evaluation and criteria

(A)

Purposes

The purposes of this paragraph are— (i)to ensure that the Secretary has access to the most current expert advice; and (ii)to promote scientific exchange and the use of sound science to guide Food and Drug Administration evaluations and decisionmaking. (B)

In general

The Secretary shall ensure that individual appointments to advisory committees are made to promote scientific and technical expertise while at the same time minimizing any potential conflicts of interest. (C)

Considerations

In making each such appointment, the Secretary shall consider, with respect to any financial interest constituting a potential conflict of interest— (i)the type of the financial interest; (ii)the nature of the financial interest; and (iii)the magnitude, expressed as a range, of the financial interest. (D)

No one factor dispositive

No one factor specified in clause (i), (ii), or (iii) of subparagraph (C) shall be dispositive in the Secretary’s evaluation of a particular financial interest. . (b)

Elimination of limitation on certain waivers and exceptions

Section 712(c)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 379d–1(c)(2)) is amended by striking subparagraph (C).